Author: Ken Dropiewski

HeartBeam Wins Industry Innovation Award for Advancing Remote Cardiac Care With Groundbreaking ECG Technology

FDA-cleared technology makes clinical-grade ECG insights for arrhythmia assessment available outside of a medical facility SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced it has been awarded the Innovation Award in Remote Cardiac Diagnostics as part […]

Longeveron® Announces Licensing of New Cardiac Selective Induced Pluripotent Stem Cell Technology for Cardiovascular Disease

Joshua Hare

Joshua Hare, MD, FACC, FAHA, Co-Founder, Chief Science Officer and Chairman, Longeveron

Longeveron has licensed issued US Patent 12,168,028 B2, entitled “Methods for obtaining cardiomyogenic precursor cells” from the University of MiamiNew patent protects a method to derive GHRH-Receptor+ cardiomyogenic cells from pluripotent stem cells (PSCs)New technology substantially advances Longeveron’s repertoire of stem cell therapy technologiesOpportunity to expand pipeline in cardiovascular, rare and pediatric disease areas MIAMI, July 21, 2025 (GLOBE NEWSWIRE) —  Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening, rare pediatric, and chronic aging-related conditions, today announced that it has licensed an issued US patent (12,168,028 B2) for a stem cell technology from the University of Miami. The composition of matter patent protects unique induced pluripotent derived cardiomyogenic cells that have widespread therapeutic indications for heart diseases. The stem/precursor cells protected by this patent are obtained by deriving cells that bear a cell surface receptor known as the GHRH-Receptor. These cells are uniquely able to differentiate into human cardiac muscle cells and have the potential to be safer than existing strategies to derive new cardiac heart muscle cells. “With the significant clinical and regulatory progress we have made in hypoplastic left heart syndrome (HLHS) and Alzheimer’s disease, and our recent IND approval for pediatric dilated cardiomyopathy, the opportunity to license this important and complimentary stem cell technology provides us a unique opportunity to expand our stem cell therapy pipeline,” said Joshua Hare, M.D., Co-founder, Chief Science Officer, and Chairman at Longeveron. “This technology provides a solution to one of the most difficult barriers to the implementation of induced pluripotent stem cells (iPS) technology in the cardiovascular space.” Developing cardiomyocytes from iPS cells was initially pursued as a potential way to repopulate the myocardium, representing a technology capable of generating an unlimited source of cardiomyocytes and/or cardiac precursors, circumventing ethical dilemmas of using embryonic stem cells, and available from any individual donor. This technology, however, was quickly appreciated to have a substantial side effect, that of causing malignant ventricular arrhythmias after engraftment into mammalian myocardium, and this complication has dramatically slowed the pace of entry into the clinic. The technology of selecting the fraction of GHRHR+ from cardiomyogenic cells circumvents the complication by selecting for cells destined to become only cardiomyocytes and eliminating cells with electrical automaticity, a property found in conduction tissue cells. In so doing, the technology allows for selection for cells that will engraft, contribute new contractile tissue, but will not cause malignant ventricular arrhythmias. Longeveron believes this technology may be applicable in a broad range of cardiovascular diseases in adults, as well as rare pediatric diseases. About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty. Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program – Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program – Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Forward-Looking Statements Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expects,” “intend,” “looks to,” “may,” “on condition,” “plan,” “potential,” “predict,” “preliminary,” “project,” “see,” “should,” “target,” “will,” “would,” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects and include, but are not limited to, statements about the various below-listed factors. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; the size of the market opportunity for certain of our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to scale production and commercialize the product candidate for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 28, 2025, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates in highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company’s management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release based on information available as of the date of this press release, are inherently uncertain, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Investor and Media Contact: Derek ColeInvestor Relations Advisory Solutionsderek.cole@iradvisory.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f106bde7-972a-4687-a91e-03e924f409fc

Revalesio Announces Publication of RESCUE Phase 2 Trial Results Evaluating RNS60 as an Adjunctive Therapy for Acute Ischemic Stroke in the Journal Stroke

Trial met primary endpoints of similar rates of serious adverse events (SAEs) and fewer deaths observed with RNS60 versus placebo Statistically significant reduction in infarct growth (brain tissue loss) – a secondary endpoint – in patients treated with RNS60 adjunct to endovascular…

Heartflow Unveils Landmark DECIDE Registry Data Demonstrating Impact of Heartflow Plaque Analysis on Coronary Artery Disease Medical Management

