The Latest Cardiac and Vascular News
KENMORE, N.Y. and MIAMI, Sept. 05, 2025 (GLOBE NEWSWIRE) — Firefly Neuroscience, Inc. (“Firefly”) (NASDAQ: AIFF), an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders, today announced a new partnership with HealingMaps, the leading directory for ketamine, psychedelic-assisted therapy, and transcranial magnetic stimulation (“TMS”) clinics, and Advanced Behavioral Strategies (ABS).
Collaboration highlights Hengrui Pharma’s successful use of the NewCo model to achieve another out-licensing deal Agreement grants Braveheart Bio exclusive global rights to develop, manufacture and commercialize HRS-1893 outside of Mainland China, the Hong Kong SAR, the Macao SAR and…
~Pivotal Launch-HTN trial of novel aldosterone synthase inhibitor lorundrostat enrolled a diverse range of participants with uncontrolled or resistant hypertension~ ~Subgroups – including Black or African American adults, older adults, women, and participants with comorbid obesity – face heightened risk of poor cardiovascular outcomes and represent high unmet need~ ~Lorundrostat demonstrated significant and clinically meaningful blood pressure reductions across all participant subgroups, with a favorable safety and tolerability profile~ RADNOR, Pa., Sept. 05, 2025 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced new subgroup analyses from the Phase 3 Launch-HTN trial, evaluating the blood pressure–lowering efficacy and safety of lorundrostat in difficult-to-treat and high-risk patient populations with high unmet medical need. The results were presented at the American Heart Association (AHA) Hypertension Scientific Sessions in Baltimore, MD, September 4-7, 2025. “In our Phase 3 Launch-HTN trial we were intentional about recruiting a diverse patient population, including those at high-risk. These participants continue to face uncontrolled hypertension despite treatment with existing therapies,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “Lorundrostat demonstrated a clinically meaningful blood pressure reduction across the full study population, including these difficult-to-treat groups. Importantly, the safety and tolerability profile was consistent with our topline results, reinforcing the potential of lorundrostat as a transformative therapeutic for patients living with uncontrolled or resistant hypertension.” Launch-HTN is the largest global Phase 3 trial to date in uncontrolled or resistant hypertension, enrolling a diverse group of participants with high cardiovascular risk, including Black/African American (29%), adults aged ≥65 years (41%), women (47%), participants with obesity (63%), and those requiring three or more background antihypertensive medications (60%). Across all of these subgroups, lorundrostat 50 mg demonstrated consistent, statistically significant, and clinically meaningful reductions in blood pressure compared with placebo. “Hypertension remains the leading modifiable risk factor for cardiovascular disease. These findings from the Launch-HTN study highlight the potential of lorundrostat to address a critical unmet medical need and improve blood pressure control in high-risk patient cohorts, including: Black and African American patients, patients 65 yrs or older, females, patients with comorbid obesity and patients on 3 or more anti-hypertensives,” said Dr. Manish Saxena, MBBS, Hypertension Specialist and Clinical Co-Director at William Harvey Heart Centre, Barts Health NHS Trust and QMUL. “With consistent blood pressure lowering effect across diverse, high-risk subgroups, lorundrostat could help improve outcomes for patients and reduce the burden of hypertension on the healthcare system.” Table. Subgroup Analysis of AOSBP Change for Lorundrostat 50 mg vs Placebo at Week 6 LSM Reduction in AOSBP, mmHg CharacteristicLorundrostat 50 mg(n=808)Placebo(n=270)LSM Difference (90%CI), Lorundrostat vs PlaceboAge ≥75 y-18.2-6.6-11.6 (-17.4, -5.8); p=0.001165-74 y-16.7-9.8-6.9 (-11.4, -2.4); p=0.0109
Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced the successful completion of the world’s first procedures using MAGiC Sweep™, the first and only robotically-navigated high-density electrophysiology (EP) mapping catheter. The procedures were performed by Dr. Raffaele Corbisiero and Dr. Pedram […]
SOUTHLAKE, Texas & MARSEILLE, France–(BUSINESS WIRE)–Rapid Medical™, a leading developer of active endovascular devices, announces that its DRIVEWIRE™ 24 steerable guidewire has been used in more than 1,000 neurovascular procedures in North America during a limited commercial launch beginning earlier this year. The company also announced receipt of CE Mark under the […]
