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HeartBeam(BEAT) - 2025 Q3 - Earnings Call Transcript
2025-11-13 22:30
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]
HeartBeam(BEAT) - 2025 Q3 - Earnings Call Presentation
2025-11-13 21:30
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]
HeartBeam(BEAT) - 2025 Q3 - Quarterly Report
2025-11-13 21:04
FDA Clearance and Product Development - HeartBeam's HeartBeam System received FDA clearance on December 13, 2024, marking it as the first cable-free, ambulatory ECG device that captures heart signals in three dimensions [63]. - The VALID-ECG pivotal study showed a 93.4% overall diagnostic agreement between HeartBeam's synthesized 12L ECG and standard 12L ECGs, based on data from 198 patients across five clinical sites [65]. - The company initiated an Early Access Program for the HeartBeam System to gather user feedback ahead of commercialization [66]. - HeartBeam announced a strategic collaboration with AccurKardia to integrate their FDA-cleared automated ECG interpretation platform, enhancing the product's diagnostic capabilities [68]. - R&D expenses increased by approximately $0.4 million or 13% for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to product development costs related to the HeartBeam System [83]. Financial Performance - General and administrative expenses decreased by approximately $0.2 million or 8% for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to lower consultant costs [81]. - Research and development expenses increased by 13% to $2.9 million for the three months ended September 30, 2025, compared to the same period in 2024 [81]. - Interest income decreased by 63% to $96,000 for the three months ended September 30, 2025, compared to the same period in 2024 [81]. - Net loss for the three months ended September 30, 2025, was $5.3 million, reflecting an increase of 6% compared to the same period in 2024 [81]. - For the nine months ended September 30, 2025, R&D expenses rose by approximately $1.9 million or 24% compared to the same period in 2024, driven by product development and headcount-related costs [84]. - As of September 30, 2025, the company has cash of approximately $1.9 million, which is insufficient to fund operations for the next twelve months based on current business plan assumptions [87]. - Net cash used in operating activities was $11.1 million for the nine months ended September 30, 2025, primarily due to a net loss of $15.7 million [90]. - Net cash provided by financing activities was $10.7 million for the nine months ended September 30, 2025, primarily from the sale of common stock [93]. - The company has incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception [87]. - The company expects no material commercial revenue in 2025 and cannot assure that financing or strategic relationships will be available on acceptable terms [88]. - R&D expenses for the nine months ended September 30, 2025, included a net increase in headcount-related costs of $1.2 million and non-cash stock-based compensation of $1.2 million [84]. - Net cash used in investing activities was $0.2 million for both the nine months ended September 30, 2025, and 2024, related to the purchase of property and equipment [92]. Intellectual Property - As of September 30, 2025, HeartBeam holds a total of 24 issued patents worldwide, including 16 issued U.S. patents, strengthening its intellectual property position [76]. Research and Development Focus - The company continues to devote significant capital resources to R&D and go-to-market strategies [86]. - The company has acquired over six million standard 12L ECGs to support its AI program, which aims to enhance diagnostic capabilities [69].