More than 50% of patients saw treatment changes following Heartflow Plaque Analysis – driving promising LDL cholesterol improvements and individualized careMONTREAL, July 17, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc., the leader in AI technology for coronary artery disease (CAD), today announced new data for its AI-enabled Heartflow Plaque Analysis, including final primary endpoint data from the DECIDE Registry. Data from the DECIDE Registry showed Heartflow Plaque Analysis led to medical management change in over half of patients beyond coronary computed tomography angiography (CCTA) alone, regardless of traditional risk factors or CCTA findings. The DECIDE Registry is the largest prospective study of its kind, enrolling approximately 20,000 patients at over 30 sites across the United States. Data will be presented this week at the Society of Cardiovascular Computed Tomography (SCCT) 2025 Annual Scientific Meeting from a cohort of 972 patients across 15 sites by Sarah Rinehart, M.D., F.A.C.C., F.S.C.C.T., medical director of cardiovascular imaging, Charleston, WV, and co-lead principal investigator of the registry. DECIDE Registry investigator Cian McCarthy, MB, BCH, BAO, SM, is the first-place recipient of the 2025 SCCT Clinical Trials and Registries Award, which will be presented at the opening session of SCCT 2025 on Friday, July 18, followed by a presentation of the study results. For DECIDE Registry patients, management changes informed by Heartflow Plaque Analysis with Plaque Staging* led to an average LDL cholesterol decrease of 18.7mg/dL, which is associated with an estimated 15% decrease in risk of a cardiac event. Additionally, 30% of patients with a calcified plaque volume of zero had a change in management.1,2 These findings suggest Heartflow Plaque Analysis can deliver clinically meaningful impact by helping clinicians identify which patients require changes to their treatment plans. “These data confirm what we’re seeing in clinical practice — Heartflow Plaque Analysis provides individualized insights that go beyond what a traditional analysis of a patient’s risk factors or CCTA alone can show,” said Dr. Rinehart. “By quantifying plaque burden and characterizing higher-risk non-calcified plaque types, Heartflow’s technology empowers physicians to personalize care and intervene earlier, which can change the trajectory of a patient’s coronary health.” Traditional risk factors such as age, smoking, hypertension, and family history are useful for population-level CAD predictions but lack precision at the individual level. Similarly, while CCTA is effective in detecting calcified plaque, it often underreports non-calcified and low-attenuation plaque, which leaves many high-risk patients incorrectly classified. Heartflow Plaque Analysis addresses this critical gap by quantifying all plaque types and supporting informed decision-making for clinicians. As part of the DECIDE Registry, Heartflow’s recently introduced Plaque Staging* framework is being used prospectively to help translate these advanced insights into simplified, actionable treatment plans. The Heartflow Plaque Staging framework, which was developed by expert consensus and clinically validated using outcomes data from the FISH&CHIPS Study,3 stratifies patients into one of four risk-based stages — mild, moderate, severe, or extensive — based on AI-quantified plaque volume and composition.4 With data from over 2,800 patients, Heartflow Plaque Staging is the leading tool for risk stratification based on AI-quantitative coronary plaque assessment. The FISH&CHIPS Study data showed higher coronary plaque-based stages, measured by Heartflow Plaque Analysis, were associated with up to five times higher risk of cardiovascular event rates at 3.3 years. The data were presented at the British Society of Cardiovascular Imaging Annual Scientific Meeting in April 2025. “The results from the DECIDE Registry clearly show how Heartflow Plaque Analysis can meaningfully change CAD care, with more than half of patients seeing their treatment plans altered after Heartflow Plaque Analysis,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer of Heartflow. “We expect that tools like Plaque Staging will enhance the impact Heartflow Plaque Analysis is already making by providing a clearer framework for personalized patient care.” *Heartflow Plaque Analysis is an FDA-cleared device. Heartflow Plaque Staging is an investigational-only framework, and its safety and effectiveness have not been reviewed by the FDA. About the DECIDE RegistryThe DECIDE Registry is the largest prospective study of its kind, collecting real-world data from multiple sites investigating how Heartflow’s AI-enabled Plaque Analysis informs medical management plans compared to CCTA alone for patients with suspected CAD. Approximately 20,000 patients will be enrolled at over 30 sites across the United States. The primary endpoint for this registry highlights changes in medical management after Heartflow Plaque Analysis. Clinical outcomes and biomarkers are the secondary endpoints. Safety endpoints include MACE (major adverse cardiovascular events), such as myocardial infarction and urgent hospitalization leading to revascularization. About Heartflow, Inc. Heartflow is advancing coronary care by transforming coronary artery disease into a screenable, diagnosable, and manageable condition. Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway. The AI-driven platform — including Roadmap™ Analysis, FFRCT Analysis and Plaque Analysis — is supported by the ACC/AHA Chest Pain Guideline and backed by more than 600 peer-reviewed publications. Heartflow has helped clinicians manage over 400,000 patients worldwide. Discover how we’re shaping the future of cardiovascular care at www.heartflow.com. Media Contact Elliot Levy elevy@heartflow.com Investor Contact Nick Laudico nlaudico@heartflow.com 1 DECIDE Registry. Rinehart, et al., Presented at SCCT July 2025.2 Collins et al. Lancet 2016. DOI: 10.1016/S0140-6736(16)31357-53 Fairbairn, et al. AI-Enabled CCTA Plaque Quantification and the Prediction of Cardiovascular Outcomes. Heart 2025.4 Rinehart, et al. Guiding Automated Implementation Strategies for Patients With Atherosclerotic Plaque on Coronary Computed Tomographic Angiography. JACC: Cardiovascular Imaging. 2025. https://doi.org/10.1016/j.jcmg.2025.03.019.

Catalyst MedTech Expands Propel Partnership with Arineta to Include Sales, Energizing Cardiac CT Market with a Complete Commercial & Service Solution

PITTSBURGH and CAESAREA, Israel, July 17, 2025 /PRNewswire/ — Catalyst MedTech, a national leader in diagnostic imaging solutions and service, announced today the expansion of its strategic partnership with Arineta, a leader in advancing cardiovascular imaging solutions, to include sales…