HeartBeam(BEAT)2025-05-13 20:04FDA 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 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 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 5.5 million, offset by 3.5 million, primarily due to a net loss of 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 8.2 million [88]. - Net cash used in investing activities for Q1 2025 was 0.1 million, attributed to the purchase of equipment [88]. Financing Activities - The company raised approximately 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].