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]

NASDAQ: MDBH We make investments that can change lives Fourth Quarter and Full Year 2024 Results March 31, 2025 FORWARD-LOOKING STATEMENTS & DISCLOSURES This presentation contains "forward-looking statements." These forward-looking statements are made as of the date they were first issued and were based on current expectations, estimates, forecasts and projections as well as the beliefs and assumptions of management. Words such as "expect," "anticipate," "should," "believe," "hope," "target," "project," "go ...