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]

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]

[Part I - Financial Information](index=4&type=section&id=PART%20I-FINANCIAL%20INFORMATION) [Condensed Unaudited Financial Statements](index=4&type=section&id=Item%201.%20Condensed%20Unaudited%20Financial%20Statements) The company reported total assets of **$6.0 million** and total liabilities of **$1.8 million** as of June 30, 2025, incurring a net loss of **$10.5 million** and using **$7.9 million** in operating cash flow, raising substantial doubt about its going concern ability Condensed Balance Sheet Data (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $3,256 | $2,377 | | Total Current Assets | $5,361 | $2,770 | | **Total Assets** | **$5,981** | **$3,276** | | Total Current Liabilities | $1,799 | $1,622 | | **Total Liabilities** | **$1,799** | **$1,622** | | **Total Stockholders' Equity** | **$4,182** | **$1,654** | Condensed Statement of Operations Data (in thousands, except per share data) | | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $6,818 | $5,272 | | General and administrative | $3,720 | $4,602 | | Loss from operations | $(10,538) | $(9,874) | | **Net Loss** | **$(10,458)** | **$(9,562)** | | Net loss per share, basic and diluted | $(0.32) | $(0.36) | Condensed Statement of Cash Flows Data (in thousands) | | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,922) | $(7,013) | | Net cash used in investing activities | $(1,899) | $(98) | | Net cash provided by financing activities | $10,700 | $84 | | **Net increase (decrease) in cash** | **$879** | **$(7,027)** | - The company has incurred losses and negative cash flows from operations each year since inception. As of June 30, 2025, cash, equivalents, and short-term investments were approximately **$5.1 million**[29](index=29&type=chunk) - Management believes existing liquidity is insufficient to fund operations for the next twelve months, which raises substantial doubt about the company's ability to continue as a going concern[30](index=30&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) HeartBeam, a pre-commercial medical technology company, received FDA clearance for its HeartBeam System and filed for 12L ECG synthesis software, but faces going concern doubts due to recurring losses and insufficient liquidity - The HeartBeam System received FDA clearance on December 13, 2024. A subsequent 510(k) application for software to synthesize a 12L ECG was filed in January 2025[60](index=60&type=chunk)[61](index=61&type=chunk) - The VALID-ECG pivotal study successfully met its clinical endpoints, showing a **93.4%** overall diagnostic agreement between HeartBeam's synthesized 12L ECG and a standard 12L ECG for arrhythmia assessment[63](index=63&type=chunk) - In April 2025, HeartBeam announced a strategic collaboration with AccurKardia to integrate its FDA-cleared automated ECG interpretation platform, aiming to expedite product development and reduce costs[66](index=66&type=chunk)[77](index=77&type=chunk) - The company has an At-the-Market (ATM) sales agreement to sell up to **$17.0 million** in common stock. As of the report date, approximately **$15.6 million** remained available for issuance under this agreement[31](index=31&type=chunk)[76](index=76&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Total operating expenses increased by **7%** to **$10.5 million** for the six months ended June 30, 2025, driven by a **29%** rise in R&D expenses, partially offset by a **19%** decrease in G&A costs Comparison of Operating Expenses (in thousands) | Expense Category | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | General and administrative | $3,720 | $4,602 | $(882) | (19)% | | Research and development | $6,818 | $5,272 | $1,546 | 29% | | **Total operating expenses** | **$10,538** | **$9,874** | **$664** | **7%** | - The decrease in G&A expenses for the six months ended June 30, 2025, was primarily due to a **$0.8 million** reduction in non-cash stock-based compensation and a **$0.2 million** decrease in consultant costs[81](index=81&type=chunk) - The increase in R&D expenses for the six months ended June 30, 2025, was mainly driven by a **$1.0 million** increase in product development, a **$1.1 million** increase in headcount costs, and a **$0.8 million** increase in stock-based compensation[83](index=83&type=chunk) [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company's **$5.1 million** in cash and investments are insufficient for future operations, necessitating additional capital to address going concern doubts - The company's existing cash and short-term investments of approximately **$5.1 million** as of June 30, 2025, are insufficient to fund operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern[86](index=86&type=chunk) - Continued operations depend on raising additional capital, as the company expects no material commercial revenue in 2025[87](index=87&type=chunk) Cash Flow Summary (in thousands) | | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,922) | $(7,013) | | Net cash used in investing activities | $(1,899) | $(98) | | Net cash provided by financing activities | $10,700 | $84 | - In February 2025, the company raised approximately **$10.3 million** in net proceeds from a public offering of common stock[45](index=45&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=21&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company does not hold derivative financial instruments nor engage in hedging activities - The company does not hold derivative instruments or engage in hedging activities[95](index=95&type=chunk) [Controls and Procedures](index=21&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[97](index=97&type=chunk) - No material changes to internal control over financial reporting were identified during the fiscal quarter ended June 30, 2025[99](index=99&type=chunk) [Part II - Other Information](index=22&type=section&id=PART%20II-OTHER%20INFORMATION) [Legal Proceedings](index=22&type=section&id=Item%201.%20Legal%20Proceedings) The company is not involved in any pending or threatened legal proceedings that could materially adversely affect its business or financial condition - There are no pending or threatened legal actions against the company that could have a material adverse effect[101](index=101&type=chunk) [Risk Factors](index=22&type=section&id=Item%201A.%20Risk%20Factors) This section is not applicable as HeartBeam, Inc. is classified as a smaller reporting company - Not applicable as the company is a smaller reporting company[102](index=102&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=22&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity securities were sold during the period covered by this report - No equity securities were sold during the period that were not registered under the Securities Act[103](index=103&type=chunk) [Exhibits](index=23&type=section&id=Item%206.%20Exhibits) This section lists filed exhibits, including corporate governance documents, equity incentive plan amendments, and CEO/CFO certifications - Filed exhibits include the Third Amendment to the 2022 Equity Incentive Plan and Sarbanes-Oxley Act certifications from the CEO and CFO[109](index=109&type=chunk)

