HeartBeam Cuts Costs Awaits FDA Decision
HeartBeam (NASDAQ: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.
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.
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.
Source Fool.com
