Expanded Scope of Clinical Validation Study Will Provide Access to a Broader Patient Population
Company Expects to File 510K No Later Than August 15, 2022
SANTA CLARA, Calif., June 30, 2022--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a developmental stage digital healthcare company with a proprietary ECG telemedicine technology for heart attack detection, announced today that HeartBeam is expanding the available patient population for the Company’s Emergency Department software technology solution.
In evaluating the ECG database for the clinical validation of HeartBeam’s platform technology, a significant portion of consecutive patients fell into the category of unstable angina, a serious cardiac condition. In light of the most recent 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain and in consultation with its clinical advisors, HeartBeam elected to include the full data set for clinical validation studying in support of the 510K submission. The expanded scope of the clinical validation study will provide access to a broader patient population for HeartBeam’s technology once cleared by the FDA.
Due to the expanded available patient population, HeartBeam expects to file a 510K with the full data set for clinical validation no later than August 15, 2022 and does not affect the timeline for 510K submission of the Telehealth product.
"It is important to include unstable angina as a diagnosis for analysis. Patients with unstable angina may have subtle electrical changes brought on by ischemia without definitive injury to the cardiac tissue," said Russell Jones, MD, Interventional Cardiologist, Chair of the Ischemia Performance Improvement Committee at Phoebe Putney Health System. "Given HeartBeam’s advanced technology solution, there is potential to identify patients who cannot be diagnosed by traditional ECG capabilities but may require intervention."
HeartBeam’s platform technology is anticipated to assist physicians in identifying patients who present with chest pain to facilitate rapid detection of a heart attack and determine an appropriate treatment regimen. Chest pain is the second most common reason for an emergency department visit, with high costs associated with these visits. HeartBeam’s software solution may offer more accurate heart attack detection to triage patients and expedite treatment. The HeartBeam technology platform has not yet been evaluated by the FDA and is not approved for clinical use in the USA or other global geographies.
"We believe our commercialization path is on track," said Branislav Vajdic, PhD, CEO and founder. "The decision to include the broader patient population does not impact the scheduled submission for HeartBeam’s core technology platform for our Telehealth solution, which remains on schedule to submit in Q4 2022."
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a development stage digital healthcare company with proprietary ECG telemedicine technology that will redefine the way high risk cardiovascular patients are diagnosed in an ambulatory setting at any time and any place. Its breakthrough solution employs a reusable, credit card sized, 3D vector ECG recording device and cloud-based software capable of assisting a physician in diagnosing a wide range of cardiovascular disease. HeartBeam is initially focusing on a huge unmet need of helping diagnose heart attacks in patients outside of a medical institution. No single lead ECG technology can offer this value to patients and their physicians. This underserved market is several times larger than the cardiac arrhythmia detection market based on the prevalence of patients with coronary artery disease at high risk of heart attack. For more information, visit www.heartbeam.com.
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