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QT Imaging Announces First Quarter 2024 Financial Results

Generated Scanner Sales Revenue of $1.4M with 56% Gross Margin in the First Quarter of 2024, Since the Company Became Public on March 4th

Streamlined Business Model via Strategic Sales and Distribution Partnership in USA

Reported in Academic Radiology the Results of a Second Blinded Screening Trial That Found That QTI Technology Is Similarly Effective as Digital Breast Tomosynthesis (DBT) or 3D Mammography

Company Completed Merger with GigCapital5

NOVATO, Calif.–(BUSINESS WIRE)–QT Imaging Holdings, Inc. (NASDAQ: QTI) (“QT Imaging” or the “Company”), a medical device company engaged in research, development, and commercialization of innovative body imaging systems, today announced financial results for the first quarter of 2024.
QT Imaging delivers today the QT Imaging Breast Acoustic CT™ Scanner, the only true 3D imaging device, FDA cleared for use as a transmission and reflection low frequency soundwaves imaging system for a patient’s breast. There is no ionizing radiation or compression associated with mammography, or the contrast dyes injections required for breast MRI.

“The QT Imaging team has been on an incredible journey since its inception in 2012, starting with a shared mission to create disruptive innovation to expand access to medical imaging while ensuring superior patient experience and improving health outcomes. Moving forward, the team will address commercialization of our scanner in the U.S. via partnership with our strategic sales and distribution partner. We are proud to announce the scanner shipments made in the first quarter, since the merger with GigCapital5 on March 4th, as well as our on-going feasibility study to solidify the partnership for large scale manufacturing,” QT Imaging CEO Dr. Raluca Dinu said.

“We are thankful to our partners in the National Institutes of Health/National Cancer Institute who continue to support the research and development of QT Imaging technology today and since the Company’s inception. We will continue to carry on clinical studies with partners in academia and medical institutions and publish comparative data to show the advantages of QT Imaging’s breast scanning technology that gives women the choice they deserve to ensure their breast health over time.”

Financial Highlights

  • Commercial revenue was $1.4 million for the first quarter of 2024, compared to less than $0.1 million for the first quarter of 2023.
  • Gross margin of 56% in the first quarter of 2024, compared to negative margin in the first quarter of 2023. The increase in margin was due to the sale and delivery of three QT Breast Scanners during the first quarter of 2024, compared to no deliveries in the first quarter of 2023.
  • Net loss of $4.3 million for the first quarter of 2024, which includes $1.9 million of net non-cash income related to the change in fair value of warrants, derivatives, and contingent consideration that were recorded as part of the closing of the business combination with GigCapital5, Inc. on March 4, 2024 and outstanding as of March 31, 2024, less than $0.1 million of equity-based compensation expense, and $4.3 million of one-time business combination transaction expenses, compared to a net loss of $1.9 million for the first quarter of 2023 which included equity-based compensation expense of $0.2 million and one-time transaction expenses of $0.4 million.
  • Non-GAAP Adjusted EBITDA* of $(1.2) million for the first quarter of 2024 compared to $(1.1) million for the first quarter of 2023.

New Developments

  • On February 6, 2024, the Company delivered a QT Breast Scanner under a unique collaboration with the Department of Radiation Oncology, and Radiation Treatment Program at the Sunnybrook Health Sciences Centre in Toronto, Canada, one of the largest cancer centers in Canada, and The University of Illinois, Urbana-Champaign, Department of Electrical and Computer Engineering and Grainger College of Engineering. This collaboration is part of a five-year research grant from the National Institutes of Health/National Cancer Institute to develop an inexpensive, portable, safe, and repeatable imaging approach capable of accurate and early identification of response of breast cancer patients to neoadjuvant chemotherapy (NAC).
  • On March 4, 2024, the Company completed the business combination of QT Imaging, Inc. and GigCapital5, Inc. in accordance with the Business Combination Agreement dated December 8, 2022, as amended.
  • On March 7, 2024, the Company announced its first commercial sale of a QT Breast Scanner to True Health Center for Functional Medicine through its strategic sales and distribution partner, as disclosed in the Company’s Form 8-K (Link), as the Company continue to focus our commercialization effort in the U.S.
  • On March 18, 2024, the Company delivered two QT Breast Scanners to its strategic partner, as disclosed in the Company’s Form 8-K (Link), in accordance with the terms of a non-binding letter of intent pursuant to which four binding purchase orders were received in earlier for the purchase of two QT Breast Scanners, with 50% of the payment for the QT Breast Scanners having taken place at the date of placement of purchase orders and the remaining balance was received within 30 days of shipment in April 2024.
  • On March 28, 2024, the Company entered into a Feasibility Study Agreement (the “Feasibility Study Agreement”) with its strategic partner, as disclosed in the Company’s Form 8-K (Link). The term of the Feasibility Study Agreement commenced on March 28, 2024 and will remain in force until the end of December 2024 or until the execution of a definitive agreement that supersedes the Feasibility Study Agreement, whichever comes earlier. In connection with the Feasibility Study Agreement, a strategic partner will initiate studies to evaluate the business, technical, and clinical values of the QT Breast Scanner including product quality validation, development and manufacturing studies, clinical evaluation, regulatory investigation, and market validation.
  • As announced on April 17, 2024 in our press release, a study in Academic Radiology, online, in January 2024: “A Multireader Multicase (MRMC) Receiver Operating Characteristic (ROC) Study Evaluating Noninferiority of Quantitative Transmission (QT) Ultrasound to Digital Breast Tomosynthesis (DBT) on Detection and Recall of Breast Lesions – Academic Radiology” found that QT Imaging technology is similarly effective as digital breast tomosynthesis (DBT), also known as 3D mammography, in that the area under receiver operating characteristic curve (AUC) was statistically non-inferior for QT Imaging scan compared with DBT for the AUC difference margin of -0.05.
  • Leadership Updates:
    • On March 12, 2024, the Board of Directors (the “Board”) appointed Dr. Raluca Dinu, who is also a member of the Board, to be employed as the Company’s Acting Chief Executive Officer. Dr. Dinu spent approximately 25 years in international executive positions within the Technology, Media, and Telecommunications industries working for privately held start-ups, middle-cap companies, and large enterprises. In these roles, Dr. Dinu has been instrumental in launching and accelerating entities, building teams, large-scale fund raising, developing key alliances and technology partnerships, M&A activities, business development, financial management, global operations and sales and marketing.
    • Anastas (Stas) Budagov has served as the Chief Financial Officer of QT Imaging, Inc. since December 2023. On March 12, 2024, the Board ratified the prior appointment of Mr. Budagov as the Company’s Chief Financial Officer of QT Imaging Holdings, Inc. following the merger with GigCapital5. Mr. Budagov will report to the Chief Executive Officer. Mr. Budagov brings over 10 years of finance and accounting leadership experience in medical device, life science, and biotech industries.
    • The Company continued to attract top talent following the onboarding of Steve Choate as the Company’s new Chief Operating Officer on April 8, 2024. Mr. Choate’s extensive experience and expertise as a production operations leader will be key to fueling the Company’s continued growth. Mr. Choate’s will be focused on overseeing manufacturing activities, product development, and production releases.
    • Following Dr. John Klock’s resignation from his previous position as the Company’s Chief Executive Officer, on April 5, 2024, the Company entered into a Services Agreement (the “Services Agreement”) with QT Imaging Center, which is owned and operated by Dr. Klock. Effective April 1, 2024, QT Imaging Center agreed to provide its services to the Company, including but not limited to providing healthcare services to patients, assisting with clinical trials and studies and assisting with drafting of institutional review board approved clinical protocols, assisting with the performance of research and development activities on behalf of the Company, providing comprehensive multi-day training on the operation of breast imaging technology for radiologist customers and other customer staff such as technicians, performing clinical validation of imaging software changes which may include recruiting patients, training, as well as other services as specified in the Services Agreement.

Outlook for the Balance of 2024

2024 is a transitional year as the Company stabilizes the business and focuses on commercialization anchored in strategic business partnerships. The Company will target to provide guidance for the rest of the year as part of the release of Q2’24 earnings.

Summary of Results for the Three Months Ended
March 31, 2024 and 2023
(Unaudited)

Three Months Ended
March 31,

$ thousands (expect per share amounts)

2024

2023

Revenues

$

1,362

$

8

Cost of revenues

602

47

Gross margin

760

(39

)

Operating expenses:

Selling, general and administrative

5,696

1,292

Research and development

643

422

Operating loss

(5,579

)

(1,753

)

Interest expense

(599

)

(130

)

Other expense

(21

)

Net increase in fair value of warrant liability

(23

)

Net decrease in fair value of derivatives

2,983

Net increase in earnout liability

(1,060

)

Net loss

(4,299

)

(1,883

)

Basic and diluted net loss per share

$

(0.33

)

$

(0.20

)

Weighted average shares outstanding

13,226

9,517

EBITDA* and Adjusted EBITDA* for the Three Months Ended
March 31, 2024 and 2023
(Unaudited)

Three Months Ended
March 31,

$ thousands

2024

2023

Net loss

$

(4,299

)

$

(1,883

)

Interest expense

599

130

Depreciation and amortization

99

117

EBITDA

(3,601

)

(1,636

)

Adjustments:

Equity-based compensation

39

209

Net increase (decrease) in fair value of warrants(1)

23

Net increase (decrease) in fair value of derivatives(2)

(2,983

)

Net increase (decrease) in fair value of earnout liability(3)

1,060

Transaction expenses(4)

4,301

356

Adjusted EBITDA

$

(1,161

)

$

(1,071

)

  1. The increase in fair value of warrants during the three months ended March 31, 2024 relates to the liability classified private placement warrants to reflect the increase of publicly traded price per warrant from $0.01 as of March 4, 2024 to $0.036 as of March 31, 2024. The additional expense related to increase in the price per share of warrants was recorded as other expense in the condensed consolidated statement of operations during the three months ended March 31, 2024.
  2. The decrease in fair value of derivatives during the three months ended March 31, 2024 related to the Yorkville Pre-paid Advance, which contained features that were bifurcated as a freestanding financial instruments and initially valued on March 4, 2024 upon consummation of the Merger. The derivative liability was subsequently revalued as of March 31, 2024 for financial reporting purposes. The favorable change in derivative liability was recorded as other income in the condensed consolidated statement of operations during the three months ended March 31, 2024.
  3. Earnout liability relates to the contingent consideration for the Merger Earnout Consideration Shares pursuant to the Business Combination Agreement dated December 8, 2022, as amended in September of 2023. The earnout liability was initially valued using the Monte Carlo Simulation method on March 4, 2024 and subsequently revalued using the same method as of March 31, 2024. The net increase in fair value of the earnout liability was recognized as other expense in the condensed consolidated statement of operations during the three months ended March 31, 2024.
  4. The Company incurred transaction expenses related to the Merger with GigCapital5, Inc,, which closed on March 4, 2024. These transaction expenses included a $3.7 million of transaction costs that were settled with issuance of common stock, $0.4 million of transaction costs settled or payable in cash and a $0.2 million loss on issuance of common stock in connection with a subscription agreement, which were recorded as selling, general and administrative expenses in the condensed consolidated statement of operations during the three months ended March 31, 2024.

Consolidated Balance Sheets as of
March 31, 2024 and December 31, 2023
(Unaudited)

$ in thousands

March 31,
2024

December 31,
2023

Assets

Current assets:

Cash and cash equivalents

$

5,620

$

165

Restricted cash

20

20

Accounts receivable, net

482

1

Inventory

4,116

4,418

Prepaid expenses and other current assets

1,195

215

Total current assets

11,433

4,819

Non-current assets:

Property and equipment, net

154

491

Intangible assets, net

44

90

Right-of-use assets

1,187

1,267

Other non-current assets

39

39

Total assets

$

12,857

$

6,706

Liabilities and stockholders deficit

Current liabilities:

Accounts payable

$

712

$

1,356

Accrued expenses and other current liabilities

2,813

370

Related party notes payable

705

Current maturities of long-term debt

130

4,199

Deferred revenue

344

347

Operating lease liabilities, current

372

361

Total current liabilities

4,371

7,338

Non-current liabilities:

Long-term debt, net

3,331

96

Related party notes payable, long term

5,409

3,144

Operating lease liabilities

966

1,063

Warrant liability

32

Derivative liability

2,138

Earnout liability

1,060

Other non-current liabilities

465

377

Total liabilities

17,772

12,018

Stockholders’ deficit:

Common stock

2

1

Additional paid-in capital

17,152

12,457

Accumulated deficit

(22,069

)

(17,770

)

Total stockholders’ deficit

(4,915

)

(5,312

)

Total liabilities and stockholders’ deficit

$

12,857

$

6,706

Consolidated Statements of Cash Flows for the Three Months Ended
March 31, 2024 and 2023
(Unaudited)

Three Months Ended March 31,

$ in thousands

2024

2023

Cash flows from operating activities:

Net loss

$

(4,299

)

$

(1,883

)

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization expense

99

117

Stock-based compensation to employees

39

209

Provision for credit losses

1

Fair value of common stock issued in exchange for services and in connection with non-redemption agreements

3,715

Loss on issuance of common stock in connection with a subscription agreement

206

Non-cash interest

299

11

Non-cash lease expense

(5

)

(2

)

Increase in fair value of warrant liability

23

Decrease in fair value of derivative liability

(2,983

)

Increase in fair value of earnout liability

1,060

Changes in assets and liabilities:

Increase in accounts receivable

(482

)

(6

)

Decrease in inventory

586

49

Increase in prepaid expenses and other current assets

(880

)

(35

)

Decrease in other assets

5

(Decrease) increase in accounts payable

(2,118

)

392

(Decrease) increase in accrued liabilities

(1,320

)

31

Decrease in deferred revenue

(4

)

Increase in other liabilities

87

119

Net cash used in operating activities

(5,976

)

(993

)

Cash flows from financing activities:

Proceeds of sale of common stock and warrants, net of issuance costs

948

Proceeds from issuance of common stock pursuant to a subscription agreement

500

Proceeds from long-term debt, net of issuance costs

10,525

Repayment of long-term debt

(32

)

(32

)

Repayment of bridge loans

(800

)

Proceeds from the Merger, net of transaction costs

1,238

Net cash provided by financing activities

11,431

916

Net increase (decrease) in cash and restricted cash and cash equivalents

5,455

(77

)

Cash and restricted cash and cash equivalents at the beginning of period

185

475

Cash and restricted cash and cash equivalents at the end of the period

$

5,640

$

398

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act of 1934, as amended. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the QT Imaging Breast Acoustic CT™ Scanner, including its commercialization, manufacturing and further development, plans for QT Imaging, new product development and introduction, product sales growth and projected revenues, QT Imaging’s industry, future events, and other statements that are not historical facts. Forward-looking statements involve certain risks and uncertainties, and actual results may differ materially from those discussed in any such statement. These statements are based on various assumptions, whether or not identified herein, and on the current expectations of QT Imaging’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by you or any other investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control. These forward-looking statements are subject to a number of risks and uncertainties, including those relating to: the ability of the Company to sell and deploy the QT Imaging Breast Acoustic CT™ Scanner; the ability to extend product offerings into new areas or products; the ability to commercialize technology; unexpected occurrences that deter the full documentation and “bring to market” plan for products; trends and fluctuations in the industry; changes in demand and purchasing volume of customers; unpredictability of suppliers; the ability to attract and retain qualified personnel and the ability to move product sales to production levels; changes in domestic and foreign business, market, financial, political, and legal conditions; the uncertainty of projected financial information; delays caused by factors outside of our control; changes in our ability to successfully receive purchase orders and generate revenue under our existing contracts with partners and distributors; our ability to realize the benefits of the strategic partnerships; the identified material weakness in our internal controls over financial reporting (including the timeline to remediate the material weakness); the rollout of the business and the timing of expected business milestones; the effects of competition on our future business; our ability to obtain and access financing in the future; and those factors discussed in the Company’s reports and other documents filed with the SEC, including under the heading “Risk Factors.” If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that QT Imaging presently does not know or that QT Imaging currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect QT Imaging’s expectations, plans or forecasts of future events and views as of the date of this release. QT Imaging anticipates that subsequent events and developments will cause QT Imaging’s assessments to change. However, while QT Imaging may elect to update these forward-looking statements at some point in the future, QT Imaging specifically disclaims any obligation to do so. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Non-GAAP Financial Measures

The financial information and data contained in this press release is unaudited. Some of the financial information and data contained in this press release, such as EBITDA and Adjusted EBITDA, have not been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). To supplement our unaudited condensed consolidated financial statements, which are prepared and presented in accordance with GAAP in our press release, we also report certain non-GAAP financial measures. A “non-GAAP financial measure” refers to a numerical measure of a company’s historical or future financial performance, financial position, or cash flows that excludes (or includes) amounts that are included in (or excluded from) the most directly comparable measure calculated and presented in accordance with GAAP in such company’s financial statements. Non-GAAP financial measures should not be considered in isolation or as a substitute for the relevant GAAP measures and should be read in conjunction with information presented on a GAAP basis. Because not all companies use identical calculations, our presentation of non-GAAP measures may not be comparable to other similarly titled measures of other companies.

The presentation of these financial measures is not intended to be considered in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with GAAP and should not be considered measures of QT Imaging’s liquidity. Investors are cautioned that there are material limitations associated with the use of non-GAAP financial measures as an analytical tool. In particular, many of the adjustments to our GAAP financial measures reflect the exclusion of certain items, as defined in our non-GAAP definitions below, which are recurring and will be reflected in our financial results for the foreseeable future. In addition, these measures may be different from non-GAAP financial measures used by other companies, even where similarly titled, limiting their usefulness for comparison purposes and therefore should not be used to compare QT Imaging’s performance to that of other companies. We endeavor to compensate for the limitation of the non-GAAP financial measures presented by also providing the most directly comparable GAAP measures and descriptions of the reconciling items and adjustments to derive the non-GAAP financial measures.

We believe these non-GAAP financial measures provide investors and analysts with useful supplemental information about the financial performance of our business, enable comparison of financial results between periods where certain items may vary independent of business performance, and allow for greater transparency with respect to key measures used by management to operate and analyze our business over different periods of time.

