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HeartBeam Accelerates Heart Attack Detection Program
"Every 40 seconds, someone suffers from a heart attack, and we believe HeartBeam's technology, incorporating our signal capture technology TriCor, is the best way to evaluate the real extent of that trauma in a wireless format," said Rich Ferrari, Executive Chairman of HeartBeam. "Our heart attack detection program is where we are accelerating the fastest. We completed ALIGN-ACS enrollment ahead of schedule, with data analysis underway, and will be presenting full results of the pilot study at TCT 2026 this fall. These results are intended to inform the design of our U.S. pivotal study as we continue to work collaboratively with the FDA on a submission to expand our indication for heart attack assessment."
Company Expects Q4 2026 Cash Outflow Below $2.5 Million
Third quarter 2026 cash outflow is expected to be in line with the second quarter of 2026, due to the short-term impact of updating the Company's cost structure. Baseline fourth quarter 2026 operating cash outflow is expected to step down to below $2.5 million, with cash receipts from customer contracts expected to reduce this further. Full year 2026 net operating cash outflow is now expected to be below $14.0 million, a further reduction from the Company's previous guidance. Cash runway is extended further into 2027 and aligned with the achievement of key milestones.
HeartBeam Secures New Patent Expanding ECG Device Capabilities
HeartBeam announced the allowance of a new U.S. patent that significantly expands the capabilities of its credit card-sized, cable-free ECG device. The patent covers the integration of acoustic sensing and thoracic impedance measurement into the existing ECG hardware platform, supporting future applications in structural heart disease and heart failure monitoring. The new capabilities protected by the patent are promising for enabling earlier identification of structural irregularities in the heart valves and signs of fluid accumulation for heart failure patients without requiring a new form factor. The patent covers the integration of acoustic sensors into the foldable arms of the HeartBeam device, enabling the use of the device as a "digital stethoscope." The sensors are intended to capture the sounds produced when the heart's valves open and close, including the mitral and tricuspid valves, which generate characteristic sounds that reflect how the heart is functioning mechanically and structurally. The patent also covers thoracic impedance measurement - the ability to inject a small, imperceptible current through the device's finger electrodes and measure the resulting voltage across the chest electrodes to assess how much fluid is present in the chest. HeartBeam's patent protects this capability in the Company's portable, patient-operated device. Unlike wrist- or finger-worn wearables, HeartBeam's device is used at the chest - the anatomically relevant location for both heart-sound and thoracic-impedance measurement. The allowed patent claims protect this capability as built into HeartBeam's device, positioning the platform where these signals are physiologically accessible.
HeartBeam Completes Patient Enrollment in ALIGN-ACS Study
HeartBeam announced completion of patient enrollment in its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection. Enrollment was completed ahead of the Company's previously communicated third quarter 2026 timeline. "Completing enrollment ahead of schedule reflects both the quality of the study design and the operational discipline our team has built, providing us a strong foundation as we move into pivotal study planning," 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. We look forward to sharing full results later this year and advancing this program with the same discipline and pace our team has demonstrated throughout this study."
HeartBeam Announces Reorganization to Enhance Market Reach and Capital Efficiency
The company states: "HeartBeam announced a reorganization to prioritize global market reach and capital efficiency while accelerating execution. The company has aligned its operations around focused implementation teams which will be led by Branislav Vajdic, Ph.D., Founder and President, and Rich Ferrari, Executive Chairman. The teams are focused on a single goal: to provide every at-risk cardiac patient access to HeartBeam's groundbreaking technology. This structure streamlines decision-making, improves accountability, and enables leadership to concentrate resources on achieving key milestones while maintaining disciplined management. The reorganization is expected to sharpen the Company's focus on delivering results and create a meaningfully lower cost structure. As part of these changes, Robert Eno, former Chief Executive Officer, will transition to a consulting role for HeartBeam. The company received FDA marketing clearance for its synthesized 12-lead ECG signal for arrhythmia assessment in December 2025 giving physicians a familiar format they already trust. The company believes this unique capability will be critical to adoption in many use cases."
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