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HeartBeam reports first quarter 2024 results

HeartBeam, Inc. has reported its financial and operational results for the first quarter ended March 31, 2024.

Management commentary
“In the first quarter we remained on track with expected regulatory and clinical milestones for the AIMIGo 3D VECG technology platform, and in tandem advanced developments related to the use of artificial intelligence (AI) applied to our VECG technology,” said Branislav Vajdic, PhD, Chief Executive Officer and Founder of HeartBeam. “Following the FDA 510(k) submission for the AIMIGo VECG system, we currently anticipate clearance by the end of Q2 2024, and a limited launch of AIMIGo by the end of 2024.

“Following the initial FDA clearance for AIMIGo, we plan to submit a second 510(k) application in Q3 2024. This submission will include results from our pivotal VALID-ECG clinical study. To date, we have enrolled more than 50% of the patients and anticipate completing enrollment in Q2 2024.

“During the first quarter, we were encouraged by our progress in using artificial intelligence with our 3D VECG technology. By leveraging AI to analyze our data-rich signals, we believe we will be able to improve diagnostic accuracy and extract unique information that today’s ambulatory ECGs are unable to detect.

“In April we presented positive new data for our deep learning algorithm, HeartBeam AI, at the EHRA conference. The study shows that HeartBeam AI combined with VCG delivers equivalent performance to a 12-lead ECG and greatly improves detection of atrial flutter over a single-lead ECG. We believe this presents an opportunity for a VCG-based algorithm that offers arrhythmia detection capabilities beyond what is available today and to make it easier to obtain a 12-lead ECG.

“We ended the first quarter of 2024 with approximately $12.6 million in cash and cash equivalents. We believe we are in a strong position as we carefully manage spending. We look forward to providing updates on our progress in the months ahead,” concluded Dr Vajdic.

First quarter 2024 financial results
Research and development expenses for the first quarter of 2024 were $2.4 million, compared to $1.7 million for the first quarter of 2023.

General and administrative expenses for the first quarter of 2024 were $2.4 million compared to $2.5 million for the first quarter of 2023.

Net loss for the first quarter of 2024 was $4.6 million, compared to a net loss of $4.1 million for the first quarter of 2023.

Cash and cash equivalents totaled $12.6 million as of March 31, 2024, compared to $16.2 million as of December 31, 2023. Net cash used in operations was $3.5 million for the three months ended March 31, 2024.
MB Bureau

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