HeartBeam(US:BEAT)2025-11-13 21:04FDA 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].