HeartBeam Inc. (NASDAQ: BEAT) is a cardiac technology company that has developed the first and only 3D-vector 12-lead electrocardiogram (ECG) platform for heart attack detection anytime, anywhere. The company’s proprietary ECG telehealth technology aims to redefine the way high risk cardiovascular patients are diagnosed in ambulatory and acute care settings. HeartBeam’s initial focus is on providing diagnostic data to help physicians with care management of patients with cardiovascular disease.
In August 2022, HeartBeam announced that it submitted its HeartBeam AIMI™ software for approval from the U.S. Food and Drug Administration (FDA). HeartBeam AIMI is a platform technology to improve the speed and accuracy of heart attack detection in acute care settings. The company is in discussions with the FDA and plans to meet with the agency in an effort to have HeartBeam AIMI cleared in line with its Q1 2023 timeframe, as detailed in a corporate update issued in December 2022.
HeartBeam sees submission of its first product based on its platform technology as an important milestone toward commercialization, which underscores the company’s continued progress toward making the HeartBeam AIMI platform widely available to help emergency department physicians quickly and accurately identify a heart attack.
While the FDA conducts its regulatory review, HeartBeam will focus on executing key components of its commercialization plan and subscription revenue model. It will also continue to engage in discussions with strategic institutions, including academic centers, regional healthcare systems and regional community hospital systems that can utilize HeartBeam products.
The company is based in Santa Clara, California.
HeartBeam’s development portfolio includes two products:
- HeartBeam AIMI is software that provides a 3D comparison of baseline and symptomatic 12-lead ECG to more accurately identify a heart attack in acute care settings and, as noted above, has been submitted for FDA approval; and
- HeartBeam AIMIGo™, the first and only credit card-sized 12-lead output ECG device coupled with a smartphone app and cloud-based diagnostic software system for remote heart attack detection.
HeartBeam is developing HeartBeam AIMIGo, a medical-grade detection and monitoring technology for use in remote heart attack detection thereby allowing physicians to diagnose a patient’s heart attack as it occurs even if the patient is not at a medical facility. The company’s system, once approved by the FDA, can be used by patients at home or almost anywhere and anytime to help their physicians assess whether chest pain is the result of a heart attack or another cause. While approximately 82% of chest pain ED visits are unnecessary, patients delay approximately 3 to 4 hours after symptoms begin, increasing mortality rates by 40%. The company’s goal is to shorten the time to treatment outside of the medical facility to improve patients’ well-being.
HeartBeam AIMIGo is a powerful, portable and easy-to-use prescription-based product. It comprises a smartphone app, a credit card-sized ECG device placed on a patient’s chest, the HeartBeam cloud platform, and a digital portal for the physician to view ECG results and direct patient action. For the first time outside of a medical setting, HeartBeam AIMIGo enables patients and their clinicians to determine if symptoms are due to a heart attack, quickly and easily, so care can be expedited, if needed.
Pending FDA clearance, HeartBeam AIMIGo is initially intended to be available by prescription, and is reimbursable under existing remote patient monitoring codes (RPM codes). This provides a new revenue stream to physicians who before did not have a way to monitor these high-risk patients. The RPM codes provide a monthly reoccurring revenue stream to the company, as well. On average, at current reimbursement rates, the practice will receive $1,300+ per year per patient they monitor, and the company will receive $600 per year per patient from this RPM reimbursement.
Adoption rates of telehealth services increased dramatically in recent years, with the COVID-19 pandemic serving as a major driver of growth. Among the areas seeing the greatest expansion are cardiology, radiology, behavioral health and online consultation.
Encouraging this growth, governments are actively developing new policies and reimbursement guidelines to promote the use of digital health platforms. The U.S. Centers for Medicare & Medicaid Services (CMS), for example, has recently expanded reimbursement for telehealth services. U.S. market growth is also being driven by the rising prevalence of chronic conditions and the growing geriatric population.
Remote heart attack detection is a previously unsolved problem with a massive and underserved market that is several times larger than the $2 billion total addressable market (TAM) in the U.S. for ECG cardiac arrhythmia monitoring.
