Aug. 14, 2025 — During HeartBeam, Inc.'s second quarter 2025 earnings conference call, the medical technology company announced its financial and operational results for the quarter ending June 30, 2025.
Among the 2025 operational highlights, the company reported it continues to make significant progress toward commercial readiness, along with key clinical and regulatory achievements on the HeartBeam System.
12-Lead ECG Synthesis Software FDA Submission:
- Productive discussions are ongoing with FDA on 510(k) submission for the 12-lead ECG synthesis software in arrhythmia assessment.
- Timeline for FDA clearance remains firmly on track, expected by the end of the year.
- Presented results from pivotal VALID-ECG study in April, demonstrating that HeartBeam successfully met the clinical endpoints, with a 93.4% overall diagnostic agreement indicating that the synthesized 12-lead ECG can support diagnosis of arrhythmias in a manner consistent with standard 12-lead ECGs.
Commercial Readiness Plans:
- Anticipate initiating commercialization upon receiving 510(k) clearance for the 12-lead ECG synthesis software.
- Executing on commercial readiness plans, including finalizing cardiology reader service to provide on-demand cardiologist reviews of synthesized 12-lead ECGs and triage patients.
- Established infrastructure for customer service, contract manufacturing, and logistics and fulfillment efforts.
- Proximity to FDA Clearance and commercialization is intensifying business development activity.
- Expanded the business development team with recognized industry expert.
“In the quarter, we continued to engage in positive and productive discussions with the FDA on the 12-lead ECG synthesis software submission for arrhythmia assessment and we continue to anticipate clearance by the end of the year. As we have discussed, that clearance, together with our foundational clearance, will form the basis for our commercial launch,” said Robert Eno, Chief Executive Officer, HeartBeam.
Other Highlights:
- Abstract on HeartBeam AI algorithm accepted for presentation at HRX Live 2025 in September.
- New international patent issued, increasing the Company’s moat around its core technology; total of 21 issued patents worldwide.
- Received two additional industry recognitions, adding to the growing list of recent industry recognitions:
- Awarded the Innovation Award in Remote Cardiac Diagnostics as part of the 2025 Medical Device Network Excellence Awards for its groundbreaking ECG technology.
- Named finalist in 2025 Octane High Tech Awards, which recognizes innovators, entrepreneurs and technology leaders with a presence in Orange County.
“We continue to make significant progress with commercial readiness plans, which is positioning us for a successful launch following 510(k) clearance of our 12-lead synthesis software.
“Additionally, we are seeing a marked increase in interest from industry partners as we get closer to our 12-lead ECG synthesis clearance and commercialization. We believe these players understand that HeartBeam’s technology is transformative and is an ideal platform in the form of a cable free ECG that produces a synthesized 12-lead ECG output. There are multiple ways for partners to get involved in the HeartBeam ecosystem, including data and AI, companion products and services, and complementary diagnostics and treatments.
“Our vision for the near future is to bring additional capabilities of a synthesized 12-lead ECG into patients’ hands outside of the healthcare setting. One of the most important trends in medicine today is the movement of medical grade devices from the hospital and clinic to the patient. Accurate, connected, medical grade technologies have been shown to expand access, reduce healthcare costs and enable personalized medicine. Within cardiac diseases there is a major gap and a huge opportunity. Cardiac diseases are the leading cause of death worldwide and most cardiac events, whether arrhythmias or ischemia, happen outside of the healthcare setting. Diagnosing these events is crucial for patients and for the healthcare system and we believe that as we implement our vision, our technology will be well positioned to accomplish this,” concluded Eno.
July 08, 2025 
