HeartBeam (BEAT) reported its Q2 2025 results on July 16, 2025, reaffirming key regulatory and commercial milestones and announcing a 23% sequential decrease in cash burn to $3.4 million. The company finished with a $5.1 million cash balance and remains on track for FDA clearance of its 12-lead ECG synthesis software in Q4 2025, which will trigger its pilot commercial launch in Florida and Southern California, targeting direct-pay patients in concierge practices.
FDA clearance process advances as HeartBeam targets year-end milestone
After securing foundational FDA 510(k) clearance in December 2024 for its system, HeartBeam’s second 510(k) application, covering the synthesis software enabling 12-lead ECG output, remains under active review with anticipated clearance by Q4 2025. This milestone is pivotal as it unlocks commercialization and is supported by clinical validation data (VALID e ECG study), which met pre-set performance goals.
"We continue to expect clearance for the software by the end of the year. This clearance will be a watershed event for HeartBeam, and these two clearances together will form the product with which we'll start our initial commercialization."
-- Rob Eno, Chief Executive Officer
HeartBeam has developed the only personal cable-free ECG device capable of producing a synthesized 12-lead ECG and is awaiting FDA clearance for its synthesis software, expected by year-end, differentiating it from current single-lead remote solutions and providing the foundation for recurring, high-margin revenue.
Capital discipline and cost reductions extend HeartBeam runway
With fewer than 20 employees at quarter-end, management reported a 23% decrease in net operating cash outflows from the previous quarter, with baseline recurring expenditures reduced to $3.1 million, which is 11% lower than the historic baseline of $3.5 million per quarter. Actions such as temporary executive-compensation deferral further address near-term liquidity while minimizing dilution risk, crucial as the company remains pre-revenue.
"net cash used in operating activities of $3.4 million, a 23% decrease from the previous quarter. Inside that number is a baseline recurring expenditure of $3.1 million which is 11% lower than the historic baseline I've talked about of $3.5 million per quarter. The additional $300,000 we spent to go from $3.1 to $3.4 was related to investments in commercial readiness activities and manufacturing capabilities in preparation for the pilot launch and all of the activities that Rob walked you through on the previous slide. Additionally, following the end of Q2, the company has continued to take measures to extend our runway by further decreasing cash burn over the course of 2025."
-- Tim Cruickshank, Chief Financial Officer
This aggressive cost management, combined with disciplined financing and an emphasis on dilution minimization, demonstrates prudent oversight and improves flexibility as HeartBeam approaches key inflection points.
HeartBeam ecosystem development underpins go-to-market strategy
In preparation for launch, HeartBeam selected Florida and Southern California for its pilot, targeting the direct-pay concierge segment, and began working with AccuCardia to integrate its automated arrhythmia algorithm, which will require a subsequent FDA submission but is not gating to the initial rollout. Management estimates a $250 million to $500 million annual recurring revenue opportunity from one-third penetration of 1.5 million U.S. concierge patients (non-GAAP), with early pricing models supporting an initial gross margin of approximately 50% and long-term recurring margins above 70%. This approach provides a pathway to demonstrate clinical and financial value to strategic partners.
"Our initial commercialization is focused on patients paying directly for the technology. We plan to reach these patients through concierge and preventive cardiology practices. We estimate there are 1.5 million patients with concierge medicine in the US. And assuming just one-third have elevated cardiac risk, a family history, or are interested in the latest cardiac monitoring technology, that's between $250 and $500 million in annual recurring revenue as an initial segment."
-- Rob Eno, Chief Executive Officer
Looking Ahead
Management reiterated the Q4 2025 target for FDA clearance of the 12-lead synthesis software, immediate commencement of pilot commercial launches upon clearance, and submission to the FDA for AccuCardia integration in Q4 2025. The initial commercial rollout will be limited to Florida and Southern California concierge practices, with full pricing and business model details to be announced within three months as launch nears.