EBITDA is defined as loss before interest expense, income tax expense, depreciation and amortization. Adjusted EBITDA is defined as EBITDA further adjusted for equity-based compensation, net increase (decrease) in fair value of derivative, earnout and warrant liabilities, capital market advisory fees, and transaction expenses. Similar excluded expenses may be incurred in future periods when calculating these measures. QT Imaging believes these non-GAAP measures of financial results provide useful information to management and investors regarding certain financial and business trends relating to the Company’s financial condition and results of operations. QT Imaging believes that the use of these non-GAAP financial measures provides an additional tool for investors to use in evaluating projected operating results and trends and in comparing QT Imaging’s financial measures with other similar companies, many of which present similar non-GAAP financial measures to investors.

Management does not consider these non-GAAP measures in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of these non-GAAP financial measures is that they exclude significant expenses and income that are required by GAAP to be recorded in the Company’s financial statements. In addition, they are subject to inherent limitations as they reflect the exercise of judgment by management about which expense and income items are excluded or included in determining these non-GAAP financial measures.

Management uses EBITDA and Adjusted EBITDA as a non-GAAP performance measure which is defined in the accompanying tables and is reconciled to net loss, the most directly comparable GAAP measure, in the tables above. The Company does not reconcile forward-looking non-GAAP financial measures to the most directly comparable GAAP financial measure (or otherwise describe such forward-looking GAAP measure) because it is not able to forecast the most directly comparable measure calculated and presented in accordance with GAAP without unreasonable effort. Certain elements of the composition of the GAAP amounts are not predictable, making it impracticable for the Company to forecast. As a result, no guidance for the Company’s net (loss) income or reconciliation of the Company’s Adjusted EBITDA guidance is provided. For the same reasons, the Company is unable to assess the probable significance of the unavailable information, which could have a potentially significant impact on its future net (loss) income.

We present reconciliations of these non-GAAP financial measures to the most directly comparable GAAP measures in the tables above.

About QT Imaging

QT Imaging Holdings, Inc. is a public (NASDAQ: QTI) medical device company engaged in research, development, and commercialization of innovative body imaging systems using low frequency sound waves. QT Imaging Holdings, Inc. strives to improve global health outcomes. Its strategy is predicated upon the fact that medical imaging is critical to the detection, diagnosis, and treatment of disease and that it should be safe, affordable, accessible, and centered on the patient’s experience. For more information on QT Imaging Holdings, Inc., please visit the company’s website at www.qtimaging.com.

Contacts

For media inquiries, please contact:

Stas Budagov
Chief Financial Officer
Stas.Budagov@qtimaging.com

QT Imaging Holdings Announces Partnership with Premier Cancer Center, The Vincere Cancer Center in Scottsdale, AZ

NOVATO, Calif.–(BUSINESS WIRE)–QT Imaging Holdings, Inc. (NASDAQ:QTI) (“QT Imaging”) a medical device company engaged in research, development, and commercialization of innovative body imaging systems, together with its strategic business and distribution partner, is proud to announce its partnership with The Vincere Cancer Center in Scottsdale, AZ.

“In recent years, there has been an increased rate of breast cancer incidents, especially amongst women younger than 40, the recommended age of initial mammogram screening”

The Vincere Cancer Center is a top cancer center in the U.S. Founded by Dr. Vershalee Shukla and Dr. Pablo Prichard, the Center focuses on cancer prevention, early detection, and specializes in radiation therapy, surgery, and chemotherapy. Using innovative precision technology, the Center is renowned for its comprehensive cancer services. Dr. Prichard and Dr. Shukla, a board-certified reconstructive surgeon and radiation oncologist, built their practice to deliver superior cancer care to a variety of patients. They employ innovative technology to mitigate against over-diagnoses while ensuring cancer is not missed. Dr. Shukla, a long-standing supporter of QT Imaging and its technology, applies the QT Imaging Breast Acoustic CT™ Scanner in their breast screening environment.

“In recent years, there has been an increased rate of breast cancer incidents, especially amongst women younger than 40, the recommended age of initial mammogram screening,” said Dr. Shukla, Director of The Vincere Cancer Center. “Despite this, there has been very little technological advancement in detection of breast cancer that is suitable and accessible to all women. By harnessing the power of the QT Imaging Breast Acoustic CT™ Scanner and eliminating the discomfort associated with traditional methods, our partnership with QT Imaging is redefining standards of care and empowering patients with precision and safety.”

“The QT Imaging team’s mission is to expand access to medical imaging while ensuring superior patient experience, lowering costs for providers, and improving health outcomes,” said Dr. Raluca Dinu, Chief Executive Officer. “We are incredibly excited about the opportunity to work with such a prestigious cancer center and to be able to provide women a choice in their care that is safe and doesn’t jeopardize accuracy or accessibility. The partnership with Vincere Cancer Center represents the continuation of our swift commercialization plan since the company went public two months ago.”

About QT Holding, Inc.

QT Imaging Holdings, Inc. is a public (NASDAQ: QTI) medical device company engaged in research, development, and commercialization of innovative body imaging systems using low frequency sound waves. QT Imaging strives to improve global health outcomes. Its strategy is predicated upon the fact that medical imaging is critical to the detection, diagnosis, and treatment of disease and that it should be safe, affordable, accessible, and centered on the patient’s experience. For more information on QT Imaging, please visit the company’s website at www.qtimaging.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as “will,” and “expect,” or the negative thereof or comparable terminology, and include (without limitation) statements regarding the partnership between QT Imaging and The Vincere Cancer Center, the QT Imaging Breast Acoustic CTTM Scanner, plans for QT Imaging, new product development and introduction, and product sales growth and projected revenues. Forward-looking statements involve certain risks and uncertainties, and actual results may differ materially from those discussed in any such statement. These risks include, but are not limited to: the ability of the parties to sell and deploy the QT Imaging Breast Acoustic CTTM Scanner, the ability to extend product offerings into new areas or products, the ability to commercialize technology, unexpected occurrences that deter the full documentation and “bring to market” plan for products, trends and fluctuations in the industry, changes in demand and purchasing volume of customers, unpredictability of suppliers, the ability to attract and retain qualified personnel and the ability to move product sales to production levels. Additional factors that could cause actual results to differ are discussed under the heading “Risk Factors” and in other sections of QT Imaging’s (and its predecessor, GigCapital5, Inc.) filings with the SEC, and in its other current and periodic reports filed or furnished from time to time with the SEC. All forward-looking statements in this press release are made as of the date hereof, based on information available to QT Imaging as of the date hereof, and QT Imaging assumes no obligation to update any forward-looking statement.

Contacts

For media inquiries:
Susan Schaffler
Head of Communications
Susan.Schaffler@qtimaging.com

Stas Budagov
Chief Financial Officer
Stas.Budagov@qtimaging.com

QT Imaging Holdings (Nasdaq: QTI) to Ring The Nasdaq Stock Market Opening Bell

NOVATO, Calif.–(BUSINESS WIRE)–QT Imaging Holdings, Inc. (NASDAQ:QTI), a medical device company engaged in research, development, and commercialization of innovative body imaging systems, is proud to announce the Opening Bell Ceremony at the Nasdaq MarketSite in Times Square.

In honor of the occasion, Dr. Raluca Dinu, Chief Executive Officer, will ring the Opening Bell.

Where:
Nasdaq MarketSite – 4 Times Square – 43rd & Broadway – Broadcast Studio

When:
Tuesday, April 23rd, 2024 – 9:15 a.m. to 9:30 a.m. ET

Feed Information:
Fiber Line (Encompass Waterfront): 4463

Galaxy 16 C Intelsat
Txp: 15C
DL: 4009.00 H Bandwidth : 18.00
FEC : 3/4
DR: 18.295441
SR : 13.235
Roll Of : MPEG : MPEG-2 Modulaton
DVB-S Modulaton Std : Pilot On :

Webcast:

A live stream of the Nasdaq Opening Bell will be available at: https://www.nasdaq.com/marketsite/bell-ringing-ceremony

About Company:

QT Imaging Holdings, Inc. is a public (NASDAQ: QTI) medical device company engaged in research, development, and commercialization of innovative body imaging systems using low frequency sound waves. QT Imaging Holdings, Inc. strives to improve global health outcomes. Its strategy is predicated upon the fact that medical imaging is critical to the detection, diagnosis, and treatment of disease and that it should be safe, affordable, accessible, and centered on the patient’s experience. For more information on QT Imaging Holdings, Inc., please visit the company’s website at www.qtimaging.com or on LinkedIn.

About Nasdaq:

Nasdaq (Nasdaq: NDAQ) is a leading global technology company serving corporate clients, investment managers, banks, brokers, and exchange operators as they navigate and interact with the global capital markets and the broader financial system. We aspire to deliver world-leading platforms that improve the liquidity, transparency, and integrity of the global economy. Our diverse offering of data, analytics, software, exchange capabilities, and client-centric services enables clients to optimize and execute their business vision with confidence. To learn more about the company, technology solutions, and career opportunities, visit us on LinkedIn, on X @Nasdaq, or at www.nasdaq.com.

Contacts

QT Imaging Holdings, Inc. Media Contact:
Susan Schaffler
(646) 753-0336
Susan.Schaffler@qtimaging.com

Nasdaq MarketSite Media Contact:
Sophia Weiss
(646) 483-6960
Sophia.weiss@nasdaq.com

QT Imaging Announces Second Blinded Screening Trial Finding Its Technology Similarly Effective as Digital Breast Tomosynthesis

NOVATO, Calif.–(BUSINESS WIRE)–QT Imaging Holdings, Inc. (NASDAQ:QTI) a medical device company engaged in research, development, and commercialization of innovative body imaging systems is proud to announce positive data regarding the diagnostic performance of QTI’s Breast Acoustic CTTM Scans for mass detection from its second blinded multi-reader multi-case study. The study was published in Academic Radiology, online, in January 2024: A Multireader Multicase (MRMC) Receiver Operating Characteristic (ROC) Study Evaluating Noninferiority of Quantitative Transmission (QT) Ultrasound to Digital Breast Tomosynthesis (DBT) on Detection and Recall of Breast Lesions – Academic Radiology

“Accurate and safe breast cancer screening is crucial for the 40% of women in US with dense breasts. Standardization and broad accessibility of any technology are essential to minimize the financial and emotional impacts of unnecessary biopsies and call backs. This study suggests that these requirements are now being met.”

Twenty-four breast radiologists participated in a study of 177 selected cases (66 with cancer, atypia, or solid mass and 111 normal or with nonsolid benign abnormality). The study found that QTI’s Breast Acoustic CTTM is similarly effective as digital breast tomosynthesis (DBT), also known as 3D mammography, in that the area under receiver operating characteristic curve (AUC) was statistically non-inferior for QTI scan compared with DBT for the AUC difference margin of -0.05. This means that QTI technology is non-inferior to DBT in the detection of breast lesions as a whole, with high specificity in determining benign cysts and thus decreasing benign recall rates. Statistical analysis was performed by Dr. Yulei Jiang from the Department of Radiology of the University of Chicago.

While fewer than 5% of women with breast cancer are diagnosed before the age of 40(1), those cancers are usually aggressive, and the young patients suffer from poor survival outcomes. Unfortunately, routine screening mammograms are not recommended for women under 40 because risks outweigh potential benefits at this young age. Fortunately, the now published results suggest that QTI’s technology can be a much-needed potential alternative to mammography for women too young to undergo mammography screening.

“We are encouraged by the consistent high performance of QTI’s technology, especially in women with dense breasts. Along with the previously published results and from comparison of QTI’s scans with mammography, these trial results will be valuable for our planned FDA submission for a screening indication in younger women identified with above-average risk for developing breast cancer and who have not yet reached the age for conventional mammography-based screening,” said Dr. Bilal Malik, Chief Science Officer. The results of the study comparing QTI’s technology performance with mammography were published in Academic Radiology, in December 2020: An Exploratory Multi-reader, Multi-case Study Comparing Transmission Ultrasound to Mammography on Recall Rates and Detection Rates for Breast Cancer Lesions – Academic Radiology

According to Jennifer Simmons, MD, Breast Surgeon, and Integrative Oncologist at Real Health MD, “Accurate and safe breast cancer screening is crucial for the 40% of women in US with dense breasts. Standardization and broad accessibility of any technology are essential to minimize the financial and emotional impacts of unnecessary biopsies and call backs. This study suggests that these requirements are now being met.” Dr. Simmons, who has been caring for women with breast disease for over 20 years, knows the increasing need for safe imaging in the younger population. “Cancers are occurring in much younger women today than when I started to practice. We need a safe imaging solution for young women. I am hopeful that QTI’s technology is that solution.”

About QT Imaging

QT Imaging Holdings, Inc. is a public (NASDAQ: QTI) medical device company engaged in research, development, and commercialization of innovative body imaging systems using low frequency sound waves. QT Imaging Holdings, Inc. strives to improve global health outcomes. Its strategy is predicated upon the fact that medical imaging is critical to the detection, diagnosis, and treatment of disease and that it should be safe, affordable, accessible, and centered on the patient’s experience. For more information on QT Imaging Holdings, Inc., please visit the company’s website at www.qtimaging.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as “will,” and “expect,” or the negative thereof or comparable terminology, and include (without limitation) statements regarding the strategic partnership between QT Imaging Holdings and our previously disclosed distribution partner, the QTI Breast Acoustic CTTM System, submission to the FDA for a screening indication, plans for QT Imaging Holdings, new product development and introduction, and product sales growth and projected revenues. Forward-looking statements involve certain risks and uncertainties, and actual results may differ materially from those discussed in any such statement. These risks include, but are not limited to: the ability of the parties to sell and deploy the QTI Breast Acoustic CTTM System, the ability to extend product offerings into new areas or products, the ability to commercialize technology, unexpected occurrences that deter the full documentation and “bring to market” plan for products, trends and fluctuations in the industry, changes in demand and purchasing volume of customers, unpredictability of suppliers, the ability to attract and retain qualified personnel and the ability to move product sales to production levels. Additional factors that could cause actual results to differ are discussed under the heading “Risk Factors” and in other sections of QT Imaging’s (and its predecessor, GigCapital5, Inc.) filings with the SEC, and in its other current and periodic reports filed or furnished from time to time with the SEC. All forward-looking statements in this press release are made as of the date hereof, based on information available to QT Imaging Holdings as of the date hereof, and QT Imaging Holdings assumes no obligation to update any forward-looking statement.

Reference:

(1)

American Cancer Society. Breast Cancer Facts and Figures 2022-2024. Atlanta, GA: American Cancer Society, 2022. (link)

 

Contacts

For media inquiries, please contact:
Susan Schaffler
Head of Communications
Susan.Schaffler@qtimaging.com

Stas Budagov
Chief Financial Officer
Stas.Budagov@qtimaging.com

QT Imaging’s Breast Acoustic CT™ Scanner to be Offered at The Center for New Medicine to Advance Personalized Prevention and Detection of Breast Cancer

NOVATO, Calif.–(BUSINESS WIRE)–QT Imaging Holdings, Inc. (NASDAQ:QTI) a medical device company engaged in research, development, and commercialization of innovative body imaging systems, together with our strategic business and distribution partner are proud to announce their partnership with the Center of New Medicine in Irvine, California. The Center for New Medicine is one of the largest integrative medical clinics in North America, providing a personalized approach to health care including cancer prevention, its early detection, and internal medicine. With the incorporation of the QT Imaging Breast Acoustic CT™ Scanner, the Center for New Medicine will expand their innovative services in women’s and breast health.

“The Center for New Medicine centers its services on an integrated and precise approach to medicine. The QT Imaging Breast scanning system provides our patients with an alternative, more accurate and less expensive choice to traditional modalities that ensure breast health”

There is tremendous opportunity for new technology to advance women’s health, especially in breast cancer detection and treatment. QT Imaging Breast Acoustic CT™; Scanner is the only 3D imaging device to receive FDA clearance for use as a transmission and reflection low frequency soundwaves imaging system for a patient’s breast. This breast scanning system offers women, especially those with dense breasts, a supplemental screening option to ensure their breast health over time. For providers, the technology is more affordable and yields better visualization of the internal structures of the breast without radiation, compression, or use of harmful contrast agents.

Dr. Leigh Erin Connealy is the Medical Director of Center for New Medicine and Cancer Center for Healing and is a prominent leader in the Integrative/Functional Medicine field. “The Center for New Medicine centers its services on an integrated and precise approach to medicine. The QT Imaging Breast scanning system provides our patients with an alternative, more accurate and less expensive choice to traditional modalities that ensure breast health,” stated Dr. Connealy.

“The QTI Breast Acoustic CT™ System presents significant advantages to a patient-centric approach,” said Dr. Raluca Dinu, Chief Executive Officer of QT Imaging Holdings. “Patients and providers should never have to choose between accuracy and experience. Our technology prioritizes the patient experience while delivering high-quality, high-resolution 3D images. Our goal is to improve health outcomes by expanding access to superior medical imaging at lower costs to providers and patients.”

About QT Imaging


QT Imaging Holdings, Inc. is a public (NASDAQ: QTI) medical device company engaged in research, development, and commercialization of innovative body imaging systems using low frequency sound waves. QT Imaging Holdings, Inc. strives to improve global health outcomes. Its strategy is predicated upon the fact that medical imaging is critical to the detection, diagnosis, and treatment of disease and that it should be safe, affordable, accessible, and centered on the patient’s experience. For more information on QT Imaging Holdings, Inc., please visit the company’s website at www.qtimaging.com.

About Center for New Medicine


The Center for New Medicine focuses on a precise and personalized approach to patient care that includes prevention, early detection of cancer, internal medicine, auto-immune disease, natural hormone replacement, chronic issues, and even aesthetics. Dr. Connealy’s clinics focus on treating “the patient with the disease and not the disease of the patient, while determining the origin of the illness.” Center for New Medicine contains some of the world’s most technologically advanced medical equipment, devices normally only found at select university research hospitals. Our prescriptions routinely feature customized dietary and lifestyle recommendations, natural nutritional supplements and other complementary therapies that produce lifelong benefits. For more information on QT Imaging Holdings, Inc., please visit the company’s website at www.cfnmedicine.com.