Summary of HeartBeam Inc. Conference Call Company Overview - **Company**: HeartBeam Inc. - **Industry**: Cardiac Care Technology - **Market Cap**: Approximately $5.06 billion [36] - **Cash Balance**: $8.2 million as of March 31 [36] - **Debt**: No debt on the books [36] - **Employees**: 20 [36] Core Technology and Product Offering - **Product**: First cable-free ECG capable of synthesizing a 12-lead ECG [4] - **Intellectual Property**: 20 issued patents covering all aspects of the technology [5] - **FDA Clearance**: Received foundational clearance in December; second application for 12-lead synthesis submitted [15][16] - **Target Market**: Initial focus on concierge medicine with a serviceable market of $500 million in recurring revenue [5][20] - **Patient Population**: 1.5 million people in concierge medicine in the U.S. [5] - **Expansion Plans**: Plans to expand into heart attack detection, targeting 20 million people at high risk for heart attacks [6][23] Market Opportunity - **Concierge Medicine**: High interest from high-net-worth individuals and concierge physicians [5] - **Heart Attack Detection**: Significant opportunity as heart disease is the leading cause of death; timely treatment is crucial [23] - **Revenue Potential**: Potential to reach $2.6 billion in recurring revenue by targeting the top 5% of income earners [21] - **High Margins**: Expected margins to exceed 70% over time [22] Competitive Landscape - **Current Solutions**: Existing single-lead ECGs (e.g., Apple Watch) are limited to basic arrhythmias; traditional 12-lead ECGs are impractical for home use [8][10] - **Unique Selling Proposition**: HeartBeam's device simplifies the process of obtaining a 12-lead ECG, making it accessible for home use [10][50] Clinical Evidence and Validation - **Clinical Studies**: Over 1,000 patients enrolled; 93.4% diagnostic agreement with standard 12-lead ECGs [15][52] - **Performance Goals**: Results from studies presented at the Heart Rhythm Society meeting [17] Go-to-Market Strategy - **Sales Channels**: Focus on concierge medicine and preventive cardiology practices; plans to pilot in two U.S. regions [19][44] - **Direct Patient Pay Model**: Initial model with potential for reimbursement from healthcare systems [7][32] - **Partnerships**: Exploring partnerships with existing patch manufacturers for extended wear patches [48] Financial Overview - **Cost Structure**: Baseline cost structure is less than $4 million per quarter; 40% of costs allocated to headcount [36][56] - **Funding**: Completed a $11.5 million public offering in February to support key milestones [38] - **Breakeven Point**: Estimated to achieve breakeven with approximately $20 million in revenue [59] Future Outlook - **AI Integration**: Plans to develop AI algorithms for heart attack detection [29] - **Long-term Vision**: Opportunities for reimbursement from healthcare systems and potential partnerships with drug manufacturers [33] Key Takeaways - HeartBeam is positioned to disrupt the cardiac care market with its innovative technology and strong market potential - The company is significantly de-risked with strong IP, clinical data, and a clear path to commercialization - The focus on concierge medicine provides a lucrative initial market, with plans for expansion into broader healthcare applications

