HeartBeam, Inc. (BEAT): Business Model Canvas [Dec-2025 Updated]

You're digging into HeartBeam, Inc. right now, and honestly, the next few months are make-or-break as they fight for that 12-lead ECG software approval, which is key to unlocking their value proposition: anytime, anywhere cardiologist-level insights. Here's the quick math I see: with Q3 2025 operating burn at $3.2 million against only $1.9 million in cash, that regulatory path is the lifeline funding the $500 to $1,000 projected annual recurring revenue per unit. This Business Model Canvas distills their entire strategy-from their 24 issued patents to their initial focus on concierge cardiology-showing you precisely where the $3.3 million R&D spend is aimed and what it takes to get this portable ECG tech to market. Dive in to see the full blueprint.

HeartBeam, Inc. (BEAT) - Canvas Business Model: Key Partnerships

You're looking at the critical alliances HeartBeam, Inc. (BEAT) has locked in to move from development to commercialization as of late 2025. These aren't just handshake deals; they represent concrete steps toward delivering their 3D ECG technology to the market, especially given the company's cash position following its February 2025 financing.

The Key Partnerships block is where HeartBeam translates its technology into a service ecosystem. It's about who they need to work with to read the data, validate the product, and fund the rollout. Here's the quick math on what these relationships mean right now.

The company secured significant capital in early 2025 to support these efforts. MDB Capital underwrote a public offering that closed on February 14, 2025, raising gross proceeds of $10.0 million. Following the exercise of the underwriter's over-allotment option on February 25, 2025, the total gross proceeds increased to approximately $11.5 million. This funding is earmarked for commercial-readiness activities and R&D, which directly fuels the integration and study milestones discussed below.

Here is a breakdown of the core partnerships and their current status:

The clinical validation partnerships were essential for regulatory progress. The VALID-ECG pivotal study, which was the foundation for the 12-lead synthesis submission, involved specific institutions and patient numbers. You should note the sites involved:

• Allegheny Health Network
• Atlanta Heart Specialists
• Mount Sinai Hospital
• Northwell Health
• Piedmont Heart Institute

Furthermore, the company is already looking ahead to the next clinical hurdle. HeartBeam expects to start enrollment in a Pilot Study for ischemia and acute coronary events in the second half of 2025. This shows a partnership strategy that evolves with the regulatory roadmap.

The recurring revenue model, which these service partnerships enable, is key to future valuation. HeartBeam anticipates gross margins of 50% on device costs and aims for over 70%+ on recurring revenue streams like the one with HeartNexus. Still, the Q3 2025 net loss was $5.3 million, so executing on these partnerships to drive revenue is defintely the near-term focus.

HeartBeam, Inc. (BEAT) - Canvas Business Model: Key Activities

You're looking at the core engine driving HeartBeam, Inc. (BEAT) right now-the day-to-day, high-stakes work required to move from development to a commercial entity. It's all about execution on a few critical fronts, especially given the recent regulatory news.

Advancing the 12-lead ECG synthesis software regulatory path (appeal/resubmission)

The most immediate key activity centers on resolving the Not Substantially Equivalent (NSE) decision received from the Food and Drug Administration (FDA) on the 510(k) submission for the 12-lead Electrocardiogram (ECG) Synthesis Software in late November 2025. The team is actively pursuing multiple parallel paths, including an official appeal process which carries an approximate timeline of 60 days from submission to resolution. This follows the foundational FDA clearance of the base HeartBeam System for arrhythmia assessment in December 2024. The clinical data supporting the software, from the VALID-ECG pivotal study, demonstrated a 93.4% overall diagnostic agreement when compared to standard 12-lead ECGs. Management has maintained that FDA clearance for the synthesis software remains firmly on track, expected by the end of 2025.

Research and development for ischemia detection and AI algorithms

Research and development activities are focused on future capabilities, specifically ischemia detection and deep learning algorithms. This work continues even as the regulatory focus remains on the synthesis software. You can see this spending reflected in the quarterly reports. For instance, Research and Development expenses for the third quarter of 2025 were $3.3 million, up from $2.9 million in the third quarter of 2024. Also, an abstract detailing HeartBeam's AI algorithm was accepted for presentation at HRX Live 2025 in September, showing progress in that specific area.

