HeartBeam, Inc. (NASDAQ: BEAT) has secured a new U.S. patent that expands the capabilities of its credit card-sized, cable-free ECG device by integrating acoustic sensing and thoracic impedance measurement. This technology aims to support future applications in structural heart disease and heart failure monitoring without requiring a new form factor. The patent reinforces the company's intellectual property portfolio, bringing its total to 26 issued patents worldwide.

The newly patented acoustic sensors are integrated into the foldable arms of the HeartBeam device, allowing it to function as a "digital stethoscope." These sensors capture sounds produced when the heart's valves, such as the mitral and tricuspid valves, open and close. This capability is designed to help physicians identify structural irregularities and assess how the heart is functioning mechanically.

The patent also covers thoracic impedance measurement, which involves injecting a small, imperceptible current through the device's finger electrodes and measuring the resulting voltage across the chest electrodes. This process assesses fluid levels in the chest, a critical metric for managing heart failure. Unlike wrist- or finger-worn wearables, HeartBeam's device is positioned at the chest, the anatomically relevant location for accurate measurement.

Heart failure affects nearly 6.7 million adults in the U.S. and costs an estimated $30,000 per patient annually. A major challenge in managing the condition is that patients accumulate fluid over days before symptoms become severe enough to require hospitalization. Earlier detection of fluid buildup could enable physicians to intervene with medication adjustments before hospitalization becomes necessary.

"Continuous fluid monitoring remains a major challenge in heart failure care," said John L. Jefferies, MD, MBA, MPH, FACC, FAHA, Professor at the School of Public Health, University of Memphis. "A non-invasive, patient-operated approach to thoracic impedance measurement could broaden access to meaningful home monitoring for a much larger population of heart failure patients."

Branislav Vajdic, Ph.D., President and Founder of HeartBeam, emphasized the strategic importance of the patent. "This patent not only deepens our IP foundation but also advances our strategy of building a multi-modal ambulatory cardiac sensing platform," he said. "The ability to detect fluid congestion and assess heart valve function from the same credit card-sized device patients already use for ECG rhythm monitoring may support future reimbursement pathways and broader clinical adoption."

The acoustic sensing and thoracic impedance capabilities described in the patent are investigational and not FDA cleared. The company's existing 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and its 12-Lead ECG synthesis software received clearance in December 2025.

Patent Portfolio and Technology Scope

HeartBeam's 26 issued patents span signal acquisition, ECG synthesis algorithms, diagnostic applications, and device hardware. The portfolio covers both the HeartBeam System and its investigational on-demand 12-lead patch.

HeartBeam, Inc. (NASDAQ: BEAT) announced the completion of patient enrollment in its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection. Enrollment was finished ahead of the company’s previously communicated third quarter 2026 timeline. The medical technology company is shifting its strategy to license its 3D ECG signal technology to established partners to accelerate global adoption, while advancing toward heart attack detection as a key platform expansion.

The study enrolled 120 patients presenting with chest pain in the emergency department across two clinical sites in Belgrade, Serbia. Patients were evaluated with both a standard 12-lead ECG and the HeartBeam System, with physician assessment for acute coronary syndrome compared against an independently adjudicated clinical-data-based gold standard. Data analysis is currently underway, and the company plans to present the results at a major cardiology conference in the coming months.

HeartBeam’s 3D ECG technology is designed to allow patients to record a clinical-grade ECG at the onset of symptoms, wherever they are. This capability aims to shorten symptom-to-door times and support faster, more informed care decisions outside a clinical setting. Heart attacks remain a leading cause of death in the United States, with millions of patients at elevated risk.

"Completing enrollment ahead of schedule reflects both the quality of the study design and the operational discipline our team has built," said Branislav Vajdic, Ph.D., Founder and President of HeartBeam. "We believe the data from the ALIGN-ACS pilot study will be an important input into our discussions with the FDA, and we are evaluating whether this milestone supports a more accelerated path toward an expanded indication for heart attack detection."

Results from the pilot study are intended to inform the design of a planned pivotal study in the United States and support a future FDA submission seeking to expand the HeartBeam System’s indication beyond arrhythmia assessment to include heart attack assessment. The company will use learnings from the pilot, together with prior proof-of-concept data recently published in JACC: Advances, to inform upcoming discussions with the FDA regarding the design and scope of the pivotal program.

The company has aligned its operations around focused implementation teams led by Branislav Vajdic, Ph.D., and Rich Ferrari, Executive Chairman. HeartBeam holds over 20 issued patents related to technology enablement and previously received FDA clearance for its 3D ECG technology for arrhythmia assessment in December 2024.