HeartSciences sees cash runway through resubmission for FDA De Novo clearance

As a development-stage company, there were no meaningful revenues for the second quarter of 2023. As of October 31, 2022, cash and cash equivalents were $3.1M. The Company continues to carefully manage its expenses and believes it has sufficient capital to support operations through resubmission for FDA De Novo clearance. Andrew Simpson, CEO 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 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. Finally, HeartSciences was named as a top ten MedTech startup in 2022 by MedTech Outlook Magazine and we participated in a number of investor focused and industry related conferences to further increase awareness of HeartSciences and MyoVista. We believe HeartSciences’ is at the leading edge of bringing new clinical capabilities to the ECG. The problem we’re seeking to solve is well known. Millions of people with heart disease remain undiagnosed until some sort of event that could have been preventable through early detection. That’s why our MyoVista device is designed to significantly increase the clinical value of the ECG by detecting cardiac dysfunction at an early stage. Our objective is to become a fixture in front-line healthcare settings to help physicians make better and earlier referral decisions for at risk patients."