Here's a quick look at the recent operational spending:

What this estimate hides is the burn rate required to sustain this level of R&D while awaiting clearance.

Commercial readiness planning and establishing initial sales infrastructure

Commercial readiness plans are accelerating in anticipation of the final FDA clearance. This involves setting up the necessary operational backbone to support a product launch. Key components of this activity include finalizing the cardiology reader service, which is designed to offer on-demand, board-certified cardiologist reviews of the synthesized 12-lead ECGs to triage patients. HeartBeam announced a partnership with HeartNexus, Inc. specifically for this purpose. In the first quarter of 2025, management attributed $0.4 million of cash used in operating activities to investments in commercial readiness. The infrastructure build-out covers customer service, contract manufacturing, and logistics and fulfillment efforts.

• Finalizing cardiology reader service with HeartNexus, Inc.
• Establishing logistics and fulfillment efforts.
• Executing on contract manufacturing agreements.
• Increasing Business Development resources due to inbound interest.

Maintaining and expanding the global intellectual property portfolio of 24 issued patents

Protecting the core technology is a constant, high-priority activity. HeartBeam reached a significant milestone, holding 24 patents now issued worldwide as of the third quarter of 2025, following the issuance of three (3) new patents in that quarter alone. This builds upon an earlier report from May 2025 where the company held 20 issued US and international patents, along with 2 allowed patents and 32 pending patents. The company was recognized in a PatentVest report as a global IP and technology leader in portable cardiac diagnostics, ranking #2 worldwide in 12-lead ECG innovation out of 243 companies analyzed.

The IP portfolio supports the differentiated technology, which includes the credit card-sized, cable-free 3D ECG device and the rhythm analysis algorithm.

Finance: draft 13-week cash view by Friday.

HeartBeam, Inc. (BEAT) - Canvas Business Model: Key Resources

You're looking at the core assets HeartBeam, Inc. (BEAT) relies on to execute its business plan as of late 2025. These aren't just line items; they are the validated technology and the cash runway supporting the next phase.

The most critical resource is the intellectual property underpinning the entire offering. HeartBeam, Inc. has built a significant moat around its core technology.

• Patented 3D ECG technology platform for cardiac signal capture.
• Total of 24 issued patents worldwide as of the third quarter of 2025.
• The core patent protects the credit card-sized, cable-free 3D ECG device capturing high-fidelity electrical signals in 3 non-coplanar directions.

Regulatory approval is the next non-negotiable asset, validating the technology for clinical use. The foundational clearance was a major step toward commercialization.

• FDA-cleared HeartBeam System for comprehensive arrhythmia assessment, granted in December 2024.
• The system is a portable, non-invasive recorder intended for adult use in clinical or home settings.

Clinical validation provides the evidence base that drives physician adoption. The pivotal study data is concrete proof of performance against the standard of care.

Here's a quick look at the key validation and financial metrics as of the third quarter of 2025:

That cash position, while tight, is being managed with improved capital efficiency. Net cash used in operating activities for the third quarter of 2025 was $3.2 million, an 8% decrease quarter-over-quarter.

HeartBeam, Inc. (BEAT) - Canvas Business Model: Value Propositions

First portable, cable-free device to synthesize a 12-lead ECG.

The platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. The device captures the heart's electrical signals in 3D, from three non-coplanar directions, and synthesizes them into a 12-lead ECG using a personalized transformation matrix. The 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024.

Cardiologist-level ECG insights available anytime, anywhere.

The company announced a partnership with HeartNexus, Inc. to provide on-demand, board-certified cardiologist reviews of synthesized 12-lead ECGs for arrhythmia assessment and triage patients. The 12-lead ECG synthesis software is under FDA review, with anticipated clearance in Q4 2025.

Remote monitoring for high-risk patients outside a medical facility.

Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care - all outside of a medical facility. This capability is supported by a robust intellectual property foundation.

• Total issued patents worldwide as of Q3 2025: 24.
• Ranking in a new PatentVest report: #2 worldwide in 12-lead ECG innovation out of 243 companies analyzed.

