ProfitScout
10 months ago
$BEAT News: HeartBeam Appoints Ken Nelson and Mark Strome to the Board of Directors
June 8, 2023
HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D-vector electrocardiogram (VECG) platform intended for patient use at home, today announced the appointment of Ken Nelson and Mark Strome to its board of directors, effective as of June 5, 2023.
Ken Nelson, 48, is a 20-year digital health, medical device, and remote patient monitoring executive and innovator. Over the past 10 years, Mr. Nelson has led commercial efforts for disruptive technologies in the digital health, wearables, and cardiac remote patient monitoring industries for three of the top four market share players in cardiac digital health and remote patient monitoring including BioTelemetry as VP of Sales, iRhythm as VP of Sales & Marketing, and Bardy Diagnostics as Chief Commercial Officer. Most recently, he served as Head of Digital Health, Diagnostics, and Monitoring for Biotronik, a leading cardiac digital health and medical device company. Mr. Nelson currently serves as partner in the Medtech Advantage Fund, which has an exclusive partnership with Medtech Innovator, the largest medtech and digital health startup accelerator globally. In addition, he serves as Chairman of the Board for CardiaCare, and is an active board member in a handful of other disruptive cardiac digital health and medtech startups. Ken earned a B.A. in Economics from Vanderbilt University.
Mark Strome, 66, combines over 40 years of experience in the investment management and securities industry. Mr. Strome is the Founder, Chief Investment Officer, and Chairman at Strome Investment Management, L.P. and Strome Group, Inc. Under his leadership, Mr. Strome's investment management company has managed private placement hedge fund investments focusing on non-traditional investments including commodities, currencies, bankruptcy reorganizations, and numerous venture capital and private equity investments. Previously, he was a Portfolio Manager at Kayne Anderson. He has also been involved in the founding and incubation of numerous publicly traded companies and several successful private companies. These include Pulse Biosciences, and iWood Studios, a company that creates original content for film and TV. Mr. Strome has been a member of the Board of Directors of multiple companies over the last three decades. He has served as a Director at Endurance Ventures, National Water and Power, Eco-Duro Corporation, NWP Services Corporation and Mobil Satellite Ventures. He serves as Member of Advisory Board at Global Analytics, Inc. He is a Trustee for New Roads School and Big Bear Foundation and serves on the Board of Advisors of John Hopkins Medical Center.
"We are privileged to welcome two members with highly relevant backgrounds to HeartBeam's Board," said Branislav Vajdic, Ph.D., HeartBeam CEO and Founder. "Ken brings extensive experience and insights in cardiac digital health, remote patient monitoring, and medical devices. His firsthand knowledge of our industry will be a critical resource as we progress on our corporate goals. Mark is an experienced investor and business executive who will help us expand the breadth and depth of our reach as a Company, positioning us to create additional value for our shareholders. Together, Ken and Mark will contribute a wealth of expertise to the Board, adding to the exceptional team that we have elected to guide us forward and commercialize our business."
Richard Ferrari, Executive Chairman of the Board of Directors, added, "I look forward to working with both Mark and Ken as they are outstanding additions to our board. I am confident that Mark and Ken will offer valuable perspectives as we continue to position the Company for the expected clearance and commercialization of the HeartBeam AIMIGo(TM) 12-Lead 3D-vector electrocardiogram device."
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a cardiac technology company that has developed the first and only 3D-vector ECG platform intended for patient use at home. By applying a suite of proprietary algorithms to simplify vector electrocardiography (VECG), the HeartBeam platform enables patients and their clinicians to assess their cardiac symptoms quickly and easily, so care can be expedited, if required. HeartBeam has two patented products in development. HeartBeam AIMI(TM) 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(TM) 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 evaluation of cardiac symptoms. HeartBeam AIMI and HeartBeam 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 http://www.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/20230608005386/en/
SOURCE: HeartBeam, Inc.
