Second regulatory approval further validates TISSIUM's polymer platform across distinct surgical applications and geographies
Paris, France, Cambridge, USA, October 21, 2026 - TISSIUM, a clinical and commercial stage MedTech company pioneering biomorphic programmable polymers for Atraumatic Tissue Reconstruction, today announced that it has received CE marking for ECLIPSIUM, its solution for atraumatic mesh fixation in ventral hernia repair.
ECLIPSIUM is CE-marked for the non-penetrating fixation of composite meshes to soft tissue for the repair of ventral hernias performed via a minimally invasive intraperitoneal approach, which paves the way for its commercialization in Europe.
Following the U.S. FDA De Novo marketing authorization of COAPTIUM CONNECT for peripheral nerve repair in 2025, ECLIPSIUM is the second product based on TISSIUM's proprietary polymer technology to receive regulatory approval. COAPTIUM CONNECT established the regulatory foundation for TISSIUM's first polymer-based product. The CE marking of ECLIPSIUM provides further demonstration of the platform's versatility.
The two products address very distinct surgical applications, from microsurgical nerve repair to abdominal wall surgery, and have received authorization in the United States and EU, respectively.
Christophe Bancel, Co-Founder and CEO of TISSIUM, said: "With COAPTIUM CONNECT, we proved our technology in microsurgery, for Atraumatic repair of nerves at the scale of few millimeters in open surgery, with our first authorization in the United States. With ECLIPSIUM, we are now addressing atraumatic fixation of large implants of 15 to 20 centimeters in minimally invasive general surgery, with approval in Europe.
Two products, at opposite ends of the surgical spectrum, built from the same polymer technology: that is the power of a true innovation platform."
ECLIPSIUM is designed to enable non-penetrating fixation of a surgical mesh to soft tissue during minimally invasive hernia repair. It combines TISSIUM's proprietary bioabsorbable, light-activated polymer with its dedicated accessories. By avoiding tissue penetration associated with conventional fixation devices such as tacks or sutures, ECLIPSIUM is designed to be atraumatic, while giving surgeons control over mesh positioning and on-demand fixation.
The CE marking of ECLIPSIUM follows the completion of enrollment in TISSIUM's European ALPHA clinical study, which evaluated the safety and performance of ECLIPSIUM in patients undergoing laparoscopic ventral hernia repair. The study was conducted across multiple clinical centers in Belgium and Spain and formed part of the clinical evidence supporting the regulatory submission.
Dr. Tim Tollens, General Surgeon at Imelda Hospital, in Bonheiden, Belgium, said: "When we treated the first patient in the ALPHA study, our goal was to find an alternative to the invasive tacks and sutures that are a frequent source of pain after minimally invasive laparoscopic ventral hernia repair. Throughout the study, I have appreciated the control ECLIPSIUM gives over mesh positioning, the simplicity of its on-demand fixation, and the potential this technology has to improve patient outcomes and quality of life. For the first time, we were treating our patients via daycare instead of being hospitalized for 1 or 2 days. The CE marking is an important step toward making this atraumatic approach available to surgeons and patients across Europe."
Dr. Salvador Morales-Conde, Head of the Department of Surgery at Virgen Macarena University Hospital, said: "As laparoscopic and robotic abdominal wall surgery continues to grow, surgeons need fixation solutions that are both secure and respectful of the tissue. Our experience in the ALPHA study suggests that ECLIPSIUM integrates well into the standard laparoscopic workflow and offers a non-penetrating alternative to tacks. I look forward to its availability in Europe and to its potential to improve the patient experience after hernia repair."
TISSIUM is now preparing for the European commercial introduction of ECLIPSIUM, with an initial release expected in 2027.
In parallel, TISSIUM is advancing the clinical development of ECLIPSIUM in the United States. As announced recently, the first U.S. patients have been treated with the ECLIPSIUM System in the UNITE study, a prospective, multicenter, randomized controlled trial conducted under an Investigational Device Exemption granted by the U.S. Food and Drug Administration.
Maria Pereira, Co-Founder, Deputy Chief Executive Officer and Chief Innovation Officer of TISSIUM, said: "When we started TISSIUM, we asked a simple question: what if surgeons could repair tissue without first having to damage it, the way it is currently done with penetrating fixation? For decades, sutures, staples and tacks have been the default, often at the cost of additional trauma. Seeing a technology we first imagined at the bench now authorized for patients on two continents is deeply rewarding. And it is only the beginning: as we bring ECLIPSIUM to European surgeons and advance the rest of our pipeline, directly and through potential strategic partnerships, our ambition is to make atraumatic tissue reconstruction the new standard across surgery."
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About TISSIUM
TISSIUM is a clinical and commercial stage MedTech company based in Paris, France, Cambridge, USA, 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 two commercial products and four products in development across three core therapeutic verticals: atraumatic sutureless nerve repair, atraumatic hernia repair, and cardiovascular sealants. Each solution is designed 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).
For more information, please visit www.TISSIUM.com and follow us on LinkedIn: TISSIUM.
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Contacts
Investor relations
Romain Attard - Chief Financial Officer
rattard@tissium.com
PR
tissium@yourstorypr.com
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