The Latest Cardiac and Vascular News
MAPLE GROVE, Minn.–(BUSINESS WIRE)–VDYNE, Inc. (“VDYNE” or “the Company”), a privately held medical device company developing next generation transcatheter valve replacement technologies, today announced that the U.S. Food & Drug Administration (FDA) has approved an investigational device exemption (IDE) for the company’s pivotal clinical trial evaluating its Transcatheter Tricuspid Valve […]
SUNNYVALE, Calif., April 02, 2026 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported submission to United States Food and Drug Administration (FDA) of the CardiAMP HF clinical study data and on its plans to meet with the FDA to discuss the accelerated approval pathway for the CardiAMP® System for ischemic chronic heart failure with reduced ejection fraction (HFrEF). This meeting request is in line with previous guidance and BioCardia expects to have the meeting during this quarter. The meeting will be held under BioCardia’s FDA Breakthrough Designation for the CardiAMP System. The key objectives of the meeting are to obtain FDA feedback on the acceptability of BioCardia’s proposed submission for approval based on the safety seen in the CardiAMP HF Trial, the well-characterized clinical response data for the 125 ischemic HFrEF patients enrolled into the trial, and the low risk and high potential benefit profile in the subgroup with elevated biomarkers of heart stress participating in the trial. For the CardiAMP HF trial subgroup with elevated biomarkers of heart stress, the cells delivered have shown meaningful benefit for these higher-risk patients already on stable American Heart Association and American College of Cardiology guideline directed medical therapy. Demonstrated benefits in the subgroup, in addition to benefits the patients received from guideline directed medical therapy over two years, include an additional 47% relative risk reduction in all cause cardiac death, 37% relative risk reduction in non-fatal major adverse cardiac events (stroke, myocardial infarction, and hospitalization), and meaningful improvements in quality of life (p=0.04). The latest results from this study were presented at the THT (Technology and Heart Failure Therapeutics) 2026 Annual Meeting and are available on the BioCardia website. About CardiAMP Autologous Cell TherapyGranted 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 of myocardial tissue to address microvascular dysfunction. Clinical development of the CardiAMP Cell Therapy 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 cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. For more information visit 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, statements relating to FDA approval of CardiAMP, the planned meeting and the likelihood of safety and patient benefit. These forward-looking statements are made as of the date of this press release. 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. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. 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 24, 2026, under the caption titled “Risk Factors” and in its 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. Media Contact:Miranda Peto, Marketing / Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact:David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120
Expands OEM Platform and Strengthens Leadership in Nuclear Medicine ImagingPITTSBURGH, April 02, 2026 (GLOBE NEWSWIRE) — Catalyst MedTech, a national leader in nuclear medicine and molecular imaging solutions, today announced the acquisition of X3D ApS (“X3D”), the OEM behind widely deployed gamma camera and SPECT systems used in nuclear cardiology and general nuclear medicine. The acquisition builds on Catalyst MedTech’s Digirad portfolio of systems—Ergo, Cardius2 XPO, Cardius3 XPO, and X-ACT+. X3D, formerly DDD-Diagnostic, is a globally recognized engineering and manufacturing partner under private label to leading medical equipment companies, with approximately 5,000 systems installed worldwide. Known for precision engineering, Danish design, and system architecture, X3D has established itself as a trusted force in nuclear medicine and molecular imaging. X3D’s flagship cardiac imaging system, CorCam, is recognized for its diagnostic accuracy, operational efficiency, and compact design. Catalyst MedTech’s acquisition also introduces QuantumCam, a general-purpose gamma camera designed to offer a flexible, space-efficient, and cost-effective solution for hospitals and imaging centers seeking to modernize or expand nuclear medicine capabilities. The combination of Catalyst MedTech’s Digirad portfolio and X3D’s CorCam and QuantumCam creates one of the most comprehensive, versatile offerings in nuclear cardiology and general nuclear medicine. The expanded platform enables Catalyst MedTech to support a broader range of clinical settings while driving innovation across cardiac imaging systems, software, and clinical applications. “This acquisition marks a pivotal step in our strategy to expand access while taking greater ownership of the technologies that power nuclear medicine,” said Martin Shirley, Catalyst MedTech’s President and CEO. “By combining the proven Digirad platform with X3D’s engineering capabilities and global OEM heritage, we are uniquely positioned to accelerate technology, strengthen our market leadership, and ensure long-term support and continuity for thousands of systems already in the field.” Manufacturing of CorCam will transition to the United States, enhancing domestic production capacity and supply chain resilience. X3D’s Denmark-based engineering team will remain in place, continuing to manufacture QuantumCam systems and serving as a key hub for innovation and system development. “We’re proud that our entire organization in Denmark will continue as an integral part of the new Catalyst MedTech structure,” said Admin Ajkunic, X3D’s CEO. “This ensures continuity for our customers and partners, while reinforcing Denmark’s role as a center for innovation and advanced engineering.” About Catalyst MedTech