HeartBeam (BEAT) Company Report

HeartBeam will attend the JP Morgan 2026 Annual Healthcare Conference from January 12-15, 2026, for off-site meetings with investors and potential commercialization and co-development partners.
The company recently received US Food and Drug Administration (FDA) 510(k) clearance for its cable-free synthesized 12-lead ECG software for at-home arrhythmia assessment.
This technology allows patients to obtain a synthesized 12-lead ECG for arrhythmia from home, which is then reviewed by a board-certified cardiologist.
HeartBeam plans to initiate a limited U.S. commercial launch in Q1 2026 with select concierge and preventive cardiology practices.

Jan 5, 2026, 12:00 PM

HeartBeam Receives FDA Clearance for 12-Lead ECG Synthesis Software

BEAT

Product Launch

New Projects/Investments

HeartBeam (NASDAQ: BEAT) announced FDA 510(k) clearance for its 12-lead electrocardiogram (ECG) synthesis software for at-home arrhythmia assessment, granted after a successful appeal.
The cable-free technology synthesizes a 12-lead ECG from 3D electrical signals, allowing patients to obtain clinically meaningful ECG data for arrhythmia assessment from home.
The company intends to initiate a limited U.S. commercial launch in Q1 2026, targeting select concierge and preventive cardiology groups.
This clearance is a pivotal milestone that enables the company to pursue heart attack detection, advance an extended wear patch, and develop AI-based screening and prediction algorithms.

Dec 10, 2025, 12:00 PM

HeartBeam Reports Q3 2025 Financial Results and Provides Commercialization Update

BEAT

Earnings

Product Launch

New Projects/Investments

HeartBeam reported a net loss of $5.3 million, or $0.15 per basic and diluted share, for Q3 2025.
The company anticipates receiving FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment by the end of 2025, which is expected to be a major inflection point for initial commercialization early next year.
Net cash used in operating activities was under $3.2 million in Q3 2025, representing an 8% decrease quarter over quarter.
HeartBeam ended Q3 2025 with $1.9 million in cash and cash equivalents and is confident in its strategic funding approach to achieve near-term milestones while minimizing shareholder dilution.
The company has partnered with HeartNexus for on-demand cardiologist review services and plans a controlled market entry focusing on concierge and preventive cardiology practices in Southern California and South Florida.

Nov 13, 2025, 9:30 PM

HeartBeam Reports Q3 2025 Financials and Anticipates Q4 2025 FDA Clearance for 12-Lead ECG Synthesis Software

BEAT

Earnings

Product Launch

Guidance Update

HeartBeam reported a net loss of $(5,255) thousand and EPS of $(0.15) for Q3 2025.
Net cash used in operating activities decreased 8% quarter-over-quarter to $3.2 million for Q3 2025, with cash and cash equivalents of $1,856 thousand as of September 30, 2025.
The company anticipates FDA 510(k) clearance for its 12-Lead ECG Synthesis Software for arrhythmia assessment in Q4 2025.
Commercial readiness plans are accelerating in anticipation of FDA clearance, with upcoming milestones including hiring a Chief Commercial Officer, signing commercial agreements, and a pilot commercial launch into two US geographies.
ROTH Capital initiated coverage on HeartBeam with a Buy rating and a $4 price target.

Nov 13, 2025, 9:30 PM

Heartbeam Inc. Presents Commercialization Strategy and Product Pipeline at Investment Conference

BEAT

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Heartbeam Inc. has developed the first cable-free ECG capable of synthesizing a 12-lead ECG, having received foundational FDA clearance in December 2024 and anticipating a second clearance for the 12-lead synthesis algorithm by the end of 2025.
The company plans to launch into the concierge medicine market by the end of 2025, estimating a serviceable market of up to $500 million in recurring revenue.
Heartbeam reported a cash balance of $8.2 million as of March 31, 2025, and completed an $11.5 million common stock public offering in February 2025.
The company expects margins to exceed 70% over time and believes it can reach breakeven with approximately 10% penetration in its initial target regions, or just over $20 million in revenue.
Future opportunities include an expanded indication for heart attack detection, with potential FDA clearance in 2027, and an on-demand 12-lead patch.

Aug 19, 2025, 4:25 PM

HeartBeam Reports Second Quarter 2025 Results

BEAT

Earnings

Guidance Update

Product Launch

HeartBeam reported a net loss of $5.0 million for the second quarter of 2025, which was consistent with the net loss for the second quarter of 2024.
As of June 30, 2025, the company's cash, cash equivalents, and short-term investments totaled $5.1 million. Net cash used in operating activities for the three months ended June 30, 2025, was $3.4 million, representing a 23% decrease quarter-over-quarter.
The company continues productive discussions with the FDA regarding the 510(k) submission for its 12-lead ECG synthesis software, with clearance still anticipated by the end of the year.
HeartBeam is actively executing on commercial readiness plans, with commercialization expected to begin upon receiving the 510(k) clearance for the 12-lead ECG synthesis software.