The Latest Cardiac and Vascular News
Recruitment of the second cohort expected to begin in H2 2025 PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure (the “Company” or “CARMAT”), today announces that it […]
WHITE PLAINS, N.Y.–(BUSINESS WIRE)–Spectrum Vascular (“Spectrum” or the “Company”), a provider of vascular access and medication management products designed to reduce health care-acquired infections, is pleased to announce the appointment of Ken Miller as Chief Executive Officer and Doug Shook as Chief Commercial Officer. These strategic leadership additions mark a […]
Fort Mill, S.C., April 14, 2025 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (VTAK – NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market announced that it has received a notice of allowance from the US Patent Office of its first patent in the US for its LockeT product, filed in December 2022, for its design of a surgical closure device for orthoscopic entry wounds.
SILVER SPRING, Md., April 14, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, today confirmed that the ongoing global tariff environment has had no material impact on its commercial or operational performance. Elutia sources, manufactures, and distributes 100% of its products within the United States, primarily from its Roswell, Georgia production facility and U.S.-based suppliers. These products include EluPro™, CanGaroo®, SimpliDerm®, and its full Cardiovascular portfolio. Furthermore, all Elutia product sales occur within the United States. “We are proud to be a U.S.-based company with all operations and sales occurring domestically,” said Dr. Randy Mills, CEO of Elutia. “Thanks to our vertically integrated manufacturing and U.S.-focused commercial strategy, we remain insulated from the uncertainties surrounding the current tariff landscape and continue to reliably produce and deliver our advanced medical products so patients can thrive without compromise.” Elutia’s Roswell facility is FDA-registered as a medical device manufacturing establishment and has not experienced any delays, cost increases, or supplier issues related to the tariffs. The Company believes it is well-positioned to continue serving the U.S. market without impacts to its pricing or margins. About Elutia Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. Forward-looking statements contained in this press release include, without limitation, any statements we make regarding any future impacts on Elutia’s performance of current or new and/or increased global tariffs, and any resulting future difficulties, delays or cost increases in securing necessary suppliers or materials for Elutia’s products. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: the risk that clinical research data may not match preclinical study data; our ability to successfully commercialize, market and sell our EluPro product; our ability to continue as a going concern; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors:Matt SteinbergFINN Partnersmatt.steinberg@finnpartners.com This press release was published by a CLEAR® Verified individual.
PRINCETON, N.J., April 14, 2025 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today announced the appointment of Thomas Shannon as Vice President of…
CardiAMP HF II is Evaluating the CardiAMP™ Cell Therapy Product for Treating Patients with Ischemic Heart Failure of Reduced Ejection Fraction and Elevated Markers of Cardiac Stress Dr. Arshed Quyyumi, Professor of Medicine, Division of Cardiology, Department of Medicine, Emory University School of Medicine, and Co-Director of the Emory Clinical Cardiovascular Research Institute to Serve as Principal Investigator SUNNYVALE, Calif., April 11, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that Emory University School of Medicine in Atlanta Georgia is now enrolling patients with ischemic heart failure in the Company’s ongoing pivotal Phase III CardiAMP HF II trial. Emory University joins esteemed clinical sites throughout the United States participating in the study. The CardiAMP HF II Study is evaluating the Company’s lead therapeutic product candidate, a system designed for the harvest, processing, and minimally invasive delivery of autologous mononuclear cells to the heart intended to enhance microvascular density and reduce fibrosis. The study is comparing treatment with CardiAMP Therapy to a placebo procedure with all patients on stable guideline directed medical therapy. “The CardiAMP cell therapy has shown compelling benefits for the treated patients in the trial results recently presented at the American College of Cardiology Scientific Sessions,” said Dr. Arshed Quyyumi, MD, Professor of Medicine, Division of Cardiology, Department of Medicine, Emory University School of Medicine, and Co-Director Emory Clinical Cardiovascular Research Institute. “The screening for CD34+ cell composition and high dosage being delivered in a interventional cardiology setting is in alignment with our own past research and enhances both my confidence in the results recently presented and the potential