HeartBeam has determined that the best course of action to reach a favorable resolution with the FDA is to pursue multiple parallel paths, which are designed for this type of situation.The Company looks forward to working with the agency to resolve the unexpected NSE letter. While this regulatory process moves forward, the Company will continue to provide shareholders with updates on the commercial launch and funding plans.“HeartBeam appreciates the extensive interactions with the FDA on the HeartBeam 12-lead Synthesis Software,” said Robert Eno, Chief Executive Officer of HeartBeam. “We have engaged in good faith with the agency over a period of two years and have had extremely positive interactions. Together with the agency, we resolved the vast majority of open questions.“After assessing our options, we believe that the best way to resolve the open questions and to get this technology into the hands of patients is to engage in the multiple paths available for constructive resolution. Since the remaining concerns from the FDA are well defined and can be readily addressed by our team, we believe these paths can lead to a favorable resolution.”
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