HeartBeam AIMI™ Platform Technology for use in Diagnosing Heart Attacks Submitted to FDA for Clearance

Company on Track for Initial FDA Submission of HeartBeam AIMIGo™, the Telehealth Solution, in Q4 2022

AIMIGo Technology Receives Two Additional Patents

Company Plans to Broaden Product Portfolio Pipeline with Smartwatch Connectivity

Management to Host Webcast and Conference Call Today At 4:30 p.m. ET

HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D-vector electrocardiogram (VECG) platform for heart attack detection anytime, anywhere, has reported its financial and operational results for the third quarter ended September 30, 2022.

Third Quarter and Subsequent 2022 Operational Highlights

• Announced the US Food and Drug Administration (FDA) 510(k) application submission of HeartBeam AIMI platform, seeking approval for the Company’s proprietary VECG technology to aid in diagnosis of heart attack in $500 million total addressable market
• Broadened product portfolio pipeline with smartwatch connectivity supporting a daily multi-hour heart monitoring solution, leveraging the HeartBeam AIMIGo platform to address the multibillion-dollar global market for detection of atrial arrhythmias
• Granted patent for signal transformation from VECG to 12-Lead Electrocardiogram (ECG), allowing the HeartBeam AIMIGo credit card-sized device to enable a 12-lead ECG anytime, anywhere
• Granted patent for 12-lead ECG patch monitor intended for detection of heart attacks and complex cardiac arrhythmias, opening a pathway to a disruptive ischemia and arrhythmia detection via 12-lead ECG patch product
• Expanded the addressable patient population for the Company’s HeartBeam AIMI software platform to provide access to a broader patient population in the emergency care setting
• Appointed Peter J. Fitzgerald, MD, PhD, as Chief Medical Officer, a renowned Stanford cardiologist who brings deep clinical, research, and industry expertise to the executive team
• Appointed healthcare and cardiac industry veteran, Ken Persen, to the role of Chief Technology Officer
• Selected as winner of the annual Cardiovascular Innovations (CVI) 2022 Innovation Summit and Shark Tank Competition, an annual awards program recognizing innovative state-of-the-art cardiac technologies
• Presented at investor conferences including the LD Micro Main Event XV, Dawson James Small Cap Growth Conference and ThinkEquity Conference, and hosted a virtual roadshow webinar during which HeartBeam unveiled a new video featuring the HeartBeam AIMI and AIMIGo Technology
• Unveiled new video featuring the HeartBeam AIMI and AIMIGo Technology, available here

Management Commentary

“Throughout the third quarter we progressed on our commercialization pathway toward a series of important milestones, including the FDA 510(k) application submission of our HeartBeam AIMI product,” said Branislav Vajdic, PhD, Chief Executive Officer and Founder of HeartBeam. “We continue to have strong conviction in our HeartBeam AIMI software platform technology and AIMIGo, our end-to-end telemedicine solution, and their potential to offer more accurate heart attack detection and to expedite treatment. As we look toward FDA clearance for HeartBeam AIMI, we are also making significant progress with our core product, the AIMIGo as we prepare for FDA submission in late fourth quarter of this year.

“The issuance of two patents during the quarter provided further intellectual property protection for the HeartBeam 3D VECG platform: A patent for a 12-lead ECG patch monitor intended for detection of heart attacks and complex cardiac arrhythmias opens a pathway to offering ischemia and arrhythmia detection via an ECG patch. The innovation builds on our growing intellectual property portfolio enabling 12-lead ECG diagnostics outside of a medical setting. The technology offers the potential to bring a level of diagnostic accuracy consistent with the current 12-lead ECG standard of care and its ischemia detection capability could have a disruptive effect on the ECG patch market.

“A second patent that enables generation of a synthesized 12-lead ECG by the HeartBeam AIMIGo credit card-sized device opens a pathway for a patient to record a set of signals using HeartBeam AIMIGo outside of a medical setting with a diagnostic synthesized 12-lead ECG immediately transmitted to a clinician for review and diagnosis. Unlike single-lead ECG products currently in the marketplace such as other credit card sized devices or smartwatches, the HeartBeam technology is intended to quickly and accurately help clinicians identify a heart attack. This could reduce the critical time to intervention for heart attack patients, saving lives and reducing healthcare costs by ruling out a heart attack and reducing the number of emergency room visits.

