Author: Ken Dropiewski

Kaneka Expands Global Reach with i-ED COIL™ Launch in Europe

TOKYO–(BUSINESS WIRE)–Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Kazuhiko Fujii) (TOKYO:4118) has begun sales of its i-ED COIL™, a brain aneurysm embolization coil (*1), in Europe as of October. The product obtained EC certification (*2) under an EU Medical Device Regulation (*3) in July and will be distributed primarily in Europe […]

AHA 2025 Late-Breaking Science: Cleerly’s AI Atherosclerosis Quantification Outperforms Traditional Risk Scoring

DENVER–(BUSINESS WIRE)–Cleerly, a leader in AI-based cardiovascular imaging, presented new, late-breaking science from the international CONFIRM2 Registry at the American Heart Association (AHA) Scientific Sessions 2025 at the Ernest N. Morial Convention Center in New Orleans, LA. “This is another step towards earlier identification and treatment for patients,” said Ibrahim Danad, MD, […]

TriSalus Life Sciences to Host Virtual KOL Event to Discuss the TriNav Infusion System for the Treatment of Uterine Fibroids on November 12, 2025

WESTMINSTER, Colo.–(BUSINESS WIRE)–TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (“TriSalus” or the “Company”), an oncology company integrating novel delivery technology with standard of care therapies to transform treatment for patients with solid tumors, announced today that it will host a virtual key opinion leader (KOL) event on Wednesday, November 12, 2025 […]

Kardigan Presents Positive Phase 2 Data on Ataciguat in Patients with Moderate Calcific Aortic Valve Stenosis at American Heart Association Scientific Sessions 2025

Results presented in oral session demonstrated that treatment with ataciguat reduced aortic valve calcium and improved cardiac function and output compared to placebo Download Press Release PDF SOUTH SAN FRANCISCO, Calif., and PRINCETON, N.J., November 7, 2025 — Kardigan, a heart health company modernizing cardiovascular drug development, announced positive Phase 2 […]

AHA 2025: New study from Genomics shows polygenic risk scores improve the accuracy of cardiovascular disease risk prediction

The addition of polygenic risk scores (PRS) improved the accuracy of the cardiovascular disease (CVD) risk prediction tool PREVENT across all groups studied, across ancestries. Over 3 million people aged 40-70 in the U.S. are at high risk of CVD but are currently invisible to the system,…

Largest Real-World Study of Wearable Defibrillators Confirms Strong Effectiveness and Safety Performance of Kestra’s ASSURE Device

KIRKLAND, Wash., Nov. 10, 2025 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a wearable medical device and digital healthcare company, today announced primary results from the ASSURE® WCD Clinical Evaluation Post-Approval Study (ACE-PAS), presented as a late-breaking science session at the American Heart Association (AHA) Scientific Sessions 2025 in New Orleans. ACE-PAS, the largest prospective real-world study of wearable defibrillators to date, confirmed the strong safety and effectiveness of the ASSURE WCD in clinical practice. “ACE-PAS delivers robust, real-world evidence on how the ASSURE WCD performs in routine care and provides contemporary data describing the risk of life-threatening ventricular tachycardia and fibrillation in diverse populations with reduced cardiac function,” said Jeanne E. Poole, MD, Professor of Medicine at the University of Washington and Principal Investigator. “Life-threatening arrhythmias can occur early in patients with low ejection fraction who have recently experienced a myocardial infarction, undergone coronary revascularization, or have been newly diagnosed with heart failure. These patients may have significant recovery of heart function during a waiting period of one to six months, such that a permanently implanted defibrillator is not indicated. The ASSURE WCD should be considered to protect patients at elevated risk of sudden cardiac death during this vulnerable time.” The study enrolled 21,612 patients across the United States. Key findings demonstrate consistent safety, effectiveness, and compliance in real-world use: Proven effectiveness The primary effectiveness endpoint was achieved, with 100% successful conversion for ventricular tachycardia and fibrillation (VT/VF) events, surpassing the prespecified performance goal. Validated safety The study met its primary safety endpoint, with an inappropriate-shock rate of 0.0065 per patient-month, below the prespecified performance goal and confirming a strong safety profile. Minimal false alarms 94% of patients experienced no false positive shock alarms, ensuring confidence and comfort during wear. Critical protection 2.6% of patients experienced at least one life-threatening VT/VF event within only a few months, highlighting the importance of protection in this vulnerable population. Additional clinically relevant arrhythmias revealed The ASSURE system facilitated detection of high-rate atrial fibrillation in 4.2% of patients (35% previously undiagnosed) and severe bradycardia/asystole in 0.3%, enabling the potential of timely intervention. High compliance Patients wore the device for a median of more than 23 hours per day, and one-third continued use beyond 90 days—highlighting its practicality in real-world, long-term care. “These results reinforce the critical role wearable device monitoring and therapy can play in protecting patients during periods of elevated risk,” said Brian Webster, President and Chief Executive Officer of Kestra Medical Technologies. “As the largest and most contemporary study of its kind, ACE-PAS provides compelling evidence that may help inform future updates to clinical practice—particularly around how physicians identify and protect patients at early risk of sudden cardiac death. By pairing proven performance with connected, data-driven insight, Kestra is redefining what’s possible in wearable protection and advancing evidence-based innovation.” The ACE-PAS results represent a significant step forward in understanding and managing sudden cardiac arrest risk. Additional analyses from the study will be shared in forthcoming scientific forums. A recorded panel discussion featuring ACE-PAS investigators and other leading clinical experts, hosted by MedAxiom, offers further perspective on the study’s design, outcomes, and implications for patient care. The full discussion can be viewed here: https://na2.hubs.ly/H01ZZM90 About ACE-PASThe ASSURE WCD Clinical Evaluation Post-Approval Study (ACE-PAS) is a prospective, multicenter registry evaluating the use, safety, and effectiveness of the ASSURE Wearable Cardioverter Defibrillator in the prevention of sudden cardiac death. The study enrolled 21,612 patients from November 2021 through July 2025 across the U.S. Primary endpoints were overall VT/VF shock conversion and inappropriate-shock rate. About Kestra Kestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, please visit www.kestramedical.com.  Forward-Looking StatementsExcept where otherwise noted, the information contained in this press release is as of November 10, 2025. Statements in this press release that express a belief, expectation or intention, as well as those that are not historical fact, are forward-looking statements. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about, among other topics, the Company’s goals and prospects, the ACE-PAS study, the potential uses and benefits of the evidence collected therefrom and additional analyses that may be shared from the ACE-PAS study in the future. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions, and we cannot ensure that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following: risks related to our limited operating history and history of net losses; our ability to successfully achieve substantial market adoption of our products; competitive pressures; our ability to adapt our manufacturing and production capacities to evolving patterns of demand, governmental actions and customer trends; product defects or complaints and related liability; our ability to obtain and maintain adequate coverage and reimbursement levels for our products; our ability to comply with changing laws and regulatory requirements and resulting costs; our dependence on a limited number of suppliers; and other risks and uncertainties, including those described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended April 30, 2025 filed with the U.S. Securities and Exchange Commission (“SEC”) on July 17, 2025, and in other periodic reports filed by the Company with the SEC. These filings, when made, are available on the Investor Relations section of our website at https://investors.kestramedical.com/ and on the SEC’s website at https://sec.gov/. CONTACT: Media contact 
Rhiannon Pickus 
rhiannon.pickus@kestramedical.com 

