Tag: hemodialysis

Humacyte to Host Virtual KOL Event to Discuss ATEV for Arteriovenous (AV) Access for Hemodialysis Patients on April 28, 2026

DURHAM, N.C., April 27, 2026 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that it will host a virtual key opinion leader (KOL) event on Tuesday, April 28, 2026 at 8:00 AM ET featuring Prabir Roy-Chaudhury MD, PhD, FASN (University of North Carolina (UNC) Kidney Center, Salisbury VA Medical Center), and Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS (Brigham & Women’s Hospital, Center for Surgery and Public Health, Harvard Medical School), who will join company management to discuss the unmet need and current treatment landscape for hemodialysis patients with End-Stage Renal Disease (ESRD). To register, click here. The event will provide an overview of the Company’s Acellular Tissue Engineered Vessel (ATEV) in arteriovenous (AV) access for hemodialysis patients. The current standard of care for providing AV access involves connecting the patient’s artery with a vein, known as an arteriovenous fistula or AV fistula (AVF). Humacyte’s ATEV is designed to provide an alternative to the current standard of care for hemodialysis patients with ESRD, as AVFs can take weeks or months to mature and become usable for hemodialysis, and in many patients fail to mature at all. One Phase 3 trial has already been completed showing the potential advantages of the ATEV in AV Access compared to autologous AV fistula in patients at high risk for fistula failure. Company management will also review the ongoing V012 Phase 3 trial in hemodialysis for which interim top-line results are expected this quarter. A live question and answer session will follow the formal presentations. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. About Prabir Roy-Chaudhury MD, PhD, FASNPrabir Roy-Chaudhury MD, PhD, FASN is the Drs. Ronald and Katherine Falk Eminent Professor and Co-Director of the University of North Carolina (UNC) Kidney Center. He is also a Staff Nephrologist at the Salisbury VA Medical Center. After graduating from the Armed Forces Medical College, Pune, India, he trained in Internal Medicine and Nephrology at the University of Aberdeen, Scotland and at the Beth Israel Hospital, Harvard Medical School, Boston, USA. In addition to being an active transplant nephrologist, Dr. Roy-Chaudhury’s main research interest is in uremic vascular biology (including both dialysis vascular access dysfunction and cardiovascular complications in kidney disease patients). Dr. Roy-Chaudhury has been the recipient of extensive NIH, VA, and industry research grant funding (over 20 million USD) has published over 250 manuscripts and book chapters (h index = 65), and has delivered over 450 lectures (including multiple named and plenary presentations) across the globe. He is also the recipient of many national and international awards including the ASDIN Lifetime Achievement Award and the KS Chugh Memorial Oration. Dr. Roy-Chaudhury has also been actively involved in the public policy and administrative aspects of dialysis vascular access care and hemodialysis through leadership roles in multiple societies such as ASN, ASDIN and VASA, and is a Past President of the American Nephrologists of Indian Origin (ANIO). Dr. Roy-Chaudhury was also the founding ASN co-chair of the Kidney Health Initiative, a public-private partnership between ASN and the US FDA and is a regular member of the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC). He is also currently the Immediate Past President of the American Society of Nephrology, which is the largest professional kidney organization in the world with over 21,000 members in 141 countries across the globe. About Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACSMohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS is a Vascular and Endovascular Surgeon-Scientist at Brigham and Women’s Hospital, Core Faculty at the Center for Surgery and Public Health, and Associate Professor of Surgery at Harvard Medical School in Boston. He is board certified in vascular surgery by both the American Board of Surgery and the Royal College of Physicians and Surgeons of Canada. He obtained his medical degree from the Michael G. DeGroote School of Medicine at McMaster University. He completed vascular surgery residency and a PhD in clinical epidemiology and health services research through the Surgeon Scientist Training Program at the University of Toronto. He also completed a cardiovascular research fellowship at the Brigham. Dr. Hussain’s clinical practice is focused on general vascular and endovascular surgery, with special interests in complex hemodialysis access, aortic dissections and aneurysms, and thoracic outlet syndrome. He also co-directs the Heart & Vascular Hemodialysis Access workgroup across the MGB health system. Dr. Hussain’s research lab VESEL (Vascular & Endovascular Surgery Epidemiology Lab) conducts observational and clinical research to improve the care of patients with vascular diseases with special interests in population-based health services research, prediction with machine learning, enhancing causal inference research using target trial emulation, and clinical trials. Dr. Hussain also serves as the Associate Program Director of Surgical Residency and Associate Clerkship Director in the Department of Surgery at the Brigham. About HumacyteHumacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. Forward-Looking StatementsThis press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials, including for our V007 and V012 Phase 3 clinical trials; the anticipated characteristics and performance of our ATEVs and the public perception thereof; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, competitive and/or reputational factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com

