HeartBeam, Inc.
- Market Cap (Float-Adj) (Float-adjusted market cap computed by the low-float screener — matches the screener row. May differ from the standard cap (price × all shares outstanding) reported elsewhere.)
- $28.0M
- Price
- $0.497
- % Change (Daily % change from the live per-ticker quote feed.)
- -8.47%
- Volume
- 1.7M
About
HeartBeam, Inc. is a development stage company, which engages in cardiovascular diagnostic technology. Its electrocardiogram (ECG) collection device provides physicians with cardiac diagnostic information for a patient that is outside of a medical institution. The device sends ECG signals to the patient's smartphone and on to a cloud-based software expert system. The company was founded by Branislav Vajdic in 2015 and is headquartered in Santa Clara, CA.
Quick stats
Shares outstanding56.3M
Computed float52.6M
Float / shares93.3%
Cash runway (months)4.2
Key info
SectorHealthcare
IndustryMedical - Specialties
CIK (Central Index Key — the unique ID the SEC assigns to every filer. Use it to look up the company's filings on EDGAR.)0001779372
Websitehttps://www.heartbeam.com
AI Summary
AI-generated1/27
standardbullishregulatory
HeartBeam Receives FDA Breakthrough Device Designation for Heart Attack Assessment
The FDA granted HeartBeam Breakthrough Device Designation for its HeartBeam System as a tool for assessing potential heart attacks at home, granted within 30 days of request versus a 60-day statutory window.
The designation provides prioritized FDA interaction ahead of a planned multicenter pivotal study and is a prerequisite for expedited Medicare coverage pathways such as the proposed RAPID pathway; HeartBeam has also requested enrollment in the FDA's TAP program.
Management sizes the MI assessment opportunity at approximately $15 billion within a $40 billion-plus cardiac platform opportunity, and expects updates on ALIGN-ACS data at TCT and the HEADSTART-ACS study in coming weeks.
Red flags
- designation is not clearance; pivotal study enrollment and FDA alignment still ahead
- pre-commercial-stage medtech with substantial forward-looking risk factors