Heartbeam Update: Device FDA Approved and Financing Completed
First cable free FDA Approved device that can measure at home 12 lead ECG
"We have fundamentally the first ever cable free 12 lead ECG for patients to use."
CEO Rob Eno
HeartBeam (NASDAQ: BEAT) stands at a transformative moment in cardiac monitoring technology, having achieved its first FDA clearance and positioning itself for significant growth in 2025 and beyond.
The company has created the first cable-free, credit card-sized 12-lead ECG device for personal use. The device uses a patented approach to capture heart signals in three directions and synthesize a full 12-lead ECG.
Below is an update to the previous article that was written by us on the company.
An updated slide deck and company video is available on their website here.
Revolutionary Technology Platform
HeartBeam's breakthrough lies in its credit card-sized device that captures heart signals in three directions using a novel resistive network. The technology enables hospital-grade cardiac monitoring through a personalized transformation matrix created during patient onboarding.
When a standard 12-lead ECG reading is taken alongside a HeartBeam reading, the system creates a unique transformation matrix specific to that patient, enabling accurate 12-lead ECG synthesis from all future readings.
This presents a unique advantage in patient monitoring not seen in any other IP on the market as all the cable free products available only allow for a single lead reading.
The Thesis
Having a twelve lead ECG available more rapidly in hospital settings, and in remote along with home settings, is something no other company can offer.
This will be a major innovation that will save lives.
Sudden cardiac events are one of the leading causes of death across the world.
Having information, that can result in faster treatment, means more lives saved due to over half of patients delaying treatment after experiencing heart symptoms.
Every moment of delay causes severe consequences:
When the heart is blocked, the affected heart muscle begins to die within 30 minutes. Without treatment, irreversible damage occurs within six hours, and after 12 hours, most of the affected heart tissue is permanently damaged.
For cardiac arrest, which can occur during a heart attack, survival decreases by approximately 10% for every minute that passes without CPR or defibrillation. After 10 minutes without intervention, survival chances are minimal.
Having an effective warning and diagnostic system that can be deployed anywhere is a gamechanger in terms of treatment.
Clinical Validation and FDA Progress
Recent studies, completed by the company, demonstrate the device matches standard 12-lead ECGs both quantitatively and qualitatively, with AI algorithms outperforming both single-lead ECGs, showing a 28% improvement in detecting atrial flutter compared to single-lead ECGs, and remarkably outperformed a panel of electrophysiologists looking at standard 12-lead ECGs.
Additionally, the system showed 40% greater accuracy than single hospital 12-lead ECGs for detecting coronary blockages when comparing baseline to symptomatic readings.
The company has emphasized that this milestone aligns with the company's vision to provide patients and physicians with an easy-to-use portable device that transforms cardiac monitoring and detection in remote, clinical, and hospital settings.
The company also plans to integrate AI-based algorithms in future advancements to further enhance cardiac care by reducing "symptom to door" times for heart attack treatment, addressing a critical focus area for the American Heart Association.
FDA Submission
The company recently announced on January 29th 2025 a significant milestone with the submission of a 510(k) application to the U.S. Food and Drug Administration (FDA) for its groundbreaking 12-lead electrocardiogram (ECG) synthesis software.
This innovative software is designed to assess various cardiac rhythms and arrhythmias, including sinus rhythm, atrial fibrillation, atrial flutter, bradycardia, tachycardia, and premature ventricular or atrial contractions.
The submission is supported by robust data from the VALID-ECG pivotal study, which enrolled 198 patients across five clinical sites.
The pilot study found excellent agreement when physicians diagnosed various arrhythmias utilizing the HeartBeam synthesized 12-lead ECG compared to a standard 12-lead ECG (Sensitivity: 94%, Specificity: 100%). Arrhythmias evaluated include sinus rhythm, atrial fibrillation, atrial flutter, and sinus with premature ventricular contraction (PVC) or premature atrial contraction (PAC).
Market Opportunity
The company has identified multiple vertical opportunities with potential partners aiming to replace or augment traditional 12-lead ECGs.
The initial target markets present substantial revenue potential:
1) The concierge medicine market with 1.5 million patients represents a $250-500 million annual revenue opportunity
2) The direct patient pay market, targeting 2.6 million potential customers with elevated cardiac risk in the top 5% income bracket, represents a $1.3-2.6 billion annual revenue opportunity
3) The hospital market, a multi-billion-dollar opportunity to replace traditional 12-lead ECG
4) Wearables, in which they replace or supplement products like the Apple watch and one time use single ECG patches
5) And finally, data monetization.
"We're starting with what we are calling direct patient pay... We're going to start with a focused direct sales and marketing operation in the US because we really want to prove the concept, really develop the playbook."
CEO Rob Eno
The company's strong IP protection, with 17 issued patents worldwide, makes it an attractive partner for these potential collaborations. It has a unique product that is found nowhere else on the market.
Financial Position
HeartBeam maintains robust financial discipline with (As of Sept 30, 2024):
No debt on the balance sheet
$5.8 million cash on hand
Operating cash burn of $3.3 million per quarter, aligned with key milestones
Closing its $10 million private placement, the company will not need to raise further funds until 2Q 2026 after the expected commercial launch of their product.
"The market cap for the company hovering around $60 million leaves a tremendous amount of opportunity for short-term and long-term appreciation. The company has no debt on the books and the company's maintained extremely strong financial discipline over the past years."
CFO Tim Khan
Commercialization Strategy
The company plans a focused commercial launch in select geographic markets initially, targeting both concierge medicine practices and direct patient marketing. The strategy involves building a proven playbook before broader expansion, with the flexibility to pursue either direct sales or strategic partnerships
The recent FDA clearance provides validation of the company's approach and sets the stage for commercial launch following the anticipated second FDA clearance in the third or fourth quarter of 2025
HeartBeam believes its patented technology creates a strong competitive moat.
"The proof is sort of in the pudding... It speaks to how strong enough of an IP we have in that space that there's really no way to synthesize a 12 BDCG without collecting the data that we do with our existing form factor."
Head of Product Richa Gujarati
Conclusion
Supported by strong clinical validation, FDA clearance, and robust intellectual property with 17 patents, HeartBeam is poised to disrupt healthcare markets worth over $100 billion. Its strategic focus on direct patient pay models, concierge medicine, and partnerships with wearable and medical device companies positions the company for significant growth. Combining AI-driven insights with personalized cardiac monitoring, HeartBeam aims to redefine the standard of care while improving patient outcomes and reducing healthcare costs.
This company is a microcap, but if it is successful, it won’t be one for long if their business plan comes to fruition.
If you enjoyed this write-up, please like and share. I don’t get paid to do this, so consider that my reward.
Also, if you have other ideas I should write about, my DM’s are always open on substack and Bluesky :)
All writeups are subject to our TOS
The 510k clearance has significant limitations that are not reflected in the article.
"The HeartBeam AIMIGoâ„¢ System does not provide any analysis of the ECG data nor provide any
recommendation toward a clinical diagnosis and is not intended to be used with automated ECG
analysis systems. "
"It reports a series of 3-lead ECG rhythm strips for manual interpretation. "
"Filters applied may impact the ECG signal morphology, including significant attenuation of lowlevel atrial activity (P-waves / Flutter-waves), which may result in inability to discriminate
certain types of arrhythmias"
"The ECG report produced by HeartBeam AIMIGo is not intended for analysis of the T-wave or
other morphological ECG evaluation."
Without the ability to analyze T-waves, there is no way to analyze myocardial infarctions which is the thesis of the company.
I am an amateur when it comes to healthcare investing. But to me, this was pretty compelling. Thanks for the great work on this write-up!