The typical approach to achieving consistent and high-quality vascular access for chronic kidney disease patients in need of dialysis is to surgically construct an arteriovenous (AV) fistula, creating a direct connection between an artery and a vein in the arm. Startup TVA Medical has a minimally invasive, catheter-based that can achieve the same goal–only without surgery.
It’s attracted some serious backers to participate in a $15 million Series C financing, including new investors Baxter Ventures, which led the round, as well as Boston Scientific ($BSX). Existing investors Sante Ventures, S3 Ventures, TriStar Technology Ventures also participated alongside additional, undisclosed strategic investors.
“We are committed to providing kidney failure patients and caregivers with a minimally invasive endovascular arteriovenous (AV) fistula option,” said TVA President and CEO Adam Berman in a statement. “This financing strengthens our ability to bring the innovative everlinQ endoAVF System to the global market.”
The Austin, TX-based company will use the financing to back its ongoing Novel Endovascular Access Trial (NEAT) clinical study for its everlinQ endoAVF System that’s in Australia, Canada and New Zealand, as well as to back further research aimed at securing reimbursement and market access. The NEAT trial includes a 12-month follow-up period that’s slated to complete next year.
In the FLEX-1 feasibility study in 33 ex-U.S. patients, 96% were able to use the AV fistula for dialysis. The same portion also retained patency at 6 months. An estimated 400,000 U.S. patients are on hemodialysis, with that figure expected to hit 530,000 by 2020, according to the company.
The procedure involves the insertion of two thin, flexible magnetic catheters into an artery and vein in the arm. A small burst of radiofrequency energy is used to connect them, thereby creating the AV fistula. TVA’s system has already received a CE mark, but the company hasn’t laid out a timeline for an FDA submission.