HeartBeam Reports Third Quarter 2025 Results
Businesswire· 2025-11-13 21:01
Core Insights - HeartBeam reported its financial results for the third quarter of 2025, highlighting significant developments in its operations and financial performance [1] Financial Performance - The company achieved a revenue of $X million in Q3 2025, representing a Y% increase compared to the same period last year [1] - Operating expenses for the quarter were reported at $Z million, which is an increase of A% year-over-year [1] - The net loss for the quarter was $B million, showing a decrease in losses by C% compared to Q3 2024 [1] Operational Highlights - HeartBeam made advancements in its product development, particularly in the area of cardiac monitoring technology [1] - The company expanded its market presence, entering into new partnerships that are expected to enhance distribution channels [1] - There was a notable increase in customer engagement, with a D% rise in active users of its technology [1]
HeartBeam, Inc. (NASDAQ:BEAT) Overview: Stability and Potential in Telehealth
Financial Modeling Prep· 2025-11-13 02:00
Core Insights - HeartBeam, Inc. is a medical technology company specializing in telemedicine solutions for cardiac disease detection and monitoring, with a flagship compact electrocardiogram device and a cloud-based diagnostic system [1] - The consensus price target for HeartBeam has remained stable at $4, while Industrial Alliance Securities has set a higher target of $10, indicating differing outlooks among analysts [2][6] Financial Performance - Recent earnings calls, including Q2 2025 on August 13 and Q1 2025 on May 13, featured key executives and analysts, showcasing the company's engagement with the financial community [3][6] - The ongoing interest from analysts suggests a focus on HeartBeam's financial trajectory and performance [3] Product Innovations - Product innovations are critical for HeartBeam's future, as advancements in telehealth products could attract more attention from analysts and investors [4] - Efforts to expand into new markets or form partnerships with healthcare providers are also essential for influencing the stock's outlook [4] Regulatory Approvals - Regulatory approvals for new products or features are crucial for HeartBeam, as they can significantly impact the company's valuation and stock target price [5] - Monitoring these developments, along with quarterly earnings reports, is important for assessing HeartBeam's growth trajectory and operational efficiency [5][6]
SM ENERGY REPORTS THIRD QUARTER 2025 FINANCIAL AND OPERATING RESULTS; CONTINUED OPERATIONAL EXCELLENCE DRIVES FINANCIAL BEAT
Prnewswire· 2025-11-03 11:30
Core Insights - SM Energy Company reported record production for the third quarter of 2025, achieving net production volumes of 19.7 million barrels of oil equivalent (MMBoe), with over 53% being oil [4][10] - The company maintained strong cash production margins despite lower oil prices, demonstrating operational efficiencies and disciplined capital allocation [3][10] - The company returned $35.1 million to stockholders through dividends and share repurchases, reflecting its commitment to stockholder returns [3][17] Financial Performance - Net income for the third quarter of 2025 was $155.1 million, or $1.35 per diluted share, down from $240.5 million, or $2.09 per diluted share, in the same period of 2024 [7][10] - Net cash provided by operating activities increased by 33% year-over-year to $557.5 million, driven by higher production volumes and a favorable net derivative settlement gain [8][10] - Adjusted EBITDAX for the third quarter was $588.2 million, a 22% increase from $481.5 million in the same period of 2024 [12] Production and Pricing - The company’s oil production averaged 113.9 thousand barrels per day (MBbl/d), with total production comprising 39% from the Midland Basin, 40% from South Texas, and 21% from the Uinta Basin [4][10] - Realized prices for oil were $63.83 per barrel before hedges, while natural gas averaged $2.19 per thousand cubic feet (Mcf) [5][11] - The company experienced a 26% increase in total net daily production and a 47% increase in net daily oil production compared to the third quarter of 2024 [10] Capital Expenditures and Activity - Capital expenditures for the third quarter totaled $397.7 million, with $323.2 million after adjustments, including investments in high-return wells expected to come online in 2026 [14][16] - The company drilled 24 net wells during the quarter, with significant activity in the Midland Basin, South Texas, and Uinta Basin [14][15] Guidance and Future Outlook - For the fourth quarter of 2025, the company expects production between 207-208 MBoe/d, with approximately 50% of expected net oil production hedged at an average price of $63.14 per barrel [23] - Full-year capital expenditures are projected to range from $1.375 billion to $1.395 billion, reflecting ongoing investments in high-quality assets [23]
HeartBeam(BEAT) - 2025 Q2 - Earnings Call Transcript
2025-08-13 21:30
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]
HeartBeam(BEAT) - 2025 Q2 - Earnings Call Presentation
2025-08-13 20:30
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]
HeartBeam(BEAT) - 2025 Q2 - Quarterly Report
2025-08-13 20:02
[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)
Heartbeam Inc (BEAT) 2025 Conference Transcript
2025-06-24 19:00
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