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
ProfitScout
11 months ago
$BEAT News: HeartBeam Enters into Strategic Alliance Agreement with Samsung
May 30, 2023 (BusinessWire)
HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D-vector electrocardiogram (VECG) platform intended for patient use at home, today announced that it has entered into a Strategic Alliance Agreement (SAA) with Samsung, extending the existing SAA between LIVMOR and Samsung. HeartBeam acquired the assets of LIVMOR earlier this year.
Under the terms of the agreement, HeartBeam and Samsung will identify and define opportunities for collaboration, tapping the HeartBeam team's expertise and patented technology in the assessment and monitoring of cardiac symptoms.
"The goal of this partnership is to bring standard of care for cardiac diagnostic capabilities to patients by utilizing cutting edge technologies of both Samsung and HeartBeam," said Branislav Vajdic, Ph.D., HeartBeam CEO and Founder. "Our newly acquired state of the art, FDA cleared, Samsung watch-based arrhythmia detection tool, once integrated with the HeartBeam AIMIGo(TM) 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 HeartBeam AIMIGo system holds significant promise to address major cardiac conditions for our veterans."
Founded in 2016, LIVMOR developed the Halo(TM) 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.
"Thanks to our cooperation with LIVMOR and Samsung, we are able to treat some of the nation's most at-risk patients as safely and effectively from the comfort of their homes as we would if they were sitting in an exam room," said Dr. Jerrold Grodin, Department of Veterans Affairs, North Texas. "We've seen an increase in early adoption from patients when their physicians are also early adopters."
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 Company's anticipated participation in the AVAIL project, HeartBeam 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.
"Veterans reported a rate of heart attacks more than twice that of non-veterans in one study," Dr. Vajdic added. "This shows that coronary artery disease is a significant problem for veterans, making improvements in heart attack detection at the VA particularly critical."
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a cardiac technology company that has developed the first and only 3D-vector ECG platform intended for patient use at home. By applying a suite of proprietary algorithms to simplify vector electrocardiography (VECG), the HeartBeam platform enables patients and their clinicians to assess their cardiac symptoms quickly and easily, so care can be expedited, if required. HeartBeam has two patented products in development. HeartBeam AIMI(TM) 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(TM) 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 evaluation of cardiac symptoms. HeartBeam AIMI and HeartBeam 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 http://www.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/20230530005171/en/
SOURCE: HeartBeam, Inc.
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
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HeartBeam Announces Automated Cardiac Detection Patent Granted for HeartBeam AIMIGo™ System
May 25 2023 - 08:31AM
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Patent Underscores AI for Vectorcardiography (VECG) IP Leadership Effort
HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D vector electrocardiogram (VECG) platform intended for patient use at home, today announced it has received a notice of allowance from The United States Patent and Trademark Office for a key patent relating to the initial AI capability in the form of an expert system for its HeartBeam AIMIGoTM System. The patent is entitled, “Hand Held Device for Automatic Cardiac Risk and Diagnostic Assessment.”
HeartBeam has developed the HeartBeam AIMIGo System, a personal, portable and easy-to-use VECG solution to assist patients and their clinicians in assessing cardiac symptoms. HeartBeam’s breakthrough solution employs a reusable, credit card-sized, VECG recording device and cloud-based software to deliver critical data to clinicians in real-time outside of a medical setting. More than 127 million people in the US have cardiovascular disease, including more than 20 million with coronary artery disease.
“We believe this patent will further our effort to create a dominant IP position in the area of ambulatory VECG. We believe that coupling AI with the highest resolution ambulatory ECG device available will have the power to deliver unprecedented diagnostic capability for patients experiencing acute cardiac symptoms, which will ultimately lead to improved care and saved lives,” said Branislav Vajdic, PhD, HeartBeam CEO and founder.
“This patent will be followed by an aggressive IP development effort with PatentVest as we refine our algorithms, systems and devices,” added Vajdic.