Forward-Looking Statements


This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as “will,” and “expect,” or the negative thereof or comparable terminology, and include (without limitation) statements regarding the strategic partnership between QT Imaging Holdings and our previously disclosed distribution partner, the QTI Breast Acoustic CTTM System, plans for QT Imaging Holdings, new product development and introduction, and product sales growth and projected revenues. Forward-looking statements involve certain risks and uncertainties, and actual results may differ materially from those discussed in any such statement. These risks include, but are not limited to: the ability of the parties to sell and deploy the QTI Breast Acoustic CTTM System, the ability to extend product offerings into new areas or products, the ability to commercialize technology, unexpected occurrences that deter the full documentation and “bring to market” plan for products, trends and fluctuations in the industry, changes in demand and purchasing volume of customers, unpredictability of suppliers, the ability to attract and retain qualified personnel and the ability to move product sales to production levels. Additional factors that could cause actual results to differ are discussed under the heading “Risk Factors” and in other sections of QT Imaging’s (and its predecessor, GigCapital5, Inc.) filings with the SEC, and in its other current and periodic reports filed or furnished from time to time with the SEC. All forward-looking statements in this press release are made as of the date hereof, based on information available to QT Imaging Holdings as of the date hereof, and QT Imaging Holdings assumes no obligation to update any forward-looking statement.

Contacts


For media inquiries, please contact:
Susan Schaffler
Head of Communications
Susan.Schaffler@qtimaging.com

Stas Budagov
Chief Financial Officer
Stas.Budagov@qtimaging.com

QT Imaging Holdings names Dr. Raluca Dinu as Acting Chief Executive Officer and Anastas Budagov as Chief Financial Officer

NOVATO, Calif.–(BUSINESS WIRE)–QT Imaging Holdings, Inc. (NASDAQ:QTI) a medical device company engaged in research, development, and commercialization of innovative body imaging systems, today announced that the Board of Directors has appointed former GigCapital5, Inc. CEO Dr. Raluca Dinu as Active Chief Executive Officer and member of the Board of Directors, effective March 12, 2024. Dr. Dinu will serve in this position for one year, when the Company will reevaluate this strategic position. Dr. John Klock will step down as Chief Executive Officer, but will remain part of the Board of Directors, transitioning to serve as a Company advisor. As previously announced, Anastas (Stas) Budagov will take the position of Chief Financial Officer.

Dr. Dinu served as a senior executive in small and large size public companies, has a global, operationally focused business background, public company governance experience, delivered strong results in turnaround and M&A situations, lead strategic growth, and consolidation in fast-paced business environments. Dr. Raluca Dinu is on the board of numerous public traded companies and philanthropic organizations and has co-founded five Private-to-Public Equity (PPE) companies, which acquire late-stage private companies for the purpose of taking them public on their continuous growth journey.

“Raluca has an impressive record of turnaround, global operations, and public company governance. She has extensive M&A experience, deep product experience in regulated and unregulated industries, and has implemented innovative and collaborative workplace environments. QTI is playing a vital role in the development of advanced, accurate, non-invasive body scanning technology, and with Raluca at the helm, the Company will transition to a solid public company, technology-led, leader in medical imaging,” said Dr. Avi Katz, Chairman of the QT Imaging Holdings, Inc. Board of Directors.

Mr. Budagov has deep accounting, audit processes, internal controls, and commercial contracts experience, in private and public companies. Mr. Budagov served as a contracting Chief Financial Officer with QT Imaging, Inc. since December 2023 and accepted a permanent full-time job with the public company.

About QT Imaging Holdings, Inc.

QT Imaging Holdings, Inc. is a public (NASDAQ: QTI) medical device company engaged in research, development, and commercialization of innovative body imaging systems using low frequency sound waves. QT Imaging Holdings, Inc. strives to improve global health outcomes. Its strategy is predicated upon the fact that medical imaging is critical to the detection, diagnosis, and treatment of disease and that it should be safe, affordable, accessible, and centered on the patient’s experience. For more information on QT Imaging Holdings, Inc., please visit the company’s website at www.qtimaging.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as “will,” and “expect,” or the negative thereof or comparable terminology, and include (without limitation) statements regarding the QTI Breast Acoustic CT™ System and its use in the research collaboration and images that may be rendered as part of this research, plans for QT Imaging Holdings, new product development and introduction, and product sales growth and projected revenues. Forward-looking statements involve certain risks and uncertainties, and actual results may differ materially from those discussed in any such statement. These risks include, but are not limited to: the ability of the parties to sell and deploy the QTI Breast Acoustic CT™ System, the ability to extend product offerings into new areas or products, the ability to commercialize technology, unexpected occurrences that deter the full documentation and “bring to market” plan for products, trends and fluctuations in the industry, changes in demand and purchasing volume of customers, unpredictability of suppliers, the ability to attract and retain qualified personnel and the ability to move product sales to production levels. Additional factors that could cause actual results to differ are discussed under the heading “Risk Factors” and in other sections of QT Imaging’s (and its predecessor, GigCapital5, Inc.) filings with the SEC, and in its other current and periodic reports filed or furnished from time to time with the SEC. All forward-looking statements in this press release are made as of the date hereof, based on information available to QT Imaging Holdings as of the date hereof, and QT Imaging Holdings assumes no obligation to update any forward-looking statement.

Contacts

Stas Budagov
Chief Financial Officer
Stas.Budagov@qtimaging.com

QT Imaging’s Breast Acoustic CT™ Scanner Used in Study for Early Identification of Response of Breast Cancer Patients to Neoadjuvant Chemotherapy

NOVATO, Calif.–(BUSINESS WIRE)–QT Imaging Holdings, Inc. (NASDAQ:QTI) a medical device company engaged in research, development, and commercialization of innovative body imaging systems, is pleased to announce the delivery of a Breast Acoustic CT™ Scanner under a unique collaboration with the Department of Radiation Oncology, and Radiation Treatment Program at the Sunnybrook Health Sciences Centre in Toronto, Canada, one of the largest cancer centers in Canada, and The University of Illinois, Urbana-Champaign, Department of Electrical and Computer Engineering and Grainger College of Engineering. This collaboration is part of a five-year research grant from National Institutes of Health/National Cancer Institute to develop an inexpensive, portable, safe, and repeatable imaging approach capable of accurate and early identification of response of breast cancer patients to neoadjuvant chemotherapy (NAC).

As part of this grant, Breast Acoustic CT™ (ACT) quantitative images with independent biomarkers known to be sensitive to cancer will be collected, and the response of cancer to therapy, will be derived from quantitative ultrasound based on backscatter analysis. The successful results of this collaboration will yield additional quantitative markers (radiomics) with improved estimate precision not afforded by conventional ultrasound scanners.

This collaboration also addresses the ongoing clinical need in breast cancer therapy for the development of an inexpensive, robust, and accurate technique to identify the response, within weeks, of breast cancer to neoadjuvant chemotherapy. The early identification of non-responders to NAC or any cancer treatment remains a highly significant medical problem and necessary for adaptive precision medicine.

“The QTI Breast Acoustic CT™ System represents the future of tomographic imaging, offering quantitatively accurate, 3D, high resolution breast images, taken with no safety or discomfort for women,” said James Wiskin, PhD, Principal Scientist and QTI Fellow. “The ACT system is especially appropriate for dense breasts and young women with risk factors. This partnership serves as a testament to collaborations between leaders in industry and academia.”

“Unfortunately, not all therapies work in cancer patients and the ability to determine which are effective and which treatments are ineffective in days instead of months is very important. With the QTI Breast Acoustic CT™ System we plan to implement quantitative ultrasound methods which can be used for exactly that kind of determination to enable personalized care,” stated Greg Czarnota, MD, PhD, Clinician Scientist Department of Radiation Oncology at Sunnybrook Health Sciences Centre in Toronto, Canada.

About QT Imaging Holdings, Inc.

QT Imaging Holdings, Inc. is a public (NASDAQ: QTI) medical device company engaged in research, development, and commercialization of innovative body imaging systems using low frequency sound waves. QT Imaging Holdings, Inc. strives to improve global health outcomes. Its strategy is predicated upon the fact that medical imaging is critical to the detection, diagnosis, and treatment of disease and that it should be safe, affordable, accessible, and centered on the patient’s experience. For more information on QT Imaging Holdings, Inc., please visit the company’s website at www.qtimaging.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as “will,” and “expect,” or the negative thereof or comparable terminology, and include (without limitation) statements regarding the QTI Breast Acoustic CT™ System and its use in the research collaboration and images that may be rendered as part of this research, plans for QT Imaging Holdings, new product development and introduction, and product sales growth and projected revenues. Forward-looking statements involve certain risks and uncertainties, and actual results may differ materially from those discussed in any such statement. These risks include, but are not limited to: the ability of the parties to sell and deploy the QTI Breast Acoustic CT™ System, the ability to extend product offerings into new areas or products, the ability to commercialize technology, unexpected occurrences that deter the full documentation and “bring to market” plan for products, trends and fluctuations in the industry, changes in demand and purchasing volume of customers, unpredictability of suppliers, the ability to attract and retain qualified personnel and the ability to move product sales to production levels. Additional factors that could cause actual results to differ are discussed under the heading “Risk Factors” and in other sections of QT Imaging’s (and its predecessor, GigCapital5, Inc.) filings with the SEC, and in its other current and periodic reports filed or furnished from time to time with the SEC. All forward-looking statements in this press release are made as of the date hereof, based on information available to QT Imaging Holdings as of the date hereof, and QT Imaging Holdings assumes no obligation to update any forward-looking statement.

Contacts

Stas Budagov
Chief Financial Officer
Stas.Budagov@qtimaging.com

QT Imaging Pioneers Patient-Centric Breast Imaging Technology through Strategic Partnership

NOVATO, Calif.–(BUSINESS WIRE)–QT Imaging Holdings, Inc. (NASDAQ:QTI) a medical device company engaged in research, development, and commercialization of innovative body imaging systems, is pleased to announce the first commercial sale of a QTI Breast Acoustic CT™ System to True Health Center for Functional Medicine. QTI’s inaugural customer was born as a result of the collaboration with our previously announced strategic distribution partner and represents the business model to be deployed by the company.

The QTI Breast Acoustic CT System, featuring the trademarked Breast ACT technology, is an advancement in breast imaging. Unlike traditional mammography, this state-of-the-art system offers numerous key advantages to a patient-centric approach. By eliminating uncomfortable breast compression, radiation exposure, and the need for contrast agents or injections, this innovative system prioritizes patient comfort and safety while delivering high-quality, high-resolution 3D images. Also, in overcoming the limitations of traditional methods, the QTI system ensures consistent and reproducible image quality for patients with dense breast tissue or implants, backed by rigorous validation from the National Institutes of Health. Lastly, this NIH-funded technology represents a significant advancement in healthcare imaging, setting a new standard in breast imaging excellence.

“The QTI Breast Acoustic CT System represents a leap forward in patient-centric breast imaging. By harnessing the power of our advanced technology and eliminating the discomfort associated with traditional methods, we’re redefining the standard of care and empowering patients with a safer, more comfortable imaging experience,” said Nasser Pirshafiey, Chief Product Officer at QTI. “This partnership serves as a testament to the advancements in breast imaging technology and as testimonial of our team’s commitment to the commercialization of QTI’s advanced products.”

“As the inaugural customer of QTI’s partnership, True Health Center for Functional Medicine is proud to lead the way in providing our patients with the latest advancements in breast imaging technology. The QTI Breast Acoustic CT System’s patient-centric approach aligns perfectly with our commitment to delivering exceptional care while prioritizing comfort and safety,” stated Dr. Kristine Burke at True Health Center for Functional Medicine.

This strategic partnership marks a significant achievement for QTI and serves as a testament to the advancements in breast imaging technology.

About QT Imaging Holdings, Inc.

QT Imaging Holdings, Inc. is a public (NASDAQ: QTI) medical device company engaged in research, development, and commercialization of innovative body imaging systems using low frequency sound waves. QT Imaging Holdings, Inc. strives to improve global health outcomes. Its strategy is predicated upon the fact that medical imaging is critical to the detection, diagnosis, and treatment of disease and that it should be safe, affordable, accessible, and centered on the patient’s experience. For more information on QT Imaging Holdings, Inc., please visit the company’s website at www.qtimaging.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as “will,” and “expect,” or the negative thereof or comparable terminology, and include (without limitation) statements regarding the strategic partnership between QT Imaging Holdings and our previously disclosed distribution partner, the QTI Breast Acoustic CT System, plans for QT Imaging Holdings, new product development and introduction, and product sales growth and projected revenues. Forward-looking statements involve certain risks and uncertainties, and actual results may differ materially from those discussed in any such statement. These risks include, but are not limited to: the ability of the parties to sell and deploy the QTI Breast Acoustic CT System, the ability to extend product offerings into new areas or products, the ability to commercialize technology, unexpected occurrences that deter the full documentation and “bring to market” plan for products, trends and fluctuations in the industry, changes in demand and purchasing volume of customers, unpredictability of suppliers, the ability to attract and retain qualified personnel and the ability to move product sales to production levels. Additional factors that could cause actual results to differ are discussed under the heading “Risk Factors” and in other sections of QT Imaging’s (and its predecessor, GigCapital5, Inc.) filings with the SEC, and in its other current and periodic reports filed or furnished from time to time with the SEC. All forward-looking statements in this press release are made as of the date hereof, based on information available to QT Imaging Holdings as of the date hereof, and QT Imaging Holdings assumes no obligation to update any forward-looking statement.

Contacts

For media inquiries, please contact:
Stas Budagov
Chief Financial Officer
stas.budagov@qtimaging.com

QT Imaging Holdings Announces Completion of Business Combination with GigCapital5

QT Imaging Holdings Expected to Begin Trading on NASDAQ Under Ticker Symbol “QTI” on March 5, 2024

NOVATO, Calif. & PALO ALTO, Calif.–(BUSINESS WIRE)–QT Imaging Holdings, Inc. a medical device company engaged in the research, development, and commercialization of innovative body imaging systems using low frequency sound waves, and GigCapital5, Inc. (“GigCapital5”; Nasdaq: GIA, GIAFW), a Private-to-Public Equity (PPE)™ entity also known as special purpose acquisition company (“SPAC”), today announced the completion of their previously announced business combination (the “Business Combination”). The Business Combination was approved at the Annual Meeting of GigCapital5’s stockholders on February 20, 2024. Upon completion of the Business Combination, the combined company changed its name to QT Imaging Holdings, Inc. (“QT Imaging”). QT Imaging’s shares of common stock are expected to commence trading on the NASDAQ on March 5, 2024, under the new ticker “QTI”.

Doctors and hospitals are increasingly turning to medical imaging to screen for and diagnose cancer, support and monitor ongoing cancer treatment (drugs, radiation, and surgery), and offer non-invasive surgical options for patients. This has resulted in a major market opportunity—the annual worldwide medical imaging market currently is estimated to be worth approximately $40 billion, with $10 billion coming from the United States.1 Global cancer screening, with an approximately $150 billion market size in 2022, is expected to grow at a CAGR of 12% and reach approximately $472 billion in 2033.Breast cancer detection and diagnostic technologies (including mammography, MRI, ultrasound, etc.) are a meaningful part of the medical imaging market and are estimated to represent a $4.6 billion global market in 2023 with an ongoing CAGR of 8%.3

QT Imaging, with the support of nearly $17.8 million in financial support from the U.S. National Institutes of Health and significant funding from private investors since its inception in 2014, has developed a novel, comprehensive body imaging technology that has high resolution, high sensitivity, high specificity, high positive and negative predictive values, and is safe and inexpensive. The technology is based on low frequency transmitted sound and uses a one-of-a-kind novel sound back-scatter design and inverse-scattering reconstruction to create its images.

The QT Imaging Breast Acoustic CT™ Scanner, with its already granted FDA clearance as adjunct to mammography, sets a new standard in breast imaging excellence. Unlike traditional mammography, this state-of-the-art system offers numerous key advantages to a patient-centric approach. By eliminating uncomfortable breast compression, radiation exposure, and the need for contrast agents or injections, this innovative system prioritizes patient comfort and safety while delivering high-quality, high-resolution 3D images. Also, in overcoming the limitations of traditional methods, the QT Imaging scanner ensures consistent and reproducible image quality for patients with dense breast tissue or implants, backed by rigorous validation from the National Institutes of Health. Those differentiating and state-of-the-art characteristics have already attracted the attention of and led to a commercialization partnership with one of the world’s major medical equipment providers, as QTI Imaging recently announced.

Dr. John Klock, Chief Executive Officer and Founder of QT Imaging, said, “The completion of our business combination with GigCapital5 and emergence as a publicly-traded company is a landmark achievement for QT Imaging, and one that we would not have reached without the hard work and focus of our dedicated employees and the support of our partners at GigCapital5, more so in this very difficult time for fund raising and growing micro-cap companies. By introducing the first body-safe imaging technology into the marketplace, we are creating disruptive innovation, a dedication to using technology, as well as software, artificial intelligence, and smart physics, to improve medical imaging and thus healthcare quality and access. As a public company, we plan to stay committed to building value for shareholders by continuing to address issues presented by conventional imaging technologies with our accurate, safe, less expensive, easily deployable imaging solutions.”

Dr. Avi Katz, Founding Managing Partner of GigCapital Global and Executive Chairman of the Board of GigCapital5, said, “The GigCapital team is very proud to have closed our fifth business combination since inception in 2017, GigCapital5 with QT Imaging. We are pleased to continue to support QT Imaging’s journey as a publicly held company, as part of its Board of Directors and other functions as the company enters its next phase of innovation and growth. This combination is yet again a successful demonstration of our Private-to-Public Equity (PPE)™ methodology, but, as importantly, of our commitment to supporting companies in the medical device space, with a clear purpose of improving the global health outcomes, and delivering solutions that are safe, affordable, accessible, and centered on the patient’s experience.”

Advisors

Brown Rudnick LLP is serving as legal counsel, and BPM is serving as auditor to QT Imaging. William Blair is serving as Capital Markets Advisor, DLA Piper LLP (US) is serving as legal counsel, and BPM LLP is serving as auditors to GigCapital5. Proskauer Rose LLP is serving as legal counsel to William Blair. Exit Strategy Partners, LLC introduced the parties and advised QT Imaging in the transaction.

About QT Imaging

QT Imaging Holdings, Inc. is a medical device company engaged in the research, development, and commercialization of innovative body imaging systems using low frequency sound waves. QT Imaging strives to improve global health outcomes. Its strategy is predicated upon the fact that medical imaging is critical to the detection, diagnosis, and treatment of disease and that it should be safe, affordable, accessible, and centered on the patient’s experience. For more information on QT Imaging please visit the company’s website at www.qtimaging.com.