LAS VEGAS, Sept. 04, 2025 (GLOBE NEWSWIRE) — Cardiac Biotech Solutions, Inc. (OTCID: CBSC) (“CBSC” or the “Company”), a designer, manufacturer, and distributor of non-invasive ambulatory cardiac monitoring products, today announced the execution of a new distribution agreement with Noventis Medical, granting the Company five-year exclusive rights to distribute CBSC’s products across Costa Rica, Panama, Colombia, and Argentina. Under the terms of the agreement, Noventis Medical has committed to a total of $600,000 USD contract value for the distribution rights. In addition, the Company has granted Noventis a right of first refusal for any future distribution opportunities across other Central and South American countries, provided it can match the terms offered by other prospective partners. “We are delighted to expand our international presence through this new strategic partnership with Noventis Medical,” said Charles Martin, Chief Executive Officer of CBSC. “This agreement strengthens our reach into key Latin American markets and, we believe, provides a solid foundation for additional regional expansion. We also believe that the right of first refusal provision also ensures that our long-term collaboration with Noventis can grow in step with future opportunities across Central and South America.” John Quam, President of Noventis Medical stated, “Noventis Medical is very excited to collaborate with CBSC and its product, MyCardia AT, to bring a reliable solution for identifying heart issues in the Latin American market. Cardiovascular disease remains the leading cause of death in the region, and this technology provides doctors with early insights so they can address problems and keep patients healthier for longer. We are committed to working alongside the medical community to deliver innovative tools that truly make a difference.” The Company continues to advance global commercialization of its MyCardia AT event monitoring platform, which integrates lightweight, easy-to-use wearable technology with AWS Cloud-based connectivity and mobile applications for iOS, Android, and WeChat. With regulatory clearance already secured in the U.S. and additional submissions progressing in Canada and China, CBSC’s newest international agreement represents another milestone in its mission to provide state-of-the-art cardiac monitoring solutions worldwide. As additional new developments occur, Cardiac Biotech Solutions, Inc. will make timely announcements through press releases and regulatory filings to keep its shareholders, industry participants, and the public markets informed. About Cardiac Biotech Solutions, Inc.:Cardiac Biotech Solutions, Inc., through its international subsidiaries, provides innovative products and services in the ambulatory non-invasive cardiac monitoring space. Our electrocardiogram (EKG) devices, interactive cloud-based acquisition software, and smartphone apps for both iOS and Android platforms provide improved compliance for patients at risk of abnormal heart rhythms, as well as more accurate information for physicians. Company Contact Information:Telephone: (888) 225-0870Investor Inquiries: investor@cardiacbiotech.com Follow CBSC: Twitter, Facebook, Instagram, LinkedIn, YouTube, and Newsletter This information disclosure may contain forward-looking statements covered within the meaning of the Private Securities Litigation Act of 1995. These forward-looking statements relate to, among other things, plans and timing for the introduction or enhancement of our services and products, statements about future market conditions, supply and demand conditions, and other expectations, intentions, and plans contained in this press release that are not historical fact and involve risks and uncertainties. Our expectations regarding future revenues depend upon our ability to develop and supply products and services that we may not produce today and that meet defined specifications. When used in this press release, the words “plan,” “expect,” “believe,” and similar expressions generally identify forward-looking statements. These statements reflect our current expectations. They are subject to a number of risks and uncertainties, including, but not limited to, changes in technology and changes in pervasive markets. This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties, including, without limitation, the ability to obtain financing and regulatory and shareholder approval for anticipated actions.