for treated patients to do well in the study ahead. Our team at Emory is looking forward to offering patients with heart failure the opportunity to participate in this minimally invasive autologous cell therapy trial.” “Dr. Quyyumi’s significant expertise in these trials and inspiring leadership, coupled with the world-class capabilities at Emory University School of Medicine, a leading institution in the development of the field of interventional cardiology in the United States, is a great addition to the CardiAMP-HF II trial,” said Peter Altman, PhD, President and CEO of BioCardia. “We believe this collaboration will assist the Company on many levels, including their anticipated strong support in accelerating patient enrollment in the CardiAMP HF II trial towards its target completion in 2027.” About Chronic Heart Failure of Reduced Ejection Fraction (HFrEF) Heart failure of reduced ejection fraction (HFrEF) is a clinical condition in which the output of blood from the heart is insufficient to meet the metabolic demands of the body. In 2022, the American Heart Association report on heart disease statistics estimated that 3 million American adults ages 20 and older have heart failure of reduced ejection fraction with a prevalence expected to increase to more than 4 million people by 2030. During heart failure progression, the heart steadily loses its ability to respond to increased metabolic demand, and mild exercise soon exceeds the heart’s ability to maintain adequate output. Towards the end stage of the disease, the heart cannot pump enough blood to meet the body’s needs at rest. At this stage, fluids accumulate in the extremities or in the lungs making the patient bedridden and unable to perform the activities of daily living. Despite guideline-directed therapies employing a wide range of pharmacologic, device, and surgical options, many patients deteriorate over time and develop advanced heart failure symptoms that cannot be effectively managed by existing medical therapies. About CardiAMP Cell Therapy Granted Breakthrough Designation by the FDA, the CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. Clinical development to date in randomized controlled double blinded trials has shown trends towards enhanced patient survival, reduced major adverse cardiac events, and improved quality of life. The CardiAMP 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) for both treatment and control procedures. CAUTION – Limited by United States law to investigational use. About CardiAMP Heart Failure Clinical Development Final study results from the randomized double blinded controlled one hundred and twenty-five subjects CardiAMP Heart Failure Study were presented at the American College of Cardiology in March 2025. Results demonstrated increased survival and reduced major adverse cardiac and cerebrovascular events (MACCE) observed study-wide. Statistically significant improvement in composite outcome measure comprised of survival, MACCE, and quality of life seen in patients suffering from active heart stress (those with elevated NTproBNP and BNP biomarkers) treated with CardiAMP Cell Therapy (p=0.02). CardiAMP HF II will focus on these patient responders. BioCardia’s clinical and regulatory team is actively working to share final results with both the FDA and Japan’s Pharmaceutical and Medical Device Agency in support of approval of the CardiAMP Cell Therapy for these patients with elevated NTproBNP, for whom existing medications may not be sufficient, and also in support of separate approval for the Helix transendocardial biotherapeutic delivery system, whose approval will have value for many biotherapeutic delivery partners. 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: 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 the Company’s investigational product candidates, the potential benefits of CardiAMP cell therapy for patients with ischemic HFrEF, the rate of enrollment in clinical trials ahead, and the approvability of the Company’s investigational product candidates in Japan and the United States. 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.” 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
MASON, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management, and post-operative pain management, today announced the first use of the newest AtriClip ® device for minimally invasive concomitant procedures, the AtriClip PRO-Mini® LAA Exclusion System. The AtriClip PRO-Mini device received […]
Recently published foundational document and AI chapter provide a framework for health systems to integrate novel paradigms of care delivery CHICAGO–(BUSINESS WIRE)–The American College of Cardiology’s (ACC’s) five-year Strategic Plan includes a major initiative focused on transforming care delivery in new areas and recognizing the importance of delivering care within […]