Potential for early detection of acute coronary events like heart attacks.

New data presented at AHA Scientific Sessions in November 2025 advanced the pipeline for ischemia detection and deep learning algorithms. A feasibility study indicated the proprietary algorithm's heart attack risk score accuracy was comparable to assessments made by emergency department physicians using standard 12-lead ECGs.

The company's financial position as of September 30, 2025, included cash and cash equivalents of $1.9 million, following a net loss of $5.3 million for the third quarter of 2025. Research and development expenses for Q3 2025 were $3.3 million.

HeartBeam, Inc. (BEAT) - Canvas Business Model: Customer Relationships

You're preparing for the initial commercial push after securing foundational FDA clearance, so the customer relationship strategy needs to be precise, especially given the cash position at the end of Q3 2025, which was $1.9 million in cash and cash equivalents.

Direct sales and implementation specialists for initial rollout

The initial commercialization strategy is highly targeted, focusing on securing buy-in before a full-scale launch. The pilot commercial launch is set to commence in specific geographies: Florida and Southern California. This initial outreach aims to secure letters of intent from practices ahead of the actual rollout. The target segment is the direct-pay patient base within concierge and preventive cardiology practices, representing an estimated 1.5 million patients in the US who utilize concierge medicine. The initial costs associated with getting a practice onboard include the device and onboarding/training, which management noted carries about a 50% margin on those upfront costs.

Subscription-based service model to drive recurring usage

HeartBeam, Inc. is structuring its core revenue around a recurring service. The business model centers on a subscription model. Management modeling projects the annual revenue per unit estimated between $500 and $1,000. The long-term goal for this recurring revenue stream is significant margin expansion; recurring margins are projected to exceed 70%, based on company modeling. This recurring revenue is key to the financial outlook as the company works toward scaling commercial activities.

The expected financial structure for the recurring revenue is laid out below:

Early Access Program for workflow refinement and feedback

The Early Access Program, also referred to as beta testing, was a crucial pre-commercial step. This program was primarily focused on learning the end-to-end system and training patients and practices. The feedback gathered has been directly used to make iterations to further enhance the software and product design. The VALID-ECG pivotal study, which successfully met its clinical endpoints with a 93.4% overall diagnostic agreement, formed the basis for the 12-lead synthesis software submission, which is a precursor to full commercialization.

• Commenced EAP in anticipation of US commercialization.
• Focused on operational readiness and establishing an early adopter funnel.
• Feedback informed enhancements to commercial software.

High-touch, dedicated support for concierge medicine practices

To ensure the physician workflow is supported post-diagnosis, HeartBeam, Inc. established a critical partnership. The company announced an agreement with HeartNexus, Inc. to deliver the necessary interpretation layer. This partnership provides on-demand, board-certified cardiologist reviews of the synthesized 12-lead ECGs. This service is designed to help triage patients and provide actionable intelligence directly to the physician. The company holds 24 issued patents worldwide as of Q3 2025, which underpins the proprietary nature of the technology being supported.

• Partnership established with HeartNexus, Inc.
• Service includes 24/7 cardiologist review.
• Reviews cover arrhythmia assessment and patient triage.

Finance: draft 13-week cash view by Friday.

HeartBeam, Inc. (BEAT) - Canvas Business Model: Channels

You're looking at how HeartBeam, Inc. plans to get its synthesized 12-lead ECG technology into the hands of cardiologists and patients, especially as they anticipate FDA 510(k) clearance for the software in Q4 2025.

The initial commercialization strategy, planned to start in early 2026, is tightly focused on specific US geographic regions and practice types. This is a direct-to-clinic approach before scaling.

Direct sales force targeting specific US geographic regions.

The initial market penetration targets are geographically specific, which makes sense when you have limited initial sales capacity and are focused on early adopters. The plan is to launch first in Southern California and South Florida.

Concierge and preventive cardiology practices (initial market focus).

The primary customer segment for the initial push is clear. HeartBeam, Inc. is aiming at concierge and preventive cardiology practices, which is a segment estimated to cover about 1.5 million patients in the US who use concierge medicine.