About GigCapital5

GigCapital5, Inc. is a Private-to-Public Equity (PPE)™ company, also known as a blank check company or special purpose acquisition company (SPAC), focusing on the technology, media and telecommunications (TMT) and sustainable industries. It was sponsored by GigAcquisitions5, LLC, which was founded by GigFounders, LLC, each a member entity of GigCapital Global, and formed for the purpose of entering into a merger, share exchange, asset acquisition, stock purchase, recapitalization, reorganization or similar business combination with one or more businesses.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding QT Imaging’s management team’s expectations, hopes, beliefs, intentions, plans, prospects or strategies regarding the future, including possible business combinations, revenue growth and financial performance, product expansion and services. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements contained in this press release are based on our current expectations and beliefs made by the management of QT Imaging in light of their respective experience and their perception of historical trends, current conditions and expected future developments and their potential effects on QT Imaging as well as other factors they believe are appropriate in the circumstances. There can be no assurance that future developments affecting QT Imaging will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the control of the parties) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, including regulatory approvals, product and service acceptance, and that QT Imaging will have sufficient capital to operate as anticipated. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respect from those projected in these forward-looking statements. Additional factors that could cause actual results to differ are discussed under the heading “Risk Factors” and in other sections of QT Imaging’s (and its predecessor, GigCapital5, Inc.) filings with the SEC, and in its current and periodic reports filed or furnished from time to time with the SEC. All forward-looking statements in this press release are made as of the date hereof, based on information available to QT Imaging as of the date hereof, and QT Imaging assume no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

1See, Fortune Business Insight, Medical Imaging Market Size, Share & COVID-19 Impact Analysis, Type (Magnetic Resonance Imaging, Computer Tomography, X-ray, Ultrasound, and Molecular Imaging), By Application (Cardiology, Neurology, Orthopedics, Gynecology, Oncology, and Others), by End User (Hospitals, Specialty Clinics, Diagnostic Imaging Centers, and Others), and Regional Forecast, 2021-2028 (Jan. 2022), available at https://www.fortunebusinessinsights.com/industry-reports/medical-imagingequipment-market-100382.

See, Market.us, Global Cancer Screening Market by Type, by Application (Medical, and Biology), by Region, and Key Companies – Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecasts 2023-2033 (Jan. 2023), available at https://market.us/report/cancer-screening-market/.

See, ReportLinker, Global Breast Imaging Technologies Market to Reach $5.8 Billion by 2030 (Feb. 2, 2023), available at https://finance.yahoo.com/news/global-breast-imaging-technologies-market-192600736.html?

Contacts
For GigCapital5:
ICR
Brian Ruby
Brian.ruby@icrinc.com

QT Imaging Announces Publication of First Whole Body Imaging Results Using Low Frequency Transmission Ultrasound

QT Imaging shows high resolution images of its technology

QT Imaging Announces Publication of First Whole Body Imaging Results Using Low Frequency Transmission Ultrasound

QT Imaging shows high resolution images of its technology

Novato, CA – March 14, 2023 – QT Imaging, Inc., (“QT”) a medical device company focused on the development and commercialization of novel products for medical imaging, today announced positive data regarding sensitivity and specificity of QT imaging for whole body imaging – recently published in Academic Radiology and available at https://www.academicradiology.org/article/S1076-6332(23)00033-8/fulltext.  Comparative MRI and anatomic correlations were done at the Department of Large Animal Sciences at Texas A&M University.

The specimens were imaged with both QT imaging and 3 Tesla MRI imaging, and anatomic correlations were done by a veterinary anatomist at Texas A&M University. The results showed that the QT imaging system showed higher resolution and contrast than the MRI images, and all anatomic features seen by QT Imaging were confirmed by pathological correlations.

“We are encouraged by the continued high performance of QT imaging, especially imaging of complex anatomy as represented by abdominal structures. Along with its previously published positive results from imaging of bone, ligaments, tendons and muscle, these latest results demonstrate the potential for the use of QT’s low-frequency transmitted ultrasound technology as a modality for body imaging in humans.” said John Klock MD, CEO and CMO of QT Imaging Inc.

“Our cancer center is acquiring a QT Breast scanner to use in our research recently funded by the NIH. We believe that this new technology is a needed platform that could assist us in our efforts to increase cancer detection and monitoring and we are excited about beginning to use it very soon.” said Gregory J. Czarnota Ph.D. M.D. F.R.C.P.C. M.R.M.D. (M.R.S.C.), Chief, Department of Radiation Oncology, Sunnybrook Health Sciences Centre, and Sunnybrook Research Institute, Professor, Departments of Radiation Oncology and Medical Biophysics, University of Toronto.

 

About MRI Imaging

Magnetic Resonance Imaging (MRI) is a popular option at present for body imaging, however, unlike QT imaging technology, MRI does not always quantitatively image certain tissues, it requires a strong magnetic field, and specialized training, it may require a contrast agent injection, the use of expensive and large machinery, and is not easily deployable in low resource environments.

 About QT Imaging, Inc.

QT Imaging, Inc. is a medical device company committed to bringing novel imaging technologies for breast and body imaging to market. The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. QT Imaging, Inc.’s strategy is predicated upon time- and cost-efficient imaging development, with the goal of delivering safe and effective imaging to patients with the utmost urgency.  For more information on QT Imaging, Inc., please visit the company’s website at www.qtimaging.com.

QT Imaging to Present at the 3rd Annual B. Riley Securities Oncology Conference

QT Imaging to Present at the 3rd Annual B. Riley Securities Oncology Conference

Novato, CA – January 13, 2023 – QT Imaging, Inc., a medical imaging company focused on the development and clinical adoption of novel products for breast cancer imaging (“QT Imaging”), today announced participation of John Klock, MD, Chief Executive Officer, in the Third Annual B. Riley Securities Oncology Conference, on January 18th and 19th. The event will feature one-on-one discussions, fireside chats, and presentations regarding cancer treatment, testing, and monitoring modalities with public and private healthcare companies.
The live and archived webcast of the presentation will be accessible from the company’s website at https://doodlebug.sbs/events-presentations. The replay of the webcast will be available for 30 days.

About QT Imaging
QT Imaging is a vertically integrated medical imaging company in the business of manufacturing ultra-low frequency transmitted sound imaging systems for breast and body imaging. QT Imaging’s FDA-cleared breast scanner is deployed in three US and two foreign locations. QT Imaging is entering a commercial growth phase and is in final stages of combining with GigCapital5, Inc. (“GigCapital5”) (NYSE: GIA.U; GIA; GIA.WS) to go public in the first half of 2023. The GigCapital5 joint Proxy Statement/prospectus and the Registration Statement in which these are contained, and other reports can be obtained, without charge, at the SEC’s web site (http://www.sec.gov). QT Imaging would use the proceeds of the merger to further expand its commercial activities.

About GigCapital5
GigCapital5 is a blank check company, also commonly referred to as a special purpose acquisition company, or SPAC, formed for the purpose of entering into a merger, capital stock exchange, asset acquisition, stock purchase reorganization or similar business combination with one or more businesses or entities. While GigCapital5’s efforts to identify a target business may span many industries, the focus of GigCapital5’s search is for prospects within the technology, media and telecommunications, aerospace and defense, advanced medical equipment, intelligent automation and sustainable industries. GigCapital5 was sponsored by GigAcquisitions5, LLC, which was founded by GigFounders, LLC, each a member entity of GigCapital Global, and formed for the purpose of entering into a merger, share exchange, asset acquisition, stock purchase, recapitalization, reorganization, or similar business combination with one or more businesses.
On December 8, 2022, GigCapital5 entered into a Business Combination Agreement (the “Business Combination Agreement”) with QT Imaging and QTI Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of GigCapital5 (“Merger Sub” and the transactions contemplated by the Business Combination Agreement, the “Business Combination”). Pursuant to the terms of the Business Combination Agreement, Merger Sub will merge with and into QT Imaging (the “Merger”), with QT Imaging as the surviving company in the Merger (the “Surviving Corporation”), and after giving effect to the Merger, the Surviving Corporation will be a wholly owned subsidiary of GigCapital5, which will be renamed as QT Imaging Holdings, Inc. (“QTI Holdings”).

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. The expectations, estimates, and projections of the businesses of GigCapital5 and QT Imaging may differ from their actual results and consequently, you should not rely on these forward-looking statements as predictions of future events. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In addition, any statements that refer to characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations of the management of QT Imaging with respect to the business and prospects of QT Imaging and the QTscan® and other products of QT Imaging, the benefits of the proposed Business Combination, the plans, expectations and intentions of QT Imaging and GigCapital5, the satisfaction of the closing conditions to the proposed Business Combination, the timing of the completion of the proposed Business Combination and the future performance of QT Imaging, including the anticipated impact of the proposed Business Combination on this performance. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the control of GigCapital5 and QT Imaging and are difficult to predict. Factors that may cause such differences include, but are not limited to: (1) the ability of GigCapital5, QT Imaging and QTI Holdings to issue equity or equity-linked securities in connection with the proposed Business Combination or in the future, (2) the outcome of any legal proceedings that may be instituted against the parties following the announcement of the proposed Business Combination and the Business Combination Agreement; (3) the inability to complete the proposed Business Combination, including the risk that any regulatory approvals or the SEC’s declaration of the effectiveness of the Proxy Statement are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect QTI Holdings or the expected benefits of the proposed Business Combination or due to failure to obtain approval of the stockholders of GigCapital5 and QT Imaging or other conditions to closing; (4) the amount of redemption requests made by GigCapital5’s stockholders; (5) the impact of the COVID-19 pandemic on (x) the parties’ ability to consummate the proposed Business Combination and (y) the business of QT Imaging and QTI Holdings; (6) the receipt of an unsolicited offer from another party for an alternative business transaction that could interfere with the proposed Business Combination; (7) the inability to obtain or maintain the listing of QTI Holdings’ common stock on the New York Stock Exchange or any other Exchange following the proposed Business Combination; (8) the risk that the proposed Business Combination disrupts current plans and operations as a result of the announcement and consummation of the proposed Business Combination; (9) the ability to recognize the anticipated benefits of the proposed Business Combination, which may be affected by, among other things, competition, the ability of QTI Holdings to grow and manage growth profitably and retain its key employees; (10) costs related to the proposed Business Combination; (11) changes in applicable laws or regulations; (12) the demand for QT Imaging’s and QTI Holdings’ services together with the possibility that QT Imaging or QTI Holdings may be adversely affected by other economic, business, and/or competitive factors; (13) risks and uncertainties related to QT Imaging’s business, including, but not limited to, the ability of QT Imaging to increase sales of its output products in accordance with its plan; (14) risks related to the rollout of QT Imaging’s business and the timing of expected business milestones; (15) the effects of competition on QT Imaging’s business; (16) changes in domestic and foreign business, market, financial, political, and legal conditions; and (17) other risks and uncertainties included in (x) the “Risk Factors” sections of the most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC by GigCapital5 and (y) other documents filed or to be filed with the SEC by GigCapital5. The foregoing list of factors is not exclusive. You should not place undue reliance upon any forward-looking statements, which speak only as of the date made. GigCapital5 and QT Imaging do not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in their expectations or any change in events, conditions, or circumstances on which any such statement is based.

Additional Information and Where to Find It
In connection with the proposed Business Combinations, GigCapital5 intends to file with the SEC the Registration Statement, which will include a preliminary Proxy Statement to be distributed to holders of GigCapital5’s common stock in connection with GigCapital5’s solicitation of proxies for the vote by GigCapital5’s stockholders with respect to the Business Combination and the other matters as described in the Registration Statement and a prospectus relating to the offer of the securities to be issued to the stockholders of QT Imaging in connection with the Business Combination. After the Registration Statement has been filed and declared effective, GigCapital will mail a definitive Proxy Statement, when available, to its stockholders. Investors and security holders and other interested parties are urged to read the Proxy Statement, any amendments thereto and any other documents filed with the SEC carefully and in their entirety when they become available because they will contain important information about GigCapital5, QT Imaging and the proposed Business Combination. Such persons can also read GigCapital5’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K for more information on the security holdings of its officers and directors and their respective interests as security holders in the consummation of the Transactions described in this press release. The Proxy Statement and Registration Statement, once available, and GigCapital5’s other reports can be obtained, without charge, at the SEC’s web site (www.sec.gov) and on GigCapital5’s website at www.gigcapital5.com.

Participants in the Solicitation
GigCapital5, QT Imaging, and their respective directors, executive officers and other members of their management and employees, under SEC rules, may be deemed to be participants in the solicitation of proxies of GigCapital5 stockholders in connection with the proposed business combination. Investors and security holders may obtain more detailed information regarding the names, affiliations and interests of GigCapital5’s directors and officers in its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, which was filed with the SEC on March 31, 2022. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies to GigCapital5’s stockholders in connection with the proposed business combination will be set forth in the Proxy Statement for the proposed Business Combination when available. Information concerning the interests of GigCapital5’s and QT Imaging’s equity holders and participants in the solicitation, which may, in some cases, be different than those of GigCapital5’s and QT Imaging’s equity holders generally, will be set forth in the Proxy Statement relating to the proposed Business Combination when it becomes available. GigCapital5 stockholders, potential investors and other interested persons should read the Proxy Statement carefully when it becomes available before making any voting or investment decisions.

No Offer or Solicitation
This press release will not constitute a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the Business Combination. This press release will also not constitute an offer to sell or the solicitation of an offer to buy any securities, nor will there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities will be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act or an exemption therefrom.

QT Imaging and GigCapital5 to Merge

NOVATO, CA, January 13, 2023 – QT Imaging, Inc., a medical imaging company focused on the development and clinical adoption of novel products for breast cancer imaging (“QT Imaging”), announced on December 8, 2022, that it entered into a Business Combination Agreement (the “Business Combination Agreement”) with GigCapital5 into a QTI Merger Sub., a Delaware corporation and wholly owned subsidiary of GigCapital5 (“Merger Sub” and the transactions contemplated by the Business Combination Agreement, the “Business Combination”). Pursuant to the terms of the Business Combination Agreement, Merger Sub will merge with and into QT Imaging (the “Merger”), with QT Imaging as the surviving company in the Merger (the “Surviving Corporation”), and after giving effect to the Merger, the Surviving Corporation will be a wholly owned subsidiary of GigCapital5, which will be renamed as QT Imaging Holdings, Inc. (“QTI Holdings”).

About QT Imaging

QT Imaging is a vertically integrated medical imaging company in the business of manufacturing ultra-low frequency transmitted sound imaging systems for breast and body imaging. QT Imaging’s FDA-cleared breast scanner is deployed in three US and two foreign locations.  QT Imaging is entering a commercial growth phase and is in final stages of combining with GigCapital5, Inc. (“GigCapital5”) (NYSE: GIA.U; GIA; GIA.WS) to go public in the first half of 2023.  The GigCapital5 joint Proxy Statement/prospectus and the Registration Statement in which these are contained, and other reports can be obtained, without charge, at the SEC’s web site (http://www.sec.gov).  QT Imaging would use the proceeds of the merger to further expand its commercial activities.

About GigCapital5

GigCapital5 is a blank check company, also commonly referred to as a special purpose acquisition company, or SPAC, formed for the purpose of entering into a merger, capital stock exchange, asset acquisition, stock purchase reorganization or similar business combination with one or more businesses or entities. While GigCapital5’s efforts to identify a target business may span many industries, the focus of GigCapital5’s search is for prospects within the technology, media and telecommunications, aerospace and defense, advanced medical equipment, intelligent automation and sustainable industries. GigCapital5 was sponsored by GigAcquisitions5, LLC, which was founded by GigFounders, LLC, each a member entity of GigCapital Global, and formed for the purpose of entering into a merger, share exchange, asset acquisition, stock purchase, recapitalization, reorganization, or similar business combination with one or more businesses.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. The expectations, estimates, and projections of the businesses of GigCapital5 and QT Imaging may differ from their actual results and consequently, you should not rely on these forward-looking statements as predictions of future events. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In addition, any statements that refer to characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations of the management of QT Imaging with respect to the business and prospects of QT Imaging and the QTscan® and other products of QT Imaging, the benefits of the proposed Business Combination, the plans, expectations and intentions of QT Imaging and GigCapital5, the satisfaction of the closing conditions to the proposed Business Combination, the timing of the completion of the proposed Business Combination and the future performance of QT Imaging, including the anticipated impact of the proposed Business Combination on this performance. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the control of GigCapital5 and QT Imaging and are difficult to predict. Factors that may cause such differences include, but are not limited to: (1) the ability of GigCapital5, QT Imaging and QTI Holdings to issue equity or equity-linked securities in connection with the proposed Business Combination or in the future, (2) the outcome of any legal proceedings that may be instituted against the parties following the announcement of the proposed Business Combination and the Business Combination Agreement; (3) the inability to complete the proposed Business Combination, including the risk that any regulatory approvals or the SEC’s declaration of the effectiveness of the Proxy Statement are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect QTI Holdings or the expected benefits of the proposed Business Combination or due to failure to obtain approval of the stockholders of GigCapital5 and QT Imaging or other conditions to closing; (4) the amount of redemption requests made by GigCapital5’s stockholders; (5) the impact of the COVID-19 pandemic on (x) the parties’ ability to consummate the proposed Business Combination and (y) the business of QT Imaging and QTI Holdings; (6) the receipt of an unsolicited offer from another party for an alternative business transaction that could interfere with the proposed Business Combination; (7) the inability to obtain or maintain the listing of QTI Holdings’ common stock on the New York Stock Exchange or any other Exchange following the proposed Business Combination; (8) the risk that the proposed Business Combination disrupts current plans and operations as a result of the announcement and consummation of the proposed Business Combination; (9) the ability to recognize the anticipated benefits of the proposed Business Combination, which may be affected by, among other things, competition, the ability of QTI Holdings to grow and manage growth profitably and retain its key employees; (10) costs related to the proposed Business Combination; (11) changes in applicable laws or regulations; (12) the demand for QT Imaging’s and QTI Holdings’ services together with the possibility that QT Imaging or QTI Holdings may be adversely affected by other economic, business, and/or competitive factors; (13) risks and uncertainties related to QT Imaging’s business, including, but not limited to, the ability of QT Imaging to increase sales of its output products in accordance with its plan; (14) risks related to the rollout of QT Imaging’s business and the timing of expected business milestones; (15) the effects of competition on QT Imaging’s business; (16) changes in domestic and foreign business, market, financial, political, and legal conditions; and (17) other risks and uncertainties included in (x) the “Risk Factors” sections of the most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC by GigCapital5 and (y) other documents filed or to be filed with the SEC by GigCapital5. The foregoing list of factors is not exclusive. You should not place undue reliance upon any forward-looking statements, which speak only as of the date made. GigCapital5 and QT Imaging do not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in their expectations or any change in events, conditions, or circumstances on which any such statement is based.

