TISSIUM® Announces First U.S. Patients Treated with the ECLIPSIUM® System in UNITE Clinical Trial
Paris, France, Cambridge, USA, October 6, 2026 - TISSIUM, a clinical and commercial stage MedTech company pioneering biomorphic programmable polymers for Atraumatic Tissue Reconstruction, today announced that the first patients have been treated with the ECLIPSIUM System in the United States (U.S.) as part of the UNITE clinical trial.
The ECLIPSIUM System is designed to enable non-penetrating fixation of surgical mesh to soft tissue during minimally invasive hernia repair. The system combines TISSIUM’s proprietary bioabsorbable, light-activated polymer with dedicated delivery accessories, and is used with a light activation device. By eliminating the tissue penetrating mechanism of conventional fixation devices such as tacks or sutures, ECLIPSIUM is designed to be fully atraumatic and provide surgeons with control over mesh positioning and on-demand fixation.
UNITE is a prospective, multicenter, randomized controlled trial conducted under an Investigational Device Exemption (IDE) granted by the U.S. Food and Drug Administration. The study aims to enroll approximately 240 patients across multiple clinical sites in the U.S. and is designed to evaluate the safety and effectiveness of the ECLIPSIUM System compared to resorbable tacks for mesh fixation in patients undergoing laparoscopic ventral hernia repair.
UNITE follows the European ALPHA study of ECLIPSIUM in laparoscopic ventral hernia repair, for which preliminary results were recently presented at the European Hernia Society meeting.
Dr. Michael Rosen, Chief of Gastrointestinal Surgery at Northwestern University and Co-Principal Investigator, said: “Fixation-related pain remains a persistent challenge we face in minimally invasive hernia repair. Continued clinical research helps us better understand whether emerging fixation approaches can reduce pain and support a smoother recovery, while maintaining the effectiveness of the repair.”
Dr. William W. Hope, General Surgeon at Novant Health New Hanover Regional Medical Center in Wilmington and Co-Principal Investigator of the UNITE Study, said: “Hernia repair has evolved considerably over the past several decades, but innovation in mesh fixation has remained relatively limited. Surgeons have largely continued to rely on tacks and sutures, each of which involves trade-offs in procedural complexity and tissue trauma. The ECLIPSIUM System represents a fundamentally different, non-penetrating approach that has the potential to simplify mesh fixation, reduce tissue trauma and improve patient outcomes, and we are excited to have begun enrolling patients into the UNITE study.”
Maria Pereira, Deputy Chief Executive Officer and Chief Innovation Officer, TISSIUM, said: “The treatment of the first U.S. patients with ECLIPSIUM System represents a significant milestone for the program and for TISSIUM, and we are honored to work with such an outstanding group of investigators. Following the completion of enrollment in our European ALPHA study, the initiation of UNITE marks an important step in the global clinical development of ECLIPSIUM. Our focus remains on advancing our platform and pipeline, building clinical evidence and delivering solutions to surgeons and patients.”
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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 one commercial product and six 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
Clinical study enquiries
Surgeons interested in referring a patient to UNITE, or in participating as an investigator: unite@tissium.com
ClinicalTrials.gov identifier: NCT07277946
Investor relations
Romain Attard - Chief Financial Officer
rattard@tissium.com
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