Veniti raises $17M to complete pivotal venous stent trial aimed at FDA approval

Vici Venous Stent--Courtesy of Veniti

Veniti started its 200-person trial of the Vici Venous Stent System on Dec. 1. Now it's got more than $17 million to complete that trial that is targeting a U.S. approval to treat venous disease.

The financing is an undisclosed mixture of equity and debt, with the Series C equity portion led by previous investors Baird Capital as well as Tekla Healthcare and Tekla Life Science Investors and the debt portion funded by New York-based Life Sciences Alternative Funding (LSAF).

The stent is for use in the lower extremity and pelvic veins, including the iliac and common femoral veins, in patients with symptoms of venous outflow obstruction such as varicose veins and venous ulcers. The pivotal VIRTUS trial is a prospective, multicenter, single-arm, nonrandomized study that is slated to include 200 patients with up to 30 investigational sites worldwide.

"Veniti's Vici Venous Stent addresses a large market need with the first technology designed specifically for the vascular system," Steve DeNelsky, President of LSAF, said in a statement. "This design delivers critical advantages, such as crush resistance and flexibility, which we believe physicians will value and lead to better patient outcomes."

The Vici system has two components: the stent implant and the disposable delivery system. The stent is laser-cut, self-expanding and made of a nickel titanium alloy (nitinol). The delivery system is a coaxial, over-the-wire design with an exterior shaft. It can be delivered via either a jugular or femoral vein.

The financing is also expected to support the ongoing commercialization of the Vici system; it has already received a CE mark. Veniti was founded in 2010.

"This additional funding will allow us to ensure completion of the VIRTUS clinical trial, demonstrating how patients can benefit from venous stenting, as well as provide us necessary working capital for commercial expansion," said Veniti CFO Catherine Matthes in a statement.

Other Veniti investors include Volcano Capital, Nitinol Devices & Components, Prolog, Vectis Healthcare & Life Sciences Fund, CD-Venture, Holton Capital Group and the St. Louis Arch Angels Network.

- here is the release