10-K - HeartBeam, Inc. (0001779372) (Filer)

Wed, Mar 20, 8:11 PM (422 days ago)

In 2023, HeartBeam, a medical technology company focusing on ambulatory cardiac monitoring solutions, made significant strides in its development and regulatory efforts. The company's proprietary Vector Electrocardiography (VECG) technology, designed to capture 3D vector images of the heart's electrical activity and synthesize a 12-Lead (12L) ECG, has shown equal or superior diagnostic capabilities in early studies compared to traditional hospital-based 12L ECG systems. HeartBeam's primary product, HeartBeam AIMIGo, a credit card-sized ECG device integrated with cloud-based algorithms, is under development to tap into the growing ambulatory cardiac monitoring market. The device requires FDA clearance, and as of the end of 2023, HeartBeam had filed a 510(k) submission for its initial product and planned a second submission for its software algorithms that synthesize a 12L ECG. Throughout 2023, HeartBeam focused on enhancing its AI program, developing deep learning algorithms for detecting various cardiac arrhythmias, and strengthening its intellectual property portfolio with 13 issued and allowed U.S. patents, alongside several international patents and applications. The company also published a landmark clinical study demonstrating the efficacy of its VECG technology in detecting coronary artery occlusion. Significant corporate developments included the appointment of Robert P. Eno as President and the expansion of the Board of Directors to eight members, adding experienced individuals to guide HeartBeam's strategic direction. Financially, the company engaged in funding activities, including agreements with Maverick Capital Partners, LLC, for up to $4,000,000 in financing through common stock sales and a convertible note settlement. HeartBeam's progress in 2023 and early 2024 underscores its commitment to advancing cardiac care through innovative monitoring solutions, although it faces challenges in regulatory approval, market competition, and the need for additional financing to support its growth strategy.