HeartBeam Reports Third Quarter 2026 Results
Business Wire•12/11/2026•16:01 ET
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Key Highlights
- ➤FDA Breakthrough Device Designation received for HeartBeam’s heart attack assessment tool
- ➤Q3 operating cash outflow $2.6M, down 23% sequentially and 18% year over year
- ➤Full-year 2026 net operating cash outflow guided to $12.0M-$12.5M
- ➤U.S. pivotal heart attack assessment study planned to begin in Q1 2027
- ➤ALIGN-ACS specificity 81.8% versus 71.4% for standard 12-lead ECG
Expert Statements
Richard Ferrari, Executive Chairman of HeartBeam
“The third quarter marked a decisive turn for HeartBeam”
Richard Ferrari, Executive Chairman of HeartBeam
“We committed the majority of our resources to heart attack assessment, and the milestones have quickly followed.”
Richard Ferrari, Executive Chairman of HeartBeam
“In just the last six weeks, we received FDA Breakthrough Device Designation, were accepted into FDA's TAP program, and aligned with the FDA on a 510(k) submission pathway for a heart attack assessment indication.”
Richard Ferrari, Executive Chairman of HeartBeam
“We also completed enrollment in HEADSTART-ACS ahead of schedule and presented positive results from the ALIGN-ACS pilot study at TCT showing higher specificity than the standard 12-lead ECG.”
Richard Ferrari, Executive Chairman of HeartBeam
“With clinical experience in more than 600 patients and no new hardware required, we are focused on beginning our U.S. pivotal study in the first quarter of 2027.”
Branislav Vajdic, Founder and President of HeartBeam
“Today, a person with chest pain at home has no reliable way to know whether it is a heart attack, and that uncertainty results in delays and potentially worse outcomes.”
Branislav Vajdic, Founder and President of HeartBeam
“Our goal is to shorten the time between the first sign of symptoms and the decision to seek care, by giving patients and their physicians clinical-grade cardiac information when every minute matters.”
Branislav Vajdic, Founder and President of HeartBeam
“We believe HeartBeam can help close that gap for the millions of people at risk.”
* Redirected the Majority of Company Resources to Heart Attack Assessment, a Market Opportunity 4x Larger than the Arrhythmia Market
* Received FDA Breakthrough Device Designation for Heart Attack Assessment and Accepted into FDA's Total Product Life Cycle Advisory Program (TAP)
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