Business
HeartSciences Provides Business Update and Reports First Quarter Fiscal 2023 Financial Results
Nearing Completion of Patient Recruitment in FDA Pivotal Clinical Validation Study of MyoVista® Remains on Track for MyoVista® FDA De Novo Resubmission in
About this update from Heartsciences Inc.
[{"type":"text","content":"Nearing Completion of Patient Recruitment in FDA Pivotal Clinical Validation Study of MyoVista® Remains on Track for MyoVista® FDA De Novo Resubmission in Current Fiscal Year Southlake, Texas, Sept. 13, 2022 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), a medical technology company focused on applying innovative AI-based technology to an ECG (also known as an EKG) to significantly expand and improve an ECG’s clinical usefulness by detecting cardiac dysfunction, today provided a business update and reported financial results for the fiscal first quarter ended July 31, 2022.Andrew Simpson, Chief Executive Officer of HeartSciences, commented, “We are nearing completion of patient recruitment for the FDA pivotal clinical validation study of the MyoVista® wavECG™ device with over 500 patients recruited out of an overall target of 550 patients. We expect to report study results following its completion. Assuming a successful outcome, we remain on track to resubmit for FDA De Novo clearance in the current fiscal year.” “We are seeking to address one of the most significant needs in healthcare by making an ECG a far more valuable cardiac screening tool. The growing body of published ECG research demonstrates that ECGs can have far greater clinical value. Our first device, the MyoVista, leverages AI machine learning to detect cardiac dysfunction that cannot be diagnosed by current conventional ECGs and its technology has been the subject of several published studies in elite cardiology journals. As a result, we believe we are positioned at the forefront of what is expected to be a new era for ECGs.” “The Company has benefited from approximately $60 million of investment to date and has built an extensive intellectual property portfolio. We intend to continue to add patents to further strengthen our long-term IP protection as we move towards commercialization. Ultimately, our goal is to make MyoVista the new standard of care, particularly in the frontline or point-of-care clinical setting. In fact, according to Allied Market Research, the global ECG market was valued at $8.3 billion in 2020 and is projected to reach $18.4 billion by 2030.” “Furthermore, during the first quarter of fiscal 2023, we completed our initial public offering with gross proceeds of a...