Financial Data and Key Metrics Changes - The company reported a net cash used in operating activities of $4.5 million for the quarter, with $3.6 million related to recurring baseline expenditures primarily for R&D and G&A aligned with milestones [33][34] - The company completed an $11.5 million common stock public offering to strategically fund operations while managing dilution [38] Business Line Data and Key Metrics Changes - The HeartBeam system is designed to synthesize a 12-lead ECG and has received foundational FDA clearance for arrhythmia assessment, with a second FDA application for software currently under review [6][7][9] - The VALID ECG study met its clinical endpoints, demonstrating that synthesized ECGs closely approximate standard 12-lead ECGs for arrhythmia assessment [20][40] 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 [27] - 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 [28] Company Strategy and Development Direction - The company aims to achieve FDA clearance for the 12-lead synthesis software and prepare for commercialization by the end of the year [41][42] - A strategic collaboration with AccuCardia has been established to enhance the HeartBeam system's capabilities, particularly in automated rhythm assessment [21][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing productive discussions with the FDA, anticipating clearance for the 12-lead synthesis software by the end of the year [62] - The company is focused on building out infrastructure for commercial readiness, including customer support and logistics [25][31] Other Important Information - The company has issued a total of 20 patents worldwide, emphasizing the importance of intellectual property in its strategy [11][26] - The early access program is providing valuable feedback on the HeartBeam system's usability and features [25][46] 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 commercial opportunity [45][46] 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 [47][48] Question: Timing for infrastructure build-out - The company plans to start commercialization in Q4 of 2025, following FDA clearance, with initial efforts focused on two target markets [52][55] Question: FDA approval process updates - There have been no disruptions or delays in the FDA approval process, and discussions remain productive [60][62] Question: Competitive position with AccuCardia partnership - The partnership enhances the competitive offering by providing automated assessments for routine recordings, filling a critical gap in the product pipeline [64][66] Question: Manufacturing capabilities and tariff exposure - The company has secured a US-based contract manufacturer to mitigate tariff impacts and ensure quality in early manufacturing runs [72][74]

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]

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]