September 4, 2025
Internationally recognized vascular surgeon, Dr. Koen Deloose provides patient access to latest innovative treatments and personalized care BERKELEY, Calif, Sept. 04, 2025 (GLOBE NEWSWIRE) — Profusa, Inc. (“Profusa” or the “Company”) (Nasdaq: PFSA), a commercial stage digital health company pioneering a next-generation technology platform enabling the continuous monitoring of an individual’s biochemistry, announces continued growth in its customer base in Europe, with a new commercial and clinical collaboration with the Department of Vascular Surgery at AZ Sint Blasius Hospital, Belgium. Koen R. Deloose, M.D., BSVS, head of the department, is an internationally recognized vascular surgeon specializing in critical limb ischemia (“CLTI”) with over 300 CLTI patients treated annually and will spearhead the collaboration at the key center. Dr. Deloose also serves in leadership roles at a clinic research organization (“CRO”) and in major European medical conferences. “I personally used the Lumee™ Oxygen measurement to monitor endovascular revascularization procedures in below the knee cases. Profusa’s technology provides a critical real-time tissue oxygen perfusion metric that is essential for our successful treatment of these patients,” said Dr. Deloose. “My case data highlighted the relationships between oxygen dynamics measured at point locations, anatomical target of delivered interventions, and treatment outcome. I’m convinced this technology will offer us more guidance in the treatment and follow-up of a constantly growing CLTI-population.” Dr. Deloose recently opened a modern vascular clinic with a multidisciplinary approach that includes diabetic foot specialists, wound care experts and podiatrists, to provide patient access to the latest treatments and personalized care. Dr. Deloose is chief medical officer of the CRO Kando Research, focusing on advancing vascular medicine and providing patients with early access to innovative technologies. He is also founding co-course director and board member of the organizing committee of Paris Vascular Insights and a member of the EVC Maastricht board. As an active researcher, Dr. Deloose has authored and co-authored more than 200 articles in peer-reviewed medical journals, more than 10 chapters in orthopedic, vascular and endovascular books, and is editorial board member of the Journal of Cardiovascular Surgery and the Journal of Critical Limb Ischemia, Endovascular Section. “We continue to add to our impressive roster of customers and warmly welcome Dr. Deloose to our network. The combination of Dr. Deloose’s clinical approach and CLTI research programs that advance the campaign against major amputations due to vascular and arterial diseases speaks to Profusa’s mission to make our body’s chemistry easily accessible, improving health and wellness,” said Ben Hwang, Ph.D., Profusa’s Chairman and CEO. “We look forward to contributing to Dr. Deloose’s clinical agenda with our Lumee Oxygen monitoring system and to future collaborations as we progress target indications of our platform technology.” About Profusa Based in Berkeley, Calif., Profusa is a commercial stage digital health company led by visionary scientific founders, an experienced management team and a world-class board of directors in the development of a new generation of tissue-integrated sensors to detect and continuously transmit actionable, medical-grade data for personal and medical use. With its long-lasting, injectable and affordable biosensors and its intelligent data platform, Profusa aims to provide people with a personalized biochemical signature rooted in data that clinicians can trust and rely on. “LUMEE”, “PROFUSA” and the PROFUSA logo are registered trademarks of Profusa Inc. in the United States, Canada, European Union, China, Japan, South Korea and Australia. For more information, visit https://profusa.com. Special Note Regarding Forward-Looking Statements Certain statements in this press release (this “Press Release”) may be considered “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or future financial or operating performance of Profusa or the combined company. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “propose,” “seek,” “should,” “strive,” “will,” or “would” or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which may be beyond the control of Profusa and could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Profusa and its management are inherently uncertain. Profusa cautions you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. There are risks and uncertainties described in the definitive proxy/final prospectus relating to the business combination, which has been filed with the SEC, and in other documents filed by Profusa from time to time with the SEC. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Profusa cannot assure you that the forward-looking statements in this communication will prove to be accurate. Contacts Investor and Media Contactsemail: info@coreir.comphone: 1 (212) 655-0924
Case series demonstrates the CorVista System®’s clinical utility in identifying pulmonary hypertension (PH) earlier, including where existing standard of care failed to raise suspicionBETHESDA, Md., Sept. 04, 2025 (GLOBE NEWSWIRE) — CorVista Health today announced the publication of a new case series in the Journal of the American College of Cardiology (JACC), showcasing real-world clinical applications of the CorVista System®, a novel non-invasive, point-of-care diagnostic test for pulmonary hypertension (PH). The publication, titled Facilitating Earlier Diagnosis of Pulmonary Hypertension Using a Novel Non-Invasive Diagnostic: A Case Series1, highlights how the FDA-cleared CorVista System can enable earlier detection of PH, even in patients where standard transthoracic echocardiography (TTE) failed to suggest disease. Pulmonary hypertension is a rare but devastating condition that affects an estimated 1% of the global population and up to 10% of people over age 65. In the