TISSIUM Advances Hernia Repair Lineup After First FDA Authorization

TISSIUM is augmenting its pipeline of atraumatic solutions with the recent U.S. Food and Drug Administration (FDA) De Novo authorization of its first product, COAPTIUM CONNECT.

“We are building strong momentum on both sides of the Atlantic” TISSIUM CEO Christophe Bancel said. “The De Novo authorization of COAPTIUM CONNECT marks a transformative milestone for TISSIUM, and we are rapidly advancing our broader product pipeline to bring new solutions to patients.” 

The company has received FDA Investigational Device Exemption (IDE) approval for ECLIPSIUM, its solution for ventral hernia repair. The approval enables TISSIUM to initiate a U.S. clinical trial in the next few weeks. 

In parallel, TISSIUM has finished enrolling patients in its European clinical study (ALPHA) for ECLIPSIUM and has engaged with its notified body, TÜV SÜD, as part of the CE Mark submission.

“The ALPHA study provides encouraging evidence that atraumatic fixation not only improves patient outcomes but also enhances surgical workflow and safety. These benefits hold promise not only in ventral hernia repair, but also in expanding the scope of atraumatic fixation” said Pr. Morales-Conde, head of the Department of General and Digestive Surgery of the University Hospital Virgen Macarena (Sevilla) and ALPHA study investigator.

Clinical progress in the United States and Europe supports TISSIUM’s global strategy of developing a product platform that leverages its proprietary polymer technology to meet diverse therapeutic needs.

TISSIUM is a clinical and commercial stage medtech company based in Paris; and Cambridge, Mass.; and with a manufacturing site in Roncq, France. The company is pioneering a proprietary platform of fully biosynthetic, biomorphic, programmable, elastomeric polymers designed to address critical unmet needs in atraumatic tissue repair and tissue reconstruction. TISSIUM’s diversified pipeline includes one commercial product and six products in development across three core verticals: sutureless nerve repair, atraumatic hernia repair, and cardiovascular sealants. Each solution aims to optimize tissue repair through controlled and consistent procedures with specialized delivery and activation devices to maximize the performance and usability of its products.

Founded in 2013, TISSIUM is built on breakthrough research and intellectual property originating from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Women’s Hospital).