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]