HeartBeam (NASDAQ:BEAT) said it submitted an FDA pre-submission for a heart attack detection indication as it advances clinical studies, begins an initial commercial rollout of its cardiac monitoring technology and works to reduce operating cash use.
Executive Chairman Richard Ferrari said the company’s platform uses its proprietary TriCor 3D signal reconstruction technology to capture ECG signals and generate clinical-grade 12-lead ECGs through several form factors, including a card-sized device, an ambulatory patch and a remote unit. The FDA has already cleared the company’s technology for arrhythmia assessment, while HeartBeam is pursuing an expanded indication for heart attack detection.
Heart Attack Detection Program Advances
HeartBeam did not provide an expected patient count for that trial, but Ferrari said management does not expect an “exorbitant” number of patients based on identified predicates and the proposed 510(k) pathway. The company said it is cautiously optimistic that it could begin the pivotal study before the end of 2026, subject to FDA feedback.
The company completed enrollment in its ALIGN-ACS pilot study in less than four months. The study enrolled 134 emergency department patients presenting with chest pain and compared conventional 12-lead ECG readings with those from HeartBeam’s card-based device. Ferrari said the results met criteria for a full presentation at the Transcatheter Cardiovascular Therapeutics conference later this year.
HeartBeam also said its 500-patient HEADSTART-ACS study in Indonesia had passed 50% enrollment in less than three months. The study, supported by the Indonesian government, is evaluating the technology’s accuracy in detecting heart attacks in a real-world setting. Founder and President Branislav Vajdic said the pilot work has provided both performance data and operational experience that the company expects to apply to a pivotal trial.
In addition, the company initiated a pilot study of its 12-lead ECG patch in about 50 patients. Ferrari said the patch is intended to support monitoring in emergency departments, hospitals and post-procedure care settings, where clinicians could obtain an on-demand 12-lead ECG without the traditional electrode-placement workflow.
Early Commercial Rollout Focuses on Concierge Practices
HeartBeam said it has begun its commercial launch, initially targeting concierge medical practices in New York, Dallas, South Florida and Southern California. Ferrari said the company has signed several agreements across those markets, shipped initial orders and begun onboarding patients.
The company’s offering includes a 24-hour reading service, which Ferrari described as a differentiator for patients and physicians. He said early implementation efforts have focused on refining workflows, including incorporating a baseline 12-lead ECG and HeartBeam device option into new-patient intake processes at concierge practices.
Chief Financial Officer Tim Cruickshank said the signed agreements currently represent potential access to thousands of patients, though he characterized the rollout as early-stage. Management said it expects greater visibility into order flow and adoption by the end of the third quarter and into 2027.
HeartBeam has previously cited approximately 30,000 patients as the level needed to reach cash-flow breakeven, Cruickshank said. He added that the figure could be lower under the company’s current cost structure. The company believes the four target geographies contain a sufficient pool of potential patients, but said the pace of adoption will depend on workflow integration and commercial momentum.
Ferrari said HeartBeam is also discussing pilots with larger integrated health networks, particularly for emergency department and post-procedure monitoring workflows. The company is prioritizing Indonesia as its only international market focus at present, beyond the U.S. market, as it evaluates how its remote unit could be incorporated into the Indonesian health system following the clinical study.
Cash Use Declines as Company Tightens Spending
HeartBeam reported net cash used in operating activities of $3.3 million in the second quarter, down 7% from the first quarter and down 3% from the year-earlier period. Cruickshank attributed the decline to tighter cost management, including pausing contractor projects not directly tied to key priorities, using artificial intelligence tools to improve efficiency and completing significant product development work on the card-sized system and patch prototype.
Executives and employees also elected to receive shares rather than cash for settlement of the company’s 2025 bonus program, reducing operating cash outflow by more than $1 million, according to Cruickshank.
The company expects baseline quarterly operating cash flow to decline to less than $2.5 million by the fourth quarter of 2026. That figure could rise if HeartBeam begins and rapidly enrolls a pivotal heart attack detection study, although the company expects customer cash receipts from the commercial launch to partially offset spending.
HeartBeam said it expects full-year 2026 operating cash outflows to come in below $14 million. Following an $11.5 million common-stock financing completed in April, the company reported $8.8 million in cash, cash equivalents and restricted cash as of June 30. Cruickshank said the lower cost profile has extended the company’s cash runway further into 2027.
Net loss for the second quarter was $5 million. The result included approximately $900,000 in one-time items related to a previously announced leadership transition, including $600,000 of non-cash stock-based compensation and $300,000 of severance accruals, the company said.
About HeartBeam (NASDAQ:BEAT)
BioTelemetry, Inc, a remote medical technology company, provides remote cardiac monitoring, remote blood glucose monitoring, centralized core laboratory services for clinical trials, and original equipment manufacturing services for healthcare and clinical research customers worldwide. It operates in two segments, Healthcare and Research. The Healthcare segment focuses on the remote cardiac monitoring to identify cardiac arrhythmias or heart rhythm disorders. This segment offers mobile cardiac telemetry services; and event monitoring services, which enable physicians to prescribe wireless event, digital loop event, memory loop event, memory loop event, and non-loop event monitors.
