HeartBeam Wins FDA Total Product Life Cycle Advisory Program Pilot Acceptance For Heart Attack Assessment Technology

• Acceptance into FDA’s TAP Pilot follows Breakthrough Device Designation granted earlier this month for HeartBeam’s heart attack assessment technology
• TAP Pilot provides dedicated FDA advisors and early engagement with payers, including CMS, as well as patient and provider organizations, to help accelerate future reimbursement and patient access
• Two FDA program milestones in less than one month underscore accelerating momentum behind HeartBeam’s myocardial infarction (MI) program

HeartBeam, Inc.(NASDAQ:BEAT), a medical technology company focused on transforming cardiac care by providing powerful cardiac insights, today announced that the U.S. Food and Drug Administration (FDA) has accepted the HeartBeam System into its Total Product Life Cycle Advisory Program (TAP) Pilot, a voluntary FDA program to accelerate patient access to Breakthrough medical devices. The acceptance, which was awarded ahead of schedule, applies to HeartBeam’s 3D ECG technology, which received FDA Breakthrough Device Designation earlier this month, as a tool for assessing potential heart attacks outside of a medical setting.

TAP Pilot assigns dedicated FDA advisors who provide proactive regulatory support and coordinate expedited feedback. TAP also connects innovators with patient advocacy groups, healthcare provider organizations, and health insurance payers to address patient engagement, reimbursement, clinical adoption, and commercialization challenges early in development.

Breakthrough Device Designation and TAP together give innovators a more predictable route from FDA clearance to patient access and clinical adoption. Engaging payers early matters for a technology like HeartBeam’s, where clinicians need confidence that ECG information obtained outside the hospital will be accessible and reimbursed for their patients.