Study Seeks to Confirm Benefits of Cagent’s Unique Serration Balloon Angioplasty Technology vs. Plain Old Balloon Angioplasty (POBA) in treating Peripheral Artery Disease (PAD) in Below-the-Knee Arteries. WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular, Inc., the exclusive developer of serration technology for vessel dilation in endovascular interventions, announced its 1st patient enrollment of the […]
Novel IVL technology designed to deliver calcium fragmentation for treatment of moderate to severely calcified coronary artery lesions without requiring an energy source. IVL technology expands company’s innovative product portfolio. MILPITAS, Calif., April 10, 2025 (GLOBE NEWSWIRE) — Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, today announced EU MDR CE Mark approval and commercial launch of its LithiX™ Hertz Contact (HC) Intravascular Lithotripsy System (IVL) in Europe. The first cases were completed by Stefano Galli, MD, Interventional Cardiologist at Centro Cardiologico Monzino in Milan, Italy; Professor Eric Van Belle, MD, Head of the Interventional Cardiology Department, Lille University Hospital, Lille, France; and Professor Nikos Werner, MD, Hospital Barmherzigen Bruder Trier, Trier, Germany. LithiX™ lithotripsy mechanism of action to create calcium fractures is based on the Hertz Contact Stress principle and does not require an external energy source or capital equipment, delivering the expected performance of IVL with additional versatility to treat complex calcified lesions based on the unique design. “Lithotripsy, introduced in urology a few decades ago, has evolved to encompass mechanical and energy-based mechanisms of action to fragment calcium deposits while minimizing injury to soft tissue. Energy-based lithotripsy for intravascular use was adapted to deliver effective calcium modification while preventing injury to adjacent non-calcified vessel associated with manual devices,” said Motasim Sirhan, CEO of Elixir Medical. “With LithiX™, we created the first mechanical IVL platform capable of treating broad calcified lesion morphologies with great final outcomes, while minimizing injury to adjacent non-calcified vessel.” LithiX™ Hertz Contact IVL System is a transcatheter device comprised of multiple low-profile metal hemispheres uniformly distributed and integrated across the surface of a semi-compliant balloon. Under low balloon inflation pressure, the hemispheres create highly localized points of contact with calcium and amplification of force to create deep and wide fractures based on Hertz Contact Stress mechanics, while minimizing vessel injury when in contact with soft non-calcified vessel tissue. “Optimal calcium modification is very important in achieving good PCI outcomes, and LithiX Hertz Contact IVL fulfills that goal as a simple-to-use and versatile option with excellent clinical performance,” said Stefano Galli, MD, Interventional Cardiologist at Centro Cardiologico Monzino in Milan, Italy. With this unique mechanism of action, LithiX™ HC-IVL is designed to enhance and expand calcium treatment with an optimized procedure workflow in the catheterization lab, positively impacting percutaneous coronary intervention (PCI) treatment. “We are excited to adopt LithiX™ in our everyday practice as a very deliverable tool designed to safely modify calcified lesions that is easy to use with high degree of precision and control,” said Nikos Werner, MD, Hospital Barmherzigen Bruder Trier, Trier, Germany. “In our first cases, we have seen confirmation of the recent PINNACLE study outcomes with LithiX HC-IVL in treating calcified coronary lesions with a great procedural result in eccentric and concentric calcium,” added Professor Eric Van Belle, MD, Head of the Interventional Cardiology Department, Lille University Hospital, Lille, France. The company recently announced six-month data from the PINNACLE I study showcasing LithiX™ HC-IVL’s unique mechanism of action with sustained clinical outcomes. An intravascular imaging sub-study using optical coherence tomography (OCT) demonstrated effective treatment in a broad range of complex calcified lesions, including concentric and eccentric calcium and lesions with calcium nodules. Stent expansion at the Minimum Stent Area (MSA) location was 101.38%, 93.95% in eccentric and concentric lesions respectively. In lesions with calcified nodules, stent expansion at maximum calcium site was 102.81%. About the PINNACLE I Trial PINNACLE I is a prospective, multicenter, single-arm clinical study evaluating the safety, effectiveness, and performance of the LithiX Hertz Contact Intravascular Lithotripsy (HC-IVL) System for the treatment of calcified lesions. The trial includes 60 patients across seven sites in Belgium and the Netherlands. An imaging subset of 32 patients underwent intravascular imaging assessment by OCT. About Elixir Medical Elixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Elixir Medical was named to Fast Company’s prestigious list of the World’s Most Innovative Companies of 2025. Visit us at www.elixirmedical.com and on LinkedIn and X. The LithiX HC-IVL system is CE Mark approved. Not available for sale in the United States. Media Contact Richard LaermerRLM PRelixir@rlmpr.com(212) 741-5106 X 216