This focus is supported by the technology's clinical validation, where the synthesized 12-lead ECG showed a 93.4% overall diagnostic agreement against standard 12-lead ECGs in the VALID-ECG pivotal study.

Potential distribution partners for efficient scaling post-launch.

To move beyond the initial direct sales effort, HeartBeam, Inc. is actively building out its ecosystem through partnerships. They are exploring multiple options, including distribution partners and chains of concierge practices, to enable efficient expansion.

Key collaborations already in place to support the channel include:

• A partnership with HeartNexus, Inc. for on-demand cardiologist reviews.
• A strategic collaboration with AccurKardia to integrate its AccurECG(TM) software.

The company holds a total of 24 patents worldwide as of the third quarter of 2025, which underpins the value proposition for any potential partner.

Telehealth and remote patient monitoring platforms (future integration).

The partnership with HeartNexus directly feeds into the remote monitoring aspect of the channel. This provides on-demand, board-certified cardiologist reviews of the synthesized 12-lead ECGs for arrhythmia assessment and patient triage, effectively creating a remote reading service layer.

The core technology is designed for portable devices to be used wherever the patient is, which inherently supports a remote patient monitoring model. The financial reality is that they are currently operating under tight constraints, so leveraging partners for services like reading is a capital-efficient channel strategy.

Here's a quick look at the financial context as they prepare for this commercialization push:

The company is focused on demonstrating value to drive retention under their planned subscription model, which is key for the long-term viability of these channels.

Finance: draft 13-week cash view by Friday.

HeartBeam, Inc. (BEAT) - Canvas Business Model: Customer Segments

You're hiring before product-market fit, so knowing exactly who you are selling to is the first step in building out the rest of the canvas. HeartBeam, Inc. (BEAT) is clearly targeting specific points of friction in cardiac diagnostics, moving from development to commercialization in late 2025.

The primary customer groups HeartBeam, Inc. (BEAT) is focused on for its synthesized 12-lead ECG technology include:

• Concierge and preventive cardiology practices in Southern California and South Florida.
• Patients with known arrhythmias or at high risk for cardiac events.
• Health systems and hospitals focused on remote patient monitoring.
• Clinical researchers and medical device partners.

The market context for these segments shows significant need. Cardiovascular disease remains the leading cause of mortality worldwide, responsible for an estimated 17.9 million deaths annually according to the World Health Organization. The company's go-to-market strategy, as of Q1 2025, leaned into high-margin patient-pay segments, specifically targeting a direct patient-pay market estimated at $1.3-$2.6 billion, which aligns with concierge medicine models.

The company's technological validation is a key draw for researchers and partners. Clinical data from the pivotal VALID-ECG study demonstrated a 93.4% overall diagnostic agreement for arrhythmia assessment. Furthermore, HeartBeam, Inc. (BEAT) has built a strong intellectual property moat, holding 24 issued patents globally as of Q3 2025.

Here's a look at the key relationships and financial context as HeartBeam, Inc. (BEAT) prepared for its anticipated commercial launch following expected FDA clearance by the end of 2025:

The partnership with HeartNexus is a critical component for the patient/clinician segment, as it provides on-demand, board-certified cardiologist reviews of the synthesized 12-lead ECGs for arrhythmia assessment and triage. This addresses the need for expert interpretation outside of a clinic setting. The device itself is designed to capture the heart's electrical signals from three distinct directions and synthesize them into a 12-lead ECG, a capability supported by the foundational FDA clearance received in December 2024.

You need to track the early adopter funnel closely. The company had commenced an Early Access Program to gather feedback on the end-to-end clinical workflow. This program is the initial touchpoint with the clinical user base, which includes practices in key geographic areas. The success of this early adoption will signal market pull ahead of the full commercial launch anticipated in early 2026. Finance: draft 13-week cash view by Friday.

HeartBeam, Inc. (BEAT) - Canvas Business Model: Cost Structure

You're looking at the core expenses HeartBeam, Inc. (BEAT) is managing as it moves toward commercialization, which is heavily weighted toward development and regulatory hurdles right now.