“Operationally, during the quarter we welcomed Peter J. Fitzgerald, MD, PhD, as Chief Medical Officer, and Ken Persen to the role of Chief Technology Officer. Peter is one of the world’s preeminent opinion leaders in cardiology and digital health and we expect that he will play a major role in defining best paths to adoption, clinical strategies, and partnerships to advance our products in the market. Ken has extensive technology, executive and start-up experience in healthcare and cardiac device industries. He will lead the overall technology strategy and development of the HeartBeam AIMI and AIMIGo platforms.

“Looking ahead, our commercialization path is on track with our AIMIGo 3D vector ECG first-generation product expected to be ready for FDA submission in the fourth quarter of this year, along with FDA clearance for HeartBeam AIMI. Our commercial team has continued to engage in positive discussions with strategic institutions, including academic centers, regional healthcare systems, and regional community hospital systems. We look forward to providing updates on our progress in the months ahead,” concluded Dr. Vajdic.

Key Milestones

• HeartBeam AIMI Platform
  • Development of FDA-Ready Product Completed – Q2 2022
  • FDA Study Completed – Q3 2022
  • FDA Submission Completed – Q3 2022
  • FDA Clearance – Q4 2022
  • Limited Market Release – Q1 2023
  • Product Launch – Q2 2023

• HeartBeam AIMIGo Device
  • Development of FDA-Ready V1 Product Completed – Q3 2022
  • FDA Submission V1 – Q4 2022
  • FDA Clearance V1 – Q1 2023
  • Limited Market Release V1 – Q2 2023
  • Development of FDA-Ready V2 Product Completed– Q2 2023
  • FDA Study V2 – Q2 2023
  • FDA Submission V2 – Q2 2023
  • FDA Clearance V2 – Q3 2023
  • Limited Market Release V2 – Q4 2023
  • Product Launch – Q1 2024

Third Quarter 2022 Financial Results

Research and development expenses for the third quarter of 2022 were $1.6 million, compared to $105,000 for the third quarter of 2021.

General and administrative expenses for the third quarter of 2022 were $2.0 million compared to $341,000 for the third quarter of 2021.

Net loss for the third quarter of 2022 was $3.6 million, compared to a net loss of $1.2 million for the third quarter of 2021.

Cash totaled $6.5 million as of September 30, 2022, compared to $13.2 million as of December 31, 2021.

Third Quarter 2022 Results Conference Call

HeartBeam CEO and Founder Branislav Vajdic, PhD, CFO Rick Brounstein, and CBO Jon Hunt, PhD, will host the conference call, followed by a question-and-answer period. The conference call will be accompanied by a presentation, which can be viewed during the webcast or accessed via the investor relations section of the Company’s website here.

To access the call, please use the following information:

A telephone replay will be available approximately two hours after the call and will run through February 10, 2023, by dialing 1-844-512-2921 from the U.S., or 1-412-317-6671 from international locations, and entering replay pin number: 7787050. The replay can also be viewed through the webinar webcast link above and the presentation utilized during the call will be available in the company’s investor relations section here.

About HeartBeam, Inc.

HeartBeam, Inc. (NASDAQ: BEAT) is a cardiac technology company that has developed the first and only 3D-vector ECG platform for heart attack detection anytime, anywhere. By applying a suite of proprietary algorithms to simplify vector electrocardiography (VECG), the HeartBeam platform enables patients and their clinicians to determine if symptoms are due to a heart attack, quickly and easily, so care can be expedited, if required. HeartBeam has two patented products in development. HeartBeam AIMI™ is software for acute care settings that provides a 3D comparison of baseline and symptomatic 12-lead ECG to more accurately identify a heart attack. HeartBeam AIMIGo™ is the first and only credit card-sized 12-lead output ECG device coupled with a smart phone app and cloud-based diagnostic software system to facilitate remote heart attack detection. HeartBeam AIMI and AIMIGo have not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA or other geographies. For more 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 in 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221110006054/en/