The company said it will use the funds to expand in “European centers” by extending its distributor network and by obtaining regulatory approval in countries outside the CE Mark system. Stentys said its 1st targets will be Russia and India, with plans to expand into Brazil, China, Korea and Japan.
“We are delighted by the follow on from our shareholders to this capital increase, despite volatile financial markets. I would like to thank them for their support. This fund raising is building solid financial foundations for Stentys and allows the company to continue its growth strategy, in France and worldwide,” CEO Gonzague Issenmann said in prepared remarks.
Stentys said it also intends to “strengthen its position” in France with the newly raised cash, as well as funding 2 clinical studies that aim to obtain reimbursement clearance for its Xposition S.
The 1st study, titled Gain, will compare Xposition S to a conventional drug-eluting stent that already has reimbursement clearance in France. The study is slated to enroll 300 patients from 30 centers, the company said. Endpoints are set at artery diameter narrowing at 9 months as measured by angiography, and major adverse cardiac events.
The 2nd study, named Win, will compliment the Gain study to examine the safety and performance of the Xposition S stent in clinical practice. The company hopes to enroll 760 patients across 30 sites with a 12 month follow-up.
A separate study is planned to examine the efficacy of the Xposition S in treating Left Main lesions, slated to enroll 20 patients across 20 centers.
Last month, Stentys touted the results of its Apposition IV trial comparing the company’s Stentys self-apposing sirolimus-eluting coronary stent to Medtronic‘s (NYSE:MDT) Resolute stent in patients with ST-segment elevation myocardial infarction.
Results from the study were published in the journal Euro Intervention.