 

Additional Information and Where to Find It

In connection with the proposed Business Combinations, GigCapital5 intends to file with the SEC the Registration Statement, which will include a preliminary Proxy Statement to be distributed to holders of GigCapital5’s common stock in connection with GigCapital5’s solicitation of proxies for the vote by GigCapital5’s stockholders with respect to the Business Combination and the other matters as described in the Registration Statement and a prospectus relating to the offer of the securities to be issued to the stockholders of QT Imaging in connection with the Business Combination. After the Registration Statement has been filed and declared effective, GigCapital will mail a definitive Proxy Statement, when available, to its stockholders. Investors and security holders and other interested parties are urged to read the Proxy Statement, any amendments thereto and any other documents filed with the SEC carefully and in their entirety when they become available because they will contain important information about GigCapital5, QT Imaging and the proposed Business Combination. Such persons can also read GigCapital5’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K for more information on the security holdings of its officers and directors and their respective interests as security holders in the consummation of the Transactions described in this press release. The Proxy Statement and Registration Statement, once available, and GigCapital5’s other reports can be obtained, without charge, at the SEC’s web site (www.sec.gov) and on GigCapital5’s website at www.gigcapital5.com.

 

Participants in the Solicitation

GigCapital5, QT Imaging, and their respective directors, executive officers and other members of their management and employees, under SEC rules, may be deemed to be participants in the solicitation of proxies of GigCapital5 stockholders in connection with the proposed business combination. Investors and security holders may obtain more detailed information regarding the names, affiliations and interests of GigCapital5’s directors and officers in its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, which was filed with the SEC on March 31, 2022. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies to GigCapital5’s stockholders in connection with the proposed business combination will be set forth in the Proxy Statement for the proposed Business Combination when available. Information concerning the interests of GigCapital5’s and QT Imaging’s equity holders and participants in the solicitation, which may, in some cases, be different than those of GigCapital5’s and QT Imaging’s equity holders generally, will be set forth in the Proxy Statement relating to the proposed Business Combination when it becomes available. GigCapital5 stockholders, potential investors and other interested persons should read the Proxy Statement carefully when it becomes available before making any voting or investment decisions.

No Offer or Solicitation

This press release will not constitute a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the Business Combination. This press release will also not constitute an offer to sell or the solicitation of an offer to buy any securities, nor will there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities will be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act or an exemption therefrom.

 

For more information on QT Imaging, please visit the company’s website at: www.qtimaging.com.

 

Contacts

QT Imaging, Inc.
John Klock
john.klock@qtimaging.com

 

Media
Michaela Kalff
michaela@kscreative.net

 

For GigCapital5, Inc.

Brian Ruby  brian.ruby@icrinc.com

QT Imaging and GigCapital5 Announce Signing of Business Combination Agreement to Bring Breast and Full Body Imaging Solutions to the Public Markets

QT Imaging and GigCapital5 Announce Signing of Business Combination Agreement to Bring Breast and Full Body Imaging Solutions to the Public Markets

Palo Alto, CA & Novato, CA – December 12, 2022 – GigCapital5, Inc. (NYSE: GIA), a publicly traded special purpose acquisition company (“GigCapital5”), and QT Imaging, Inc. (“QT Imaging™”), a medical imaging company that develops novel products for body imaging, announced today that they have entered into a definitive business combination agreement that would result in QT Imaging becoming a publicly listed company subject to closing. Upon closing of the transaction, the combined company will be named QT Imaging Holdings, Inc. and will be traded on the NYSE under the new ticker symbol “QTI”. The goal is to complete the business combination in the first half of 2023.

Approximately 39 million women in the United States get mammograms every year (Source: CDC). For every 20 positive findings in mammograms, only one is actually cancer. Such a high callback rate leads to unnecessary, risky, painful, and expensive follow up medical procedures. QT Imaging exists to provide an improved imaging modality to address critical deficiencies in the current breast imaging paradigm. The FDA granted clearance for the QT ultrasound scanner, QTscan®, as an adjunct to mammography and the National Institute of Health (NIH) has awarded over $15.5 million in funding for QT Imaging research.

Unlike traditional breast imaging modalities, the company’s QTscan does not require radiation, injection contrast agents, or compression, and is highly accurate and repeatable, allowing earlier and more frequent monitoring for women undergoing non-surgical breast cancer treatments such as adjuvant chemotherapy, radiation therapy, cryotherapy, and hormone or selective hormone receptor modulation treatments. No other ultrasound-based breast imaging modality is cleared by the FDA to quantify fibroglandular volume.

There is a great clinical need for a new body imaging modality that can be used for screening healthy people, infants, children, and pregnant women who are at risk when subjected to conventional whole body imaging systems, such as CT and MRI. There is also a great need for a low cost, comprehensive medical imaging modality that can be deployed in low resource environments. There are billions of people in the world who have no access to comprehensive medical imaging, a key medical tool that could dramatically improve medical care. QT Imaging’s technology offers the imaging modality for screening of healthy people, infants, and children at low costs.

QT Imaging, as a vertically integrated medical software – hardware imaging platform company in the business of designing and manufacturing ultra-low frequency transmitted sound imaging systems for breast and body imaging, is entering a commercial growth phase and plans to use the proceeds of the merger to seek to attain additional FDA approvals and further expand its commercial activities.

“QT Imaging’s core mission is to provide safe, highly accurate and inexpensive imaging systems to women and children,” said John Klock, MD, Founder and CEO of QT Imaging. “Healthcare’s high costs are in large part due to the high cost of medical imaging, and this needs to be addressed with safe, low-cost comprehensive imaging solutions.”

Dr. Avi Katz, Founding Managing Partner of GigCapital Global and Chairman of the board of directors of GigCapital5, commented: “It is a moral mission for the GigCapital5 team to partner with QT Imaging’s team to bring to the public markets their first breakthrough, FDA-cleared for breast imaging scanner, QTscan, as well as to support development and FDA clearances for imaging applications beyond the breast. GigCapital5 is our 5th SPAC and the GigCapital team is committed to working with exceptional teams of late stage, private companies to orchestrate the transition to the public markets and beyond in bettering the lives of the planet’s inhabitants, more so of minority and unprivileged communities. We are thrilled to be part of this exciting opportunity, improving, and extending the human life by reimagining the possibilities of imaging technology, bringing higher quality, safer, and lower cost medical imaging to all, and are humbled by the opportunity to partner with Dr. Klock and his team.”

Transaction Overview

The business combination values QT Imaging at an equity value of $151 million. The combined company will receive approximately $41 million in gross proceeds from GigCapital5’s trust account, assuming no redemptions by GigCapital5’s public stockholders, and up to $26 million in additional financing to be raised prior to the closing of the business combination.

The transaction has been approved unanimously by the boards of directors of both QT Imaging and GigCapital5 and is currently expected to close in the first half of 2023, subject to regulatory and stockholder approvals, and other customary closing conditions.

Additional information about the proposed transaction, including a copy of the business combination agreement and investor presentation, will be provided on a Form 8-K to be filed by GigCapital5 with the Securities and Exchange Commission (“SEC”) and will be available on GigCapital5’s website at www.gigcapital5.com, QT Imaging’s website at www.QTimaging.com, and at the SEC’s website at www.sec.gov.

Advisors

Northland Securities, Inc. is serving as Financial and Capital Markets Advisors. DLA Piper LLP (US) is acting as legal counsel to GigCapital5. Seyfarth Shaw LLP is serving as legal counsel to QT Imaging.

About QT Imaging, Inc.

QT Imaging™ is engaged in the research, development, and commercialization of an innovative automated imaging system producing high-resolution transmission ultrasound images. The company has received FDA 510(K) clearance for its QT Imaging Breast Scanner. The company’s clinical trials have been conducted at prestigious institutions in the US and Europe, and the National Institutes of Health (NIH) has supported the development of the technology with over $15 million in grants.

The QT Imaging Breast Scanner is indicated for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The QT scanner software also calculates the breast fibroglandular volume and total breast volume. The device is not intended to be used as a replacement for screening mammography. (FDA 510k K162372 and K220933)

“QT Imaging” and “QTscan” are trademarks of QT Imaging, Inc.

About GigCapital Global and GigCapital5, Inc.

GigCapital Global (“GigCapital”) is a Private-to-Public Equity (PPE)™ technology, media, and telecommunications (TMT) focused investment group led by an affiliated team of technology industry corporate executives and entrepreneurs, and TMT operational and strategic experts in the private and public markets, including substantial, success-proven M&A and IPO activities. The group deploys a unique Mentor-Investor™ methodology to partner with exceptional TMT companies, managed by dedicated and experienced entrepreneurs. The GigCapital Private-to-Public Equity (PPE) companies (also known as blank check companies or Special Purpose Acquisition Companies (SPACs)) offer financial, operational and executive mentoring to U.S. and overseas private, and non-U.S. public companies, in order to accelerate their path from inception and as a privately held entity into the growth-stage as a publicly traded company in the U.S. The partnership of GigCapital with these companies continues through an organic and roll-up strategy growth post the transition to a public company. GigCapital was launched in 2017 with the vision of becoming the lead franchise in incepting and developing TMT Private-to-Public Equity (PPE) companies. For more information, visit www.gigcapitalglobal.com or www.GigCapital5.com.

“Private-to-Public Equity (PPE)” and “Mentor-Investor” are trademarks of GigFounders, LLC, a member entity of GigCapital Global and the founder of GigAcquisitions5, LLC, used pursuant to agreement.

Additional Information and Where to Find It

This communication is being made in respect of the proposed business combination involving QT Imaging, GigCapital5 and GigCapital5’s wholly-owned subsidiary, QTI Merger Sub, Inc. This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. In connection with the proposed transaction, (the “GigCapital5 proxy statement/prospectus”) to be filed with the Securities and Exchange Commission (the “SEC”) and mailed to GigCapital5’s stockholders. GigCapital5 and QT urge investors and other interested persons to read, when available, the GigCapital5 proxy statement/prospectus, as well as other documents filed by GigCapital5 with the SEC, because these documents will contain important information about the proposed business combination. Such persons can also read GigCapital5’s Annual Report on Form 10-K and Form 8-K reports for more information on the security holdings of its officers and directors and their respective interests as security holders in the consummation of the transactions described herein. The GigCapital5 proxy statement/prospectus, once available, and GigCapital5’s other reports can be obtained, without charge, at the SEC’s web site (http://www.sec.gov) and on GigCapital5’s website at www.gigcapital5.com.

Participants in the Solicitation

GigCapital5, QT Imaging, and their respective directors, executive officers and other members of their management and employees, under SEC rules, may be deemed to be participants in the solicitation of proxies of GigCapital5 stockholders in connection with the proposed business combination. Investors and security holders may obtain more detailed information regarding the names, affiliations and interests of GigCapital5’s directors and officers in its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, which was filed with the SEC on March 31, 2022. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies to GigCapital5’s stockholders in connection with the proposed business combination will be set forth in the proxy statement/prospectus for the proposed business combination when available. Information concerning the interests of GigCapital5’s and QT Imaging’s equity holders and participants in the solicitation, which may, in some cases, be different than those of GigCapital5’s and QT Imaging’s equity holders generally, will be set forth in the GigCapital5 proxy statement/prospectus relating to the proposed business combination when it becomes available. GigCapital5 stockholders, potential investors and other interested persons should read the GigCapital5 proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions.

Forward Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. The expectations, estimates, and projections of the businesses of GigCapital5 and QT Imaging may differ from their actual results and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations of the management of QT Imaging with respect to the business and prospects of QT Imaging and the QTscan and other products of QT Imaging, the benefits of the proposed business combination, the plans, expectations and intentions of QT Imaging and GigCapital5, the satisfaction of the closing conditions to the proposed business combination, the timing of the completion of the proposed business combination and the future performance of QT Imaging, including the anticipated impact of the proposed business combination on this performance. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the control of GigCapital5 and QT Imaging, and are difficult to predict. Factors that may cause such differences include, but are not limited to: (1) the ability of GigCapital5, QT Imaging and the surviving company to issue equity or equity-linked securities in connection with the proposed business combination or in the future, (2) the outcome of any legal proceedings that may be instituted against the parties following the announcement of the proposed business combination and the definitive agreements with respect thereto; (3) the inability to complete the proposed business combination, including the risk that any regulatory approvals or the SEC’s declaration of the effectiveness of the GigCapital5 proxy statement/prospectus are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect the surviving company or the expected benefits of the proposed business combination or due to failure to obtain approval of the stockholders of GigCapital5 and QT Imaging or other conditions to closing; (4) the amount of redemption requests made by GigCapital5’s stockholders; (5) the impact of the COVID-19 pandemic on (x) the parties’ ability to consummate the proposed business combination and (y) the business of QT Imaging and the surviving company; (6) the receipt of an unsolicited offer from another party for an alternative business transaction that could interfere with the proposed business combination; (7) the inability to obtain or maintain the listing of the surviving company’s common stock on the New York Stock Exchange or any other national stock exchange following the proposed business combination; (8) the risk that the proposed business combination disrupts current plans and operations as a result of the announcement and consummation of the proposed business combination; (9) the ability to recognize the anticipated benefits of the proposed business combination, which may be affected by, among other things, competition, the ability of the surviving company to grow and manage growth profitably and retain its key employees; (10) costs related to the proposed business combination; (11) changes in applicable laws or regulations; (12) the demand for QT Imaging’s and the surviving company’s services together with the possibility that QT Imaging or the surviving company may be adversely affected by other economic, business, and/or competitive factors; (13) risks and uncertainties related to QT Imaging’s business, including, but not limited to, the ability of QT Imaging to increase sales of its output products in accordance with its plan; (14) risks related to the rollout of QT Imaging’s business and the timing of expected business milestones; (15) the effects of competition on QT Imaging’s business; (16) changes in domestic and foreign business, market, financial, political, and legal conditions; and (17) other risks and uncertainties included in (x) the “Risk Factors” sections of the most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC by GigCapital5 and (y) other documents filed or to be filed with the SEC by GigCapital5. The foregoing list of factors is not exclusive. You should not place undue reliance upon any forward-looking statements, which speak only as of the date made. GigCapital5 and QT Imaging do not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in their expectations or any change in events, conditions, or circumstances on which any such statement is based.

No Offer or Solicitation

This press release shall not constitute a solicitation of a proxy, consent, or authorization with respect to any securities or in respect of the proposed business combination. This press release shall also not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any states or jurisdictions in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.

Contacts
For QT Imaging, Inc.
John Klock, MD
John.Klock@qtimaging.com

For GigCapital5, Inc.
Brian Ruby
brian.ruby@icrinc.com

QT Imaging, the University of Illinois, and the Sunnybrook Research Institute Receive $3.1 Million National Cancer Institute Grant for Breast Cancer Treatment Monitoring

QT Imaging, the University of Illinois, and the Sunnybrook Research Institute Receive $3.1 Million National Cancer Institute Grant for Breast Cancer Treatment Monitoring 

The QTscan to be used to improve the assessment of tumor response in neo-adjuvant chemotherapy treatments

NOVATO, CA, October 13, 2022  – QT Imaging, Inc., a medical imaging company focused on the development and clinical adoption of novel products for breast cancer imaging, today announced the award of a five-year National Cancer Institute grant to study the progress of neo-adjuvant therapy for women with breast cancer using the QTscan. The grant will use QT Imaging’s Breast Scanning System enhanced with reflection back-scatter algorithms developed by the University of Illinois to assess tumor response to treatment in days rather than weeks or months. The study is a collaboration of Dr. James Wiskin, Principal Scientist at QT Imaging, Prof. Michael Oelze in the Department of Electrical and Computer Engineering at the University of Illinois Urbana-Champaign (UIUC), and Dr. Gregory Czarnota from the Radiation Oncology Department of the Sunnybrook Research Institute in Toronto, Canada.

Only some women benefit from early-stage chemotherapy for breast cancer. While there are tests to determine who is likely to benefit, there are no FDA-approved tests to determine if applying these early treatments is working other than long-term repeated standard medical imaging. This grant project is designed to use more accurate imaging technology and software to improve the assessment of the efficacy of these neo-adjuvant chemotherapy treatments. The QT Imaging system does not use ionizing radiation or contrast agents and can be safely used to image the breasts of women undergoing neo-adjuvant chemotherapy treatments at repeated short intervals to accurately (+ 0.2%) measure tumor volumes and quantify tumor state based on their sound speed and backscatter properties.

“Currently, if a breast cancer patient does not respond to the initial chemotherapy regimen, there may be little recourse for adjusting the therapy regimen to the benefit of the patient because the lack of response is not identified early on during the course of therapy. By identifying response or lack of response early on during the course of therapy, physicians will be able to adjust therapy approaches and thereby improve outcomes,” said Dr. Michael Oelze.

“We are encouraged by the continued high performance of QT imaging in breast imaging, and these results will demonstrate the clinical value of QT’s low frequency transmitted sound volography as a high-resolution imaging modality, specifically in the context of tumor monitoring and response to neo-adjuvant chemotherapy. We gratefully acknowledge the NIH-NCI in their generous acknowledgement of the potential of this unique confluence of technologies with Dr. Czarnota and Dr. Oelze, recognized leaders in their fields,” said Dr. James Wiskin, Principal Scientist at QT Imaging.

About QT Imaging, Inc.

QT Imaging™ is a privately held company engaged in the research, development, and commercialization of an innovative automated imaging system producing high-resolution transmission ultrasound images. The company has received FDA 510(K) clearance for its QT Imaging Breast Scanner. The company’s clinical trials have been conducted at prestigious institutions in the US and Europe, and the National Institutes of Health (NIH) has supported the development of the technology with over $18 MM in grants.

