HeartBeam Partners with Evolve Manufacturing to Build HeartBeam AIMIGoTM 12-Lead 3D Vector Electrocardiogram Device
December 07 2022 - 8:31AM
Business Wire
Partnership Positions AIMIGo for Early Market
Testing in Q2 2023 After Expected FDA Clearance
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 announced it has signed an agreement (the
“Agreement”) with Evolve Manufacturing Technologies (“Evolve”), a
contract medical device manufacturing company, to build the credit
card-sized AIMIGo 3D vector electrocardiogram (VECG) recording
device that provides a 12 lead ECG readout for remote heart attack
detection. Under the terms of the Agreement, HeartBeam will
leverage Evolve’s manufacturing and packaging expertise to support
commercialization of the HeartBeam AIMIGo device in anticipation of
early market testing in Q2 2023 following expected FDA Clearance in
early 2023.
HeartBeam has developed a personal, portable and easy-to-use
heart attack detection solution that can be used by patients
anytime, anywhere to assist patients and their clinicians in
assessing whether symptoms may be the result of a heart attack.
HeartBeam’s breakthrough solution employs a reusable, credit
card-sized, 3D vector ECG recording device and cloud-based software
to deliver critical data to clinicians in real-time outside of a
medical setting. More than 18 million people in the U.S. have
coronary artery disease, and every 40 seconds someone in the U.S.
has a heart attack.
As Silicon Valley’s premier medical device manufacturer, Evolve
provides end-to-end contract manufacturing for medical device and
life sciences instrument companies. Coupled with best-in-class
guidance and attention along with proven quality processes, Evolve
offers ISO-certified turnkey contract manufacturing for medical
device companies. Evolve has previously collaborated with Triple
Ring Technologies, HeartBeam’s co-developer of the AIMIGo device,
creating additional synergies as the device moves into
manufacturing technology transfer.
“Evolve has deep medical device manufacturing expertise and a
strong reputation in the industry for delivering consistent product
quality and customer care rarely found in medical contract
manufacturers,” said Branislav Vajdic, PhD, CEO and Founder of
HeartBeam. “Evolve’s dedicated customer teams use Design for
Excellence (DFX) methodologies, and state-of-the-art, end-to-end
quality processes, plus world-class materials suppliers to ensure
consistent and high-quality products. We have now begun technology
transfer from Triple Ring Technologies to Evolve as they develop
and obtain experience with our product in preparation for
manufacturing.
“With our successful five-phase device technology development
project with Triple Ring nearing completion, we are advancing
towards pre-commercial production. We believe Evolve’s long
standing collaborative relationship with Triple Ring will greatly
benefit HeartBeam in expediting technology transfer through
commercial production once we have received FDA clearance for
AIMIGo, estimated for the first quarter of 2023,” concluded Dr.
Vajdic.
“Evolve is excited to partner with HeartBeam to manufacture the
integral medical device that is part of their AIMIGo solution for
detecting heart attacks outside of a medical setting,” said Noreen
King, CEO of Evolve Manufacturing Technologies. “We look forward to
providing our manufacturing expertise to the HeartBeam team to help
turn their innovative science into a commercial product.”
About Evolve Manufacturing
Evolve Manufacturing provides end-to-end contract manufacturing
for medical device and life sciences instrument companies. Based in
Silicon Valley, Evolve offers turnkey contract manufacturing for
OEMs that need low to medium production volumes coupled with
best-in-class guidance and attention. From first article builds to
prototypes and clinical units, our dedicated customer teams use DFX
methodologies to deliver flawless and consistent product quality
and a level of flexibility, agility, and customer care rarely found
in medical contract manufacturers. For more information visit
www.evolvemfg.com.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221207005302/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
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