Financial Data and Key Metrics Changes - The net loss for Q3 2025 was $5.3 million, or $0.15 per basic and diluted share, consistent with the prior quarter and in line with expectations [15][16] - Net cash used in operating activities was under $3.2 million, representing an 8% decrease quarter over quarter, building on a 23% decrease from the prior quarter [16] - Cash and cash equivalents at September 30, 2025, were $1.9 million, with a focus on maintaining a tight balance sheet [16][17] Business Line Data and Key Metrics Changes - The HeartBeam System is positioned as the first portable, cable-free ECG capable of synthesizing a 12-lead ECG, aimed at enhancing patient confidence in heart health [4][5] - The company has achieved significant milestones, including FDA 510(k) clearance for arrhythmia assessment and submission for 12-lead ECG synthesis software [10][11] Market Data and Key Metrics Changes - The initial commercial launch is anticipated to focus on prominent concierge and preventive cardiology practices in two U.S. regions, Southern California and South Florida, targeting approximately 75,000 patients [28][29] - Market research indicates strong interest from both physicians and patients, with a willingness to pay a premium for the HeartBeam System's functionality [9] Company Strategy and Development Direction - The company aims to create a new product category with the HeartBeam System, differentiating itself by combining an easy-to-use device with on-demand cardiologist support [13][14] - A controlled market entry strategy will be implemented, starting with a small number of practices to gather feedback before broader expansion [14] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about FDA interactions, categorizing them as productive, and anticipates clearance by year-end [22] - The company is focused on user experience and operational readiness ahead of commercialization, with plans to hire key commercial team members post-FDA clearance [11][17] Other Important Information - HeartBeam has been recognized as a global leader in portable cardiac diagnostics, ranking second worldwide in 12-lead ECG innovation [12][20] - The company has added three new patents, bringing the total to 24 issued patents worldwide [12][20] Q&A Session Summary Question: Can you discuss the FDA discussions and what factors need to be addressed for clearance? - Management described interactions with the FDA as productive and anticipates clearance before year-end [22] Question: What territories will be focused on for initial market launch? - The initial focus will be on prominent concierge and preventive cardiology practices in Southern California and South Florida [28][29] Question: How will pricing be structured for symptomatic versus asymptomatic readings? - A subscription model is planned, with details on pricing and the number of cardiology reads to be finalized [24] Question: How is inventory management and manufacturing capability being handled? - The company has a U.S.-based contract manufacturer and is confident in its manufacturing capabilities with off-the-shelf components [26] Question: What are the expectations for sales following commercialization? - Management indicated that while initial sales may be slow, significant growth is expected in the second half of 2026 [36] Question: Will the company work exclusively with HeartNexus for cardiology services? - While HeartNexus is a key partner, the company is open to expanding its network based on demand [39][40] Question: Are there plans for additional strategic partnerships to enhance production or operational capabilities? - The company is exploring various strategic partnerships to scale efficiently and enhance operational capabilities [42]

Company Overview & Strategy - HeartBeam aims to shift cardiac care from hospitals to home, similar to trends seen with glucose, blood pressure, and oxygen monitors[15, 16] - The company's synthesized 12-Lead ECG system, combined with on-demand cardiologist interpretation, is the foundation for a new cardiac care model[21] - HeartBeam is building an ecosystem around its core technology to deepen patient engagement and provide actionable insights for physicians[21, 23] - The company's near-term commercial strategy focuses on creating a new category, market entry through pilot programs, a focused commercial model, and patient retention[30] Regulatory & Clinical Milestones - HeartBeam received foundational FDA clearance for its system for arrhythmia assessment in December 2024[9, 13, 25] - FDA 510(k) clearance for the 12-Lead ECG Synthesis Software for arrhythmia assessment is anticipated in Q4 2025[13, 25, 34] - A pivotal clinical study (VALID-ECG) showed 93.4% overall diagnostic agreement for arrhythmia assessment[25] - New data presented at AHA Scientific Sessions in November 2025 supports HeartBeam's potential for early heart attack detection[27] Financial Performance (Q3 2025) - Total operating expenses were $5290 thousand[31] - Net loss was $5255 thousand, with an Earnings per Share (EPS) of $(0.15)[31] - Net cash used in operating activities was $3160 thousand, an 8% decrease quarter-over-quarter[31, 33] - Cash and cash equivalents and short-term investments totaled $1856 thousand as of September 30, 2025[31]

Product & Regulatory Milestones - HeartBeam System 在 2024 年 12 月获得了 FDA 的基础许可[21] - 12-lead ECG synthesis software application 已于 2025 年 1 月提交给 FDA，预计在 2025 年底获得批准[21] - 公司正在与 FDA 进行富有成效的讨论，以获得 12-lead ECG 合成软件的许可，并进一步讨论未来的许可和适应症，包括缺血适应症和 AccurKardia 自动算法[67] Financial Performance - 2025 财年第二季度运营活动中使用的净现金为 344 万美元[91] - 运营活动中使用的净现金环比减少 23%[91] - 经常性基线支出约为 310 万美元，低于历史基线 350 万美元[91] - 用于商业准备活动和制造能力的投资约为 30 万美元[91] - 截至 2025 年 6 月 30 日，现金和现金等价物总额为 5053000 美元[88] Market & Commercialization Strategy - 总体直接患者市场估计为每年 13 亿至 26 亿美元[76] - 公司正在执行商业准备计划，包括产品、基础设施和目标实践[66, 94] - 公司正在与目标礼宾实践会面，以建立溢价定价和订阅模式[79, 81] - 由于临近 FDA 批准，行业合作伙伴的兴趣显着增加[87, 94] Recognition - HeartBeam 因其在远程心脏诊断方面的创新而获得 2025 年医疗设备网络卓越计划奖[74] - HeartBeam 被评为 2025 年 Octane 高科技奖的决赛入围者[74]

Clinical and Regulatory Progress - The VALID-ECG pivotal study successfully met clinical endpoints for arrhythmia assessment[24, 31, 60] - The study results showed a 93.4% overall agreement between standard and synthesized 12-lead ECG in sinus rhythm and arrhythmia[34] - The company commenced initial FDA interactions on ischemia indication[24, 60] Commercial Readiness - The Early Access Program commenced in Q1 2025, providing key insights[47, 62] - The company signed a contract manufacturer for scaling[47, 62] - A strategic collaboration was signed with AccurKardia to enhance the commercial offering[28, 39, 62] Financial Results - Net cash used in operating activities was $4477 thousand for Q1 FY'25, an 8% increase quarter-over-quarter[55, 56] - The company completed an $11500 thousand common stock Public Offering in February 2025[56] - Total cash and cash equivalents and short-term investments were $8150 thousand as of March 31, 2025[55]