HeartBeam—a developmental stage digital healthcare company—signed a professional services agreement to co-developing a heart attack monitor with company Triple Ring Technologies to assist in the design and development of its Telehealth complete solution 3D vector Electrocardiogram (ECG) collection device for remote heart attack or myocardial infarction (MI) monitoring.
The joint partnership is a five-phase expedited device development project scheduled to be completed in the fourth quarter of 2022 for a 510k submission to the FDA.
HeartBeam has developed a personal, portable and easy-to-use heart attack detection solution that can be used by patients at home to help their physicians assess whether chest pain is the result of a heart attack or MI. HeartBeam’s breakthrough solution employs a reusable, credit card sized, 3D vector ECG recording device and cloud-based software to deliver critical data to physicians 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, or MI.
Triple Ring is an innovative company with an established reputation for working with small and large medtech companies on co-developing successful medical technologies in the marketplace. Capabilities span early R&D, product development, manufacturing, regulatory approval, market access, strategic investment and incubation.
“Triple Ring has a long history of designing a wide variety of innovative medical devices and underlying technologies, and we are pleased to be working with its medical device team for our telehealth device,” says Branislav Vajdic, PhD, chief executive officer and founder of HeartBeam. “The joint effort will be a five-phase expedited device development project to rapidly build and test our 3D vector collection device. Patients place this credit card sized device on their chest for a 30 second signal ECG recording, capturing the heart’s electrical activity from three angles in 3D by recording 3 (xyz) projections of the heart vector. A smartphone application connected to the device communicates with the HeartBeam cloud for a diagnostic suggestion and synthesized 12-lead ECG overlaid with baseline. A physician can then remotely view the results through an online portal and can direct the next steps for the patient.”
Under the terms of the agreement, the joint project will include HeartBeam Telehealth 3D vector ECG collection device builds for design verification and validation, device packaging, and a manufacturing technology transfer to a contract manufacturer to be named later. HeartBeam is currently in discussions with several contract manufacturers.
“Triple Ring is pleased to partner with HeartBeam to develop the integral medical device that is part of their complete Telehealth solution for the detection of heart attacks outside of a medical institution,” says Joe Heanue, CEO of Triple Ring Technologies. “We look forward to contributing our capabilities and experience to the HeartBeam team to help turn their innovative science into commercial and business success.”
