HeartBeam Provides Update on Regulatory Path Following FDA Decision on 12-Lead ECG Synthesis Software Application

Key Terms

12-lead electrocardiogram (ECG) medical

A 12-lead electrocardiogram (ECG) is a noninvasive test that records the heart’s electrical activity from 12 different viewpoints, like taking simultaneous security-camera angles of the heart’s rhythm and conduction. Investors care because ECG findings are key safety and efficacy signals in clinical trials and regulatory reviews — abnormal results can delay approvals, trigger additional studies, or affect a company’s valuation and market access for therapies.

food and drug administration (fda) regulatory

A U.S. government agency that reviews and approves drugs, medical devices, vaccines, food safety measures and related products before they reach the market. Think of it as a gatekeeper whose decisions, inspections and safety warnings can make or break a product’s ability to sell; investors watch FDA actions closely because approvals speed revenue and failed reviews, delays or recalls can sharply change a company’s value.

510(k) regulatory

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

not substantially equivalent (nse) regulatory

A "not substantially equivalent" (NSE) determination means a regulator has decided a new medical device is not similar enough to an already approved device to use the faster clearance pathway, so it must undergo more rigorous review or different approval steps. For investors, an NSE can signal longer time to market, higher development costs and greater uncertainty about commercial prospects, much like a product failing an initial quality check and needing a full rework.

clinical endpoints medical

Clinical endpoints are the specific health outcomes researchers measure in a medical trial to decide whether a treatment works — like reduced symptoms, longer survival, or improved function. Think of them as the trial’s scorecard or finish line that regulators and doctors use to judge success. Investors watch endpoints because they determine whether a drug can be approved, how it can be marketed, and the size and timing of potential sales, so they directly affect a company’s risk and value.

labeling regulatory

Labeling is the official set of written information that accompanies a regulated product—such as a drug, medical device, or food ingredient—describing what it is for, how to use it, dosing, warnings, and known risks. Investors care because labeling determines how broadly a product can be sold, what safety claims can be made, and how insurers and doctors will use it; think of it as the product’s legal instruction manual and warning label that directly affects sales, liability, and market acceptance.

appeal process regulatory

A structured series of steps allowing a party to challenge and seek reversal of an administrative, regulatory, or legal decision, like a denied permit, rejected drug approval, or a sanction. Investors care because the appeal can delay or change outcomes that affect a company’s operations, revenues, or legal liabilities — similar to asking a referee to review a call, where the result can alter the score and future strategy.

• Company engaging in multiple options for a constructive resolution
• Strategy is underpinned by a clinical study that achieved the agreed upon endpoints
• Company believes that labeling modifications can address any outstanding concerns

SANTA CLARA, Calif.--(BUSINESS WIRE)-- HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced its regulatory strategy following receipt of a Not Substantially Equivalent (NSE) decision on the Company’s 510(k) submission for its 12-lead Electrocardiogram (ECG) Synthesis Software.

Immediately following the receipt of the NSE letter and through today, HeartBeam has been engaging with the Food and Drug Administration (FDA) review staff to better understand the concerns and determine the best path forward.

• The FDA has signaled a willingness to work with the Company towards a constructive resolution.
• The Company stands behind the clinical study (VALID-ECG) submitted in support of the application. The study met its clinical endpoints and the Company believes it has a viable argument to address outstanding concerns of the agency.
• The Company believes these concerns can be addressed through modifications to the proposed labeling of the device.

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 range of options include, but are not limited to, an appeal process or a resubmission of a 510(k) application.
• Based on the recent discussions with the FDA and the information available at present, the Company believes there is a path forward under an appeal process.
• The official appeal process has a timeline of approximately 60 days from submission of an appeal to resolution.

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.”

About HeartBeam, Inc.

HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company is creating the first-ever cable-free device capable of collecting ECG signals in 3D, from three non-coplanar dimensions, and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will 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. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024. The Company holds over 20 issued patents related to technology enablement. For additional information, visit HeartBeam.com.

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.

Cleared Indications for Use

The HeartBeam System is a portable non-invasive recorder intended to record, store, and transfer a patient’s 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional. For full safety information, see the full Instructions for Use or Clinician Portal Manual.

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Investor Relations Contact:

Chris Tyson

Executive Vice President

MZ North America

Direct: 949-491-8235

BEAT@mzgroup.us

www.mzgroup.us

Media Contact:

media@heartbeam.com

Source: HeartBeam, Inc.