HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology
company that has developed the first and only 3D-vector
electrocardiogram (VECG) platform for heart attack detection
anytime, anywhere, today issued a letter to shareholders from its
Chief Executive Officer and Founder, Branislav Vajdic, PhD.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20221229005042/en/
Dear Fellow Shareholders,
2022 was a transformative year for HeartBeam and for our
technology and business, highlighted by ongoing advancements in our
product launch timeline for the HeartBeam AIMIGo™ 12-Lead 3D Vector
Electrocardiogram (ECG) Device and HeartBeam AIMI™.
I could not be more enthusiastic about the future for HeartBeam,
the rapid pace of our product timeline, and our team’s ability to
scale our commercialization path. Our mission to deliver medical
grade heart attack detection that is with the patient anytime,
anywhere could not be timelier, with more than 18 million people in
the U.S. suffering from coronary artery disease. Every 40 seconds
in the US, someone experiences a heart attack.
On average, people wait three hours before seeking care which
often leads to heart damage or death. Patients often have
difficulty identifying if the chest pain and other heart attack
symptoms they are experiencing are due to a heart attack. The
ability to quickly detect a heart attack and instantly share that
information with a doctor could significantly reduce mortality.
Conversely, chest pain is the second most common reason for an
emergency department visit, yet 82% of those visits are
unnecessary, costing the healthcare system about $10 billion
annually. We are uniquely positioned to impact these patients
across their episode of care journey, getting heart attack patients
to treatment quickly while facilitating reassurance for patients
whose symptoms do not require immediate medical attention, as well
as saving on unneeded Emergency Department (ED) visits.
Developed by our pioneering team, our HeartBeam AIMI and
HeartBeam AIMIGo solutions will transform the way patients and
doctors detect heart attacks. By providing remote, 12-lead 3D
vector ECG (VECG™) capability, the HeartBeam platform intends to
offer fast, accurate detection of heart attacks and complex cardiac
arrhythmias for the first time outside of a medical setting.
We expect the HeartBeam AIMI system for use in acute care
settings to receive regulatory approval in the near future. We are
in discussions with the FDA and plan to meet with them soon and
expect HeartBeam AIMI to be cleared in the Q1 2023 time frame. The
HeartBeam algorithm used in an emergency department setting
leverages existing 12-lead ECG hardware and provides the attending
physician with an instant comparison of the patient’s baseline and
symptomatic ECG with a diagnostic suggestion for their
consideration in the patient’s diagnosis. This will allow
physicians to quickly determine if a patient needs intervention or
can be discharged which helps manage ED capacity.
Our HeartBeam AIMIGo solution is the first and only credit
card-sized device with 12-lead 3D vector ECG capability coupled
with a smartphone app and diagnostic software for remote heart
attack detection. FDA submission for HeartBeam AIMIGo Version 1 is
projected for Q1 2023. In preparation for commercial launch, we
recently signed an agreement with Evolve Manufacturing
Technologies, a contract medical device manufacturing company, to
build the credit card-sized HeartBeam AIMIGo device. We will
leverage Evolve’s manufacturing and packaging expertise to support
commercialization of the HeartBeam AIMIGo Version 1 device in
anticipation of early market testing in Q2 2023. We anticipate the
HeartBeam AIMIGo Version 2 device with synthesized 12L capability
to be ready for FDA submission at the end of Q2 2023.
We plan to focus in 2023 and 2024 on the expansion of our core
technology features, the 3D VECG data and clinical studies that we
believe will establish our platform as the standard of care for
ambulatory-based cardiology and taking advantage of the
comprehensiveness of our technology.
Novel technologies that solve real healthcare problems are the
bedrock of HeartBeam. During the year we strengthened the
intellectual property (IP) around our technologies by receiving
several seminal patents. Among these patents, one has particular
importance. This is the patent for a 12-lead 3D vector ECG patch
monitor intended for detection of heart attacks, a limitation of
current patch technology, along with the ability to detect complex
cardiac arrhythmias. Our 12-lead ECG patch technology will open the
door to the global ECG patch monitor market which is estimated to
reach $4.8B by 2030 and bring a level of diagnostic accuracy
consistent with current 12-lead ECG standard of care. Additionally,
we broadened our future product portfolio with a patent for a
12-lead ECG smartwatch-based monitor for detection of heart attacks
and complex cardiac arrhythmias. With the global wearables medical
device market estimated to reach $196B by 2030, incorporating our
cutting edge 12-lead 3D vector ECG technology into a smartwatch
could make all current single lead smart watch products obsolete
for detecting cardiac conditions. We believe that for the first
time, and based on our technology, a smartwatch will provide enough
data to a physician to be able to detect a heart attack and other
complex cardiac conditions.
