AI Analysis | Feedback

Here are 1-3 brief analogies to describe HeartBeam:

• AliveCor, but with advanced 3D ECG technology specifically designed for remote heart attack detection.
• Teladoc, but for urgent cardiac diagnostics, allowing patients to send doctors a detailed 3D heart scan from home.
• Dexcom, but for urgent heart attack diagnostics, enabling doctors to receive crucial 3D data from a patient's home.

AI Analysis | Feedback

• HeartBeam AIMIGo™ System: A credit-card sized device that captures 3D vector ECGs, enabling patients to remotely monitor and transmit clinical-grade heart data during cardiac symptoms.
• HeartBeam 12L Patch: A disposable patch that allows for convenient self-collection of diagnostic-quality 12-lead ECGs from home, providing comprehensive cardiac data for physicians.

AI Analysis | Feedback

HeartBeam (BEAT) sells primarily to other companies, specifically healthcare providers and institutions that utilize advanced cardiac diagnostic tools.

As of its current stage of commercialization, HeartBeam has not publicly identified or disclosed specific "major customer companies" by name in its SEC filings or investor presentations. The company is focused on market penetration and establishing its presence within the healthcare sector. Therefore, while its customers are other companies (B2B), specific named entities that could be listed as major customers are not publicly available.

Generally, its target customers for its 3D vector electrocardiogram (VECG) platform and related devices include:

• Cardiology clinics and practices
• Hospitals and emergency departments
• Telehealth platforms and integrated delivery networks

AI Analysis | Feedback

• Flex Ltd. (FLEX)

AI Analysis | Feedback

Robert P. Eno, Chief Executive Officer

Mr. Eno brings over 30 years of experience in developing markets and commercializing disruptive medical technologies. Before joining HeartBeam, he served as Chief Executive Officer of Preview Medical, Inc., a diagnostic equipment company focused on AI-driven cancer diagnostics. He also held the position of Senior Vice President of Marketing for HeartFlow, Inc., where he led marketing and product functions for noninvasive heart disease testing. Mr. Eno's career includes senior marketing and sales leadership roles at OptiMedica (acquired by Abbott), NeoGuide Systems (acquired by Intuitive), and Avantec Vascular (acquired by Goodman Co. Ltd).

Timothy Cruickshank, Chief Financial Officer

Mr. Cruickshank possesses over 15 years of experience in strategic planning, financial stewardship, and commercial success. Prior to HeartBeam, he served as the Chief Financial Officer of ImpediMed, where he was instrumental in transforming the company from a traditional medical device company to one with a high-margin Software-as-a-Service (SaaS) business model, notably through the launch of the SOZO® Digital Health Platform.

Branislav Vajdic, PhD, President and Founder

Dr. Vajdic combines over 30 years of experience in technology development and senior management. He founded HeartBeam in 2015. From 2007 to 2010, he was the CEO and Founder of NewCardio, a publicly traded company in the cardiovascular devices space. Earlier in his career, from 1984 to 2007, he was at Intel, where he was a co-inventor of Flash memory and led engineering groups responsible for Pentium 1 through Pentium 4 designs.

Lance Myers, PhD, Chief Artificial Intelligence Scientist

Dr. Myers previously served as the Head of Cardiovascular Devices at Verily Life Sciences (formerly Google Life Sciences), where he led a team developing a novel heart failure monitoring solution. Before that, he was the Head of Data Science at Verily, building a high-performance AI organization. He has also held leadership roles at XAI. health, Sentrian, VivoSense, Boston Neurosciences and Vivometrics.

Kenneth Persen, Chief System Development Officer

Mr. Persen has over 25 years of experience in the digital healthcare and cardiac device industries. He founded LIVMOR, Inc., a digital health company, and served as its Chief Technology Officer. His career began in the cardiac rhythm device industry in software engineering and development roles with Guidant Corporation and Cameron Health, both of which were subsequently acquired by Boston Scientific.

