HeartBeam, Evolve Manufacturing Team Up on Electrocardiogram Device

HeartBeam Inc. has signed an agreement with Evolve Manufacturing Technologies 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 terms of the Agreement, HeartBeam will leverage Evolve’s manufacturing and packaging expertise to commercialize the HeartBeam AIMIGo device in anticipation of early market testing in Q2 2023 after the device is cleared by the U.S. Food and Drug Administration (FDA). 

“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,” HeartBeam Founder/CEO Branislav Vajdic, Ph.D., said. “Evolve’s 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.
 
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 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 United States have coronary artery disease, and every 40 seconds someone in the United States has a heart attack.

“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,” Vajdic said.
 
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 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,” Evolve Manufacturing Technologies CEO Noreen King said. “We look forward to providing our manufacturing expertise to the HeartBeam team to help turn their innovative science into a commercial product.”
 
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. 

HeartBeam 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.