In April 2025, HeartBeam announced a strategic collaboration with AccurKardia to potentially add their FDA-cleared, automated ECG interpretation platform to our Product. Adding AccurKardia’s FDA-cleared, automated ECG interpretation platform to HeartBeam’s device will enhance HeartBeam’s commercial offering for arrhythmia assessment by enabling patients and physicians to get an automated rhythm assessment, which will facilitate a quicker diagnosis and faster access to clinical care when needed. The strategic collaboration is expected to expedite HeartBeam’s product development efforts, reducing both costs and timelines.
In addition, the Company also has an active AI program underway. We have acquired over six million standard 12L ECGs from various sources, a key element in our fast-paced AI development efforts. We believe that, when combined with our Products, these deep learning algorithms will provide additional value to patients and physicians in several ways.
The custom software and hardware of our Products are classified as Class II medical devices by the FDA. Premarket review and clearance by the FDA for Class II devices is generally accomplished through the 510(k) premarket notification process or De Novo process. Given the proposed intended use of our device, the 510(k) submission or De Novo process is expected to require clinical data to support future FDA clearances.
HeartBeam has 16 issued and 1 allowed U.S. patents (U.S. 10,433,744, U.S.10,117,592, U.S. 11,071,490, U.S. 11,419,538, U.S. 11,445,963, U.S. 11,701,049, U.S. 11,529,085, U.S. 10,980,433, U.S. 11,412,972, U.S. 11,234,658, U.S. 11,793,444, U.S. 11,877,853, U.S. 11,969,251, U.S. 12,207,908, U.S. 12,290,368, U.S. 12,402,823 and allowed U.S. app. no. 18/363,685). Outside of the U.S., HeartBeam holds seven issued patents across Japan, South Korea, Germany, France, the Netherlands, the United Kingdom and Australia, in addition to one European patent granted with unitary effect under Unitary Patent system.
As of September 30, 2025, we had 16 employees. We intend to strike a balance of managing our headcount in line with cash resources, while also, at the appropriate time, hiring or engaging additional full-time professionals, employees, and / or consultants in alignment with our growth strategy. Although the market is highly competitive for attracting and retaining highly qualified professionals in our industry, we continue our endeavor to find such candidates for our Company. Our management team and additional personnel that we may hire in the future will be primarily responsible for executing and implementing growth opportunities, making tactical decisions related to our strategy and pursuing opportunities to invest in new technologies through strategic partnerships and acquisitions.
Recent Developments
New and Existing Patent Assignments
We believe our intellectual property (“IP”) protects our innovations, and our goal is to become a leader in the ambulatory ECG sector. For some aspects of our proprietary technology, we rely on trade secret protection, while for others we pursue patent protection. It is our view that the combination of these two methods of IP protection maximizes our chances for success.
Thus far in 2025, we have been granted seven new U.S. patents relating to its compact, mobile three-lead cardiac monitoring technologies and automated diagnostics, methods for atrial fibrillation detection, and photoplethysmogram data analysis and presentation. Furthermore, the company has received a Notice of Allowance for an additional U.S. patent application directed to electrocardiogram patch devices and methods. These patents significantly strengthen HeartBeam’s intellectual property position surrounding its credit card–sized ECG device, reinforcing both the defensive and offensive moats around the company’s core technology. They also expand the application of risk-based diagnostic algorithms across HeartBeam’s wearable device portfolio and cover methods for automatically assessing a patient’s risk of an acute cardiac event by evaluating clinical risk factors and generating a diagnostic report.
In addition, HeartBeam continues to expand its intellectual property portfolio and has recently filed two non-provisional, two provisional and one continuing U.S. patent applications intended to further strengthen the protection of its proprietary technologies.
The Company now holds a total of twenty-four (24) issued patents worldwide, including sixteen (16) issued U.S. patents. Within the United States, the Company has one (1) allowed U.S. patent application and twelve (12) pending U.S. patent applications (including the allowed case). Outside of the U.S., the Company owns seven (7) issued patents across Japan, South Korea, Germany, France, the Netherlands, Australia, and the United Kingdom, in addition to one European patent granted with unitary effect under Unitary Patent system. In addition, there are twenty-two (22) pending applications in jurisdictions including Canada, China, the European Union, Japan, South Korea, and Australia. The issued patents are expected to expire between April 11, 2036, and April 21, 2042.
The Company’s issued and pending U.S. patent claims are directed to compact electrocardiogram (ECG) systems for remote detection and/or diagnosis of acute myocardial infarction (“AMI”). Outside of the U.S., the pending applications in the European Union, Canada (“CA”), Australia (“AU”), Japan (“JP”), South Korea (“KR”), and China (“CN”) generally correspond to the Company’s U.S. filings.