BEATW 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-13

• We believe we have created the most info-rich ambulatory ECG signal available, led by our patented 3D signal technology. It is one platform, with many form factors. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intellig…

• The Company is focused on executing on a $40 billion cardiac monitoring platform opportunity, going after a patient pool of more than 50 million people across multiple applications and form factors.

• Our initial form factor and service offering is the HeartBeam System. The HeartBeam System is the first U.S. Food and Drug Administration (“FDA”) cleared cable-free, ambulatory synthesized 12-lead ECG that captures the heart’s electrical signals from three dimensions for high-fidelity data collectio…

• HeartBeam’s credit card sized 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the additional 12-Lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 2025. During the six months ended June 30, 2025 and June 30, 2026, the Hear…

• Future form factors include the 12-Lead Patch and a ruggedized, industrial form factor for rural and international usage.

相对上期删除的文字 · 来源:10-Q · 2026-05-13

• Our initial product and service offering is the HeartBeam System. The HeartBeam System is the first U.S. Food and Drug Administration (“FDA”) cleared cable-free, ambulatory synthesized 12L ECG that captures the heart’s electrical signals from three dimensions for high-fidelity data collection and ad…

• HeartBeam’s credit card sized 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the additional 12-Lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 2025. During the three months ended March 31, 2025 and March 31, 2026, the …

• We are focused on advancing several key initiatives as part of our growth strategy:

• Limited Launch: On the back of our recent FDA Clearance for the HeartBeam System, we are initiating a market introduction in early 2026, focusing on select concierge and preventive cardiology groups that have proactively signaled strong interest in adopting HeartBeam’s technology. This limited marke…

• Heart Attack Detection: We are pursuing an expansion of our cleared indications for heart attack detection, supported by compelling proof-of-concept data and representing a major expansion opportunity to tens of millions of patients in the U.S.

相对上期新增的文字 · 来源:10-Q · 2026-08-13

• As a smaller reporting company, we are not required to provide the information required by this Item. We do not hold any derivative instruments and do not engage in any hedging activities.

相对上期删除的文字 · 来源:10-Q · 2026-05-13

• We do not hold any derivative instruments and do not engage in any hedging activities.