CAIRO–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced new eight-year data showing that patients receiving aortic surgical valves treated with its proprietary RESILIA tissue technology have significantly improved long-term outcomes compared to those receiving non-RESILIA tissue bioprosthetic valves. For more than 65 years, Edwards has been the leader in heart valve […]
Coronary/Structural Heart
FDA Clearance and First in Human Use for SoloPace™ Temporary Pacing System for TAVR
SAN FRANCISCO, April 17, 2025 /PRNewswire/ — Solo Pace Incorporated, an emerging medical technology company, announced both FDA Clearance and First-In-Human use of their SoloPace Control System for temporary pacing in Transcatheter Aortic Valve Replacement (TAVR) procedures. With…
Daxor Corporation to Showcase Innovative Blood Volume Analysis at MedAxiom Cardiovascular Transforum Spring 2025
WellStar Health System to Highlight New BVA-Driven Strategy That Significantly Reduces Kidney Injury Following LVAD Implantation Oak Ridge, TN, April 17, 2025 (GLOBE NEWSWIRE) — Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology, announces today it will be exhibiting at the MedAxiom CV Transforum Spring’25 Conference being held at the Renaissance Orlando at SeaWorld in Orlando, FL from April 24-26, 2025. The Cardiovascular Transforum conference unites cardiovascular thought leaders from across the country to transform cardiovascular care together with leading industry innovators. Wellstar Health System’s Dr. Brian Howard will present findings showing how their Advanced Heart Failure program successfully reduced acute kidney injury rates following left ventricular assist device implantation through a multi-tiered approach centered on blood volume analysis (BVA). The presentation will share results from their retrospective cohort study and provide implementation strategies for attendees to replicate in their own programs. “We’re honored to have expert clinicians share their firsthand experience with BVA—why it matters, how to effectively integrate it into heart failure programs, and the meaningful impact it has on patient outcomes and quality of life,” said Michael Feldschuh, CEO and President of Daxor. BVA guided care has been shown in peer-reviewed studies to significantly improve multiple measures of patient outcomes including a reduction in 30-day mortality by 82%, 1-year mortality by 86%, 30-day readmissions by 56%, and results in a 55% reduction in length of stay when done on admission (P
Terumo Health Outcomes Now Offers FDA-Cleared Medis QFR® 3.0 Software for Coronary Physiology Assessment in the US
– Innovative AI software supports hospital adoption of advanced tools to improve cath lab workflow and patient comfort – SOMERSET, N.J., April 16, 2025 /PRNewswire/ — Terumo Health Outcomes (THO), a division of Terumo Interventional Systems (TIS), today announced that Medis QFR 3.0, an…
Cellino Announces Partnership with Karis Bio to Develop First Nebula™-Powered Autologous iPSC Therapy for Cardiovascular Disease
CAMBRIDGE, Mass. & ATLANTA & SEOUL, South Korea–(BUSINESS WIRE)–Cellino, a biotechnology company pioneering autonomous biomanufacturing for personalized regenerative medicine, today announced its expansion into the Asia-Pacific region through a strategic collaboration with Karis Bio, a leading South Korean cell therapy biotech. The partnership aims to industrialize the world’s first clinical-stage […]
FDA grants clearance for HeartFocus, the transformative AI-powered cardiac imaging software
The milestone signals a new era of access for cardiac care, enabling any healthcare professional to perform diagnostic-grade echos anytime, anywhere. BORDEAUX, France, April 15, 2025 – DESKi today announced FDA clearance for HeartFocus, its AI-enabled heart exam software that empowers any healthcare professional, including novices, to perform clinical-quality […]
BioCardia Announces Positive DSMB Review of CardiALLO Allogeneic Cell Therapy for Heart Failure Phase 1/2 Clinical Trial
