HeartBeam(BEAT)2025-03-14 02:43Financial Data and Key Metrics Changes - Net cash used in operating activities was $14.5 million for FY 2024, representing a 20% increase year over year, primarily due to investments in R&D and achieving FDA clearance [37][38] - G&A expenses remained largely flat, with less than a 4% increase year over year, indicating financial discipline [39] Business Line Data and Key Metrics Changes - The company received its foundational FDA clearance in December 2024, which is a significant milestone for the HeartBeam system [10][16] - A second 510(k) application for the twelve-lead synthesis software was submitted in January 2025, currently under FDA review [17][48] Market Data and Key Metrics Changes - The initial target market includes concierge medicine, with approximately 1.5 million patients in the US, translating to a revenue opportunity of $250 to $500 million annually [29][30] - The broader direct patient pay market is estimated to be worth $1.3 to $2.6 billion annually, focusing on patients aged 35 to 74 with elevated cardiac risk [31] Company Strategy and Development Direction - The company aims to establish itself as the first personal cable-free synthesized twelve-lead ECG, starting with direct patient pay and expanding to payer plans and integrated healthcare systems [22][24] - The go-to-market strategy includes a pilot commercialization phase in two geographic markets, focusing on customer experience and retention [26][27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about achieving key milestones in 2025, including FDA clearance for the twelve-lead synthesis software and pilot commercialization [48][50] - The company is focused on minimizing cash burn while preparing for commercialization, with a baseline expenditure of $14.5 million for 2025 [40][62] Other Important Information - HeartBeam, Inc. was awarded the Diamond Pinnacle Health Care Award for medical device innovation, marking the third award received in the past year [14] - The company has initiated an early access program to refine workflows and establish a sales funnel ahead of commercialization [20][88] Q&A Session Summary Question: What went into your decision to not immediately commercialize upon clearance? - The initial clearance is for the system with three-lead output, and the company believes it is important to commercialize with the twelve-lead software for differentiation [54][55] Question: What are your expectations for cash burn in 2025 and timing of next raise? - The cash burn for 2025 is expected to align with the $14.5 million spent in 2024, with stable G&A costs and opportunistic R&D spending [57][60] Question: Can you discuss the pathway or roadmap to get to heart attack detection? - The company plans to engage with the FDA soon and initiate a clinical study for heart attack detection later this year [64][68] Question: Is there any competition in the same space? - The company does not see direct competitors for its small cable-free ECG that synthesizes a twelve-lead, as most existing devices are bulky or limited to basic arrhythmias [69][73] Question: Are you concerned about political changes affecting timely FDA approval? - Management has not seen an impact on their submission and feels confident about their interactions with the FDA [74][76] Question: Does your initial go-to-market plan include wearables? - The device is not a wearable, but there is potential for integration with wearable data [77][79] Question: Are you planning to initially commercialize this technology alone or with a partner? - The initial pilot commercialization will be conducted by the company's own team, with options for partnerships being assessed [80][82] Question: When is the expected clearance time from FDA for the second clearance? - The company estimates receiving clearance before the end of the year but acknowledges the challenges in predicting FDA review timelines [84][86] Question: Can you give us more details on the early access program? - The early access program aims to evaluate the offering, refine clinical workflows, and establish customer service operations [87][89]