Latest news with #VALID-ECG
Yahoo
2 days ago
- Business
- Yahoo
IBN Coverage: HeartBeam (NASDAQ: BEAT) VALID-ECG Study Confirms Diagnostic Accuracy of Synthesized 12-Lead ECG
This article was published by IBN, a multifaceted communications organization engaged in connecting public companies to the investment community. LOS ANGELES, CA - June 16, 2025 (NEWMEDIAWIRE) - HeartBeam (NASDAQ: BEAT) announced its synthesized 12-lead ECG met clinical endpoints in the VALID-ECG pivotal study, achieving 93.4% diagnostic agreement with standard ECGs for arrhythmia assessment. The findings, presented by Dr. Thomas Deering of Piedmont Heart Institute at the Heart Rhythm Society's annual meeting in San Diego, validate HeartBeam's compact, patient-friendly ECG technology. HeartBeam's credit card-sized device demonstrated 93.4% diagnostic agreement with standard ECGs VALID-ECG study results presented at Heart Rhythm Society conference Company eyes U.S. commercialization pending FDA clearance The study compared ECG intervals and amplitudes between HeartBeam's synthesized output and simultaneously collected standard ECGs in 198 patients across five U.S. clinical sites. The results support the company's FDA submission for its ECG synthesis software, filed in January 2025. CEO Robert Eno emphasized the significance of enabling accurate, on-demand arrhythmia monitoring outside medical facilities. With FDA clearance anticipated, HeartBeam has launched an Early Access Program to refine clinical workflows and prepare for U.S. market entry. To view the full press release, visit About HeartBeam Inc. HeartBeam is a medical technology company dedicated to transforming cardiac care by providing powerful cardiac insights wherever the patient is. The company is creating the first-ever cable-free 12-lead ECG capable of capturing the heart's electrical signals from three dimensions. This platform technology is designed to be used in 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. The company holds 13 U.S. and 4 international-issued patents related to technology enablement. For more information, visit NOTE TO INVESTORS: IBN is a multifaceted financial news, content creation and publishing company utilized by both public and private companies to optimize investor awareness and recognition. For more information, please visit Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: The latest news and updates relating to BEAT are available in the company's newsroom at Forward Looking Statements Certain statements in this article are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management's control, including the risks set forth under the heading "Risk Factors" discussed under the caption "Item 1A. Risk Factors" in Part I of the Company's most recent Annual Report on Form 10-K or any updates discussed under the caption "Item 1A. Risk Factors" in Part II of the Company's Quarterly Reports on Form 10-Q and in the Company's other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this article in making an investment decision, which are based on information available to us on the date hereof. All parties undertake no duty to update this information unless required by law. About IBN IBN is a cutting-edge communications and digital engagement platform providing tailored Platform Solutions for select private and public companies. Over the course of 19+ years, IBN has introduced over 70 investor facing brands to the investment public and amassed a collective audience of millions of social media followers. These distinctive investor brands amplify recognition and reach as well as help fulfill the unique needs of our rapidly growing and diverse base of client-partners. IBN will continue to expand our branded network of influential properties as well as leverage the energy and experience of our team of professionals to best serve our clients. IBN's Platform Solutions provide access to: (1) our Dynamic Brand Portfolio (DBP) through 70+ investor facing brands; (2) article and editorial syndication to 5,000+ news outlets; (3) full-scale distribution to a growing Social Media Network (SMN) ; (4) a network of wire solutions via InvestorWire to effectively reach target markets and demographics; (5) Press Release Enhancement to ensure accuracy and impact; (6) a full array of corporate communications solutions; and (7) total news coverage solutions. For more information, please visit Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: Media Contact IBNLos Angeles, OfficeEditor@ View the original release on Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
13-05-2025
- Business
- Business Wire
HeartBeam Reports First Quarter 2025 Results