CorMedix Inc. Announces Outpatient Availability of DefenCath

BERKELEY HEIGHTS, N.J., July 03, 2024 (GLOBE NEWSWIRE) — CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, today announced that it has commenced commercialization of DefenCath® (taurolidine and heparin) to outpatient dialysis centers and vascular access clinics where patients receive outpatient dialysis and catheter placement services. The outpatient launch coincides with the effective date of July 1st for outpatient reimbursement of DefenCath as directed by the Center for Medicare & Medicaid Services (CMS). CorMedix received NDA approval of DefenCath under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) on November 15, 2023, and began commercialization of the product in the inpatient setting on April 15, 2024. This week CorMedix began shipping orders for DefenCath to dialysis operators under previously announced commercial agreements, and anticipates additional customer agreements and orders in the upcoming weeks. “I am very excited to have now commenced outpatient distribution of DefenCath, an important milestone for CorMedix and for patients, who will now have access to the first and only FDA approved antimicrobial catheter lock solution,” says CorMedix CEO, Joseph Todisco. “I am impressed with how efficiently our customers are rolling out the launch of DefenCath thus far, and I am looking forward to expanding access in the upcoming months as we solidify additional customer contracts.” DefenCath® (taurolidine and heparin)IMPORTANT SAFETY INFORMATION These highlights do not include all the information needed to use DefenCath safely and effectively. See full prescribing information for DefenCath. LIMITED POPULATION: DefenCath is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients. DefenCath is contraindicated and has warnings and precautions in patients with: Known heparin-induced thrombocytopenia (HIT).Known hypersensitivity to any drug products in DefenCath, including taurolidine, heparin or the citrate excipient or pork products. If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures. To report any safety concerns including suspected adverse reactions, contact CorMedix Inc. at 1-888-424-6345 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. Please see the full Prescribing Information. About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath®, which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and began outpatient commercialization on July 1st following the effectiveness of outpatient reimbursement from CMS. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com. Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact:Dan FerryManaging DirectorLifeSci Advisorsdaniel@lifesciadvisors.com (617) 430-7576

TVA Medical Release: Meta-Analysis Demonstrates Positive Clinical Experience Using everlinQ™ endoAVF System for Hemodialysis Acces

Results from 236 patients across 28 sites in seven countries presented at LINC 2018 support growing body of evidence for pioneering clinical approach [01-February-2018] LEIPZIG, Germany, Feb. 1, 2018 /PRNewswire/ — An international meta-analysis of clinical experience in patients who received an endovascular arteriovenous fistula (endoAVF) for hemodialysis access was […]

Laminate Medical Technologies Receives IDE Approval From FDA To Initiate Clinical Study Of The VasQ Device

TEL AVIV, Israel–(BUSINESS WIRE)–Laminate Medical Technologies (Laminate), an Israeli biomedical start-up developing VasQ, an implanted blood vessel external support device for patients requiring arteriovenous fistula as vascular access for hemodialysis, today announced that it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). IDE approval […]

TVA Medical Release: Study Published In Prominent Journal Supports Use Of Innovative Endovascular Hemodialysis Access Technology

AUSTIN, Texas, June 15, 2017/PRNewswire/ — TVA Medical, Inc. today announced the online publication of positive results from the Novel Endovascular Access Trial (NEAT) evaluating its everlinQTM endoAVF System. The 12-month data published online in the American Journal of Kidney Diseases (AJKD), the official journal of the National Kidney Foundation, […]