Currently, available smartwatches are limited to detecting only
irregular heart rhythms and recent studies show they generate a
high rate of false positives and inconclusive results. The
combination of a current generation single lead smartwatch with the
HeartBeam AIMIGo 3D VECG technology provides the patient and
clinician the benefit of a 12-lead ECG to interpret the cardiac
event. We believe the integration of these platforms will transform
the clinical accuracy of mobile technologies for monitoring at-risk
cardiac patients.
Operationally, we added several key executives in 2022 to build
out our team. Peter J. Fitzgerald, MD, PhD, joined as our Chief
Medical Officer. Dr. Fitzgerald is a world-renowned cardiologist
with expertise in interventional cardiology, as well as an
accomplished inventor, entrepreneur, and investment fund founder
with a rich history of developing successful collaborations in the
industry and across investment and medical communities. We also
welcomed Ken Persen to the role of Chief Technology Officer. Ken
has extensive technology, executive and start-up experience in the
healthcare and cardiac device industries. He continues to lead the
overall technology strategy and development of the HeartBeam AIMI
and HeartBeam AIMIGo platforms. We also established a Scientific
Advisory Board (“SAB”) to provide scientific guidance and insight
to our medical studies, research, and product pipelines. In
conjunction, world-renowned cardiologist C. Michael Gibson, MS, MD,
an interventional cardiologist, and a prolific cardiovascular
researcher and educator, was appointed as Chairman of the new SAB.
Dr. Gibson pioneered understanding of the “open artery hypothesis”
and published some of the most quoted articles on the importance of
timely intervention for heart attack patients. Both Dr. Fitzgerald
and Dr. Gibson are also providing guidance on the types of clinical
studies needed to validate our products and accelerate their
acceptance.
We are incredibly proud of our accomplishments in the past year
since our Nasdaq IPO in late 2021. Looking ahead, we are highly
focused on the continued execution of our product launch timeline.
Our path is on track with our HeartBeam AIMIGo 3D vector ECG
first-generation product which we expect will be ready for FDA
submission in Q1 2023, and the anticipated FDA clearance for our
HeartBeam AIMI system. We are leveraging our strategic partnerships
with multiple industry leaders to move toward production and
commercialization of our products, with plans to broaden our
product portfolio pipeline with smartwatch connectivity. Our
commercial team has continued to engage in productive discussions
with strategic healthcare institutions, including academic centers,
regional systems, and regional community hospital systems. We enter
2023 with tremendous momentum and look forward to sharing our
accomplishments in the coming year as we strive to create value for
our customers, shareholders, employees, and communities. We thank
all of you for your dedication to our mission.
Sincerely,
Branislav Vajdic, PhD CEO & Founder
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a cardiac technology company
that has developed the first and only 3D-vector ECG platform for
heart attack detection anytime, anywhere. By applying a suite of
proprietary algorithms to simplify vector electrocardiography
(VECG), the HeartBeam platform enables patients and their
clinicians to determine if symptoms are due to a heart attack,
quickly and easily, so care can be expedited, if required.
HeartBeam has two patented products in development. HeartBeam AIMI™
is software for acute care settings that provides a 3D comparison
of baseline and symptomatic 12-lead ECG to more accurately identify
a heart attack. HeartBeam AIMIGo™ is the first and only credit
card-sized 12-lead output ECG device coupled with a smart phone app
and cloud-based diagnostic software system to facilitate remote
heart attack detection. HeartBeam AIMI and AIMIGo have not yet been
cleared by the US Food and Drug Administration (FDA) for marketing
in the USA or other geographies. For more information, visit
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 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/20221229005042/en/
Investor Relations Contact: Chris Tyson Executive Vice
President MZ North America Direct: 949-491-8235 BEAT@mzgroup.us
www.mzgroup.us Media Contact: Capwell Communications
media@heartbeam.com
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