Independent Data Safety Monitoring Board (DSMB) recommends that the study proceeds as designed based on 30-day data safety assessment of participants treated in low dosage group. The company plans to progress the trial to enrollment of 39 participants in the United States. SUNNYVALE, Calif., April 15, 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 that the study’s independent DSMB, which conducted a planned review of the 30-day safety data from the roll-in 20 million cell dosing cohort in the CardiALLO-HF trial, recommended that the study continue as designed. There have been no treatment emergent major adverse cardiac events observed nor has there been any clinical evidence of immune reactions to the allogeneic cells implanted. “We are pleased with the DSMB’s recommendation, an important step forward in advancing this allogeneic off the shelf mesenchymal stromal/stem cell therapy,” said Peter Altman, BioCardia Chief Executive Officer. “Today’s result has potential to be helpful with ongoing discussions around nondilutive funding and partnering opportunities for our MSC platform. Success in this trial can enable future pivotal trial design and funding in the USA, conditional time limited approval with reimbursement in Japan, as well as the advancement of CardiALLO MSC therapy for the likely orphan indications of pediatric and adult congenital heart disease.” Previous clinical results of MSC in ischemic heart failure from our co-sponsored TRIDENT trial1 demonstrated that higher MSC cell dosages reduced myocardial scar and increased left ventricular ejection fraction, and peer results2 have indicated that patients with active inflammation have sustained reduction in cardiovascular major morbidity. CardiALLO HF at high dosage is anticipated to have at least twice the effective dosage of these previous studies and will be the first trial to target patients with active inflammation. About CardiALLO HFThe CardiALLO Heart Failure Trial is a Phase I/II study with an open label Phase I nine-patient dose escalation cohort, followed by a thirty-patient randomized double-blinded placebo procedure-controlled cohort, intended to develop support for safety and efficacy of this treatment. For Phase I, three patients are to be treated at one of three escalating doses of 20 million cells, 100 million cells, and 200 million cells, using the efficient Helix minimally invasive delivery system. The proprietary CardiALLO human MSCs and their dedicated proprietary catheter delivery system are manufactured at BioCardia’s facility in Sunnyvale, California. About BioCardiaBioCardia, 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 whether these results are helpful with ongoing discussions around nondilutive funding and partnering opportunities, what success in the CardiALLO HF trial enables, and what the ultimate dosage in CardiALLO HF is relative to other studies. 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. (1) Florea V, Rieger AC, DiFede DL, El-Khorazaty J, Natsumeda M, Banerjee MN, Tompkins BA, Khan A, Schulman IH, Landin AM, Mushtaq M, Golpanian S, Lowery MH, Byrnes JJ, Hendel RC, Cohen MG, Valasaki K, Pujol MV, Ghersin E, Miki R, Delgado C, Abuzeid F, Vidro-Casiano M, Saltzman RG, DaFonseca D, Caceres LV, Ramdas KN, Mendizabal A, Heldman AW, Mitrani RD, Hare JM. Dose Comparison Study of Allogeneic Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy (The TRIDENT Study). Circ Res. 2017 Nov 10;121(11):1279-1290. doi: 10.1161/CIRCRESAHA.117.311827. Epub 2017 Sep 18. PMID: 28923793; PMCID: PMC8742223. (2) Perin EC, Borow KM, Henry TD, Jenkins M, Rutman O, Hayes J, James CW, Rose E, Skali H, Itescu S, Greenberg B. Mesenchymal precursor cells reduce mortality and major morbidity in ischaemic heart failure with inflammation: DREAM-HF. Eur J Heart Fail. 2024 Nov 26. doi: 10.1002/ejhf.3522. Epub ahead of print. PMID: 39593178. Media Contact: Miranda Peto, Investor RelationsEmail: mpeto@BioCardia.com Phone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120
Tectonic Therapeutic to Present Phase 1b Data for TX45 at European Society of Cardiology Heart Failure 2025
Late-breaking oral presentation to include full Phase 1b results for TX45 in the Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (“PH-HFpEF”) cohort Late-breaking oral presentation to include full Phase 1b results for TX45 in the Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (“PH-HFpEF”) cohort
New Research at ACC25 Shows Daxor BVA-Identified Euvolemic Heart Failure Patients Experience 2.61 Times Better Survival
Precise Volume Measurement Prior to Discharge Identifies Mortality Risk
Edwards SAPIEN M3 Receives CE Mark, Becoming World’s First Transfemoral Transcatheter Mitral Valve Replacement System
IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences Corporation (NYSE: EW) today announced the company’s SAPIEN M3 mitral valve replacement system received CE Mark for the transcatheter treatment of patients with symptomatic (moderate-to-severe or severe) mitral regurgitation (MR) who are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy. Leveraging the company’s SAPIEN technology, […]