HeartBeam reports Q4 FY22 financial results

HeartBeam, Inc., a cardiac technology company that has developed the first and only 3D vector electrocardiogram (VECG) platform for heart attack detection anytime, anywhere, has reported its financial and operational results for the fourth quarter and full year ended December 31, 2022.

Fourth quarter and subsequent 2023 operational highlights

• Strategic acquisition (the “Acquisition”) of substantially all assets from LIVMOR, a digital health solutions company providing a patient-engaging remote monitoring system of critical physiological biomarkers, including FDA-cleared Halo+™ Atrial Fibrillation Detection System and physician-prescribed Integrated Patient Care Platform deployed within the Dallas, TX VA Healthcare System
• Acquisition includes 3 issued United States patents, LIVMOR’s business contracts and relationships as well as all Samsung watch and tablet inventory
• Partnered with Evolve Manufacturing to build HeartBeam AIMIGo 12-Lead 3D vector electrocardiogram device, positioning HeartBeam AIMIGo for early market testing in Q4 2023 after anticipated FDA clearance
• Granted European patent for signal transformation from vector electrocardiogram to 12-Lead electrocardiogram, offering protection for HeartBeam’s flagship technology in multiple countries in Europe
• Received new patent for 12-Lead electrocardiogram smartwatch-based monitor intended for detection of heart attacks and complex cardiac arrhythmias
• Appointed senior medical technology executive Robert Eno as President to enhance HeartBeam’s strategic operations and capabilities
• Announced Robert Eno will assume the duties and responsibilities of Executive Vice President and Chief Business Officer Jon Hunt, Ph.D., who stepped down from his position and transitioned to the role of strategic advisor and consultant
• Appointed Peter J. Fitzgerald, MD, PhD, a renowned Stanford cardiologist with deep clinical, research, and industry expertise, as Chief Medical Officer

Management commentary
“In our first year as a public company, 2022 was focused on advancing our product launch timeline for the HeartBeam AIMIGo 12-Lead 3D vector electrocardiogram device and HeartBeam AIMI™ platform,” said Branislav Vajdic, PhD, Chief Executive Officer and Founder of HeartBeam. “Throughout the fourth quarter and into 2023, our movement toward production and commercialization of our products was underscored by a series of milestones including new acquisitions, partnerships, IP protection, and a strengthened management team. We continue to have strong conviction in our HeartBeam AIMI software platform technology and HeartBeam AIMIGo, and their potential to offer more accurate heart attack detection and expedite treatment. As we look toward FDA clearance for HeartBeam AIMI, we are also making significant progress with our core HeartBeam AIMIGo product as we prepare for FDA submission early this year.

“Most recently we announced the acquisition of LIVMOR’s intellectual property and technology, including 3 US patents and the Halo+™ Atrial Fibrillation (AF) Detection System. The Acquisition extends our reach in remote monitoring and detection with full ownership of an existing cutting-edge FDA-cleared product. The Halo+™ AF Detection System is the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring. The Halo system provides continuous monitoring of pulse rhythms for the detection of AF on-demand during the day and automatically overnight. The Acquisition is a natural fit and extension of our successful partnership with LIVMOR and our complementary goals to dramatically improve patient outcomes and to significantly reduce healthcare system costs.

“In the fourth quarter we partnered with Evolve Manufacturing Technologies, a contract medical device manufacturing company, to build the credit card-sized HeartBeam AIMIGo 3D vector electrocardiogram recording device that provides a 12 lead ECG readout for remote heart attack detection. Evolve has deep medical device manufacturing expertise and a strong reputation in the industry for delivering consistent product quality and customer care rarely found in medical contract manufacturers. We can now leverage Evolve’s manufacturing and packaging expertise to support commercialization of the HeartBeam AIMIGo device following expected FDA Clearance.

“The recent issuance of two patents provided further intellectual property protection for our technologies. An initial European patent strengthens IP for the HeartBeam AIMIGo technology offering 12-lead ECG capability, as we expand our product applications to reach a variety of regions in the global marketplace. In the fourth quarter, we also received a U.S. patent for a 12-lead electrocardiogram smartwatch-based monitor intended for detection of heart attacks and complex cardiac arrhythmias. The breakthrough inventions protected by this patent enable our proprietary 3D VECG technology to be built into a smartwatch, offering 12-lead ECG capability enabling heart attack and complex arrhythmia detection in a wearable device. We believe this patent may prove to be one of the most valuable, and we continue to expand on our granted and pending core patents for remote heart attack detection.

“Operationally, we recently welcomed Robert Eno to the newly created position of President. Rob is a passionate and visionary senior executive with over 28 years of experience creating go-to-market strategies for multiple breakthrough products. He plays a key role in our strategic direction, commercialization efforts, and day-to-day operations. We also welcomed Peter J. Fitzgerald, MD, PhD, as Chief Medical Officer. One of the world’s preeminent opinion leaders in cardiology and digital health, Peter is now playing a major role in defining best paths to adoption, clinical strategies, and partnerships to advance our products in the market.

“Looking ahead into 2023, our next milestones on the commercialization path include FDA submission for the HeartBeam AIMIGo 3D VECG first-generation product and FDA clearance for HeartBeam AIMI, both expected in the near future. We have continued to engage in positive discussions with strategic institutions, including academic centers, regional healthcare systems, and regional community hospital systems. We also plan to focus in 2023 and 2024 on the expansion of our core technology features, the 3D VECG data and clinical studies that we believe will establish our platform as the standard of care for ambulatory-based cardiology and taking advantage of the comprehensiveness of our technology. We look forward to providing updates on our progress in the months ahead,” concluded Dr. Vajdic.

Key anticipated ,ilestones

• HeartBeam AIMI
  • FDA Submission Completed – Q3 2022
  • FDA Clearance – Q2 2023
  • Limited Market Release – Q3 2023

• HeartBeam AIMIGo
  • FDA Submission V1 – Q2 2023
  • FDA Clearance V1 – Q3 2023
  • Limited Market Release V1 – Q4 2023
  • FDA Submission V2 – Q4 2023
  • FDA Clearance V2 – Q1 2024
  • Limited Market Release V2 – Q2 2024

Fourth quarter & full year 2022 financial results
Research and development expenses for the fourth quarter of 2022 were $1.6 million, compared to $96,000 for the fourth quarter of 2021. For the year ended December 31, 2022, Research and development expenses increased to $5.7 million compared to $255,000 the prior year.

General and administrative expenses for the fourth quarter of 2022 were $2.1 million compared to $1.2 million for the fourth quarter of 2021. For the year ended December 31, 2022, G&A expense increased to $7.4 million compared to $2.0 million in the same period of 2021.

Net loss for the fourth quarter of 2022 was $3.7 million, compared to a net loss of $2.1 million for the fourth quarter of 2021, and $13.0 million for the full year 2022 compared to $4.4 million in the year ago period.

Cash totaled $3.6 million as of December 31, 2022, compared to $13.2 million as of December 31, 2021. Business Wire