Approximately 8 million Americans have suffered at least one heart attack, and a total of 18 million have been diagnosed with coronary artery disease (CAD). Based on these figures, HeartBeam projects a total addressable U.S. market TAM valued at $10 billion annually for its HeartBeam AIMIGo solution for remote heart attack monitoring of CAD.
Branislav Vajdic, Ph.D., Chief Executive Officer and Founder of HeartBeam, Inc, combines over 30 years of experience in technology development and senior management positions. Dr. Vajdic has been deeply involved with the development of HeartBeam’s technology to fit his vision for the company. Prior to HeartBeam, from 2007 to 2010, Dr. Vajdic was CEO and Founder of NewCardio, a publicly traded company in the cardiovascular devices space. From 1984 to 2007, Dr. Vajdic was at Intel, where he held various senior management position. At Intel, Dr. Vajdic was the designer of first Flash memory and two key inventions that enabled Flash as a product and led engineering groups responsible for Pentium 1 through Pentium 4 designs. Dr. Vajdic was awarded two Intel Achievement Awards, the highest level of award for outstanding contributions to Intel. Dr. Vajdic is author of numerous patents and publications in the fields of cardiovascular devices, as well as chip design. Dr. Vajdic holds a Ph.D. in Electrical Engineering from the University of Minnesota.
Robert P. Eno, President of HeartBeam, brings over 28 years of experience with a proven track record of developing markets and commercializing disruptive medical technologies. He has created go-to-market strategies for multiple breakthrough products, including noninvasive FFRCT diagnostic for coronary artery disease, laser cataract surgery, scanning laser photocoagulation and intravascular brachytherapy. Before joining HeartBeam, Mr. Eno was Chief Executive Officer of Preview Medical Inc., a diagnostic equipment company creating a new category of real-time, in vivo tissue classification for solid tumor cancers using machine learning and proprietary optical signals. Previously, he served as Senior Vice President of Marketing for HeartFlow Inc., leading all aspects of the marketing and product functions for a new category of personalized, noninvasive testing for heart disease, including its initial product, HeartFlow FFRCT. He has also held senior marketing and sales leadership roles at OptiMedica (acquired by Abbott), NeoGuide Systems (acquired by Intuitive) and Avantec Vacular (acquired by Goodman Co. Ltd). Mr. Eno began his career at Guidant, where he held a series of marketing and strategic planning roles in the Vascular Intervention business. He holds an MBA from the Stanford Graduate School of Business and a BA, with Honors and Distinction, from Stanford University, where he was Phi Beta Kappa.
Peter J. Fitzgerald, MD, Ph.D., HeartBeam’s Chief Medical Officer, is the Director of the Center for Cardiovascular Technology and Director of the Cardiovascular Core Analysis Laboratory at Stanford University Medical School. He is an interventional cardiologist and holds a Ph.D. in electrical engineering. Dr. Fitzgerald is Professor Emeritus in the Departments of Medicine (Cardiology) at Stanford University and has led or participated in over 175 clinical trials and published over 650 manuscripts/chapters and lectures worldwide. Over the past two decades, he has trained over 150 post-doctoral candidates in engineering and medicine. Dr. Fitzgerald has been principle and founder of 24 medical device companies in the San Francisco Bay area, transitioning 18 of these start-ups to medium/large-cap life science companies. In 2009, he co-founded TriVentures, an Israeli-based incubator/venture fund for early-stage medical technology and digital health. He has also been a consultant to the U.S. Food and Drug Administration for the past 20 years, focused on medical technology and data driven health analytics.