United States, more than 500,000 people are estimated to be living with PH, though many remain undiagnosed. Timely identification is critical, as untreated PH leads to progressive right heart failure and significantly reduced survival. Unfortunately, PH is frequently underdiagnosed due to the limitations of TTE, particularly when tricuspid regurgitant velocity (TRV) is unmeasurable.2 Unlike TTE, which can fail to visualize TRV in up to 41 percent of cases1, the CorVista System uses machine-learned algorithms to analyze non-invasive signals collected at rest, providing diagnostic results within minutes. In the reported case series, the CorVista System detected PH in a patient who underwent multiple TTEs negative for PH, prompting confirmatory right heart catheterization (RHC), an invasive and resource-intensive procedure. Three additional cases with measurable TRV also tested positive with the CorVista System and were confirmed via RHC to have PH, including both pre-capillary and post-capillary subtypes. “People living with undiagnosed PH are being asked to endure years of uncertainty, undergoing repeated echocardiograms and visiting multiple specialists before receiving an accurate diagnosis. For those with a rare and particularly deadly type of PH which primarily affects young women, Pulmonary Arterial Hypertension (PAH), the delay has severe consequences. They wait, on average up to three years for a correct diagnosis—time during which the disease silently progresses, often with irreversible heart failure,” said Charles R. Bridges, M.D., Sc.D., Executive Vice President and Chief Scientific Officer, CorVista Health. “The results published in JACC are a landmark step in showing that the CorVista System can change this paradigm. By enabling physicians to identify pulmonary hypertension within minutes, non-invasively, and even when traditional tests fail, we are offering a new standard of care that has the potential to save lives and preserve quality of life for countless patients worldwide” The published case series includes four real-world patients evaluated at clinical sites in the United States and Hong Kong. Each patient underwent testing with the CorVista System, followed by confirmatory right heart catheterization (RHC), the gold standard for pulmonary hypertension diagnosis. Cases included both patients with clear echocardiographic signs of PH and those where echocardiography failed to raise suspicion, demonstrating the system’s utility across varied clinical scenarios. Key insights from the case studies series published include: The CorVista System identified PH in a patient whose prior echocardiograms, including three TTEs and a transesophageal echocardiogram, showed no signs of PH.Positive results prompted RHC, which confirmed PH with a mean pulmonary artery pressure (mPAP) of 35 mmHg.In all four patients, results were confirmed by RHC, identifying both pre-capillary and post-capillary PH with 100 percent confirmation in real-world use.Across the three supporting cases, the CorVista System detected PH in patients with confirmed mPAP ranging from 22 mmHg to 43 mmHg.All four patients tested positive using the system’s score threshold.Results directly influenced clinical care in all four patients, prompting earlier diagnosis and changes in treatment, including referrals to heart failure and PH specialists, SGLT2 inhibitor therapy, and sleep apnea treatment.By identifying PH in minutes using a non-invasive test, the CorVista System may help reduce the current years-long average delay and the need for multiple echocardiograms and multiple specialist visits typically required for diagnosis.3 About CorVista System® The CorVista System is a point-of -care digital health solution that detects multiple heart conditions in a single, non-invasive test. The system uses machine learned algorithms to quickly analyze heart signals and detect issues like blocked arteries or high pressure in the lungs—all in under 30 minutes, allowing clinicians to interpret results and guide treatment decisions in a single visit. The system received clearance from the U.S. Food and Drug Administration (FDA) for coronary artery disease in September 2023 and Pulmonary Hypertension in April 2024, with additional indications, including heart failure, in active development. In 2022, the CorVista System’s PH indication was awarded an FDA Breakthrough Device Designation—marking the first major advancement in PH diagnostics in over 40 years and setting a new standard for patient care. About CorVista Health CorVista Health is on a mission to transform cardiovascular care with diagnostics that shorten the path from symptoms to diagnosis, empowering earlier treatment and better patient outcomes. We are dedicated to enabling more equitable care by providing access to immediately actionable, high-quality cardiovascular test results for previously underserved patient populations – with the goal of contributing to a future where everyone has timely access to life-saving cardiovascular care. For more information on CorVista Health, please visit: www.corvista.com Media Contact:media@corvista.com 1Aben R, Burton T, Fathieh F, et al. Facilitating Earlier Diagnosis of Pulmonary Hypertension Using a Novel Non-Invasive Diagnostic: A Case Series. J Am Coll Cardiol. 2025. https://www.jacc.org/doi/10.1016/j.jaccas.2025.104876 2Janda S, Shahidi N, Gin K, Swiston J. Diagnostic accuracy of echocardiography for pulmonary hypertension: a systematic review and meta-analysis. Heart. 2011;97(8):612-622. 3Didden E, Lee E, Wyckmans J, Quinn D, Perchenet L. Time to diagnosis of pulmonary hypertension and diagnostic burden: A retrospective analysis of nationwide US healthcare data. Pulm Circ. 2023;13(1):e12188.
MINNEAPOLIS, Sept. 4, 2025 /PRNewswire/ — VentureMed Group, Inc., a privately held leader in medical device innovations for arteriovenous (AV) access and peripheral arterial disease (PAD), was recently featured in a published study on the outcomes of FLEX VP + DCB in the Journal of…
