STENTYS Reallocates Resources to focus on its Advanced Drug-Eluting Stent Program

PRINCETON, N.J. and PARIS – STENTYS, a medical technology company commercializing in Europe the world's first and only Self-Apposing® stent to treat acute myocardial infarction (AMI), today announces that it has discontinued enrollment of the APPOSITION V trial evaluating its bare metal stent (BMS) and that the Company will instead direct those financial resources towards developing its next-generation Sirolimus-eluting stents (SES) on a new delivery catheter.

The APPOSITION V study was designed to compare the clinical outcome of patients suffering from STEMI treated with the bare metal STENTYS Self-Apposing® Stent versus a conventional balloon-expandable BMS, at 12 months after the procedure. However, recently published articles have accelerated the market trend of treating STEMI patients with a drug-eluting stent (DES) rather than a BMS, and this trend is particularly pronounced in the U.S. As a result, the Company has experienced slower enrollment in the U.S. portion of the APPOSITION V trial. Of the 297 patients enrolled to date, only 20% were enrolled in the U.S. STENTYS recognized that slower than expected enrollment rates could result in both a significant delay of final study results and that the final APPOSITION V population may not capture enough U.S patients to adequately satisfy the FDA for a PMA approval.

This strategic decision was reinforced by the recent clinical results obtained from the APPOSITION IV study, where the STENTYS Sirolimus-eluting stent demonstrated excellent efficacy compared to market leading stents and faster healing compared to balloon-expandable stents. With these final results, the STENTYS SES could receive CE Mark before the end of this year.

With a cash position of €23 million at June 2014, STENTYS intends to focus on the commercialization of its new sirolimus-eluting stent worldwide.

Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, stated: “This decision to terminate enrollment in the study was made in close collaboration with the study’s Steering Committee. We are affirming our plan to invest the Company’s financial resources where we can make the greatest positive impact on a patient’s health in the future and be best positioned to take a leading share of this dynamic market.”

About the STENTYS Self-Apposing® Stent
The STENTYS Self-Apposing® Stent addresses the stent-sizing dilemma that cardiologists are confronted with when treating heart attack patients or patients with atypical artery anatomy. Its flexible, self-expanding design takes the shape of the patient’s unique vessel anatomy and apposes to the irregular contours of a blood vessel, in particular after an AMI as the vessel dilates and the clot dissolves. It reduces the risk of malapposition and complications associated with conventional stents in this setting. The STENTYS Self-Apposing Stent has been marketed in Europe since receiving CE Mark in 2010. The STENTYS Sirolimus-eluting stent should receive the CE Mark during the second half of 2014.

Source: STENTYS