The QT Imaging Breast Scanner is indicated for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The QT scanner software also calculates the breast fibroglandular volume and total breast volume.  The device is not intended to be used as a replacement for screening mammography. FDA 510k K162372 and K220933

Contacts

Investors
Mikie Price
mikie.price@qtimaging.com

Media
Michaela Kalff
michaela.kalff@qtimaging.com

GigCapital5 and QT Imaging Sign an Exclusive Term Sheet for a Business Combination

GigCapital5 and QT Imaging Sign an Exclusive Term Sheet for a Business Combination

QT Imaging expected to be public in the first half of 2023

Palo Alto, CA & Novato, CA – October 3, 2022 – GigCapital5, Inc. (NYSE: GIA), a publicly traded special purpose acquisition company (“GigCapital5”), and QT Imaging, Inc. (“QT”), a medical imaging company that develops novel products for body imaging, announced today that they have entered into an exclusive, non-binding term sheet, with the goal of completing a business combination in the first half of 2023, resulting in QT becoming a publicly traded company.

QT is a vertically integrated medical imaging company in the business of manufacturing ultra-low frequency transmitted sound imaging systems for breast and body imaging. In 2014, QT purchased the assets of Techniscan Medical and relocated from Salt Lake City, Utah, to Novato, California. QT’s FDA-cleared breast scanner addresses critical deficiencies in the current breast imaging paradigm. The device is currently deployed in three U.S. and two foreign locations, and QT plans to place four additional scanners before the end of 2022. QT is entering a commercial growth phase and would use the proceeds of the merger to further expand its commercial activities.

“QT’s core mission is to provide safe, highly accurate and inexpensive imaging systems to women and children,” said John Klock, MD, Founder and CEO of QT. “Our broad-based medical imaging solution spans from breast scanning today to scanning infant body and orthopedics in the future. The combination and partnership with GigCapital5 will allow us to further deliver on our mission, accelerate our growth, and provide significant shareholder value as a public company.”

Dr. Avi Katz, Founding Managing Partner of GigCapital Global and Chairman of the board of directors of GigCapital5, commented: “We incepted GigCapital Global in 2017 as a lead sponsor of Private-to-Public Equity (PPE) TMT companies, also known as special purpose acquisition companies (SPAC), driven by the purpose of bettering our world and our planet. Our sixth PPE fund, GigCapital5, Inc. was incepted in September 2021 with special focus on sophisticated technologies, with emphasis on advanced medical equipment. We are delighted to partner with John and the QT team on their journey to the public market, as it represents a timely investment opportunity in the development of next-generation, radiation-free, patient-friendly, high resolution medical imaging technology. Hence, QT’s purpose and mission, FDA-cleared technology, global growth potential and substantial impact on health care make it an ideal target for GigCapital5. We look forward to supporting their transition to a public company and beyond.”

About GigCapital Global and GigCapital5, Inc.

GigCapital Global (“GigCapital”) is a Private-to-Public Equity (PPE) technology, media, and telecommunications (TMT) focused investment group led by an affiliated team of technology industry corporate executives and entrepreneurs, and TMT operational and strategic experts in the private and public markets, including substantial, success-proven M&A and IPO activities. The group deploys a unique Mentor-Investor™ methodology to partner with exceptional TMT companies, managed by dedicated and experienced entrepreneurs. The GigCapital Private-to-Public Equity (PPE) companies (also known as blank check companies or Special Purpose Acquisition Companies (SPACs)) offer financial, operational and executive mentoring to U.S. and overseas private, and non-U.S. public companies, in order to accelerate their path from inception and as a privately held entity into the growth-stage as a publicly traded company in the U.S. The partnership of GigCapital with these companies continues through an organic and roll-up strategy growth post the transition to a public company. GigCapital was launched in 2017 with the vision of becoming the lead franchise in incepting and developing TMT Private-to-Public Equity (PPE) companies. For more information, visit www.gigcapitalglobal.com or https://www.GigCapital5.com.

Additional Information and Where to Find It

If a definitive agreement is entered into in connection with the proposed business combination, GigCapital5 will prepare a proxy statement/prospectus (the “GigCapital5 proxy statement/prospectus”) to be filed with the Securities and Exchange Commission (the “SEC”) and mailed to GigCapital5’s stockholders. GigCapital5 and QT urge investors and other interested persons to read, when available, the GigCapital5 proxy statement/prospectus, as well as other documents filed by GigCapital5 with the SEC, because these documents will contain important information about the proposed business combination. Such persons can also read GigCapital5’s Annual Report on Form 10-K and 8-K Reports for more information on the security holdings of its officers and directors and their respective interests as security holders in the consummation of the transactions described herein. The GigCapital5 proxy statement/prospectus, once available, and GigCapital5’s other reports can be obtained, without charge, at the SEC’s web site (http://www.sec.gov).

Participants in the Solicitation

GigCapital5, QT, and their respective directors, executive officers and other members of their management and employees, under SEC rules, may be deemed to be participants in the solicitation of proxies of GigCapital5 stockholders in connection with the proposed business combination. Investors and security holders may obtain more detailed information regarding the names, affiliations and interests of GigCapital5’s directors and officers in its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, which was filed with the SEC on March 31, 2022. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies to GigCapital5’s stockholders in connection with the proposed business combination will be set forth in the proxy statement/prospectus for the proposed business combination when available. Information concerning the interests of GigCapital5’s and QT’s equity holders and participants in the solicitation, which may, in some cases, be different than those of GigCapital5’s and QT’s equity holders generally, will be set forth in the proxy statement/prospectus relating to the proposed business combination when it becomes available.

Forward Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. The expectations, estimates, and projections of the businesses of GigCapital5 and QT may differ from their actual results and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations with respect to entry into a definitive agreement for the proposed business combination, the satisfaction of the closing conditions to the proposed business combination, the timing of the completion of the proposed business combination and the future performance of QT, including the anticipated impact of the proposed business combination on this performance. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the control of GigCapital5 and QT, and are difficult to predict. Factors that may cause such differences include, but are not limited to: (1) the occurrence of any event, change or other circumstances that could give rise to the termination of the negotiations and any subsequent definitive agreements with respect to the proposed business combination, and the possibility that the terms and conditions set forth in any definitive agreements with respect to the proposed business combination may differ materially from the terms and conditions set forth in the term sheet, (2) the outcome of any legal proceedings that may be instituted against the parties following the announcement of the proposed business combination and any definitive agreements with respect thereto; (3) the inability to complete the proposed business combination, including due to failure to obtain approval of the stockholders of GigCapital5 and QT or other conditions to closing, including the failure of the stockholders of GigCapital5 to approve the extension of time for GigCapital5 to consummate its initial business combination at the upcoming annual meeting of stockholders of GigCapital5 that GigCapital5 intends to hold; (4) the impact of the COVID-19 pandemic on (x) the parties’ ability to negotiate and consummate the proposed business combination and (y) the business of QT and the surviving company; (5) the receipt of an unsolicited offer from another party for an alternative business transaction that could interfere with the proposed business combination; (6) the inability to obtain or maintain the listing of the surviving company’s common stock on the New York Stock Exchange or any other national stock exchange following the proposed business combination; (7) the risk that the proposed business combination disrupts current plans and operations as a result of the announcement and consummation of the proposed business combination; (8) the ability to recognize the anticipated benefits of the proposed business combination, which may be affected by, among other things, competition, the ability of the surviving company to grow and manage growth profitably and retain its key employees; (9) costs related to the proposed business combination; (10) changes in applicable laws or regulations; (11) the demand for QT’s and the surviving company’s services together with the possibility that QT or the surviving company may be adversely affected by other economic, business, and/or competitive factors; (12) risks and uncertainties related to QT’s business, including, but not limited to, the ability of QT to increase sales of its output products in accordance with its plan; and (13) other risks and uncertainties included in (x) the “Risk Factors” sections of the most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC by GigCapital5 and (y) other documents filed or to be filed with the SEC by GigCapital5. The foregoing list of factors is not exclusive. You should not place undue reliance upon any forward-looking statements, which speak only as of the date made. GigCapital5 and QT do not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in their expectations or any change in events, conditions, or circumstances on which any such statement is based.

No Offer or Solicitation

This press release shall not constitute a solicitation of a proxy, consent, or authorization with respect to any securities or in respect of the proposed transaction or the extension of time for GigCapital5 to consummate its initial business combination. This press release shall also not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any states or jurisdictions in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Contacts

For QT Imaging, Inc.
Meg Donigan  meg.donigan@qtimaging.com

For GigCapital5, Inc.
Brian Ruby  brian.ruby@icrinc.com

FDA Grants QT Imaging™ Clearance to Calculate Fibroglandular Volume of the Breast

FDA Grants QT Imaging™ Clearance to Calculate Fibroglandular Volume of the Breast
QTscan delivers safe, accurate monitoring of breast cancer treatment

Novato, CA – September 22, 2022 – The U.S. Food and Drug Administration (FDA) has granted QT Imaging, Inc. 510(K) clearance to calculate the fibroglandular volume (FGV) of the breast and the ratio of FGV to total breast volume (TGV). This ratio can contribute to an assessment of risk for breast cancer and changes in this ratio can be used to measure the efficacy of medication used to treat or prevent breast cancer.

Unlike traditional breast imaging modalities, the company’s QTscan™ does not require radiation, injection, or compression, and is highly accurate (+ 0.2%), allowing earlier and more frequent monitoring for women undergoing non-surgical breast cancer treatments such as adjuvant chemotherapy, radiation therapy, cryotherapy, and hormone or selective hormone receptor modulation treatments. No other ultrasound-based breast imaging modality is cleared by the FDA to quantify fibroglandular volume.

“The ability to determine a therapeutic clinical response using a quantitative volumetric method is crucial for effective and timely treatment of breast cancer and for patients at high risk for developing breast cancer who are receiving hormonal therapy. The FGV tool will allow this assessment to be made early and in follow-up to maximize treatment benefit, which is an exciting development for breast care patients,” said Dr. Elaine Iuanow, a Breast Imaging specialist and medical consultant for QT Imaging.

“We are excited to expand the tools available using low frequency transmitted ultrasound volography to serve women, especially those with dense breasts, providing an imaging option that is safe, comfortable, and effective,” said Dr. John Klock, CEO, Chief Medical Officer and Founder of QT Imaging, Inc.

The proposed indications for use, as designated by the FDA as breakthrough, are:
“The QT Scanner 2000 Model A is for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The QT Scanner 2000 Model A software also calculates the breast fibroglandular tissue volume (FGV) value and the ratio of FGV to total breast volume (TBV) value as determined from reflection-mode and transmission-mode ultrasound images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.” FDA K220933

About QT Imaging, Inc.
QT Imaging™ is a privately held company engaged in the research, development, and commercialization of an innovative automated imaging system producing high-resolution transmission ultrasound images. The company has received FDA 510(K) clearance for its QT Imaging Breast Scanner. The company’s clinical trials have been conducted at prestigious institutions in the US and Europe, and the National Institutes of Health (NIH) has supported the development of the technology with over $15 MM in grants.

The QT Imaging Breast Scanner is indicated for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.

QT Imaging Quantifies Changes in Breast Glandular and Ductal Volume During Menstrual Cycle

QT Imaging Quantifies Changes in Breast Glandular and Ductal Volume During Menstrual Cycle 

Novato, CA – September 8, 2022 – QT Imaging, Inc.,a medical device company focused on the development and clinical adoption of novel products for body imaging, announced findings of a study analyzing changes in breast glandular and ductal volume during the menstrual cycle for pre-menopausal, peri-menopausal and post-menopausal women. The results showed that glandular tissue has greater menstrual cycle variation in pre-menopausal breasts than in post-menopausal breasts, whereas ductal tissue does not have significantly more variation in pre-menopausal breasts than in post-menopausal breasts. The study, done in collaboration with the Dr. Susan Love Foundation, analyzed over 400 images of 24 women without any identified breast malignancy during their menstrual cycle.

The FDA-cleared QT Scanner was used to collect routine breast scans on women ages 18 to 71. These women were scanned weekly from six to ten times through at least two months of observation. The scanner was able to directly determine volumetric breast density and separate glandular and ductal tissue volumes. The glandular and ductal tissue variations for pre- and post-menopausal breasts were compared. This study provides a more accurate description of tissue changes during the menstrual cycle. These observations show quantitatively different behavior in glandular and ductal tissue in vivo and represents the first time that such an observation has been made.

Studies of normal glandular and ductal breast anatomy are important as they enable delineation of what is normal as a woman passes through puberty, menstruation, pregnancy, post-partum nursing, and menopause. Additionally, breast tissue glandular and ductal volumes can be important to measure in women on various hormone treatments for benign and malignant conditions, cancer prevention treatments and treatments of hormone-receptor positive cancers with hormones or SERMs. These results were reported at the SPIE Medical Imaging Conference, Feb. 2022, in San Diego.

Teresa Soler de Lara, Director of Research of the Dr. Susan Love Research Foundation, says “the study carried out by QT Imaging helps us understand the changes involved in the breasts during the menstrual cycle. This might ultimately aid and make better the early detection of the mechanisms that contribute to the development of breast cancer, making screening a more accurate process for all women.”

“Along with previously published comparative anatomic studies in breasts, these results demonstrate the viability of low frequency transmitted sound volography as a low-cost, high-resolution imaging modality of important clinical value,” said John Klock, MD, CEO and CMO at QT Imaging.

About QT Imaging, Inc.
QT Imaging™ is a privately held company engaged in the research, development, and commercialization of an innovative automated imaging system producing high-resolution transmission ultrasound images. The company has received FDA 510(K) clearance for its QT Imaging Breast Scanner, and the National Institutes of Health (NIH) has awarded over $15 million in funding to support QT Imaging research. The company’s clinical trials have been conducted at prestigious institutions in the US and Europe.

The QT Imaging Breast Scanner is indicated for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.

About Dr. Susan Love Foundation for Breast Cancer Research
Dr. Susan Love Foundation for Breast Cancer Research is dedicated to achieving a future without breast cancer by igniting visionary, collaborative research, and a distinctive approach to education.

National Cancer Institute Prostate Cancer Screening Study Indicates QTscan® Has Equal or Better Sensitivity Than MRI

National Cancer Institute Prostate Cancer Screening Study Indicates QTscan Has Equal or Better Sensitivity Than MRI 

Novato, CA – July 28, 2022 – QT Imaging, Inc., a medical device company focused on the development and clinical adoption of novel products for body imaging, today announced results of a National Cancer Institute study comparing the QTscan with 7-Tesla MRI for prostate cancer screening. In an initial series of 10 patients, blinded QT Imaging interpretation demonstrated equal or better sensitivity for detection of cancer compared with multi-parametric 7-Tesla MRI. The study was done in collaboration with the Urologic Oncology Branch, Center for Interventional Oncology National Cancer Institute, Bethesda, MD and the Department of Biomedical Engineering, Johns Hopkins University, Baltimore, MD.

On blinded sector-based analysis, QT’s low frequency transmitted ultrasound volography™ had a sensitivity of 85.7% and specificity of 93.9%, while mpMRI had a sensitivity of 65.3% and specificity of 96.6%. These results demonstrate that QT’s imaging technology has significant potential as a low-cost, high resolution imaging modality for prostate cancer.

From the Abstract: While multiparametric MRI (mpMRI) and targeted biopsy have improved detection of high-risk prostate cancer (PCa) over traditional B-mode gray scale ultrasound, use of mpMRI in the diagnostic pathway for PCa remains limited due to variability in image acquisition and interpretation, accessibility, and cost. Low frequency transmitted ultrasound volography, previously shown to have high sensitivity for the diagnosis of breast cancer, provides 360-degree submillimeter-resolution imaging for tissue characterization and cancer detection even in the presence of bone and air, and with limited view tomographic data. In this study, we sought to validate this technique for detection of prostate cancer by imaging ex vivo whole prostate specimens after radical prostatectomy, comparing lesion detection and visualization with low frequency transmitted ultrasound volography with mpMRI, and correlating imaging findings with wholemount histopathology.

Prostate specimens were collected from fifty-three patients undergoing Robot Assisted Radical Prostatectomy (RARP) for biopsy-confirmed PCa from February 2021 to February 2022. Thirteen of fifty-three prostate specimens had scanned and annotated histopathology slides and mpMRI scans; three were excluded for a history of androgen deprivation therapy or radiation. Of the remaining ten, the median age at surgery was 60 years [IQR 58.3-67.5] and median PSA was 6.85 ng/mL [IQR 5.78-8.73]. Six patients had Gleason Grade Group (GG) two cancer on RARP, one had GG 3, two had GG 4, and 1 had GG 5.

“These results demonstrate the clinical value of QT’s low frequency transmitted sound volography as a high-resolution imaging modality. We are encouraged by the continued high performance of QT imaging, especially in general anatomic and body imaging,” said John Klock, MD, CEO and CMO at QT Imaging.

These results were reported at three scientific meetings:
American Urological Association meeting Sept. 2021
Engineering and Urology Society 35th Annual Meeting, “2022 Best Abstract Award”, J. Enders
SPIE Medical Imaging, Feb. 2022

About QT Imaging, Inc.
QT Imaging™ is a privately held company engaged in the research, development, and commercialization of an innovative automated imaging system producing high-resolution transmission ultrasound images. The company has received FDA 510(K) clearance for its QT Imaging Breast Scanner, and the National Institutes of Health (NIH) has awarded over $15 million in funding to support QT Imaging research. The company’s clinical trials have been conducted at prestigious institutions in the US and Europe.

The QT Imaging Breast Scanner is indicated for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.

QT Imaging Announces Second Blinded Screening Trial Finding Non-Inferiority to Mammography

QT Imaging Announces Second Blinded Screening Trial Finding Non-Inferiority to Mammography

QT Imaging meets non-inferiority endpoint for mass detection when compared to conventional full field digital mammography (FFDM)

Novato, CA – July 20, 2022 – QT Imaging, Inc., a medical device company focused on the development and commercialization of novel products for medical imaging, today announced positive data regarding sensitivity and specificity of QT Imaging for mass detection from its second blinded Multi-Reader Multi-Case study. Statistical analysis was performed by Dr. Yulei Jiang, PhD of the University of Chicago Department of Radiology and completed this month.

