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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