SANTA CLARA, Calif.--(BUSINESS WIRE)-- HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, has reported its financial and operational results for the first quarter ended March 31, 2025. First Quarter & Subsequent 2025 Operational Highlights The Company continues to make significant progress towards commercial readiness with key clinical and regulatory achievements on the HeartBeam System. VALID-ECG Pivotal Study: Successfully met the clinical endpoints in the VALID-ECG pivotal study, which enrolled 198 patients across five (5) US sites for arrhythmia assessment. Data showed a 93.4% overall diagnostic agreement, indicating that the synthesized 12-lead ECG can support diagnosis of arrhythmias in a manner consistent with standard 12-lead ECGs. Data was presented by Thomas Deering, M.D., of Piedmont Heart Institute, at the Heart Rhythm Society (HRS) meeting in April 2025 and showed that the study met its performance goals. Study formed the basis of the US Food and Drug Administration (FDA) 510(k) submission for 12-lead ECG synthesis software for arrhythmia assessment. 12-Lead ECG Synthesis Software FDA Submission: Received foundational FDA 510(k) clearance of the HeartBeam System, which captures the heart's electrical signals in 3D (by capturing 3 non-coplanar directions), for comprehensive arrhythmia assessment in December 2024. Submitted FDA 510(k) application focused on the patented HeartBeam software that converts the heart's electrical signals captured in 3 non-coplanar directions into a synthesized 12-lead ECG in January 2025. Ongoing productive discussions with FDA related to the 510(k) application throughout the quarter. Combined with the VALID-ECG results, these interactions provide confidence that the stated timeline for FDA clearance remains intact. Commercial Readiness Plans: Anticipate initiating commercialization upon receiving 510(k) clearance for the 12-lead ECG synthesis software. Commenced an Early Access Program to obtain important feedback on the end-to-end clinical workflow, ensure operational readiness and establish an early adopter funnel in anticipation of US commercialization. Signed contract manufacturer with ability to scale production alongside Company growth. Finalized strategic collaboration with AccurKardia, an innovator in ECG-based diagnostics technology, focusing on making AccurKardia's FDA-cleared ECG analysis software, AccurECG™, available on HeartBeam's devices. Other Highlights: Closed a public offering of common stock with gross proceeds of approximately $11.5 million in February 2025, including the exercise of the underwriter's over-allotment option, to fund key growth milestones and preparation for US commercialization. Received two new US patents, and now owns 20 issued US and international patents, as well as two (2) allowed patents and 32 pending patents, adding to an already robust IP portfolio that supports the company's differentiated position in remote cardiac diagnostics. Appointed Chief Executive Officer, Robert Eno, to the Board of Directors. Appointed Dr. Vivek Reddy of Mount Sinai, one of the nation's premier cardiac electrophysiologists, to the HeartBeam Scientific Advisory Board. Cash, cash equivalents, and short-term investments totaled $8.2 million as of March 31, 2025, with net cash used in operating activities of $4.5 million for the three months ended March 31, 2025. Management Commentary 'The first quarter of 2025 demonstrated continued progress on commercial readiness plans, underscored by successful pivotal study results, a new strategic partnership, and strengthened intellectual property protection,' said Robert Eno, Chief Executive Officer, HeartBeam. 'Since submitting a 510(k) application to the FDA for the 12-lead ECG synthesis software designed for the assessment of arrhythmias, we have had ongoing productive discussions with the FDA. The submission is backed by robust data demonstrating HeartBeam successfully met the clinical endpoints in the VALID-ECG pivotal study. This important milestone confirms that our technology has the ability to deliver 12-lead ECG-like insights through the convenience of a credit card-sized device that patients can use whenever arrhythmia symptoms occur. 'We recently partnered with AccurKardia, an innovator in ECG-based diagnostics technology, to add its FDA-cleared ECG analysis software, AccurECG, to our devices. We believe combining our platforms will enhance our commercial offering for arrhythmia assessment by enabling patients and physicians to get an automated rhythm assessment. This will facilitate quicker diagnosis and faster access to clinical care when needed. The strategic collaboration is expected to expedite our product development efforts, reducing both costs and timelines. 'We received two new US patents to bolster the defensive and offensive moat around our core technology. The first patent significantly advances intellectual property for our credit card-sized ECG device, and the second patent expands the use of risk-based diagnostic algorithms into our product portfolio around wearable devices. We now own 20 issued patents worldwide, cementing our leadership in cardiac monitoring innovation. 