Business
HeartSciences Provides Business Update and Reports Second Quarter Fiscal 2023 Financial Results
Patient Enrollment Close to Completion and Continue to Target FDA De Novo Resubmission Around Current Fiscal Year End Southlake, Texas, Dec. 16, 2022 (GLOBE
About this update from Heartsciences Inc.
[{"type":"text","content":"Patient Enrollment Close to Completion and Continue to Target FDA De Novo Resubmission Around Current Fiscal Year End\nSouthlake, Texas, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), a medical technology company focused on saving lives by making an ECG (also known as an EKG) a far more valuable screening tool through the use of Artificial Intelligence (AI), today provided a business update and reported financial results for the fiscal 2023 second quarter ended October 31, 2022. Andrew Simpson, Chief Executive Officer of HeartSciences, stated, “Since our initial public offering in June 2022, we have achieved a number of important milestones which add to HeartSciences’ strategic value as we progress towards commercialization of the MyoVista®. Resubmission for FDA De Novo clearance is our main priority and we are close to completing enrollment for our pivotal validation study and have also enrolled additional enrichment study patients to provide extra data. We continue to target an FDA De Novo resubmission around the current fiscal year end, assuming positive results.” “We strengthened our intellectual property portfolio with the grant of a U.S. patent for ECG quantification of echocardiographic measures of diastolic function of the heart using AI methods, as well as the grant of a European patent covering our proprietary electrode and connector system. Additionally, The American Medical Association issued new industry-first Category III Current Procedural Terminology (CPT®) codes covering novel AI assistive algorithmic ECG risk assessments for cardiac dysfunction, which would include the MyoVista®.” “Furthermore, earlier this month, we entered into an important multi-year collaboration agreement with Rutgers University to develop AI-based algorithms, which we expect will accelerate our development pipeline for further expanding the clinical value of an ECG. Additionally, an independent study utilizing our proprietary MyoVista® technology was published in Advocate Aurora Health’s Journal of Patient-Centered Research and Reviews, which concluded that the MyoVista® technology ECG-derived machine learning model provides a cost-effective strategy for predicting patient subgroups with a high-risk of major adverse cardiovascular events (MACE)....