Larry Holub's questions to Heartbeam Inc (BEAT) leadership • Q1 2025
Question
Webcast questions moderated by Larry Holub focused on the key takeaways from the VALID-ECG pivotal study for FDA clearance and the company's current manufacturing capabilities and exposure to tariffs.
Answer
CEO Robert Eno explained that the VALID-ECG study was pivotal because it successfully demonstrated the similarity of their patient-used synthesized ECG to the standard 12-lead ECG, which strengthens the case for FDA clearance and physician adoption. Executive Timothy Cruickshank added that manufacturing is U.S.-based, minimizing direct tariff exposure, with a current capacity of thousands of devices per month and a stable supply chain.