Calling 2022 “a transformative year,” Vajdic updated the expectations for HeartBeam’s AIMIGo and AIMI systems.
The company designed AIMIGo as a credit card-sized, 12-lead 3D vector electrocardiogram (ECG) device. It developed AIMI for acute care settings. AIMI provides a 3D comparison of baseline and symptomatic 12-lead ECG to more accurately identify a heart attack.
“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,” Vajdic wrote.
He added that the company believes its AIMI and AIMIGo solutions can “transform” heart attack detection.
Vajdic said the company expects the FDA to approve AIMI for use in acute care settings “in the near future.” The company remains engaged in discussions with the agency and plans to meet it soon. HeartBeam expects AIMI to receive clearance in the first quarter of 2023.
Additionally, HeartBeam intends to submit to the FDA for AIMIGo (version 1) in the first quarter of 2023. It signed a contract manufacturing agreement with Evolve Manufacturing Technologies to build the device. Version 2 of AIMIGo, which features synthesized 12L capability, is earmarked for FDA submission at the end of the second quarter.
“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,” Vajdic said.