Financial Data and Key Metrics Changes - The company reported net cash used in operating activities of $3.4 million for the quarter, a 23% decrease from the previous quarter [27] - The baseline recurring expenditure was $3.1 million, which is 11% lower than the historical baseline of $3.5 million per quarter [27] - The cash balance at the end of Q2 2025 was $5.1 million when cash, cash equivalents, and short-term investments were combined [28] Business Line Data and Key Metrics Changes - The company is focused on capital efficiency and has implemented measures to reduce cash burn, including a temporary reduction in board fees and executive salaries [28] - The company is preparing for pilot commercialization in Florida and Southern California, targeting concierge and preventive cardiology practices [21][22] Market Data and Key Metrics Changes - The company estimates that there are 1.5 million patients in the U.S. with concierge medicine, with a potential annual recurring revenue of between $250 million and $500 million from this segment [22] - There is increasing interest from industry partners as the company approaches FDA clearance and commercialization [23] Company Strategy and Development Direction - The company aims to secure FDA clearance for the twelve lead synthesis software by Q4 2025, which will be crucial for commercialization [30] - The company is building an ecosystem around its HeartBeam system, which includes automated arrhythmia assessments and integration with wearables [9][10] - The strategy includes engaging with the FDA to expand indications to include ischemia detection [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for the business, highlighting strong interest from concierge and preventive cardiology practices [31] - The company believes that with a small fraction of adoption compared to other popular devices, it can create a valuable platform and that share value should reflect this [32] - Management emphasized the importance of training for both physicians and patients to ensure successful adoption of the technology [61] Other Important Information - The company has received two additional industry recognitions, including the Innovation in Remote Cardiac Diagnostics honor [19] - The company has a total of 21 patents worldwide, indicating a strong intellectual property position [18] Q&A Session Summary Question: Update on commercial strategy and early access program - The early access program is focused on learning the end-to-end system and training patients and practices, with progress being made [36] Question: Status of Chief Commercial Officer search - A candidate is lined up, and the timing for hiring will be aligned with the company's focus on cash burn and dilution [38] Question: Impact of government policy on plans - There are no changes to plans due to government policy, and positive statements regarding wearable technology are seen as beneficial [39] Question: Types of strategic partners being considered - Interest exists in partnerships that can help scale the business, including companies with ties to data and AI [40][43] Question: Details on discussions with the FDA - Discussions with the FDA are positive and productive, with a focus on the valid ECG study submitted for the twelve lead synthesis software [47][48] Question: Future funding plans and managing dilution - The company is focused on managing dilution and maintaining a clean cap table while refining expenditures for maximum flexibility [49][50] Question: Anticipated unit price and subscription costs - Pricing and business model are being validated, with expectations of annual revenue per unit between $500 and $1,000 [53][56] Question: Competitive landscape with companies like iRhythm - The company views itself as complementary to iRhythm, focusing on different use cases rather than direct competition [57][59] Question: Training for doctors and hospitals - The company plans extensive training for both physicians and patients to ensure successful adoption of the device [60][62] Question: Pilot program timelines and wearable integration - The pilot commercial launch is planned to begin soon after FDA clearance, with ongoing development of the ecosystem [64][66]

Financial Data and Key Metrics Changes - The company reported a net cash used in operating activities of $4.5 million for Q1 2025, with $3.6 million attributed to recurring baseline expenditures primarily for R&D and G&A aligned with milestones [34] - The company completed an $11.5 million common stock public offering to strategically fund operations while managing dilution [39] Business Line Data and Key Metrics Changes - The HeartBeam system is positioned as the first personal cable-free ECG capable of synthesizing a 12-lead ECG, with significant advancements in regulatory approvals and clinical studies [5][6] - The VALID ECG study met its clinical endpoints, supporting the FDA submission for the 12-lead synthesis software [41][70] Market Data and Key Metrics Changes - The target market segment for the HeartBeam system is estimated to be a $500 million serviceable market in the US, with strong demand from patients and physicians [28] - The coronary artery disease market is larger than the atrial fibrillation market, with 20 million patients in the US at elevated risk for heart attacks [29] Company Strategy and Development Direction - The company aims to secure FDA clearance for the 12-lead synthesis software and prepare for commercialization by the end of 2025 [42] - A strategic collaboration with AccuCardia is expected to enhance the commercial product offering by integrating ECG algorithms for rhythm classification [21][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing discussions with the FDA, indicating no disruptions or delays in the approval process [61][62] - The company is focused on building out infrastructure and customer support systems to ensure a successful product launch [25][32] Other Important Information - The company has achieved 20 issued patents worldwide, emphasizing the importance of intellectual property in its business strategy [26] - The early access program is providing valuable feedback on the product and its usability in real-world settings [25] Q&A Session Summary Question: Insights from the early access program - The company learned valuable insights from real patient interactions, including onboarding and training, which have helped refine the product [46][48] Question: Pricing strategy for commercialization - The anticipated pricing is expected to be between $50 to $100 per month, with potential tiered options for additional services [49][50] Question: Timing for building out infrastructure - The company plans to begin commercialization in Q4 2025, following FDA clearance, with initial efforts focused on two target markets [54][56] Question: Updates on FDA approval process - The company reported no disruptions from FDA staff attrition and remains on track for clearance by the end of the year [60][62] Question: Competitive position with AccuCardia partnership - The collaboration enhances the product offering by providing automated assessments for ECG readings, filling a critical gap in the workflow [64][66] Question: Manufacturing capabilities and tariff exposure - The company has secured a US-based contract manufacturer to mitigate tariff impacts and ensure quality control during initial production runs [72][74]