First Patients Enrolled in Pivotal Study Evaluating HeartBeam’s AIMIGo™ System for Synthesizing a 12-Lead ECG
14 Marzo 2024 - 1:31PM
Business Wire
VALID-ECG Study will Form the Basis of the
Company’s Upcoming FDA 510(k) Submission
HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company
focused on transforming cardiac care through the power of
personalized insights, announced today that it has enrolled the
first patients in the VALID-ECG (Clinical Validation of the AIMIGo
12-Lead ECG Synthesis Software for Arrhythmia Detection) pivotal
study. The first patients were enrolled at Atlanta Heart
Specialists, a top cardiology physician practice in Atlanta,
GA.
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.
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Investor Relations Contact: Chris Tyson Executive Vice
President MZ North America Direct: 949-491-8235 BEAT@mzgroup.us
www.mzgroup.us
Media Contact: media@heartbeam.com
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