The newly allowed patent describes a system that combines the recorded cardiac signals from the HeartBeam AIMIGo VECG device with the patient’s symptoms and cardiac risk factors to calculate a cardiac risk score, providing simplified diagnostic information and actionable instructions to the patient. It aims to replicate the decision-making process a physician uses when assessing a patient with cardiac symptoms but performed remotely in an automated manner.
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a cardiac technology company that has developed the first and only 3D-vector ECG platform intended for patient use at home. By applying a suite of proprietary algorithms to simplify vector electrocardiography (VECG), the HeartBeam platform enables patients and their clinicians to assess their cardiac symptoms 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 evaluation of cardiac symptoms. 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/20230525005355/en/
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
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12 months ago
NEWS: $BEAT -HeartBeam Completes $25 Million Capital Raise and Updates 2023 Strategic Focus and Financial Guidance
HeartBeam to Focus on Becoming the Global Leader in Ambulatory Vectorcardiography, the Highest Resolution ECG Monitoring Platform
Funding to Enable Company to Execute on Upcoming Clinical, Regulatory and Commercial Milestones, Extends Cash Runway into Late 2024
HeartBeam to Host Conference Call to Discuss Financing, Strategic Initiatives and First Quarter 2023 Financial Results on Thursday May 11, 2023 at 4:30 p.m. ET
SANTA CLARA, Calif., May 03, 2023--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D-vector electrocardiogram (VECG) platform to help physicians detect heart attacks anytime, anywhere as well as diagnose other common heart conditions today announced closing of its secondary offering of 16,666,666 shares of HeartBeam’s common stock. This financing will allow HeartBeam to fund its upcoming clinical and regulatory milestones related to its HeartBeam AIMIGo™ system and prepare for commercialization in 2024.
HeartBeam received net proceeds of $23.2 million from the offering, after deducting the placement agent discounts and commissions and offering expenses.
Public Ventures LLC acted as placement agent for the offering.
HeartBeam has adjusted its strategic focus to enable 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 HeartBeam’s 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 we believe is the most advanced ambulatory cardiac detection platform available. HeartBeam believes this will drive clinical and patient adoption.
Shift the commercial launch until obtaining the 510(k) clearance for 12-lead equivalence. The company 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 our Medical Advisory Board to help guide our clinical and regulatory development. These Advisory Board members will be announced in the near future.
As a result of these strategic goals, we are updating our financial guidance and expect no material commercial revenue for 2023.
"We are extremely pleased to have received this additional funding, which will allow us to achieve our important upcoming milestones and extends our cash runway into late 2024," said Branislav Vajdic, Ph.D. HeartBeam Founder and CEO. "We are also excited to be working with Public Ventures, which is an outstanding strategic partner with a long track record of helping companies grow and realize their full potential. The strategic focus we are announcing today are important steps for us to demonstrate the value of our novel VECG technology and to achieve the clinical and regulatory milestones to bring these important products into the hands of physicians and patients."
Christopher Marlett, Co-Founder and CEO of Public Ventures, added, "HeartBeam has the potential to positively impact the lives of millions of people, to change the standard of care, and to be the leader in the emerging area of ambulatory VECG. We are pleased to be supporting the Company as it executes on this vision, and we believe that it has the plan in place to achieve its goals."
HeartBeam will hold a conference call to discuss the financing and the strategic initiatives, along with our first quarter 2023 financial results, on Thursday May 11, 2023 at 4:30 p.m. ET.
To access the call, please use the following information:
Date:
Thursday May 11, 2023
Time:
4:30 p.m. Eastern time (1:30 p.m. Pacific time)
Dial-in:
1-844-826-3035
International Dial-in:
1-412-317-5195
Conference Code:
10178249
Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1611445&tp_key=13a316a5f0
A telephone replay will be available approximately two hours after the call and will run through 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.
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 HeartBeam 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/20230503005321/en/
Contacts
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
https://finance.yahoo.com/news/heartbeam-completes-25-million-capital-123100140.html
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