Investor contact 
Neil Bhalodkar 
neil.bhalodkar@kestramedical.com 

JenaValve‘s Trilogy™ System Featured in Live Procedure at TCT 2025

IRVINE, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced highlights from the 2025 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium in San Francisco, CA with a live case broadcast from the ARTIST study as well as late-breaking data from PREVUE-VALVE.

BioCardia Announces Henry Ford Health Enrolls Their First Patient in Phase 3 CardiAMP HF II Cell Therapy Pivotal Trial

SUNNYVALE, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the first patient enrolled at Henry Ford Health in its ongoing Phase 3 CardiAMP® HF II clinical trial for patients with ischemic heart failure of reduced ejection fraction (“HFrEF”). “The CardiAMP-HF trial, in which Henry Ford Health participated, was groundbreaking for the field of heart failure. Although the primary endpoint was not met, the study showed impressive results with an autologous cell therapy in patients with HFrEF, particularly those with elevated biomarkers of heart stress,” said Dr. Gerald Koenig, M.D., Director of the Cardiac Catheterization Laboratory at Henry Ford West Bloomfield Hospital and Director of Clinical Research in the Cardiac Catheterization Laboratory at Henry Ford Health System, and Principal Investigator in the Phase 3 CardiAMP HF II trial. “Our team is actively offering patients the opportunity to participate in this important confirmatory study intended to enhance microvascular function and improve patient outcomes, including quality of life.” “We greatly value our collaboration with Dr. Koenig and the world class Henry Ford Health team in the CardiAMP HF II Trial,” said Peter Altman, PhD, CEO of BioCardia. “Between the U.S. and the EU, there are roughly 2 million ischemic HFrEF patients with NYHA Class II and III symptoms. Many of these patients have a prognosis worse than many cancers and few remaining options. This places a terrible burden on patients, their families, and the healthcare system. We are excited by the CardiAMP HF results showing that our cell therapy system reduced both mortality and major adverse cardiac events, improved quality of life, and showed positive impacts to other study endpoints in patients with HFrEF. These results suggest that our investigational cell therapy could address important clinical needs.” About the CardiAMP Heart Failure II Study CardiAMP HF II is a 250-patient randomized multicenter procedure placebo-controlled study of the CardiAMP autologous cell therapy as a one-time treatment for patients with ischemic heart failure with reduced ejection fraction (HFrEF) on guideline directed medical therapy having elevated NTproBNP. The study is intended to confirm the safety and efficacy results in these patients observed in the CardiAMP HF study. The CardiAMP HF II study uses a similar three-tier composite primary outcome measure to the CardiAMP HF study consisting of all cause death, nonfatal major adverse cardiac events, and a validated quality of life measure. In CardiAMP HF, this composite efficacy endpoint was achieved with statistical significance in the patients with elevated NTproBNP who are the focus of the CardiAMP HF II study. Advances in this therapeutic approach for this trial include using the cell population analysis at screening to define treatment doses and improvements to the Helix system including the FDA approved Morph DNA steerable platform. About CardiAMP Autologous Cell Therapy Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis, treating microvascular dysfunction. The CardiAMP Cell Therapy clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION – Limited by United States law to investigational use. About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms. For more information visit: https://www.BioCardia.com. Forward Looking Statements This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to our investigational product candidates, the potential benefits and mechanism of actions of the CardiAMP cell therapy, future regulatory approvals, enrollment in our clinical trials, and the safety and efficacy of our product candidates and therapies. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. CONTACT: Media Contact:
Miranda Peto, Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120

Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120