The cost structure is dominated by the necessary investment in technology refinement and the push for final regulatory sign-off on the 12-lead ECG synthesis software. Here's a breakdown of the key spending areas based on the third quarter of 2025 results.

The R&D expenses for the third quarter of 2025 were $3.3 million, which is an increase from the $2.9 million reported in the third quarter of 2024. This reflects the continued focus on derisking the business and advancing the technology pipeline, including initial FDA interactions for expanding indications beyond arrhythmia assessment. The G&A overhead for the same quarter was $2.0 million, a slight decrease from the $2.2 million in Q3 2024.

The company's cash usage reflects these operational costs. Net cash used in operating activities was $3.2 million for the three months ended September 30, 2025. This represented an 8% decrease quarter-over-quarter from the prior period's operating cash usage.

Costs related to intellectual property (IP) and regulatory efforts are significant, even if not always itemized as a single line item in the quarterly expense report. HeartBeam, Inc. (BEAT) is actively maintaining and expanding its patent moat. As of the third quarter of 2025, the company reported having a total of 24 issued patents worldwide. The regulatory cost is tied to the final stages of the FDA 510(k) review for the 12-lead ECG synthesis software, which management anticipated clearance for by the end of 2025.

Building out the commercial infrastructure is a forward-looking cost that is starting to ramp up in anticipation of clearance. The projected commercial readiness spend for the full year 2025 was estimated to be between $1.5 million to $3.5 million. This spending covers the establishment of necessary operational elements:

• Finalizing the cardiology reader service for on-demand reviews.
• Establishing infrastructure for customer service.
• Setting up logistics and fulfillment efforts.
• Securing contract manufacturing agreements.

These expenses are essential for the transition from a development-stage company to a commercial-stage one, which is a major inflection point for HeartBeam, Inc. (BEAT).

HeartBeam, Inc. (BEAT) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of HeartBeam, Inc. (BEAT) as they move from R&D to commercialization in late 2025. The model is clearly centered on recurring revenue tied to their cleared technology and the forthcoming 12-lead synthesis software.

The primary revenue driver is structured around the Subscription fees for the HeartBeam System (device plus cardiology reads). This bundles the use of the portable device with the necessary professional interpretation service. HeartBeam, Inc. has established a clear target for this recurring stream.

Here is the projected value for that recurring service:

• Projected annual recurring revenue per unit is set in the range of $500 to $1,000.
• This annual figure is intended to cover both the device access and the ongoing service component.

To support the service component of the subscription, HeartBeam, Inc. announced a partnership with HeartNexus, Inc. to provide on-demand, board-certified cardiologist reviews of the synthesized 12-lead ECGs for arrhythmia assessment and patient triage. This partnership directly underpins the service aspect of the subscription fee.

The go-to-market strategy, as detailed in early 2025, focused on establishing a 'premium pricing and subscription model' within the direct patient-pay segment, avoiding initial reliance on insurance reimbursement cycles. While specific Initial device sales or setup fees to medical practices weren't quantified, the focus on a subscription model suggests these fees, if any, would be secondary to the recurring revenue.

The potential for future revenue from intellectual property is supported by a growing patent portfolio. As of the third quarter of 2025, HeartBeam, Inc. reported having 24 patents issued worldwide, which bolsters the foundation for Potential future revenue from licensing proprietary AI algorithms or IP. The company also has an active AI program underway, which, once fully cleared by the FDA for its 12L synthesis algorithm, is expected to unlock more material revenue.

Given the anticipated FDA clearance for the 12-lead ECG synthesis software in Q4 2025, the company is pre-commercial for its full offering. While the prompt suggested a full year 2025 revenue estimate around $6.10 million, public filings as of late 2025 indicated that the company did not expect material commercial revenue before the final software clearance. However, the targeted market potential is substantial, with projections for annual revenue potential in the range of $250 million to $500 million from preventive cardiology practices following a successful launch.

Here's a snapshot of the revenue-related data points as of late 2025:

The immediate focus is on converting the FDA clearance, expected by the end of the year, into active sales to realize the targeted $500 to $1,000 per unit ARR. Finance: draft 13-week cash view by Friday.