HeartBeam Reports Third Quarter 2024 Results

In This Article:

  • Continued Clinical and Regulatory Progress on the HeartBeam System

  • Key Appointments to Management Team Completed as Part of Planned Evolution in Preparation for US Commercialization

  • Strengthening Clinical Evidence Base, with Two Additional Studies to be Presented at the American Heart Association Conference in November 2024

  • Management to Host Webcast and Conference Call Today at 4:30 p.m. ET

SANTA CLARA, Calif., November 07, 2024--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, has reported its financial and operational results for the third quarter ended September 30, 2024.

Third Quarter & Subsequent 2024 Operational Highlights

The Company continues to make steady progress toward key clinical and regulatory milestones on the HeartBeam system.

FDA 510(k) Submission:

  • The 510(k) submission for the HeartBeam system continues to progress through active review by the FDA.

  • The Company has successfully responded to the questions asked by the FDA and is currently working through clarifications.

  • HeartBeam continues to be confident in FDA clearance as the Company works interactively through the process.

  • Upon the initial 510(k) clearance, the Company is prepared to start an Early Access Program to obtain important feedback on the use of the system by patients, prescribing physicians, and a cardiologist reader service.

12-Lead Synthesis Software FDA Submission:

  • HeartBeam has completed two pre-submission meetings with the FDA on the planned second 510(k) submission focused on the algorithms that convert the 360-degree signals captured by the HeartBeam system into a synthesized 12-lead ECG.

  • The Company currently anticipates submitting the 510(k) application soon after receiving clearance for the initial HeartBeam system.

  • Upon receiving 510(k) clearance for the 12-lead synthesis software, the Company anticipates initiating a limited commercial launch.

Key Appointments to Management Team Completed:

  • Long-planned evolution of the team in preparation for US commercialization.

  • Robert Eno appointed as Chief Executive Officer.

    • Mr. Eno is an industry leader who brings extensive experience in developing go-to-market strategies for breakthrough products and delivering growth.

    • Mr. Eno joined HeartBeam as President in January 2023 and will lead as the Company continues to work towards securing the foundational FDA 510(k) clearance for its vector-based technology and prepares for commercialization and growth.

  • Branislav Vajdic, Ph.D., Founder of HeartBeam, appointed as President.

    • Dr. Vajdic will be focused on innovating on the Company’s groundbreaking vector-based technology, driving research and development efforts, and advancing artificial intelligence (AI) applications.

  • Tim Cruickshank appointed as Chief Financial Officer.

    • Mr. Cruickshank brings more than 15 years of public company experience with a focus on growing businesses with disruptive technologies and taking clinical-stage companies to commercial operating entities.

  • Lance Myers, Ph.D., appointed as Chief Artificial Intelligence (AI) Scientist.

    • Dr. Myers is a pioneer in digital health data analytics and body-worn biosensor technologies, and was previously Head of Data Science at Verily (Google Life Sciences).

    • In this newly created position, Dr. Myers will play a pivotal role in guiding how AI is applied to the Company’s core technology.