February 13th, 2025: HeartBeam Announces Pricing of $10.0 Million Underwritten Public Offering of Common Stock @ $1.70. MDB Capital acted as the underwriter for the offering and Paulson Investment Company LLC participated as a selected dealer.
We’ve been following this from the sidelines since then went public. We loved the product, a wearble heart monitor, the first-ever cable-free device capable of collecting ECG signals. Physicians would be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management.
We met management, very nice and very smart crew.
On November 11th in a press release:
- HeartBeam is engaging in productive discussions with the FDA and is in the final stage of FDA review for the 510(k) submission of the 12-lead ECG synthesis software in arrhythmia assessment, a major inflection point for the Company.
- The timeline for FDA clearance remains firmly on track and is expected by the end of the year.
“In the third quarter, we made significant progress with commercial readiness plans in anticipation of FDA clearance for the 12-lead ECG synthesis software submission for arrhythmia assessment,” said Robert Eno, Chief Executive Officer, HeartBeam. “We continue to engage in positive and productive discussions with the FDA and our anticipated timeline for this clearance by year end remains intact
Then in an 8K (as in no press release), nine days later:
- On November 20, 2025, HeartBeam, Inc. (the “Company”) received a Not Substantially Equivalent (NSE) letter from the U.S. Food and Drug Administration (FDA) related to the Company’s 510(k) application for its 12-Lead Electrocardiogram (ECG) Synthesis Software.
- The Company stands behind its clinical data and will be working with the FDA to come to a resolution.
Damn..that sucks.
With $1.9 million in the bank, we will continue to watch from the sidelines. (Cash and cash equivalents totaled $1.9 million as of September 30, 2025, with net cash used in operating activities of $3.2 million for the three months ended September 30, 2025)
Forward-Looking Statements
All statements in this release that are not based on historical fact are “forward-looking statements.” While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our Forms 10-K, 10-Q and other reports filed with the SEC and available at www.sec.gov. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
