VenoStent conducts an individual prospective, randomized, controlled trial of two hundred subjects with access to dialysis
HOUSTON, TX / ACCESSWIRE / January 30, 2024 /VenoStent, Inc. , a venture-backed clinical-stage healing medical device company that is developing bioabsorbable sleeves for hemodialysis patient outcomes, announced the directory of its first subjects in its SAVE-FistulaS clinical study. trial at Surgical Specialists of Charlotte, P. A. in Charlotte, North Carolina, and Cardiothoracic and Vascular Surgeons in Austin, Texas.
U. S. Clinical Trial
“This is the first randomized controlled trial (RCT) of a medical device in the U. S. “We have been working in the U. S. on the outcomes of arteriovenous fistula (AVF) surgery,” said Timothy Boire, PhD, CEO and co-founder of VenoStent. ambitious and sets the highest bar for FDA approval, we owe it to the chronic kidney disease (CKD) patient network to provide the highest point of clinical evidence. We are confident, based on years of preclinical and clinical data, that “we will demonstrate our superiority over the criteria of care with this innovative technology. “
VenoStent enrolls its first patient into a first-of-its-kind, 200-subject clinical trial to improve outcomes from arteriovenous fistula creation surgery. From the left: VenoStent Director of Clinical Affairs Mark Barakat, MD; Project Coordinator Hala Barakat; Surgeon Jason Burgess, MD; and VenoStent Co-Founders, CEO Tim Boire, PhD, and COO Geoffrey Lucks.
“I’m thrilled that the company has progressed to this stage. I applaud them for doing an RCT with Level A clinical evidence in mind, as this will be essential to convince physicians of its utility if and when it attains FDA Approval,” said Dr. Eric Peden, Chief of Vascular Surgery at Houston Methodist Hospital in Houston, Texas and the National Principal Investigator (PI) of the SAVE-FistulaS clinical trial that has collaborated with VenoStent since 2018 on National Institute of Health (NIH)- and National Science Foundation (NSF)-funded studied.
“We are proud to be the first site to enroll a patient in the study, as we, this generation, can make a genuine difference in the lives of hemodialysis patients,” added Dr. Jason Burgess, PI of Surgical Specialists of Charlotte.
Geoffrey Lucks, COO and co-founder of VenoStent, explains how the SelfWrap procedure works: “We use the body’s healing mechanisms to our advantage by mimicking the arterial environment in the veins. When a vein connects to an artery, as in the When creating an AVF, the vein reports a buildup of tension and flow ten times greater, which is traumatic for the veins. Many are not suitable for dialysis. Our generation closes this hole to help “arterialize” the vein, and then it is slowly reabsorbed and replaced by venous tissue. A confusing challenge that we aim to solve with a sublime solution: mimic the arterial environment until you don’t have to anymore.
About VenoStent
VenoStent, Inc. (www. venostent. com) is a privately held curative medical device company that is developing a bioabsorbable wrap, SelfWrap, to reshape the outcomes of vascular surgery, starting with access to hemodialysis. The company recently completed a $16 million Series A financing led by Good Growth Capital and IAG Capital for this clinical trial, as well as operations for FDA approval and commercialization.
Forward-Looking Statements
Some of those statements are forward-looking and the product is under investigation. It is not available for sale in the United States or worldwide.
Media Contact
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SOURCE: VenoStent