'Looking ahead, we are focused on commercial readiness activities and key growth milestones, leveraging gross proceeds of approximately $11.5 million from the recent fundraising we completed during the quarter. With productive discussions with the FDA on our 12-lead ECG synthesis software submission, we believe our timeline for clearance remains intact. We also commenced initial FDA interactions on expanding our indication to include ischemia and acute coronary events such as heart attacks. We expect to start enrollment in a Pilot Study on this indication in the second half of 2025. Taken together, we are advancing steadily on our milestones and look forward to additional updates in the months to come,' concluded Eno. First Quarter 2025 Financial Results Research and development expenses for the first quarter of 2025 were $3.5 million, compared to $2.4 million for the first quarter of 2024. General and administrative expenses for the first quarter of 2025 were $2.0 million compared to $2.4 million for the first quarter of 2024. Net loss for the first quarter of 2025 was $5.5 million, compared to a net loss of $4.6 million for the first quarter of 2024. Net cash used in operating activities was $4.5 million for the three months ended March 31, 2025, as compared to $3.5 million for the first quarter of 2024. Cash, cash equivalents, and short-term investments totaled $8.2 million as of March 31, 2025, compared to $2.4 million as of December 31, 2024. On February 25, 2025, the Company closed a public offering of common stock with gross proceeds of $11.5 million in February 2025, including the exercise of the underwriter's over-allotment option. First Quarter 2025 Results Conference Call HeartBeam CEO Robert Eno and CFO Tim Cruickshank 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 three hours after the call and will run through August 13, 2025, by dialing 1-844-512-2921 from the U.S., or 1-412-317-6671 from international locations, and entering replay pin number: 10199007. 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 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 3 non-co-planar directions, 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 20 issued patents related to technology enablement. For additional information, visit 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 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. HEARTBEAM, INC. Condensed Statements of Cash Flows (Unaudited) (In thousands) Three months ended March 31, 2025 2024 Cash Flows From Operating Activities Net loss $ (5,484 ) $ (4,606 ) Adjustments to reconcile net loss to net cash used in operating activities Depreciation 7 — Stock based compensation expense 1,109 1,207 Changes in operating assets and liabilities: Prepaid expenses and other current assets (65 ) 33 Accounts payable and accrued expenses (44 ) (97 ) Net cash used in operating activities (4,477 ) (3,463 ) Cash Flows From Investing Activities Purchase of property and equipment — (88 ) Purchase of short-term investments (3,760 ) — Net cash used in investing activities (3,760 ) (88 ) Cash Flows From Financing Activities Proceeds from sale of equity, net of issuance costs 10,250 — Net cash provided by financing activities 10,250 — Net increase (decrease) in cash and restricted cash 2,013 (3,551 ) Cash, cash equivalents and restricted cash – Beginning of period 2,433 16,239 Reconciliation of cash, cash equivalents and restricted cash: Cash and cash equivalents $ 4,390 $ 12,638 Restricted cash (included in other assets) 56 50 Total cash, cash equivalents and restricted cash $ 4,446 $ 12,688 Supplemental Disclosures of Cash Flow Information: Purchase of property and equipment in accounts payable $ 2 $ — Expand
Yahoo
01-05-2025
- Business
- Yahoo
HeartBeam's ECG technology shows promise in study for arrhythmia diagnosis
HeartBeam's synthesised 12-lead electrocardiogram (ECG) has met the clinical endpoints in the VALID-ECG pivotal study, assessing non-life-threatening arrhythmias. In the study, the mean difference in ECG intervals and amplitude between the company's ECG and the standard 12-lead ECG was assessed. Findings highlight a 93.4% diagnostic agreement, suggesting that HeartBeam's system is comparable to traditional 12-lead ECGs in diagnosing arrhythmias. The multicentre study enrolled 198 subjects across five US clinical sites, including Mount Sinai Hospital, Atlanta Heart Specialists, Allegheny Health Network, Piedmont Heart Institute, and Northwell Health. HeartBeam CEO Robert Eno said: "This important milestone successfully confirms that our novel technology can deliver diagnostic insights similar to a standard 12-lead ECGs for arrhythmia assessment. 