- Developed The First and Only 3D-Vector ECG Platform for Heart Attack Detection Anytime, Anywhere.
- Two Patented Products in Development: 3-D Software for Acute Care Settings and Credit Card Sized ECG Smart Phone App Device for Remote Detection.
- Acquired Assets from LIVMOR, Extending Reach in Remote Monitoring and Detection with FDA-Cleared Product, Halo+™ Atrial Fibrillation Detection System.
- Partnered with Evolve Manufacturing for 3D Vector Electrocardiogram Device.
- Initial FDA Submission of HeartBeam AIMIGo™, the Telehealth Solution, Projected Within 2023.
- Focus on Becoming the Global Leader in Ambulatory Vectorcardiography, the Highest Resolution ECG Monitoring Platform.
- Entered into Strategic Alliance with Samsung.
- Potential Collaboration with the Department of Veterans Affairs Involving a Five-Year, $650 million Healthcare Technology Research and Development Program.
- $25 Million Capital Raise to Support Funding of Upcoming Clinical, Regulatory, and Commercial Milestones, Extends Cash Runway into Late 2024.
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 BEAT 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. More than 18 million people in the US have Coronary Artery Disease. Every 40 seconds someone in the US has a heart attack or myocardial infarction.
BEAT 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 smartphone app and cloud-based diagnostic software system to facilitate remote heart attack detection. The BEAT 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.
- Strategic Alliance Agreement with Samsung
On May 30th BEAT announced that it has entered into a Strategic Alliance Agreement (SAA) with Samsung, extending the existing SAA between LIVMOR and Samsung. BEAT acquired the assets of LIVMOR earlier this year.
Under the terms of the agreement, BEAT and Samsung will identify and define opportunities for collaboration, tapping the BEAT team's expertise and patented technology in the assessment and monitoring of cardiac symptoms.
“The goal of this partnership is to bring the standard of care for cardiac diagnostic capabilities to patients by utilizing cutting-edge technologies of both Samsung and HeartBeam,” said Branislav Vajdic, Ph.D., BEAT CEO and Founder. “Our newly acquired state-of-the-art, FDA-cleared, Samsung watch-based arrhythmia detection tool, once integrated with the BEAT AIMIGo™ telehealth platform, presents a unique opportunity to extend our product capabilities well beyond what is currently available for cardiac patients outside of a medical setting.”
Kevin Jones, Senior Director, Federal Healthcare, Samsung Electronics America, added, “The strategic collaboration between Samsung and LIVMOR was very successful, resulting in an FDA-cleared solution for Atrial Fibrillation detection centered around the Samsung Galaxy watch and tablet running Samsung's defense-grade cyber-security system, Knox. We are excited that LIVMOR is now part of HeartBeam and look forward to continuing our successful collaboration. The potential of combining LIVMOR’s technology and the BEAT AIMIGo system holds significant promise to address major cardiac conditions for our veterans.”
Founded in 2016, LIVMOR developed the Halo™ Atrial Fibrillation (AF) Detection System, the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring. The Halo system provides continuous monitoring of pulse rhythms for the detection of AF on-demand during the day and automatically overnight. Under the previous SAA, LIVMOR, and Samsung developed a physician-prescribed and fully integrated patient care platform that provides extended monitoring of patient cardiovascular health in virtually any setting, using medical-grade equipment. LIVMOR’s technology was commercially deployed within the VA Healthcare System in Dallas, Texas.
Among the available opportunities is a potential collaboration with the Department of Veterans Affairs through its Accelerating VA Innovation and Learning (AVAIL) program. In September, the VA announced that 17 companies had won spots in a potential five-year, $650 million healthcare technology research and development program. Participants provide subject-matter expertise to help the agency design, build and test novel platforms, services, and care models that could be scaled into clinical production to support the Veterans Health Administration.
One of the AVAIL program's awardees is Longview International Technology Solutions (LTS), a systems integration company. LIVMOR and Samsung have been designated as official collaborators with LTS for the AVAIL project. With the anticipated participation in the AVAIL project, BEAT could share its expertise in the assessment and monitoring of cardiac symptoms as it collaborates with Samsung to innovate and develop solutions for the VA, the largest integrated healthcare system in the U.S.
- $25 Million Capital Raise Plus 2023 Strategic Focus and Financial Guidance
On May 3rd BEAT announced the closing of a secondary offering of 16,666,666 shares of its common stock. This financing will allow BEAT to fund its upcoming clinical and regulatory milestones related to its HeartBeam AIMIGo™ system and prepare for commercialization in 2024.
BEAT received net proceeds of $23.2 million from the offering, after deducting the placement agent discounts and commissions and offering expenses.
BEAT has adjusted its strategic focus to enable the timely delivery of its breakthrough ambulatory VECG products, the Company’s key future value drivers, as follows:
Immediately focus on obtaining an FDA 510(k) clearance for the HeartBeam AIMIGo credit card-sized VECG device, followed by a second 510(k) clearance on the system’s ability to synthesize an electrocardiogram (ECG). The goal of this second FDA clearance is to demonstrate that the BEAT synthesized 12-lead ECG is equivalent to standard recorded 12-lead ECGs. These clearances provide a key value creation path, as they will enable physicians to remotely monitor patients and immediately interpret any concerning cardiac events.
Demonstrate through clinical trials in 2023 the performance of the HeartBeam AIMIGo platform, which BEAT management believes is the most advanced ambulatory cardiac detection platform available. BEAT believes this will drive clinical and patient adoption.
Shift the commercial launch until obtaining the 510(k) clearance for 12-lead equivalence. BEAT plans to submit this application to the FDA in late 2023 and pursue initial commercialization in 2024.
Undertake an aggressive pre-commercial effort to define initial market segments and identify potential business partners.
Continue aggressive development of its intellectual property through our partnership with PatentVest, a unified technology development and patent law firm focused on creating IP leadership for development-stage technology companies. The partnership is clearly focused on the goal of creating clear leadership in the area of ambulatory VECG cardiac detection.
Add world-leading Key Opinion Leaders (KOLs) to the Company’s Medical Advisory Board to help guide BEAT clinical and regulatory development.
BEAT held a conference call to discuss the financing and the strategic initiatives, along with its first quarter 2023 financial results on May 11th.
A telephone replay will be available on August 11, 2023, by dialing 1-844-512-2921 from the U.S., or 1-412-317-6671 from international locations, and entering replay pin number: 10178249. The replay can also be viewed through the webcast link above and the presentation utilized during the call will be available in the company’s investor relations section here: https://www.otcmarkets.com/stock/BEAT/news/story?e&id=2516338
For more information on $BEAT visit www.HeartBeam.com
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Company Name: HeartBeam, Inc.
Contact Person: Branislav Vajdic, PhD, CEO
Email: Send Email
Phone: (408) 899-4443
Address:2118 Walsh Avenue Suite 210
City: Santa Clara
State: CA 95050
Country: United States