FDA Clearance and Product Development - The HeartBeam System received FDA clearance on December 13, 2024, as the first cable-free, ambulatory 3-D ECG device, capturing heart signals from three directions for advanced diagnostics [59]. - The company initiated an Early Access Program for the HeartBeam System to gather user feedback ahead of commercialization, which is expected to occur after FDA clearance for the 12L synthesis software [65][64]. - A strategic collaboration with AccurKardia was announced to integrate an automated ECG interpretation platform, expected to expedite product development and enhance diagnostic capabilities [66][72]. Financial Performance - Operating expenses for Q1 2025 totaled $5.5 million, a 15% increase from $4.8 million in Q1 2024, primarily driven by a 44% increase in research and development expenses [76][77]. - The net loss for Q1 2025 was $5.5 million, compared to a net loss of $4.6 million in Q1 2024, reflecting a 19% increase in losses year-over-year [76]. - Net cash used in operating activities for Q1 2025 was $4.5 million, primarily due to a net loss of $5.5 million, offset by $1.1 million in non-cash expenses [85]. - Net cash used in operating activities for Q1 2024 was $3.5 million, primarily due to a net loss of $4.6 million [86]. Cash and Investments - As of March 31, 2025, the company had cash and short-term investments of approximately $8.2 million, with a cash burn rate raising concerns about the ability to fund operations for the next twelve months [81][83]. - As of March 31, 2025, the company held cash and cash equivalents of $4.4 million, bringing total liquidity to $8.2 million [88]. - Net cash used in investing activities for Q1 2025 was $3.8 million, resulting from the purchase of short-term investments [87]. - Net cash used in investing activities for Q1 2024 was $0.1 million, attributed to the purchase of equipment [88]. Financing Activities - The company raised approximately $11.5 million in gross proceeds from a public offering in February 2025, selling shares at $1.70 each [72][74]. - Net cash provided by financing activities for Q1 2025 was $10.3 million, mainly from net proceeds from the sale of common stock [89]. - There was no financing activity reported for Q1 2024 [90]. Intellectual Property and Research - HeartBeam has 20 issued patents worldwide, including 15 in the U.S., enhancing its intellectual property portfolio and competitive position in the market [71][69]. - The company has acquired approximately one million standard 12L ECGs for AI development, aiming to improve diagnostic insights through deep learning algorithms [67]. Accounting and Financial Estimates - The company has not made any material changes to its critical accounting estimates since the 2024 Annual Report [91]. - The company did not hold any derivative instruments or engage in hedging activities [92].

Financial 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]

Financial 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][40] - 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 FDA clearance for the HeartBeam system in December, marking a significant milestone [9][16] - A second 510(k) application for the twelve-lead synthesis software was submitted in January, currently under FDA review [10][17] Market Data and Key Metrics Changes - The initial target market includes concierge medicine patients, estimated at 1.5 million in the US, with a potential revenue opportunity of $250 to $500 million annually [29][30] - The broader direct patient pay market could represent a revenue opportunity of $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][51] 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 [48][50] - The company is focused on minimizing cash burn while preparing for commercialization, with a strong belief in the value of its technology [45][46] Other Important Information - The company completed a public offering of $11.5 million, which will support upcoming milestones and operational readiness [14][36] - HeartBeam, Inc. received the Diamond Pinnacle Health Care Award for medical device innovation, highlighting its contributions to patient care [15] Q&A Session Summary Question: What went into your decision to not immediately commercialize upon clearance? - The company decided to wait for the twelve-lead synthesis software clearance to ensure differentiation in the market [55] Question: What are your expectations for cash burn in 2025 and timing of next raise? - The expected cash burn for 2025 is similar to the $14.5 million spent in 2024, with a focus on prudent spending in the first half of the year [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 device that synthesizes a twelve-lead ECG, emphasizing its unique IP [69][72] Question: Are you concerned about political changes affecting timely FDA approval? - Management has not seen an impact on the FDA submission process and remains confident in their interactions with the review team [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 evaluated later [80][82] Question: When is the expected clearance time from FDA for the second clearance? - The company estimates receiving FDA clearance for the twelve-lead synthesis software before the end of the year [84][86] Question: Can you give us more details on the early access program? - The early access program aims to evaluate the offering and prepare for commercialization, involving hundreds of patients [87][89]