HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, is reporting on its financial and operational results for first quarter 2024, for the period ended March 31, 2024. Highlights of the report include the 510(k) submission for BEAT’s AIMIGo(TM) system for review by the U.S. Food and Drug Administration (“FDA”); presubmission meetings being held with the FDA in preparation to submit a second 510(k) for BEAT’s 12-lead synthesis software; beginning patient enrollment for a study designed to demonstrate the similarity between the synthesized 12-lead ECG and a standard 12-lead ECG; the presentation of key data at the European Heart Rhythm Association (“EHRA”) conference; and receiving two new patents on ambulatory VECG technology from the U.S. Patent and Trademark Office. Notable financial numbers from the report include R&D expenses for the quarter totaled $2.4 million, compared to $1.7 million for Q1 2023; general and administrative expenses for the quarter totaled $2.4 million compared to $2.5 million for Q1 2023; net loss for the quarter was $4.6 million; and cash and cash equivalents totaled $12.6 million as of March 31, 2024. “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 HeartBeam founder and CEO Branislav Vajdic, PhD, in the press release. “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. . . . 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.”
To view the full press release, visit https://ibn.fm/PjQFX
About HeartBeam Inc.
HeartBeam is a medical technology company dedicated to transforming cardiac care through the power of personalized insights. The company’s proprietary vectorelectrocardiography (“VECG”) technology collects 3D signals of the heart’s electrical activity and converts those signals into a 12-lead ECG. This platform technology is designed to be used on portable, patient-friendly devices such as a credit-card-sized monitor, watch or patch. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care, all outside of a medical facility, thus redefining how cardiac health is managed. For more information, visit www.HeartBeam.com.
NOTE TO INVESTORS: The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT
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