SANTA CLARA, Calif. - HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company, has announced results from two clinical studies that suggest its vector-based technology could be pivotal in advancing cardiac care. The studies, which were presented at the American Heart Association's annual Scientific Sessions held on November 16-18, 2024, focused on arrhythmia detection and the evaluation of chest pain for heart attack patients.
The first study, an 80-patient pilot, demonstrated that HeartBeam's synthesized 12-lead ECG waveforms closely aligned with standard 12-lead ECGs in arrhythmia detection, boasting a 94% sensitivity and 100% specificity. The findings are preparatory for the company's VALID-ECG pivotal study, which is part of the FDA submission process.
The second study explored the feasibility of a proprietary algorithm designed by HeartBeam to calculate an acute coronary syndrome (ACS) risk score. This algorithm aims to expedite the assessment of chest pain, potentially reducing the time to treatment for heart attack symptoms. The study showed that the algorithm's assessments were consistent with those of Emergency Department physicians who typically use standard 12-lead ECGs.
HeartBeam's technology captures the heart's electrical signals in three dimensions with a device small enough to fit in a wallet, allowing patients to record an ECG when symptoms arise. This convenience could minimize care delays and enable timely diagnoses outside of healthcare facilities.
These studies add to the clinical evidence for HeartBeam's technology, which is currently under FDA review. The company's CEO, Robert Eno, expressed gratitude towards physician collaborators for their role in evaluating the technology's clinical utility.
HeartBeam, Inc. is committed to transforming cardiac care by providing insights into cardiac health that can be accessed outside of medical facilities. The company holds several US and international patents related to its technology platform.
This news is based on a press release statement from HeartBeam, Inc. and does not include any forward-looking statements or endorsements of claims. The article aims to present the information clearly and factually, based on the recent clinical study results.
In other recent news, HeartBeam Inc. reported significant developments during its Q3 2024 earnings call. The company disclosed a net loss of $4.979 million for the quarter, despite advancing in the cardiac care market with its innovative 12-lead ECG technology. HeartBeam remains optimistic about receiving FDA clearance for this technology and is preparing for a limited commercial launch in 2025.
The company also emphasized its commitment to financial discipline as it readies for commercialization. HeartBeam's technology has been validated by nine peer-reviewed studies involving over 500 patients, and the company holds 17 issued patents, bolstering its confidence in its innovative approach.
The VALID-ECG study, which is crucial to an upcoming FDA submission, has completed enrollment and data analysis. HeartBeam is also actively engaging with stakeholders and shareholders, ensuring strong support as it navigates these recent developments.
InvestingPro Insights
HeartBeam's recent clinical study results align with its innovative approach to cardiac care, but investors should consider the company's financial position alongside its technological advancements. According to InvestingPro data, HeartBeam has a market capitalization of $63.48 million, reflecting its status as a small-cap medical technology company.
InvestingPro Tips reveal that HeartBeam holds more cash than debt on its balance sheet, which could provide financial flexibility as it pursues FDA approval and commercialization of its technology. However, the company is quickly burning through cash, a common characteristic of medical technology firms in the development stage.
Despite the promising clinical results, HeartBeam is not currently profitable, with an adjusted operating income of -$19.05 million over the last twelve months as of Q3 2023. This aligns with the InvestingPro Tip indicating that the company is not profitable over the last twelve months.
Interestingly, HeartBeam's stock has shown a strong performance, with a 1-year price total return of 83.85% as of the latest data. This suggests that investors are optimistic about the company's potential, possibly due to the positive clinical study outcomes and the innovative nature of its cardiac care technology.
For investors considering HeartBeam, it's worth noting that InvestingPro offers 8 additional tips that could provide further insights into the company's financial health and market position. These additional tips could be particularly valuable given HeartBeam's status as a developing medical technology company with promising clinical results but current financial challenges.
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