AI Analysis | Feedback

Key Risks to HeartBeam (BEAT)

1. Financial Viability and Cash Burn: HeartBeam is currently operating with zero revenue and has reported ongoing losses, negative earnings, and zero gross or net margins. The company has been burning through its cash reserves, with a negative free cash flow, and has a limited cash runway. This raises significant concerns about its ability to fund commercialization efforts without resorting to dilutive capital raises, which could negatively impact existing shareholders.
2. Regulatory Delays and FDA Clearance: While HeartBeam has achieved some FDA clearances for its technology, it has also faced regulatory setbacks, including a "Not Substantially Equivalent" (NSE) decision from the FDA for its 12-lead ECG Synthesis Software. Although the company is pursuing multiple regulatory paths to address these concerns, delays in obtaining necessary clearances for its products or expanded indications could further deplete cash reserves and postpone the generation of revenue.
3. Market Adoption and Competitive Landscape: Operating in the highly competitive healthcare sector, HeartBeam must contend with existing players and convince healthcare providers to adopt its novel, portable ECG solutions. Successful market penetration will require substantial investment in robust clinical evidence, effective marketing and distribution strategies, and favorable reimbursement support, all of which are currently in development.

AI Analysis | Feedback

There are two clear emerging threats to HeartBeam:

1. Evolution and widespread adoption of personal ECG devices from established competitors: Companies like AliveCor, with its KardiaMobile device, have already achieved significant market penetration and brand recognition in the personal, at-home ECG monitoring space. While KardiaMobile's primary focus has been on arrhythmia detection (such as atrial fibrillation), it is a direct competitor for consumers seeking at-home cardiac monitoring. As these established competitors continue to innovate and potentially expand their diagnostic capabilities or market reach to include broader cardiac event detection, they could outcompete HeartBeam in terms of market share, ease of use, and integration into existing healthcare workflows.

2. Increasing sophistication and integration of ECG capabilities in popular consumer smartwatches: Major technology companies, such as Apple (with the Apple Watch) and Samsung (with the Galaxy Watch), have integrated FDA-cleared ECG features into their widely adopted smartwatches. While these features are primarily cleared for detecting atrial fibrillation, the rapid pace of innovation in wearable technology, combined with significant research and development investments from these tech giants, suggests that these devices could evolve to offer more advanced and validated cardiac event detection capabilities. The ubiquity, convenience, and multi-functionality of smartwatches could make dedicated, single-purpose ECG devices like HeartBeam's less appealing to consumers and potentially even healthcare providers, particularly if they gain further regulatory clearances for broader cardiac monitoring applications.

AI Analysis | Feedback

HeartBeam (NASDAQ: BEAT) is a medical technology company focused on developing and commercializing ambulatory electrocardiogram (ECG) solutions for detecting and monitoring cardiac disease. The company's main products and services revolve around remote cardiac monitoring, including a credit card-sized 3D vector ECG device (HeartBeam AIMIGo), 12-lead ECG synthesis software, and AI algorithms for arrhythmia detection and predictive cardiac monitoring.

The addressable markets for HeartBeam's offerings include:

• Global Remote Cardiac Monitoring Market: This market was valued at approximately USD 5.4 billion in 2024 and is projected to reach USD 12.1 billion by 2030, growing at a compound annual growth rate (CAGR) of 14.2%. Another estimate places the global market at USD 4.1 billion in 2024, expected to reach USD 12 billion by 2034 with a CAGR of 11.3%.

• U.S. Remote Cardiac Monitoring Market: The cardiology segment, which is the largest within the U.S. remote patient monitoring market, was valued at US$14.15 billion in 2024 and is forecasted to grow to US$29.13 billion by 2030, with a CAGR of 12.8%. The broader North American remote cardiac monitoring market is projected to reach US$ 7.73 billion by 2028.

• Global Wearable ECG Monitors Market: This market, which includes devices like HeartBeam's patch and smartwatch-based monitors, was valued at USD 3.97 billion in 2024 and is expected to grow to $11.31 billion in 2029 at a CAGR of 23.8%. Other projections estimate the global wearable cardiac devices market size to reach USD 32.16 billion by 2034, increasing from USD 4.68 billion in 2025, at a CAGR of 23.97% from 2025 to 2034. In 2021, the global wearable ECG devices market size was USD 12.28 billion and is expected to reach USD 35.45 billion by 2027.

