The U.S. FDA approved Phraxis Inc.’s Endoforce Connector for endovascular venous anastomosis, which eliminates the need for surgical dissection for individuals undergoing hemodialysis for kidney failure. The device is designed to reduce tissue trauma and improve long-term graft performance.
Xeltis BV completed enrollment in the EU pivotal trial for its restorative vascular access conduit, Axess. The prospective study will investigate the patency, safety and performance of Axess in adult patients with end-stage renal disease requiring vascular access to start or maintain hemodialysis therapy.
The first acellular tissue engineered vessel for adults with vascular trauma in a bodily extremity has been approved by the U.S. FDA. Symvess, which comes from regenerative tissue developer Humacyte Inc., can be used to repair an arterial injury that could be life threatening and require immediate attention.
One-year data from Xeltis AG’s first-in-human Axess vascular conduit trial showed outstanding results in patients with end stage renal disease who were deemed unsuitable for arteriovenous (AV) fistula creation. The results, presented at the VEITHsymposium in New York, showed 100% secondary patency, 78% primary assisted patency and no infections were observed in data from 20 patients implanted with the Axess conduit.
Regenerative tissue developer Humacyte Inc. has posted positive top-line phase II/III results for its Human Acellular Vessel, a tissue-engineered graft consisting entirely of decellularized extracellular matrix, for vascular trauma repair. The data showed higher rates of patency, a measure of the lack of vascular obstruction, when compared to synthetic graft benchmarks.
Xeltis AG reported the first-in-human results for its fully synthetic electrospun vascular access graft, showing 100% patency at six months in 20 patients with end stage renal disease who were not suitable for arteriovenous (AV) fistula creation.
Humacyte Inc. provided its Human Acellular Vessel (HAV) implants to Ukrainian hospitals on the front-line of the Russian invasion as part of the company’s humanitarian relief initiative. Two patients have received the implants for treatment of vascular trauma injuries. One patient had sustained a severe gunshot wound to the leg and the other was injured by shrapnel.
Humacyte Inc., which develops universally implantable, bioengineered human tissue at commercial scale, has agreed to go public via a merger with Alpha Healthcare Acquisition Corp. (AHAC), a blank-check company led by Rajiv Shukla. Upon closing of the deal, AHAC will be renamed Humacyte Inc. and will be led by Humacyte’s current CEO, Laura Niklason. The combined company’s stock is expected to list on the Nasdaq Capital Market under the ticker symbol HUMA.