HeartBeam’s ECG software shows promise in clinical study

SANTA CLARA, Calif. – HeartBeam, Inc. (NASDAQ: BEAT), a pioneer in cardiac care technology with a market capitalization of $65.76 million, has announced positive results from its VALID-ECG pivotal study, which evaluated its synthesized 12-lead electrocardiogram (ECG) technology. The study’s findings were presented at the Heart Rhythm Society’s annual conference in San Diego. According to InvestingPro data, the company’s stock has shown strong momentum with a 25.81% return over the past week, although it currently trades above its Fair Value.

The VALID-ECG study compared HeartBeam’s synthesized 12-lead ECG to the traditional standard 12-lead ECG, focusing on mean differences in ECG intervals and amplitudes that are crucial for assessing non-life-threatening arrhythmias. The results demonstrated a 93.4% overall diagnostic agreement with the standard ECG, suggesting that HeartBeam’s technology could reliably support arrhythmia diagnosis.

HeartBeam’s 3D ECG technology, which received FDA clearance for arrhythmia assessment in December 2024, captures the heart’s electrical signals in three non-coplanar directions. These signals are then synthesized into a 12-lead ECG using a personalized transformation matrix. The technology aims to enable patients to monitor cardiac health outside medical facilities using a device the size of a credit card.

The company submitted an application to the FDA for the 12-lead ECG synthesis software in January 2025, based on data from the VALID-ECG study. Upon FDA clearance, HeartBeam plans to initiate commercialization of the software. In preparation, it has launched an Early Access Program to gather feedback on clinical workflow and establish an early adopter base. With analyst price targets ranging from $2 to $8 per share and upcoming earnings scheduled for May 8, 2025, investors can access detailed financial analysis and additional insights through InvestingPro’s comprehensive research reports.

The multicenter VALID-ECG trial enrolled 198 patients across five U.S. clinical sites, including Allegheny Health Network, Atlanta Heart Specialists, Mount Sinai Hospital, Northwell Health, and Piedmont Heart Institute.

HeartBeam, Inc. is dedicated to transforming the detection and monitoring of critical cardiac conditions with its innovative technology. The company’s platform is designed for portable devices that can be used by patients wherever they are, delivering actionable heart intelligence to physicians and potentially redefining the future of cardiac health management. While the company shows promise in innovation, InvestingPro analysis indicates current financial challenges with an EBITDA of -$19.88 million and a weak overall financial health score. Subscribers can access over 30 additional financial metrics and expert insights about HeartBeam’s growth potential.

This article is based on a press release statement from HeartBeam, Inc.

In other recent news, HeartBeam Inc. reported its fourth-quarter earnings for 2024, which fell short of expectations with an EPS of -$0.73 compared to the forecasted -$0.17. Despite this earnings miss, the company remains focused on its innovative ECG technology and future commercialization plans. Benchmark analysts have maintained a Speculative Buy rating and an $8.00 price target for HeartBeam, underscoring the company’s progress and potential market opportunities. HeartBeam has also made strides with the FDA’s 510(k) clearance for its portable heart monitoring technology, which is a significant step toward its planned commercial launch. Additionally, HeartBeam announced a strategic collaboration with AccurKardia to integrate FDA-cleared ECG analysis software into its devices, enhancing remote cardiac monitoring capabilities. The company’s recent public offering raised $11.5 million, bolstering its financial position with a pro forma cash balance of approximately $12.6 million. HeartBeam has appointed CBIZ CPAs P.C. as its new auditor following the resignation of Marcum LLP, ensuring continuity in its financial oversight. These developments reflect HeartBeam’s ongoing efforts to expand its technological capabilities and prepare for future market entry.

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