Twenty-four breast radiologists participated in a study of 177 selected cases (32 normal cases and 147 with ground-truth lesions including cancers and benign masses). The study found that QT Imaging is non-inferior to FFDM in screening for breast cancer (positive call-backs) with -0.05 AUC margin.

“We are encouraged by the long-term and continued high performance of QT imaging, especially in women with dense breasts. Along with our previously published study results showing non-inferiority these trial results will be valuable for our FDA submission later this year for a screening indication in younger women with genetic risk factors and who do not qualify for mammography,”  said John Klock MD, CEO and CMO of QT Imaging.

“The findings are extremely exciting and set the stage for young women at high risk for developing breast cancer, who currently do not have a technology available to them for safe screening, to finally have a safe and effective method for breast screening evaluation,” according to Elaine Iuanow, MD a Boston-based Breast Imaging Specialist and President of Interpret4U, Inc., a consultant to QT Imaging.

About Dense Breast Imaging
The mammogram is less sensitive in women with dense breasts. According to the National Cancer Institute and the American Cancer Society, mammography has false negative rates of 15 per 100 women and up to 20%, with rates highest in women with dense breasts. Breast ultrasound is important as an adjunct technology particularly in women with mammographically dense breast tissue, where the lack of contrast between dense breast tissue and breast abnormalities renders the mammogram less accurate.

About QT Imaging, Inc.
QT Imaging is a medical device company committed to bringing novel imaging technologies for breast and body imaging to market. The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. QT’s strategy is predicated upon time- and cost-efficient imaging development, with the goal of delivering safe and effective imaging to patients with the utmost urgency.

US Capital Global Securities Launches $10MM Convertible Note Offering QT Imaging, Inc

US Capital Global Securities Launches $10MM Convertible Note Offering for QT Imaging, Inc.

US Capital Global Securities engaged as lead placement agent by innovative MedTech company developing new-paradigm ultrasound technology for breast cancer screening.

San Francisco, CA – March 31, 2020 – US Capital Global Securities LLC, an affiliate of US Capital Global, is offering to eligible investors an investment opportunity of up to $10 million in QT Imaging, Inc. (“QT Imaging”). Founded in 2012, QT Imaging is a privately held medical device company engaged in the research, development, and commercialization of innovative body imaging systems using transmitted low-energy sound, in contrast with traditional ultrasound which uses reflective sound.

The company’s first product, the QT Breast Scanner, is FDA-cleared for whole breast imaging. The technology can be used for medical screening, diagnosis, and as a treatment platform for image-guided procedures, including a novel approach to non-surgical treatment of early-stage breast cancer. QT Imaging’s next products, point-of-care orthopedic and infant imaging systems, aim to provide the first 100% safe body imaging systems.

With offices in San Francisco and London, US Capital Global is a full-service private financial group with an established track record in investment banking, asset management, and capital formation services. All securities are offered by the group through its FINRA-member, SEC-registered broker-dealer affiliate, US Capital Global Securities LLC.

“We are thrilled to be partnering with US Capital Global Securities on this $10 million convertible note offering,” said John C. Klock, M.D., CEO and Chief Medical Officer of QT Imaging. “US Capital Global has a reputation for supporting innovative medical and technological advancements, and we are proud to be presenting the industry with our unique NIH-funded, FDA 501(K) cleared transmission ultrasound technology utilizing 3D acquisition and reconstruction. This will go a long way to improve screening, diagnosis, and patient experience in breast and body imaging, all while lowering costs.

“95% of all mammogram positives are false positives, and for every person diagnosed with breast cancer, 19 more will receive abnormal results when nothing is wrong. The resulting cost, time, and psychological distress takes an enormous toll. We exist to change the paradigm of breast imaging and prevent women from undergoing the trauma of this ordeal.

“Our QTscan®, now proven in clinical trials to have better sensitivity and specificity, can safely identify the difference between benign and problematic tissue without the need for compression, injections, and potentially harmful radiation. The financing from this convertible note raise will allow us to secure additional clearances for our QTscan, fund production ramp up, and support improvements to the device, which will also accelerate development of our body imaging systems.”

Charles Towle, CEO at US Capital Global Securities, said: “QT Imaging is playing a vital role in the development of more advanced, accurate, non-invasive body scanning technology, and we are proud to support the company in its MedTech developments. QT Imaging competes in the large and growing medical imaging market, which is estimated at $40 billion globally and $10 billion in the United States annually. The company has already received recognition for its QT Scan and been awarded over $15 million in funding by the National Institute of Health to continue its product development. If you are interested in QT Imaging, the opportunity to participate in this $10 million convertible note offering is now open to eligible investors.”

About QT Imaging

QT Imaging is a privately held medical device company engaged in the research, development, and commercialization of innovative body imaging systems using low energy sound. This contrasts with traditional medical imaging using ionizing radiation (e.g., x-ray and CT) or magnetic fields (e.g., MRI), which may require contrast injections and specialized facilities. The company provides medical screening, diagnosis, and a treatment platform for image-guided procedures, including a novel approach to non-surgical treatment of early-stage breast cancer. Its clinical trials have been conducted at prestigious institutions in the US and Europe. The QT Breast Scanner will soon be available in Asia through a joint venture with TCL Healthcare Equipment and in Europe, the Middle East, and North Africa through a distribution arrangement with QT Scan, B.V.

About US Capital Global

US Capital Global Securities LLC (USCGS) is the FINRA-member broker-dealer division of US Capital Global that acts as placement agent for growth-stage companies, projects, and investment funds. Since 1998, US Capital Global has been committed to providing lower middle market businesses and investors with sophisticated debt, equity, and investment opportunities usually available only to larger middle market companies and institutional investors, using the latest FinTech and RegTech innovation. US Capital Global entities manage direct investment funds and provide wealth management and capital raise services. USCGS or its affiliates may provide advice to, be compensated by, or may from time to time acquire, hold or sell a position in the securities of the issuers mentioned herein. Any such offer or solicitation shall be made only pursuant to the confidential private placement memorandum. Private debt and equity investments are not suitable for all investors, are generally illiquid, offer no guarantee of returns, and subject investors to possible loss of principal. View USCGS’ Form CRS at www.uscgs.com/crs.html.

Transmission Ultrasound Breast Imaging to Become Available in EMEA Markets

Transmission Ultrasound Breast Imaging to Become Available in EMEA Markets

QT Imaging signs distribution agreement with Freedom Ventures for its FDA-cleared breast scanner

Novato, CA – January 7, 2021 – QT Imaging™, developer of the QTscan®, has selected Freedom Ventures B.V., as the exclusive distributor of its 3D breast imaging technology for the European, Middle Eastern and North African markets.  Freedom Ventures, a Dutch company which will do business as QT Scan BV, is well established in the field of medical devices, with an extensive network of distributers, and a Center of Excellence for technical, marketing, and clinical training.

“As a small company, working with an established distribution network provides us global market reach while being able to maintain the level of quality in marketing, sales, technical service, and most importantly patient care, that we have established in the US. Freedom Ventures has the experience to be that partner in this important region,” says Meg Donigan, Chief Operating Officer at QT Imaging.  Freedom Ventures will also assist QT Imaging in securing a CE Mark and manage the registration process in its markets.

The European medical imaging market, currently valued at $38 Billion, is expected to grow almost 10% annually over the next decade, with advancements in medical imaging technology driving that increased demand.  QT’s medical imaging technology generates 3D images with remarkable accuracy and precision, and the volumetric images are produced without the need of contrast injections or radiation.  The QTscan® is an FDA-cleared breast imaging tool, and the company will seek CE marking to provide confidence to the healthcare community that the device meets EU safety, health, and environmental protection requirements before market launch.

Rutger Brest van Kempen, CEO of Freedom Ventures, says “We’re very excited about the opportunity the radiation-free QTscan has to fill a unique need in the European breast imaging market where women are being screened later and less frequently due to concerns about radiation. In the Middle East and North Africa, this new technology will also be embraced for its ease of adoption as it requires no costly facilities or special licensing for operators. Hisham Hasaan, Freedom Ventures Vice-President for the Middle East and Africa says, “With QTscan we will have a huge opportunity to screen woman, who now have to travel far to hospitals where radiology equipment is available whereas our technologies can be installed virtually anywhere. We will focus on creating regional QTscan centers to bring this unique technology to the masses.”

About QT Ultrasound

QT Imaging™ is a privately held company engaged in the research, development, and commercialization of an innovative automated imaging system producing high-resolution transmission ultrasound images. The company has received FDA 510(K) clearance for its QT Imaging Breast Scanner, and the National Institutes of Health (NIH) awarded over $15 million in funding to continue QT Imaging research. The company’s clinical trials have been conducted at prestigious institutions in the US and Europe.

The QT Imaging Breast Scanner is indicated for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.

Quantitative Transmission Ultrasound Research Shows Better Performance than Mammography

Quantitative Transmission Ultrasound Research Shows Better Performance than Mammography

First-in-class, first-in-human study compares new breast imaging modality to digital mammography 

Novato, CA – January 5, 2021 – QT Imaging™, developers of the FDA-cleared QTscan®, has completed a first-in-class and first-in-human study of transmission ultrasound as a new imaging technology for breast health screening. The recently published study in Academic Radiology found that, compared to full-field digital mammography (FFDM), transmission ultrasound showed increased sensitivity, increased specificity, and lower recall rates.

Dr. John Klock, CEO and Chief Medical Officer of QT Imaging Inc., explains that “This research represents an important milestone because it’s the first time a novel technology was compared to the standard of care in breast imaging in a primary breast cancer screening setting. While we are very encouraged by a 4% higher sensitivity, meaning the new modality can detect more lesions, the results of 16% higher specificity for transmission ultrasound is extremely promising. To have the ability to know if a lesion is problematic or not can be a game-changer, resulting in reduced call backs, reduced biopsies, less anxiety for women, and perhaps even reduced healthcare costs.”

Transmission ultrasound is free of radiation, compression, and contrast injections, which makes it a safe, comfortable imaging experience for women of all ages. For younger women at high-risk for breast cancer, who do not qualify for x-ray mammography, it may provide a safer option that would allow them to have breast screening earlier and more often. QT Imaging will use this study, and additional ones, to secure FDA clearance for screening younger at-risk women under its FDA Breakthrough Device Designation.

While the published retrospective study shows that the inherently 3D nature of transmission ultrasound resulting in high resolution and high contrast-to-noise ratio makes it effective in evaluating breast tissue, a prospective study comparing true 3D transmission ultrasound to 3D breast tomosynthesis is warranted and will be published in the future. Based on learnings thus far, QT Imaging believes it is likely that transmission ultrasound will maintain its advantage in improved specificity and reduced callback rates.

Digital mammography has reduced mortality in the last couple of decades, but the industry now understands that interpreting mammographic images can be challenging in some scenarios, especially for women with extremely dense breasts. Advancements in the field will be welcome by healthcare professionals, imaging experts, and the women they serve.

About QT Imaging

QT Imaging™ is a privately held company engaged in the research, development, and commercialization of an innovative automated imaging system producing high-resolution transmission ultrasound images. The company has received FDA 510(K) clearance for its QT Imaging Breast Scanner, and the National Institutes of Health (NIH) awarded over $15 million in funding to continue QT Imaging research. The company’s clinical trials have been conducted at prestigious institutions in the US and Europe.

The QT Imaging Breast Scanner is indicated for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.

QT Ultrasound to Bring Breast Imaging Innovation to Asia Through Joint Venture with TCL Healthcare Equipment

QT Ultrasound to Bring Breast Imaging Innovation to Asia Through Joint Venture with TCL Healthcare Equipment

Common mission of safe, advanced, affordable medical imaging brings together international leaders 

Novato, CA – September 10, 2020QT Ultrasound®, developer of the QTscan®, will bring its radiation- and compression-free 3D breast imaging technology to China, and other Asian markets, through a partnership with TCL Healthcare Equipment. The Shanghai-based company focuses on medical imaging equipment with proven expertise in bringing innovative products to Asia.

QT Ultrasound focused on China for international expansion because China is the second largest medical device market in the world, following the United States. The market will continue to grow because the Chinese government is focused on improving healthcare access and outcomes by embracing technological innovation.  The QTscan is particularly advantageous for Asian women because of its ability to accurately image dense breasts; an estimated 70% of Asian women have dense breasts, for which mammography has proven to be less sensitive in identifying masses. Both companies believe China is a country where the QTscan can have a very positive impact on women’s healthcare.

“QT Ultrasound is excited to partner with TCL Healthcare to bring our safe, innovative breast imaging technology to China. This team has the knowledge, experience, and relationships to take the QT Ultrasound Breast Scanner from approval through commercialization. We could not have found better partners,” says QT Ultrasound’s CEO and Founder, Dr. John Klock.

Mr. George Chan, Chairman of TCL Healthcare, understands that for health care to help save more lives, it needs to be affordable, which became the company’s mission. Mr. Chan says, “The QT Ultrasound Breast Scanner is exactly the right technology at the right time and will further our goal of screening for common cancers, especially screening for women – quickly, safely, and affordably.”

QT Ultrasound and TCL Healthcare share ambitious goals for providing women across Asia access to the QTscan. They expect to quickly commercialize the QTscan in China’s healthcare institutions and become a leader in the rapidly growing, breast imaging arena.

About QT Ultrasound

QT Ultrasound® is a privately held company engaged in the research, development, and commercialization of an innovative automated imaging system producing high-resolution transmission ultrasound images. The company has received FDA 510(K) clearance for its QT Ultrasound Breast Scanner, and the National Institutes of Health (NIH) awarded over $15 million in funding to QT Ultrasound research. The company’s clinical trials have been conducted at prestigious institutions in the US and Europe.

The QT Ultrasound Breast Scanner is indicated for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast.

About TCL Healthcare Equipment

TCL Healthcare Equipment is an innovative supplier of medical imaging diagnostics and radiation oncology devices. With the vision of providing affordable healthcare to everyone, TCL Healthcare devotes itself to research and development, manufacturing and sales, aiming to provide comprehensive medical imaging and radiation therapy solutions.

QT Ultrasound Leaders to Present Breakthrough Research on Breast Imaging Technology

QT Ultrasound Leaders to Present Breakthrough Research on Breast Imaging Technology

CEO, John Klock, MD, and Principal Scientist, James Wiskin, Ph.D, Present Innovation in Quantitative Transmission Ultrasound

 

Novato, CA – February 10, 2020 – QT Ultrasound®, developers of the QTscan®, will be among the innovators in imaging technology to address audiences at some of the most influential industry events kicking off this new year.

Dr. Susan Love Foundation for Breast Cancer Research hosted the 10th International Symposium on the Human Breast on February 7 & 8, 2020 in Los Angeles. Dr. John Klock, CEO and Chief Medical Officer of QT Ultrasound, was part of the multidisciplinary and international group of iconoclastic researchers, clinical scientists, and advocates to formulate new technical approaches to the study of breast cancer. By facilitating this intimate, think-tank environment, the Symposium goals included stimulating ideation, collaboration and, ultimately, breakthroughs that will end breast cancer.

Dr. Klock’s presentation Making 3D Printed Models of Human Breast Tissues Using Transmitted Sound Imaging described how 3D image acquisition using transmission ultrasound can generate high-resolution datasets that can be used to 3D print specific tissue configurations from living subjects. Klock states that “this technology has many potential diagnostic and research applications.”

SPIE Medical Imaging 2020, the leading conference exploring the science of medical imaging, will host over 1,200 attendees, February 15-20, in Houston. Among the important scientific sessions planned will be four oral platform talks by QT Ultrasound. Dr. James Wiskin, Principal Scientist for the company, will be chairing the USCT and 3D Ultrasound Session and presenting on the latest advances in transmission ultrasound and related clinical applications. Presentations include:

  • Quantitative Breast Density (QBD) estimation with 3D transmission ultrasound and incomplete information
    •   Author(s): James W. Wiskin, Sanghyeb Lee, Martin Cwikla, Bilal H. Malik
  • Clustering-based quantitative breast density assessment using 3D transmission ultrasound
    •   Author(s): Bilal H. Malik, Sanghyeb Lee, James W. Wiskin
  • Limited view reconstructions with 3D transmission ultrasound tomography: clinical implications and quantitative accuracy
    •   Author(s): James W. Wiskin, Bilal Malik, Nasser Pirshafiey, John Klock
  • Orthopedic and myopathic imaging with 3D transmission ultrasound tomography: experimental verification, quantitative accuracy and clinical implications
    •   Author(s): James W. Wiskin, Bilal Malik, D. Borup, Veena Theendakara, John Klock

Life Science Intelligence (LSI) is hosting Emerging Medtech Summit 2020 February 18-20, 2020 in Dana Point, California and QT Ultrasound will be there among 100 other innovators, strategists, and thought leaders participating and working to build the future of MedTech.

About QT Ultrasound

QT Ultrasound® is a privately held company engaged in the research, development, and commercialization of an innovative automated imaging system producing high-resolution transmission ultrasound images. The company has received FDA 510(K)clearance for its QT Ultrasound Breast Scanner, and the National Institutes of Health (NIH) awarded over $15 million in funding for QT Ultrasound’s research. The company’s clinical trials have been conducted at prestigious institutions in the US and Europe and at the Marin Breast Health Trial Center in Novato, California. QTscans are now available commercially through the QTbreasthealth™ imaging center.

The QT Ultrasound Breast Scanner is indicated for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.

Quantitative Transmission Ultrasound to be Featured at Acoustical Society of America

Quantitative Transmission Ultrasound to be Featured at Acoustical Society of America

James Wiskin, Ph.D, QT Ultrasound’s Principal Scientist, invited to lecture on innovative technology

 

Novato, CA – May 13, 2019QT Ultrasound® has been invited to showcase an evolution in ultrasound technology at one of the most prestigious industry events. The Acoustical Society of America (ASA) has invited James Wiskin, Ph.D, Principal Scientist, to lecture at their 177th Meeting, taking place in Louisville, Kentucky, May 13-17.