'The ability to deliver 12-lead ECG-like data through a credit card-sized device that patients can use whenever and wherever arrhythmia symptoms occur underscores our long-term vision of bringing advanced cardiac health insights beyond medical facilities to improve patient outcomes.' In January 2025, HeartBeam rolled out an application for its 12-lead ECG synthesis software to the US Food and Drug Administration (FDA), based on the data from this study. In anticipation of FDA clearance, the company has initiated an early access programme to gather feedback on clinical workflows and prepare for US commercialisation. The company noted that its patented three-dimensional ECG technology captures the electrical signals of the heart from three non-coplanar directions. These signals are then synthesised into a 12-lead ECG using a transformation matrix. HeartBeam's platform technology is tailored for portable devices used by individuals anywhere to deliver actionable heart intelligence. Healthcare providers can guide their patients to the appropriate care outside of medical facilities by detecting acute heart conditions and health trends. HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December last year. Last week, HeartBeam partnered with AccurKardia to enhance cardiac monitoring solutions' accessibility. "HeartBeam's ECG technology shows promise in study for arrhythmia diagnosis" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Associated Press
29-01-2025
- Business
- Associated Press
HeartBeam Achieves Major Milestone with FDA Submission for its Groundbreaking 12-Lead ECG Synthesis Software
SANTA CLARA, Calif.--(BUSINESS WIRE)--Jan 29, 2025-- HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the Company's groundbreaking 12-lead electrocardiogram (ECG) synthesis software designed for the assessment of rhythms and arrhythmias, including sinus rhythm, atrial fibrillation, atrial flutter, bradycardia, tachycardia, and sinus with premature ventricular contraction (PVC) or premature atrial contraction (PAC). The FDA submission is backed by robust data from the VALID-ECG pivotal study, which enrolled 198 patients across five clinical sites. The Company believes the study's findings support the clinical equivalence of HeartBeam's synthesized 12-lead ECG where the leads are similar to standard 12-lead ECGs for rhythm and arrhythmia assessment. The submission builds on HeartBeam's recent FDA clearance for its patented technology which captures the heart's electrical signals from three distinct directions. The software synthesizes these signals into a familiar 12-lead ECG using a personalized transformation matrix. Upon FDA clearance for the software, the Company plans to initiate commercial launch leveraging the learnings and feedback gained from its Early Access Program. Hundreds of physicians and patients have already joined the waitlist underscoring the widespread interest in a powerful and convenient cardiac monitoring option that can be used outside of a medical facility. Robert Eno, Chief Executive Officer of HeartBeam, commented, 'The FDA submission for the 12-lead synthesis software is a significant step as we work towards fulfilling HeartBeam's vision to offer patients and physicians an easy-to-use portable device and transform how cardiac conditions are monitored and detected.' Additional future planned advances include the integration of AI-based classification algorithms and detection of heart attacks to aid in reducing 'symptom to door' times – an area of major focus for the American Heart Association (AHA) to shorten the time from heart attack symptom onset and treatment. HeartBeam believes its groundbreaking technology presents a transformative opportunity to bring about a paradigm shift in cardiovascular care for millions of patients globally. Additional Details About Data Supporting FDA Submission The FDA submission was supported by data from the VALID-ECG pivotal study, which completed enrollment in June 2024. VALID-ECG used the same protocol as an 80-person pilot study which was presented at the AHA 2024 Scientific Sessions. The Company plans to present the results from VALID-ECG at a scientific conference in 2025. Data from the pilot study presented at the AHA Scientific Sessions, which also supported the FDA submission, found similar performance of HeartBeam's synthesized 12-lead ECG waveforms compared to simultaneously collected standard 12-lead ECGs for arrhythmia detection. The pilot study found excellent agreement when physicians diagnosed various arrhythmias utilizing the HeartBeam synthesized 12-lead ECG compared to a standard 12-lead ECG (Sensitivity: 94%, Specificity: 100%). Arrhythmias evaluated include sinus rhythm, atrial fibrillation, atrial flutter, and sinus with premature ventricular contraction (PVC) or premature atrial contraction (PAC). 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 synthesized 12-lead ECG capable of capturing the heart's electrical signals from three distinct directions. 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. The Company holds 13 US and 4 international issued patents related to technology enablement. For additional information, visit About the HeartBeam System 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. 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 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. CONTACT: Investor Relations Contact: Chris Tyson Executive Vice President MZ North America SOURCE: HeartBeam, Inc. Copyright Business Wire 2025. PUB: 01/29/2025 08:31 AM/DISC: 01/29/2025 08:31 AM
