First Patients Enrolled in Pivotal Study Evaluating HeartBeam’s AIMIGo™ System for Synthesizing a 12-Lead ECG
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The commencement of the VALID-ECG study by HeartBeam, Inc. is a significant step in the medical technology field, particularly in the development of cardiac diagnostic tools. The study focuses on comparing the effectiveness of HeartBeam's AIMIGo system against the standard hospital-based 12-lead ECG. This comparison is critical as it seeks to validate the AIMIGo system's accuracy and reliability in arrhythmia detection, which is a key factor in diagnosing and managing cardiac conditions.
HeartBeam's AIMIGo system utilizes proprietary 3D vectorelectrocardiography (3D VECG) technology. This advanced technology offers a potential improvement over traditional methods by providing a more comprehensive view of the heart's electrical activity. If the study results are positive, this could lead to a paradigm shift in how cardiac arrhythmias are monitored and diagnosed, particularly outside of hospital settings.
Furthermore, the compact size of the AIMIGo system could enhance patient compliance and convenience, potentially leading to earlier detection and intervention for cardiac events. The broader implications for healthcare could include reduced hospital visits and healthcare costs, improved patient outcomes and a stronger emphasis on preventive care.
For investors and stakeholders in HeartBeam, Inc., the VALID-ECG study represents a pivotal milestone that could significantly impact the company's market position and financial future. Successful completion and positive results from the FDA 510(k) submission process could open up considerable market opportunities for HeartBeam's AIMIGo system. This is particularly relevant given the growing demand for remote and personal health monitoring technologies.
Investors should monitor the progress of the VALID-ECG study closely as it will provide critical data that could influence HeartBeam's stock performance. A favorable outcome could lead to increased investor confidence, potential partnerships and broader market adoption of the AIMIGo system. Conversely, any setbacks in the study or regulatory process could have adverse effects on the company's valuation and growth prospects.
It is also important to consider the competitive landscape of the medical device sector, where innovation and regulatory approval are key drivers of success. HeartBeam's progress should be evaluated against industry benchmarks and the performance of competing technologies to understand its potential market share and revenue growth.
The VALID-ECG study by HeartBeam, Inc. is not only a significant development for the company itself but also for the broader healthcare industry, particularly in the context of cardiac care innovation. The study's outcomes could influence the adoption rate of new cardiac monitoring technologies and set new standards for arrhythmia detection and patient care protocols.
As remote monitoring and telehealth continue to gain traction, the validation of HeartBeam's AIMIGo system could catalyze further advancements in the field. Healthcare providers may need to adapt their practices to integrate such technologies, which could result in a shift towards more personalized and data-driven cardiac care.
The potential for the AIMIGo system to be used in various applications beyond arrhythmia detection could also stimulate research and development in related areas, fostering innovation and potentially leading to new use cases for 3D VECG technology in the diagnosis and management of cardiac diseases.
VALID-ECG Study will Form the Basis of the Company’s Upcoming FDA 510(k) Submission
The VALID-ECG study will evaluate the performance of a 12-lead ECG synthesized from its credit card-sized HeartBeam AIMIGo™ system compared to that of a standard hospital-based 12-lead ECG using both quantitative and qualitative methodologies for assessment of arrhythmias. HeartBeam AIMIGo leverages HeartBeam’s proprietary 3D vectorelectrocardiography (3D VECG) technology to capture signals in three projections (X, Y, Z) and synthesize a 12-lead ECG.
“We are thrilled to be part of this important study as AIMIGo represents a significant leap in cardiac monitoring technology. It brings the power of 3D VECG into a familiar 12-lead ECG waveform which is used to evaluate a range of cardiac conditions on a daily basis,” said David D. Suh, MD, FACC, Director of Research at Atlanta Heart Specialists. “The attractive, small form factor of AIMIGo makes it easy for patients to use the device whenever necessary. In addition, the clinical implications of 3D VECG technology could be potentially broad-ranging and extend to a variety of applications.”
More About the VALID-ECG Study and FDA Submissions
The VALID-ECG Study will enroll a total of 198 patients presenting with a variety of underlying cardiac conditions at up to five US sites. All patients enrolled in the study will receive simultaneously recorded ECGs from a standard 12-lead ECG machine and the HeartBeam AIMIGo system.
The primary objective of the study is to demonstrate the equivalence of ECG waveforms between the AIMIGo synthesized 12-lead ECG and a standard 12-lead ECG by analyzing key ECG parameters called amplitudes and intervals. The study will also examine the accuracy of physician diagnosis for various arrhythmias with the AIMIGo synthesized 12-lead ECG, compared to a standard 12-lead ECG.
HeartBeam’s 510(k) submission for the credit card-sized AIMIGo system is currently being reviewed by FDA. This application is for the entire 3D VECG system, which consists of the AIMIGo device, the patient application, the physician portal, and the wireless communications between them. The company expects that, when cleared, this would be the first FDA clearance for a handheld VECG system.
The VALID-ECG study will be a component of HeartBeam’s subsequent 510(k) submission, which will focus on the algorithms that take the 3D VECG signal and synthesize a 12-lead ECG, providing physicians with a visual representation of the gold standard ECG output. HeartBeam expects enrollment of the VALID-ECG study to be complete in Q2 2024.
“The initiation of the VALID-ECG study is a major milestone for the company and a reflection of our commitment to provide a strong foundation of clinical data as we strive to provide patients and physicians with the ability to accurately monitor cardiac disease outside of a medical facility,” said Branislav Vajdic, PhD, CEO and Founder of HeartBeam. “In addition, our product pipeline includes coupling AI with our data-rich 3D VECG technology which will enable us to extract unique information and longitudinal insights to transform how cardiac care is monitored in the future.”
The company has already completed an 80-patient pilot study using the same protocol as the VALID-ECG study. The company anticipates presenting the results of the pilot study at a scientific meeting in the second half of 2024. HeartBeam will also present data on its deep learning algorithm at two prestigious Electrophysiology conferences in Q2 2024.
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company that is 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 them 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 in the future. For additional information, visit HeartBeam.com.
Forward-Looking Statements
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Investor Relations Contact:
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Direct: 949-491-8235
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Media Contact:
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Source: HeartBeam, Inc.
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