Entered into Transformative Agreements with Icahn Mount Sinai
Filed FDA Pre-Submission Request to Change to 510(k) Submission from De Novo following Issuance of New Classification for AI ECG by FDA
To host conference call on Wednesday, October 25, 2023
Southlake, TX, Oct. 19, 2023 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (Nasdaq: HSCS; HSCSW) ("HeartSciences" or the "Company"), an AI-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced a conference call to update investors on recent key achievements and positive developments. The conference call will be hosted on Wednesday, October 25, 2023, at 9:00 AM ET.
- Executed license agreements with the Icahn School of Medicine at Mount Sinai (Icahn Mount Sinai), New York, covering the rights to 13 AI-based ECG/EKG algorithms, technologies and patent rights for the screening and diagnosis of cardiovascular disease. The agreements provide HeartSciences with an industry leading library of AI-based ECG algorithms. HeartSciences intends to deliver these algorithms using a cloud-based, hardware agnostic platform to be developed, allowing HeartSciences platform to accept ECGs from millions of existing ECG devices around the world as well as its MyoVista device. The Icahn Mount Sinai AI-based ECG algorithms were developed using a database of tens of millions ECG records enabling its leading researchers to develop a range of AI-based ECG algorithms using state-of-the art data science methods. Terms and requirements related to the agreements will be discussed on the investor call or can be found in HeartSciences’ recently filed S-1 at https://ir.heartsciences.com/sec-filings.
- The Company filed an FDA Pre-Submission Request on October 2, 2023, to change to a more standard 510(k) submission from the current and more complex De Novo submission process. The FDA recently cleared an industry first De Novo clearance and created a new Class II product code for cardiovascular machine learning-based notification software in respect of a hypertrophic cardiomyopathy algorithm. In late September 2023, the FDA cleared an algorithm for low ejection fraction (less than 40%) under the 510(k)-pathway using the new product code. Accordingly, we now believe it is probable that we could submit the MyoVista algorithm for clearance under the 510(k) pathway. The 510(k) pathway is more common than De Novo and, on average, has a much quicker decision process than De Novo by the FDA. We have formally filed the request with the FDA and expect a response in late Q4 2023.
Andrew Simpson, CEO of HeartSciences, said, "We believe recent announcements fundamentally transform and de-risk HeartSciences. Our agreements with Icahn Mount Sinai is a transformative event for the Company and provide HeartSciences with the largest AI-based ECG algorithm portfolio of any commercial organization.” Mr. Simpson adds, “The AI industry continues to make exciting progress, with the recent creation of a new FDA product classification for AI ECG algorithms which we expect to make clearance more structured and quicker under the 510(k) process. We believe AI-based ECG algorithms are the bridge that will finally allow front-line healthcare professionals to close the diagnostic gap and detect heart disease much earlier and at a lower cost.”
Conference Call and Webcast
HeartSciences will host a conference call on Wednesday, October 25, 2023, at 9:00 AM ET to discuss highlights of the collaboration agreement.
Participants may access the conference call live via webcast on the investor relations section of HeartSciences’ websites or via this link. Alternatively, you may access the live conference call by dialing 1-877-423-9813 (U.S) or 1-201-689-8573 (international) and using the conference ID: 13742271. An audio archive of the webcast will be available following the call on the Investors page at https://ir.heartsciences.com/.
About HeartSciences
Heart Test Laboratories, Inc. d/b/a HeartSciences is a medical technology company focused on applying innovative AI-based technology to an ECG (also known as an EKG) to expand and improve an ECG's clinical usefulness. Millions of ECGs are performed every week and the Company's objective is to improve healthcare by making an ECG a far more valuable cardiac screening tool, particularly in frontline or point-of-care clinical settings. HeartSciences' first product candidate for FDA clearance, the MyoVista® wavECG™, or the MyoVista®, is a resting 12-lead ECG that is also designed to provide diagnostic information related to cardiac dysfunction which has traditionally only been available through the use of cardiac imaging. The MyoVista® also provides conventional ECG information in the same test. The business model, which involves the use of the MyoVista® Device and consumables for each test, is expected to be "razor-razorblade" as the electrodes used with the MyoVista® are proprietary to HeartSciences, and new electrodes are required for every test performed.
For more information, please visit: https://www.heartsciences.com. Twitter: @HeartSciences
Safe Harbor Statement
This announcement 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. These forward-looking statements are made under the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and relate to the Company's future financial and operating performance. All statements, other than statements of historical facts, included herein are "forward-looking statements" including, among other things, statements about HeartSciences' beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences' Annual Report on Form 10-K for the fiscal year ended April 30, 2023, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 18, 2023, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended July 31, 2023, filed with the SEC on September 14, 2023, and in HeartSciences' other filings with the SEC at www.sec.gov. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
Contacts:
HeartSciences
Gene Gephart
+1-737-414-9213 (US)
info@heartsciences.com
Investors
Gilmartin Group
Vivian Cervantes
investorrelations@heartsciences.com