Jon Hunt, Ph.D., HeartBeam’s Executive Vice President and Chief Business Officer, has over 35 years’ experience in the medical/medical device industry with extensive domestic and international experience in general management, clinical/regulatory, sales and marketing. He also has diverse experience in Fortune 500 companies, as well as start-up environments. Dr. Hunt was the Vice President of Clinical Science and Technology, Medical Device Innovation Consortium, from July 2019 to July 2021, and Vice President of Clinical and Regulatory Affairs, Cryterion Medical from January 2018 to June 2019 (acquired by Boston Scientific Corporation in July 2018 for $202M). Dr. Hunt was the Founding President and CEO of Bardy Diagnostics, Inc. from October 2013 to November 2017 (acquired by Hill-Rom Holdings, Inc.). Prior to joining Bardy Diagnostics, Dr. Hunt spent the previous 11 years as the Vice President of Clinical & Regulatory Affairs with Cameron Health, Inc. (acquired by Boston Scientific Corporation). Dr. Hunt spent the previous 10 years with Cardiac Pacemakers, Inc., St. Jude Medical and Cardiac Pathways Corporation. Dr. Hunt began his career with Cardiac Pacemakers, Inc. (now Boston Scientific Corporation) as the Director of Clinical Programs. He subsequently held positions at St. Jude Medical in Clinical Affairs and as the Business Unit Director for the Cardiac Rhythm Management division for Europe, the Middle East and Africa. At Cardiac Pathways Corporation, Dr. Hunt held various executive positions as Vice President of International Sales and Marketing and Vice President of Worldwide Sales and Marketing (acquired by Boston Scientific Corporation). Dr. Hunt received his Ph.D. in Motor Control from The Pennsylvania State University, his Master’s from California State University, Long Beach and his undergraduate degree from Keele University in the United Kingdom.
Rick Brounstein, HeartBeam’s Chief Financial Officer, combines over 30 years of experience in health technology senior management. Since 2017, Mr. Brounstein has been and is currently a partner of Hardesty, LLC, a financial services firm, and Mr. Brounstein is currently a managing director of CTRLCFO, LLC, a firm Mr. Brounstein founded in 2016 to support funded start-ups in life science and technology. From 2008 to 2011, Mr. Brounstein was Chief Financial Officer of NewCardio, Inc., a microcap public company in the cardiology space, and, over his career, he has been with nine other companies in life science or technology, holding positions including Chief Financial Officer, Chief Operating Officer, Treasurer and Accounting Manager. From June 2001 through November 2007, Mr. Brounstein held several positions at Calypte Biomedical Corporation, a publicly traded medical device company, including Chief Financial Officer and Executive Vice President. In January 2007, Mr. Brounstein was appointed as the National Member Representative for the 2007 COSO Monitoring Project, which published new guidelines for monitoring internal financial controls in February 2009; Mr. Brounstein subsequently was a member of the FEI task force that issued the updated COSO Internal Control Framework in 2013. In March 2005, Mr. Brounstein was appointed to the SEC Advisory Committee on Smaller Public Companies. Mr. Brounstein earned his Certified Public Accountant (CPA) certification while working at Arthur Andersen LLP, formerly a public accounting firm. Mr. Brounstein holds a B.A. in accounting and an M.B.A. in finance, both from Michigan State University.
Ken Persen, HeartBeam’s Chief Technology Officer, combines over 28 years of experience in the medical device and digital health industries in engineering and senior management positions. Mr. Persen has been involved in several companies in Cardiac Rhythm Management, holding positions including Chief Executive Officer, Chief Technology Officer, Executive Vice President and Director of Engineering. Since 2016 and prior to joining HeartBeam, Mr. Persen was the Chief Technology Officer at LIVMOR, Inc., a digital health company. In addition, from 2016 through November 2021, he was also Chief Executive Officer of LIVMOR. Prior roles included Director of Engineering at Cameron Health (acquired by Boston Scientific), a late-stage medical device start up, and engineering and management positions at Guidant Corp. (acquired by Boston Scientific), a large medical device manufacturer. He has an undergraduate degree from University of Minnesota, Duluth, with a BA in Computer Science.
- HeartBeam is a cardiac technology company that has developed the first and only 3D-vector ECG platform for heart attack detection anytime, anywhere.
- In September 2022, the company announced it was granted a patent for its 12-lead ECG Patch Monitor, opening a pathway to ischemia and arrhythmia detection innovation in ECG Patch products.
- In August 2022, the company announced it was seeking FDA approval for its HeartBeam AIMI platform technology used to detect and diagnose heart attacks.
- On November 15, 2021, HeartBeam had its IPO on the Nasdaq under ticker symbol ‘BEAT’.
- The company’s management team has significant experience in software and medical device product development, with over $1 billion in successful exits over the past 18 months.
- HeartBeam was selected as a winner at the annual Cardiovascular Innovations (CVI) 2022 Innovation Summit, which recognizes state-of-the-art cardiac technologies.