In the special conference session, Inverse problems in Biomedical Ultrasound I, Dr. Wiskin will be presenting on “Full Wave 3D Transmission Tomography:  21st Century Technology for Whole Body Imaging”. Word has spread in the ultrasound community that QT Ultrasound’s clinical and research team have made remarkable strides in orthopedic and whole-body imaging. In support of those developments, the presentation will show quantitative accuracy of tissue parameters in the presence of bone and air (validated against literature values), previously thought to have been impossible. Further evidence will show the ability of Quantitative Transmission Ultrasound (QTU) to image regions which do not show up in Magnetic Resonance Images (MRI). Fusion with registered speckle free compounded reflection images leads to novel biomarkers for tissue and concomitant segmentation/classification algorithms.  This and the lack of ionizing radiation and contrast agents point towards QTU as a viable technology for whole body, breast and orthopedic imaging.

Fused QT Ultrasound 3D quantitative transmission ultrasound and compounded reflection axial images showing high resolution image of internal organs, tissue, skin and hair of neo-natal piglet. Anatomy courtesy of Dr. C. Ruoff, DVM.

Dr. Wiskin’s lecture will discuss the clinical value of 3D quantitative tissue characterization and how whole body and orthopedic images are constructed using inherently 3D reconstruction algorithms and 3D data.  Wiskin noted “I believe the clinical importance of 3D transmission ultrasound is understood by the ASA, which is the reason they sought out this presentation for their annual conference. It’s an honor to share our research findings and developments with scientists and engineers that are at the forefront of medical ultrasound research.”

Conference attendees are encouraged to attend this valuable educational session on Thursday, May 16, at 8:00AM.  QT Ultrasound’s quantitative imaging of tissue parameters by solving inverse scattering and related problems, will also be mentioned on May 15, at 2:05PM in an ASA summary lecture of recent notable developments in biomedical ultrasound.

QT Ultrasound’s technology has already received FDA 510(k) clearance for breast imaging for which the company’s research has demonstrated a higher degree of accuracy than mammography or handheld ultrasound at identifying certain breast structures and that it produces image contrast comparable to a typical MRI.

About QT Ultrasound

QT Ultrasound® is a privately held company engaged in the research, development, and commercialization of an innovative automated imaging system producing high-resolution transmission ultrasound images. The company has received FDA 510(K)clearance for its QT Ultrasound Breast Scanner, and the National Institutes of Health (NIH) awarded over $15 million in funding to continue QT Ultrasound research. The company’s clinical trials have been conducted at prestigious institutions in the US and Europe and include ongoing trials at the Marin Breast Health Trial Center in Novato, California. QTscans are now available commercially through the breast imaging centers of QTbreasthealth.

The QT Ultrasound Breast Scanner is indicated for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.

QT Ultrasound Delivers the First 3D Printing of Human Breast Microanatomy In Vivo

QT Ultrasound Delivers the First 3D Printing of Human Breast Microanatomy In Vivo

3D Transmission Ultrasound Technology Advances How We Look at Breast Health

  

Novato, CA – February 28, 2019 – QT Ultrasound, the developer of the only FDA-cleared transmission ultrasound breast imaging technology, has now created the first 3D printing of the breast duct system in a living woman, using its technology.

Transmission ultrasound can image microanatomy in living humans and can isolate human tissue types using speed of sound. QT Ultrasound’s first application of their technology is breast imaging and the QTscan™, was cleared for marketing by the FDA in 2017. Unlike traditional breast imaging, the QTscan has no radiation, no compression, and no injections, which makes it a welcome addition to the arsenal of breast health modalities. The technology produces high-fidelity detailed scans, providing clarity even for women with dense breasts.

Beyond the accomplishments of this new imaging modality the company has now demonstrated that the technology has the ability to produce 3D printed images of a person’s breast tissue-specific microanatomy. This is the first example of 3D printing of human breast tissue-specific microanatomy using any medical imaging modality and has the potential to be a new diagnostic tool, and a new way for physicians to visualize human health and disease.

 

 

“We are on a mission to change the paradigm of breast imaging.” Says QT Ultrasound’s CEO, Dr. John Klock. “Transmission ultrasound provides high definition imaging of breast tissue, and we’re excited to show why true 3D data acquisition and image reconstruction matters.  The benefits of being able to see breast tissue information in a true 3D volume, and then segment and isolate the tissue types, include new opportunities to examine the ductal network of the female breast, in ways we never could before.”

In 2018, the Food and Drug Administration (FDA) granted  QT Ultrasound Breakthrough Device designation for its QT Scanner, potentially offering new opportunities for earlier and more frequent screening for young women at high risk for breast cancer who have no available FDA-cleared screening options.

About QT Ultrasound

QT Ultrasound® is a privately held company engaged in the research, development, and commercialization of an innovative automated breast imaging system producing high-resolution transmission ultrasound images. The company has received FDA 510(K)clearance for its QTscan™, and the National Institutes of Health (NIH) awarded over $15 million in funding to continue QT Ultrasound research.  The company’s clinical trials have been conducted at prestigious institutions in the US and Europe and include ongoing trials at the Marin Breast Health Trial Center in Novato, California. QTscans are now available commercially through the breast imaging centers of QTbreasthealth.

The QT Ultrasound Breast Scanner is indicated for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.

 

Quantitative Transmission Ultrasound Featured Throughout SPIE Medical Imaging Conference

Quantitative Transmission Ultrasound Featured Throughout SPIE Medical Imaging Conference

QT Ultrasound’s principal scientists and technologists deliver five presentations at key industry event

 

Novato, CA – February 18, 2019 – Members of the QT Ultrasound® team of scientists and researchers have authored and co-authored five presentations to be delivered at SPIE Medical Imaging 2019, February 16-21.

The event is the internationally recognized premier forum for reporting state-of-the-art research and development in medical imaging and focuses on the latest innovations found in underlying fundamental scientific principles, to technology developments, scientific evaluation, and clinical application. During the conference, taking place in San Diego, quantitative transmission ultrasound technology will be among the cutting-edge research and innovations presented to attendees. Among those presentations is Radiologic-pathologic validation of transmission ultrasound tomography using microscopy with UV surface excitation (MUSE), findings that are an outcome of QT Ultrasound’s collaboration with UC Davis. Correlation of ultrasound tomography to MRI and pathology for the detection of prostate cancer is a presentation of findings that are a result of the company’s collaboration with the National Institutes of Health (NIH).

Mark Lenox, Ph.D, QT Ultrasound’s Chief Technology Officer, explains “this is an important opportunity for the company to present the only true 3D transmission ultrasound technology, and for the industry to understand the importance of this emerging trend.”

QT Ultrasound scientists, Bilal Malik, Ph.D and James Wiskin, Ph.D have also been invited to be part of the SPIE Program Committee for Ultrasound Imaging and Tomography, a substantial honor that places QT Ultrasound’s team members alongside esteemed scientists that are unquestionably considered the leaders in all aspects of ultrasound imaging.

Quantitative transmission ultrasound is an emerging trend and the only true 3D transmission ultrasound technology that uses biomarkers for early detection of breast masses – with no radiation and no compression. Transmission ultrasound together with reflection ultrasound provide highly complementary and synergistic information about breast tissue. With images that show clear information about breast tissue, QT Ultrasound’s goal is to identify what is benign and what is problematic.

Conference attendees are encouraged to participate in these valuable learning opportunities:

3D full inverse scattering ultrasound tomography of the human knee: 17 February 2019 • 4:10 – 4:30 PM

Correlation of ultrasound tomography to MRI and pathology for the detection of prostate cancer: 17 February 2019 • 3:50 – 4:10 PM

Accuracy of quantitative breast density (QBD) score based on 3D ultrasound tomography: 18 February 2019 • 5:30 – 7:00 PM

3D inverse scattering in wholebody ultrasound applications: 18 February 2019 • 2:40 – 3:00 PM

Radiologic-pathologic validation of transmission ultrasound tomography using microscopy with UV surface excitation (MUSE): 19 February 2019 • 9:00 – 9:20 AM

 

About QT Ultrasound

QT Ultrasound® is a privately held company engaged in the research, development, and commercialization of an innovative automated breast imaging system producing high-resolution transmission ultrasound images. The company has received FDA 510(K)clearance for its QTscan™, and the National Institutes of Health (NIH) awarded over $15 million in funding to continue QT Ultrasound research.  The company’s clinical trials have been conducted at prestigious institutions in the US and Europe and include ongoing trials at the Marin Breast Health Trial Center in Novato, California. QTscans are now available commercially through the breast imaging centers of QTbreasthealth.

The QT Ultrasound Breast Scanner is indicated for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.

 

QT Ultrasound® Presents Breakthrough Research Results on Quantitative Transmission Ultrasound

QT Ultrasound Presents Breakthrough Research Results on Quantitative Transmission Ultrasound 

Chief Medical Officer, Rajni Natesan, MD, MBA and Principal Scientist, Bilal Malik, Ph.D, will introduce cutting edge research at RSNA 2018

 

Novato, CA – November 24, 2018QT Ultrasound will be among the companies to address the audience at RSNA 2018. The 104th Scientific Assembly of the Radiological Society of North America (RSNA), a conference billed as “Tomorrow’s Radiology Today”, is one of the most important and well attended events by industry leaders, visionaries and game changers in medical imaging. Over 50,000 meeting attendees will get hands-on experience with cutting-edge technology and dive into the latest research, including QT Ultrasound’s quantitative transmission ultrasound.

QT Ultrasound’s Chief Medical Officer, Rajni Natesan, MD, MBA, will be delivering an oral presentation on the “Accuracy of Volumetric Measurements in the Breast: A Study Comparing Ultrasound Tomography and Hand-Held Ultrasound,” demonstrating the benefits of automated true 3D transmission ultrasound technology. This work speaks to the tremendous potential of this technology to accurately and quantitatively assess the volume of masses which, in the breast, can change over time, with implications in improving our estimation of tumor growth and furthering our understanding of tumor response to treatment.

QT Ultrasound’s Principal Scientist, Bilal Malik, Ph.D, will be leading a poster discussion on the “Detection of Calcification in the Breast Using Ultrasound Tomography: A Feasibility Study,” showing that certain calcifications can be effectively detected using the QT Utrasound platform.

Quantitative transmission ultrasound is an emerging trend and the only true 3D, transmission ultrasound technology that uses biomarkers for early detection of breast masses. Transmission ultrasound together with reflection ultrasound provide highly complementary and synergistic information about breast tissue. With images that show clear information about breast tissue, QT Ultrasound’s goal is to identify what is benign and what is problematic. The FDA-cleared QT Ultrasound Breast Scanner can image through dense breasts, with no radiation and no compression.

Conference attendees are encouraged to participate in this valuable learning opportunity.

Rajni Natesan, MD, MBA
Title: Accuracy of Volumetric Measurements in the Breast: A Study Comparing Ultrasound Tomography and Hand-Held Ultrasound
Section: Physics (Ultrasound in Imaging and Radiation Therapy)
Time: Sunday 11/25/2018, 11:15-11:25 AM

Bilal Malik, Ph.D
Title: Detection of Calcification in the Breast Using Ultrasound Tomography: A Feasibility Study
Section: Physics Poster Discussions
Time: Sunday 11/25/2018, 12:30-1:00 PM

About QT Ultrasound 

QT Ultrasound® is a privately held company engaged in the research, development, and commercialization of an innovative automated breast imaging system producing high-resolution transmission ultrasound images. The company has received FDA clearance for its QTscan, and the National Institutes of Health (NIH) awarded over $15 million in funding to continue QT Ultrasound research. The company’s clinical trials have been conducted at prestigious institutions in the US and Europe and include ongoing trials at the Marin Breast Health Trial Center in Novato, California. QTscans are now available commercially through the breast imaging centers of QTbreasthealth™.

The QT Ultrasound Breast Scanner is for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.

 

FDA Grants QT Ultrasound® Breakthrough Device Designation

FDA Grants QT Ultrasound® Breakthrough Device Designation

The FDA has designated the QT Ultrasound Breast Scanner as meeting an unmet medical need for screening women at high risk for breast cancer

 

 Novato, CA – October 31, 2018 – Today the Food and Drug Administration (FDA) granted  QT Ultrasound LLC’s Breakthrough Device designation request for its QT Ultrasound Breast QT Scanner-1.  Unlike traditional breast imaging modalities, the company’s QTscan™ has no radiation, no injections, and no compression, potentially offering new opportunities for earlier and more frequent screening for young women at high risk for breast cancer who have no available FDA-cleared screening options.

Women at high risk have a 20% lifetime risk of developing breast cancer.1 Causes include genetic factors, family history, and exposure to radiation. With one first-degree female relative, such as a mother or sister, diagnosed with breast cancer, a woman’s risk is doubled. Women who carry a mutation in their BRCA 1 or BRCA 2 genes have a 40-85% lifetime risk of developing breast cancer and are more likely to develop breast cancer at a younger age. 2 While only about 7% of women with breast cancer are diagnosed before the age of 40 years, the most aggressive form of breast cancer and the worst survival rates occur in younger women.3 However, routine mammograms are not recommended for women under 40 years old. Quantitative Transmission Ultrasound is an emerging trend in ultrasound technology that can see through dense breasts and uses no radiation, giving it the potential to have significant benefits for younger women at high risk. “Breast cancer screening is important for all women, but women who are at a higher risk of breast cancer may need to be screened earlier and more often than other women. We hope to provide an imaging option that is safe, comfortable, and effective.” Says Dr. John Klock, CEO and Founder of QT Ultrasound.

The proposed indications for use, as designated by the FDA as breakthrough are:

“The QT Ultrasound Breast Scanner is an ultrasonic imaging system that provides reflection-mode and transmission-mode images of a patient’s breast, without emitting ionizing radiation. The device is intended to be used as an initial evaluation method for asymptomatic women identified with above-average risk for developing breast cancer based upon genetic testing and/or other established criteria, who have not reached the age of mammography screening for their risk level in applicable breast cancer screening guidelines. Diagnostic work-up of findings may follow as clinically appropriate. The QT Scanner is not to be used as a replacement for standard screening mammography.”

The company will be working with the FDA to submit an appropriate pre-market submission.  If approved, the device may be legally marketed for use as a breast cancer screening device in younger women at high risk for breast cancer.

About QT Ultrasound

QT Ultrasound® is a privately held company engaged in the research, development, and commercialization of an innovative automated breast imaging system producing high-resolution transmission ultrasound images. The company has received FDA clearance for its QTscan™, and the National Institutes of Health (NIH) awarded over $15 million in funding to continue QT Ultrasound research.  The company’s clinical trials have been conducted at prestigious institutions in the US and Europe and include ongoing trials at the Marin Breast Health Trial Center in Novato, California. QTscans are now available commercially through the breast imaging centers of QTbreasthealth.

The QT Ultrasound Breast Scanner is for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.

1 American Cancer Society  2 Rethink Breast Cancer  3 NCBI

QT Ultrasound receives FDA clearance for new QTviewer

QT Ultrasound® receives FDA clearance for new QTviewer™

As part of the QT Ultrasound Breast Scanner the new viewer for true 3D breast images offers radiologists clarity, customizable views, faster response time, and powerful research mode.

 

Novato, CA – October 24, 2018QT Ultrasound LLC has received FDA 510(k) clearance for the latest update to their QT Ultrasound Breast Scanner – the new QTviewer. The QTviewer stores the breast images and allows them to be reviewed on a radiologist workstation. Coronal, axial and sagittal images for speed of sound and reflection modalities are generated for review by the radiologist. There are tools built into the QTviewer for further image analysis (such as correlate, probe, and region of interest) to aid in the diagnostic evaluation of the breast.

The latest release of the viewer software gives users more features which enable them to customize the viewer to their individual preferences. In addition, the QTviewer has been updated with new graphics rendering libraries that give it a faster response to making adjustment of window levels, and much more responsive pan and zoom functions.

Mark Lenox, Ph.D, QT Ultrasound’s Chief Technology Officer, explains that “one of the more exciting options of the new QTviewer is Research Mode, specifically targeted at the company’s many research collaborators. Research Mode allows researchers the ability to calculate doubling time to determine how much a tumor has grown in a certain amount of time – a critical calculation which assists in determining if a mass is a malignant tumor.” Another powerful feature of Research Mode is the ability to calculate and display the specific Quantitative Breast Density (QBD®) of the breast – something radiologists can typically only estimate. 

The QT Ultrasound Breast Scanner generates high fidelity 360° images of the breast with excellent image clarity. The elimination of harmful radiation and breast compression make the QTscan™ an important breast imaging modality for women.

About QT Ultrasound

QT Ultrasound® is a privately held company engaged in the research, development, and commercialization of an innovative automated breast imaging system producing high-resolution transmission ultrasound images. The company has received FDA clearance for its QTscan™, and the National Institutes of Health (NIH) awarded $16 million in funding to continue QT Ultrasound research.  The company’s clinical trials have been conducted at prestigious institutions in the US and Europe and include ongoing trials at the Marin Breast Health Trial Center in Novato, California. QTscans are now available commercially through the breast imaging centers of QTbreasthealth.

The QT Ultrasound Breast Scanner is for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.

FDA clearance granted to QT Ultrasound for new breast imaging device

FDA clearance granted to QT Ultrasound® for new breast imaging device

Transmission ultrasound technology provides 360° images and a new level of clarity for breast scans, without breast compression

 

Novato, CA – June 14, 2017QT Ultrasound LLC has received 510(k) marketing clearance from the U.S. Food and Drug Administration to market its Transmission Wave Ultrasound breast scanner. The company’s Transmission Ultrasound technology generates high fidelity 360° images of the breast with excellent image clarity. The elimination of radiation and breast compression make the QT scan™ an important additional breast imaging tool for physicians and the women they treat; at this time it is not intended as a replacement for screening mammography.

John Klock, M.D., founder and CEO of QT Ultrasound explains that the company’s recent publications have shown that Transmission Ultrasound technology is especially useful in seeing breast anatomy.

The company has initiated a broad-ranging clinical trial program designed to evaluate whether Transmission Ultrasound technology can (1) aid in the reduction of call-back and false-positive biopsy rates; and (2) replace screening mammography. “Our clinical trials are progressing to help us answer these important questions and learn how this new technology can make a difference in women’s health,” added Dr. Klock.

 

About QT Ultrasound

QT Ultrasound is a privately held company engaged in the research, development, and commercialization of transmission ultrasound technology. Their research has been supported by over $16 million in funding from the Cancer Imaging Program of the National Cancer Institute of the US National Institutes of Health.  The company’s clinical trials have been conducted at many prestigious institutions in the US and Europe and it is currently enrolling women in trials at the Marin Breast Health Trial Center in Novato, California.

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