• U.S. Wearable Cardiac Devices Market: The U.S. market for wearable cardiac devices was estimated at USD 1.72 billion in 2024 and is predicted to be worth around USD 14.96 billion by 2034, growing at a CAGR of 24.15% from 2025. North America held the largest share (61%) of the global wearable cardiac devices market in 2024.

• HeartBeam's Specific U.S. Market Opportunities:

  • For elevated-risk patients in concierge care settings, HeartBeam identifies an annual revenue opportunity ranging from $250 million to $500 million (U.S.).
  • For a larger direct-pay segment of elevated-risk individuals, the company sees a potential annual revenue opportunity of $1.3 billion to $2.6 billion (U.S.).
  • Approximately 18 million individuals in the U.S. with coronary artery disease are considered ideal candidates for remote heart attack detection, a key target for HeartBeam AIMIGo.
  • HeartBeam also targets approximately 5,000 Emergency Departments in the U.S. with its ED software product, HeartBeam AIMI.

AI Analysis | Feedback

1. Commercialization and Broader Adoption of the HeartBeam System with 12-Lead ECG Synthesis Software: HeartBeam received initial FDA clearance for its HeartBeam System in December 2024. A significant driver of future revenue will be the anticipated FDA 510(k) clearance for its 12-lead ECG Synthesis Software, expected by the end of 2025, which will enable the full commercialization of its groundbreaking cable-free 12-lead ECG device for arrhythmia assessment. This technology, which allows for at-home cardiac monitoring and synthesizes 12-lead ECGs, is designed to transform cardiac care by providing actionable heart intelligence outside traditional medical facilities.
2. Expansion into Targeted U.S. Geographic Pilot Markets and Direct Patient Pay Model: The company plans to initiate its commercialization efforts by expanding into U.S. geographic pilot markets, specifically targeting concierge and preventive cardiology practices. HeartBeam's go-to-market strategy includes a Direct Patient Pay model, which has a potential annual revenue market of $1.3 billion to $2.6 billion. This approach aims to reach patients with elevated cardiac risks, leveraging the convenience and efficiency of its at-home monitoring solution.
3. Leveraging Newly Introduced CPT Codes for Synthesized 12-Lead ECGs: HeartBeam plans to capitalize on newly introduced Current Procedural Terminology (CPT) codes for synthesized 12-lead ECGs. These codes are expected to facilitate reimbursement for its technology, thereby supporting wider adoption and contributing to revenue growth as the system becomes integrated into standard medical practice.
4. Development of a Comprehensive Ecosystem and Strategic Partnerships: HeartBeam is building a broader ecosystem around its device to increase its overall value and drive deeper adoption. This includes integrating with automated arrhythmia algorithms (like AcuCardia), incorporating wearable data prompts, developing AI wellness features, and offering a 24/7 cardiologist review service. The company is also experiencing increased interest from industry partners for collaborations in areas such as data and AI, companion products and services, and complementary diagnostics and treatments. These partnerships and the expanded ecosystem are expected to create scalable and recurring revenue streams.

AI Analysis | Feedback

Share Issuance

• In November 2021, HeartBeam completed its Initial Public Offering (IPO), generating $16.5 million in gross proceeds from the sale of 2,750,000 units, each consisting of one share of common stock and one warrant.
• A secondary offering of 16,666,666 shares of common stock in May 2023 resulted in net proceeds of $23.2 million.
• In February 2025, HeartBeam completed a public offering that, including the exercise of an over-allotment option, raised approximately $11.5 million in gross proceeds from the sale of 6,746,386 shares of common stock.

Outbound Investments

• HeartBeam made a strategic acquisition in March 2023, purchasing substantially all assets from LIVMOR, a digital health solutions company specializing in remote monitoring systems.

Capital Expenditures

• Capital expenditures were $0.26 million in 2023 and $0.20 million in 2024. For the nine months ended September 30, 2024, purchases of property and equipment amounted to $201,000.
• For the six months ended June 30, 2025, capital expenditures for the purchase of property and equipment were $0.102 million.
• The primary focus of capital expenditures is on commercial readiness activities and manufacturing capabilities, in anticipation of product launches and FDA clearances for their ambulatory electrocardiogram (ECG) solutions.