HeartBeam Expands Patient Population for Emergency Department Software Technology Solution
June 30 2022 - 8:31AM
Business Wire
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
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.
Forward-Looking Statements
All statements in this release that are not based on historical
fact are “forward-looking statements.” While management has based
any forward-looking statements included in this release on its
current expectations, the information on which such expectations
were based may change. Forward-looking statements involve inherent
risks and uncertainties which could cause actual results to differ
materially from those in the forward-looking statements, as a
result of various factors including those risks and uncertainties
described in the Risk Factors and in Management’s Discussion and
Analysis of Financial Condition and Results of Operations sections
of our in our Forms 10-K, 10-Q and other reports filed with the SEC
and available at www.sec.gov. We urge you to consider those risks
and uncertainties in evaluating our forward-looking statements. We
caution readers not to place undue reliance upon any such
forward-looking statements, which speak only as of the date made.
Except as otherwise required by the federal securities laws, we
disclaim any obligation or undertaking to publicly release any
updates or revisions to any forward-looking statement contained
herein (or elsewhere) to reflect any change in our expectations
with regard thereto or any change in events, conditions or
circumstances on which any such statement is based.
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version on businesswire.com: https://www.businesswire.com/news/home/20220630005317/en/
Media and Investor Relations Contact: Chris Tyson
Executive Vice President MZ North America Direct: 949-491-8235
BEAT@mzgroup.us www.mzgroup.us
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