In a letter to shareholders, HeartBeam (Nasdaq:BEAT) founder and CEO Branislav Vajdic laid out potential regulatory timelines for 2023.

Calling 2022 “a transformative 12 months,” Vajdic up to date the expectations for HeartBeam’s AIMIGo and AIMI methods.

The corporate designed AIMIGo as a credit score card-sized, 12-lead 3D vector electrocardiogram (ECG) gadget. It developed AIMI for acute care settings. AIMI supplies a 3D comparability of baseline and symptomatic 12-lead ECG to extra precisely determine a coronary heart assault.

“I couldn’t be extra enthusiastic concerning the future for HeartBeam, the speedy tempo of our product timeline, and our workforce’s capacity to scale our commercialization path,” Vajdic wrote.

He added that the corporate believes its AIMI and AIMIGo options can “remodel” coronary heart assault detection.

Vajdic mentioned the corporate expects the FDA to approve AIMI to be used in acute care settings “within the close to future.” The corporate stays engaged in discussions with the company and plans to satisfy it quickly. HeartBeam expects AIMI to obtain clearance within the first quarter of 2023.

Moreover, HeartBeam intends to undergo the FDA for AIMIGo (model 1) within the first quarter of 2023. It signed a contract manufacturing settlement with Evolve Manufacturing Applied sciences to construct the gadget. Model 2 of AIMIGo, which options synthesized 12L functionality, is earmarked for FDA submission on the finish of the second quarter.

“We plan to focus in 2023 and 2024 on the growth of our core expertise options, the 3D VECG knowledge and medical research that we consider will set up our platform as the usual of look after ambulatory-based cardiology and making the most of the comprehensiveness of our expertise,” Vajdic mentioned.