Catalyst MedTech is a national leader in nuclear medicine and molecular imaging, delivering equipment, service, and clinical solutions to healthcare providers across the United States. Our purpose is to provide access to advanced diagnostic imaging so that patients get the care and treatment they need. As both an OEM innovator and ISO-certified service provider, Catalyst offers a comprehensive, multi-vendor approach that enables healthcare organizations to overcome barriers and expand access to advanced diagnostic imaging. The company supports cardiology, neurology, and oncology through advanced imaging technologies, including SPECT, PET, PET/CT, and optimized Brain PET. With one of the largest multi-vendor service networks in the country and a nationwide team of clinical and technical experts, Catalyst ensures imaging programs operate efficiently, reliably, and at scale. See What’s Possible.www.catalystmedtech.com Media Contact: Kate KinsellDirector of MarketingCatalyst MedTechkkinsell@catalystmedtech.com
Proven percutaneous AV fistula technology set to re-enter the market with phased rollout in 2026 SAN CLEMENTE, Calif., April 2, 2026 /PRNewswire/ — Ellipsys Medical, Inc. today announced that the Ellipsys® Vascular Access System will once again be commercially available, with initial…
Goal to unlock value in cardiac electrophysiology assets Strategic process to include outreach to leading global medical device companiesFORT MILL, S.C., April 02, 2026 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (NYSE American: VTAK) (“VTAK” or the “Company”) today announced that it has engaged a strategic advisor to formally market for sale its cardiac electrophysiology business. This strategic initiative is designed to create shareholder value by monetizing the Company’s legacy medical device assets while sharpening its focus on the high-growth Flyte aviation platform. David Jenkins, CEO of VTAK, commented, “We believe that our cardiac electrophysiology portfolio may provide significant value to larger, better capitalized, companies than our own that is not reflected in our own company’s current market capitalization. Both LockeT and VIVO are being used by surgical and recovery teams in many hospitals in the U.S. and internationally including leading teaching hospitals. We believe LockeT provides multiple competitive advantages including large-bore closure capability, cross-functional applications spanning electrophysiology, structural heart, and interventional radiology, and lower cost per procedure. Both our product lines of LockeT and VIVO, our ventricular mapping product, have now gained FDA market clearance as well as the CE mark. With the infrastructure of a larger strategic acquirer, these assets have the potential to have their usage significantly increase within the broader cardiovascular industry. We look forward to the potential value that this strategic process may bring to our shareholders.” Mr. Jenkins continued, “By separating and monetizing these assets, we believe that over time our company will become valued in the stock market as a pure-play aviation business. Our objective is straightforward- drive shareholder value through execution, transparency, and disciplined capital allocation.” About LockeTCatheter Precision’s LockeT is a suture retention device intended to assist in wound closure after percutaneous venous punctures. LockeT is a Class 1 device registered with the FDA and has received CE Mark approval. About VIVO™ Catheter Precision’s VIVO (View Into Ventricular Onset), is a non-invasive 3D imaging system that enables physicians to identify the origin of ventricular arrhythmias pre-procedure, thereby streamlining workflow and reducing procedure time. VIVO has received marketing clearance from the U.S. FDA and has the CE Mark. About Catheter PrecisionCatheter Precision is an innovative U.S.-based medical device company bringing new solutions to market to improve the treatment of cardiac arrhythmias. It is focused on developing groundbreaking technology for electrophysiology procedures by collaborating with physicians and continuously advancing its products. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “expect,” “anticipate,” “potential,” “will,” “may,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, expectations regarding potential strategic transactions, valuation outcomes, market opportunities, and the Company’s growth strategy. These statements involve risks and uncertainties that could cause actual results to differ materially. For a discussion of these risks, please refer to the Company’s filings with the SEC, including its most recent Forms 10-K and 10-Q. The Company undertakes no obligation to update any forward-looking statements. CONTACTS: Investor Relations973-691-2000IR@catheterprecision.com # # #
SAN DIEGO–(BUSINESS WIRE)–Exactice Medical, Inc. today announced a definitive agreement with ImSonic Medical, Inc. to complete advanced prototype development of its AIM device—the industry’s first combined imaging and transseptal access solution, designed to make transseptal procedures faster, safer, and more cost-effective. Exactice’s proprietary AIM device combines 2D/3D intracardiac echocardiography (ICE) with a fully integrated, deployable steerable needle guide. The needle guide remains
LATHAM, N.Y.–(BUSINESS WIRE)–AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options, and improving quality of life for patients, today announced financial results for the third quarter of fiscal year 2026, which ended February 28, 2026. Fiscal Year 2026 Third Quarter Highlights Quarter Ended February 28, 2026 Pro Forma* YoY Growth Net Sales $78
SAN JOSE, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular applications, today announced enrollment of the first patients in FLAGSHIP, the Company’s prospective, single‑arm, open‑label first‑in‑human study evaluating its investigational False Lumen Embolization (FLE) System for the treatment of aortic dissection. Aortic dissection is a life‑threatening condition in which a tear in the aortic wall creates a secondary channel known as
LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that the pivotal results from the FULCRUM-VT study have been accepted for presentation in a late-breaking clinical science session at Heart Rhythm 2026 (HRS), the annual meeting of the Heart Rhythm Society. This is the first Investigational Device Exemption (IDE) study powe
IRVINE, Calif., April 01, 2026 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy® Transcatheter Heart Valve (THV) System, today announced the successful first cases and official U.S. commercial launch of the Trilogy THV System, following the U.S. Food and Drug Administration’s (FDA) recent premarket approval (PMA) for the treatment of patients with symptomatic, severe aortic regurgitation (ssAR) who are at high or greater risk for surgical aortic valve replacement (SAVR). The first commercial U.S. procedures were performed simultaneously at NewYork-Presbyterian/Columbia University Irving Medical Center by Dr. Torsten Vahl, at Cedars-Sinai Medical Center by Dr. Raj Makkar and at Piedmont Heart Institute by Dr. Vinod Thourani. The Trilogy THV System is the first and only transcatheter device in the United States with a dedicated indication for high-risk aortic regurgitation (AR) – a historically underserved and underdiagnosed patient population that, until now, had no approved transcatheter treatment option. With its official launch, JenaValve begins a new era in the treatment of AR in America, bringing a minimally invasive, purpose-built solution to the patients who need it most. “It is an honor to have been on this journey with Trilogy from the very first implants of the ALIGN-AR trial to FDA approval and the very first commercial implants” said Dr. Torsten Vahl, director of translational research and interventional cardiologist at NewYork-Presbyterian/Columbia University Irving Medical Center and national PI of the ALIGN-AR trial. “This is a significant achievement for the field and more importantly, for the many thousands of high-risk AR patients that finally have TAVR available as an option to them.” “These first cases are a defining moment for the many Americans who have been suffering from severe aortic regurgitation,” said Raj Makkar, MD, Cedars-Sinai Medical Center, and highest enroller in the ALIGN-AR trial. “I have seen firsthand how many patients need a dedicated treatment option like Trilogy. With this groundbreaking FDA approval and commercial launch, I believe we will soon gain a clearer understanding of how many patients can truly benefit from this important therapy.” “We finally have the option of TAVR for AR patients at high-risk of surgery.,” said Dr. Vinod H. Thourani, Chairman of Cardiovascular Surgery at Piedmont Heart Institute and national PI of the ALIGN-AR trial. “I am excited for what this means for the future of AR treatment because this now opens the door to whether or not we expand this treatment beyond high-risk patients. The randomized ARTIST trial which we are enrolling now will give us the critical answers to that question.” “The commercial launch of Trilogy in the United States is the beginning of a transformation in how we identify, diagnose, and treat aortic regurgitation,” said Peter Spadaro, Chief Commercial Officer of JenaValve. “We have assembled a world-class commercial organization to introduce the Trilogy valve to hospitals throughout the country to ensure patients have access to this therapy. The unmet need is enormous, and we are already experiencing strong demand. We are committed to reaching every patient who can benefit from the Trilogy System, while prioritizing patient outcomes and safety as we expand access to this game changing technology.” About the Trilogy® THV SystemThe Trilogy THV System is the first and only transcatheter heart valve in the United States indicated for native, symptomatic, severe aortic regurgitation in patients who are judged by a Heart Team to be at high or greater risk for surgical aortic valve replacement. The Trilogy THV System received CE Mark in 2021, and has now been used in more than 1,200 commercial procedures in Europe. The Trilogy System was purpose-built to address the unique anatomical challenges of aortic regurgitation. Unlike conventional TAVR valves that rely on annular calcification for anchoring — which is typically absent in AR patients — the Trilogy System features three proprietary radiopaque locators that attach directly to the native aortic leaflets, enabling secure and stable implantation even in the absence of calcium. The locators also provide commissural alignment for precise valve positioning and ensure a reliable seal to minimize paravalvular regurgitation. The system’s large, open-cell nitinol frame is designed to preserve future coronary access. Dr. Vahl discloses that he previously served as a paid consultant to JenaValve, and reports institutional funding to Columbia University from JenaValve. About JenaValveJenaValve Technology, Inc. is a medical device company focused on the design, development, and commercialization of innovative THV solutions for the treatment of patients suffering from heart valve disease. The Company’s Trilogy THV System is a TAVR system designed to treat patients with symptomatic, severe AR, and symptomatic, severe aortic stenosis (AS) who are at high surgical risk. The Trilogy THV System bears the CE Mark for the treatment of AR and AS and is FDA approved for the treatment of AR. JenaValve is headquartered in Irvine, California, with additional locations in Leeds, United Kingdom, and Munich, Germany. JenaValve is backed by Bain Capital Life Sciences, Andera Partners, Valiance Life Sciences, Rosetta Capital, Cormorant Asset Management, Legend Capital, NeoMed Management, RMM, VI Partners, Pictet Alternative Advisors SA, Qatar Investment Authority (QIA), Innovatus Capital Partners, and Peijia Medical Limited. Additional information is available at www.jenavalve.com. JenaValve Contact:Daniel Sun dsun@jenavalve.com Investor Contacts:Marissa Bych or Webb CampbellGilmartin Group LLCWebb@Gilmartinir.com
