Paris, France, Cambridge, USA, September 4 2025 – TISSIUM, a MedTech company pioneering biomorphic programmable polymers for tissue reconstruction, today announced further progress in its clinical pipeline of atraumatic solutions following the recent U.S. Food and Drug Administration (FDA) De Novo authorization of its first product, COAPTIUM Connect.
The company has received an Investigational Device Exemption (IDE) from the FDA for ECLIPSIUM, its innovative solution for ventral hernia repair. TISSIUM will initiate a Clinical Trial in the United States in the coming weeks under this approval.
In parallel, TISSIUM has successfully completed the enrollment 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 investigator of the ALPHA study.
“We are building strong momentum on both sides of the Atlantic” said Christophe Bancel, Chief Executive Officer of TISSIUM. “The De Novo authorization of COAPTIUM Connect marked a transformative milestone for TISSIUM, and we are rapidly advancing our broader product pipeline to bring new solutions to patients.”
Clinical progress in the U.S. and Europe supports TISSIUM’s global strategy of developing a platform of products leveraging its proprietary polymer technology to meet diverse therapeutic needs.
