HeartBeam (NASDAQ:BEAT) narrowed its third-quarter loss and reduced its cash outflow as it shifted resources toward heart attack assessment, executives said on the company’s earnings call. Management also outlined plans for a U.S. pivotal study that could begin as early as the end of 2026.
The company reported a net loss of $3 million for the quarter ended Sept. 30, compared with $5.3 million a year earlier. Operating expenses fell 35% year over year to $3.5 million, while cash used in operating activities declined 18% to $2.6 million.
Executive Chairman Richard Ferrari said heart attack detection is HeartBeam’s top strategic priority. The company has aligned with the U.S. Food and Drug Administration on a 510(k) regulatory pathway for heart attack assessment, although the design and size of the study intended to support its submission remain under discussion with the agency.
U.S. Study Design Still Under Review
Founder and President Branislav Vajdic said HeartBeam expects to complete the pivotal study design in the fourth quarter. The company has received FDA Breakthrough Device designation and entered the agency’s Total Product Life Cycle Advisory Program, or TAP, which management said has provided more frequent interaction with regulators and opportunities to engage with payers.
Ferrari said HeartBeam has proposed a statistical model to the FDA and estimates the study could include approximately 300 patients at eight to 10 centers. The company has not reached an agreement with the agency on the final size, and secondary endpoints have not been fully defined.
Management expects the trial to begin in the first quarter of 2027, potentially enrolling its first patient before the end of 2026. Ferrari said the study could finish around mid-2027, depending on its start date and size. Vajdic cautioned that the FDA’s response to the proposal could change the details.
Clinical Results Inform Planned Trial
Vajdic discussed results from ALIGN-ACS, a study of 132 adults at emergency departments in Belgrade, Serbia. Eight cardiologists independently interpreted HeartBeam recordings and standard 12-lead electrocardiograms, with the HeartBeam readings supported by a clinical decision-support system. Their interpretations were compared with each patient’s final diagnosis.
In assessing acute coronary syndrome, which includes heart attacks, HeartBeam’s specificity was 81.8%, compared with 71.4% for the standard ECG. Sensitivity was 60.2% for HeartBeam and 63.0% for the standard test, Vajdic said. For ST-elevation myocardial infarction, a time-sensitive type of heart attack, sensitivity was 82.9% and 83.8%, respectively.
Vajdic said the findings would help inform the U.S. study design. Separately, HeartBeam completed enrollment in October in its HEADSTART-ACS study of 486 patients in Indonesia. Data analysis is underway, with results anticipated at a cardiology conference in 2027.
HeartBeam is also developing artificial intelligence tools for its platform. Vajdic said an early internal analysis found that its AI identified more heart attacks than physicians reading the same HeartBeam recordings, at similar specificity. He emphasized that the findings are early and not peer-reviewed, and that the AI remains investigational and has not been FDA-cleared.
Cash Runway and Commercial Plans
Chief Financial Officer Tim Cruickshank said cash and equivalents were $6.1 million at quarter-end. HeartBeam subsequently raised approximately $4 million in net proceeds through its at-the-market facility, giving it a pro forma cash balance of about $10.1 million.
The company expects that balance, along with reductions in non-core spending, to extend its cash runway further into 2027. HeartBeam now forecasts full-year operating cash outflow of $12 million to $12.5 million, down from earlier guidance of less than $14 million. Cruickshank said an accelerated start to the pivotal study could add to fourth-quarter spending.
HeartBeam already has FDA clearance for arrhythmia detection, but Ferrari said large-scale monetization is not currently the focus. The company is working with concierge practices that purchase devices and provide them to selected patients, while it studies reimbursement, usage and prescribing patterns.
Asked about the approaching Nasdaq minimum bid compliance deadline, Cruickshank said the company was in communication with the exchange and expected an additional 180-day extension. He said management was focused on regaining compliance organically, while recognizing it would need to consider other measures if necessary.
About HeartBeam (NASDAQ:BEAT)
HeartBeam, Inc. is a medical technology company developing portable and digital solutions for cardiac monitoring. Its proprietary technology is designed to capture, analyze and transmit electrocardiogram (ECG) data outside traditional clinical settings, with a focus on helping identify cardiac events such as atrial fibrillation and heart attacks. The company’s flagship product is the HeartBeam AIMIGo system, which combines a compact, credit-card-sized ECG device with a smartphone application. The system is designed to record a three-dimensional, vector-based ECG and securely share the results with healthcare professionals for review.
