Successful enrollment in initial feasibility trial to support future regulatory submissions and provide better outcomes for patients with end-stage renal disease
HOUSTON, October 26, 2021--(BUSINESS WIRE)--VenoStent, Inc., a clinical-stage tissue engineering company developing tunable, bioabsorbable, smart polymer wraps to fundamentally transform the efficacy of the five million vascular surgeries performed each year, announces successful enrollment in its initial feasibility clinical trial. The clinical trial is testing the safety and efficacy of its 3D-printed bioabsorbable wraps in humans, a new methodology to improve surgical outcomes for hemodialysis patients.
"We are very pleased to announce that we have successfully enrolled twenty end-stage renal disease patients in our initial feasibility study taking place in Asuncion, Paraguay," says Tim Boire, CEO. "After years of development, we are confident that our bioabsorbable wrap technology can have a positive impact on the lives of patients that require hemodialysis to sustain life. This is a major milestone toward our mission to improve the quality and length of life for end-stage renal disease patients, as well as others needing vascular surgery."
Enrollment was completed for the initial VenoStent Feasibility Study in Paraguay involving 20 end-stage renal disease patients that were referred for creation of an arteriovenous fistula—surgical connection of an artery to a vein in the arm—to enable hemodialysis treatments. The participants in the study are followed up for several months and the team has already seen highly encouraging safety and performance signals, which could indicate much greater clinical outcomes and quality of life for kidney disease patients when treated with the VenoStent SelfWrap® Bioabsorbable Perivascular Wrap technology.
Approximately 60% of the blood vessels used for dialysis, and 20% of the blood vessels used for quadruple bypass, fail within 12 months of the vascular surgery, risking the lives of 5 million patients every year. The reason for this 60% failure rate is that the vein is not accustomed to, nor equipped for, the high pressure, high flow arterial environment. The thin-walled vein expands, causing tearing of the protective inner lining of the vein. In response to this expansion and tearing, the cells inside the vein wall begin a repair process and migrate inward. This remodeling and cell growth response (also called neointimal hyperplasia) ultimately leads to reduction in, or complete blockage of, blood flow. VenoStent’s proprietary bioabsorbable scaffold goes around these blood vessels at the time of vascular surgery to aid in their "arterialization" process. To make its implantable smart polymer wraps, VenoStent utilizes advanced stereolithography fabrication with 3D printers supplied by Volumetric, a fellow Houston alum of the California-based accelerator Y Combinator.
VenoStent®, Inc. is a tissue engineering medical device company based out of Houston, Texas. The company has developed novel bioabsorbable smart polymers and utilizes advanced stereolithography techniques to make its implantable wraps. The initial focus for VenoStent is on improving the quality and length of life of dialysis patients with a bioengineered scaffold that goes around blood vessels to prevent failures. This approach can be readily adopted for peripheral and coronary artery bypass grafting patients as well, giving this technology the potential to treat over five million patients worldwide. More information coming soon to venostent.com.
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Media Contacts on behalf of VenoStent
Jennifer L. Horspool