HeartBeam, Inc. Q4 FY2023 earnings call

Branislav Vajdic provided an overview of HeartBeam's VECG technology, highlighting its difference from common personal ECGs and the aim to help clinicians identify cardiac conditions. Rob Eno updated on progress with AIMIGo, including its 510(k) application with FDA, anticipation of clearance by end of Q2 2024, and plans for a limited launch by end of 2024. Deborah Castillo discussed regulatory efforts, including the 510(k) process for AIMIGo and the upcoming second 510(k) for 12-Lead synthesis. Rob Eno also detailed the valid ECG study. Branislav Vajdic spoke about AI efforts, including development of deep learning algorithms using 12-Lead ECG data. Rick Brounstein reviewed financials, noting general and administrative expenses, research and development expenses, cash position, and net loss for 2023.

Anticipate AIMIGo clearance by end of Q2 2024. Plan for limited launch of AIMIGo by end of 2024. Cash balance of $16.2 million as of Dec 31, 2023, provides runway into early 2025.

Forward-looking statements subject to risks and uncertainties affecting actual results. Regulatory clearance challenges with FDA. Cybersecurity risks and ensuring compliance.

Q: Could you describe the valid ECG study in more detail, specifically as it relates to patient follow-up or endpoints?

A: Rob Eno explained the study aims to show synthesized 12-Lead is clinically comparable to standard 12-Lead, primary endpoint on intervals and amplitudes, secondary on arrhythmia categorization, no patient follow-up.

Q: It seems like you're developing AI tools internally, but so many of them are already developed by arrhythmia. Why not license?

A: Branislav Vajdic noted unique 3D ECG signals and longitudinal data from AIMIGo device as key differentiators, making internal development beneficial.

Q: Where will the AIMIGo device be manufactured?

A: Rick Brounstein said working with Triple Ring and Evolve Manufacturing for initial manufacturing.

Q: Are you able to deal with cybersecurity aspects?

A: Deborah Castillo mentioned internal teams and cybersecurity experts to meet regulatory expectations.

Q: Medical studies are usually very expensive. Did you fully account for the cost of your valid ECG study within your final financial projections? Can you speak to the cost of the study?

A: Rick Brounstein said the study cost is about $700,000, with commitment to CRO and patient enrollment costs.