Latest news with #COAPTIUM®CONNECTSystem
Business Upturn
24-06-2025
- Business
- Business Upturn
TISSIUM Receives FDA De Novo Authorization for COAPTIUM® CONNECT in Atraumatic Sutureless Peripheral Nerve Repair
This regulatory milestone marks TISSIUM's entry into the U.S. market and establishes the foundation of the TISSIUM polymer platform for atraumatic tissue repair Paris, France, Cambridge, USA, June 24, 2025 – TISSIUM, a MedTech company pioneering biomorphic programmable polymers for tissue reconstruction, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for COAPTIUM® CONNECT with TISSIUM Light, a first-of-its-kind atraumatic sutureless solution for peripheral nerve repair. This authorization represents a pivotal regulatory milestone for TISSIUM, further validating its biopolymer platform and enabling U.S. commercialization of its first product. COAPTIUM® CONNECT is now the only FDA-authorized system designed for atraumatic sutureless nerve coaptation. Christophe Bancel, Co-Founder and CEO of TISSIUM said: 'This FDA marketing authorization validates over a decade of scientific and clinical commitment to developing next-generation solutions in tissue reconstruction. COAPTIUM® CONNECT is the first demonstration of the transformative potential of our polymer platform and an important step in making atraumatic tissue repair available to patients.' Peripheral nerve injuries affect hundreds of thousands of patients annually and are typically repaired using microsurgical sutures. However, this approach presents limitations—including technical complexity, risk of additional trauma, and variable outcomes. COAPTIUM® CONNECT addresses these challenges by offering a reproducible, atraumatic sutureless alternative that preserves nerve integrity and simplifies the coaptation process1. In a recent clinical study on 12 patients with digital nerve injuries, COAPTIUM® CONNECT achieved 100% procedural success, defined as successful atraumatic sutureless coaptation using the polymer-assisted coaptation device, with all patients regaining full flexion and extension of the injured digit and reporting no pain 12 months after the procedure1. TISSIUM plans to initiate commercial rollout of COAPTIUM® CONNECT in the coming months. The COAPTIUM® CONNECT System leverages TISSIUM's unique biopolymer platform, invented by Maria Pereira, Jeffrey Karp and Robert Langer at the MIT and Brigham & Women's Hospital, using its bioresorbable light-activated surgical polymer and its 3D-printed polymer chamber. Maria Pereira, Co-Founder and Chief Innovation Officer, said: 'This first product illustrates the technical versatility and the potential of the TISSIUM polymer platform, not only in peripheral nerve repair where other solutions are currently under development, but also in other surgical applications, such as atraumatic hernia repair and cardiovascular sealing.' *** 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 seven products across three core verticals: 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 and follow us on LinkedIn: TISSIUM. *** Contacts Investor relationsRomain Attard – Chief Financial Officer [email protected]
Yahoo
23-06-2025
- Business
- Yahoo
TISSIUM Receives FDA De Novo Authorization for COAPTIUM® CONNECT in Atraumatic Sutureless Peripheral Nerve Repair
This regulatory milestone marks TISSIUM's entry into the U.S. market and establishes the foundation of the TISSIUM polymer platform for atraumatic tissue repairParis, France, Cambridge, USA, June 24, 2025 - TISSIUM, a MedTech company pioneering biomorphic programmable polymers for tissue reconstruction, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for COAPTIUM® CONNECT with TISSIUM Light, a first-of-its-kind atraumatic sutureless solution for peripheral nerve repair. This authorization represents a pivotal regulatory milestone for TISSIUM, further validating its biopolymer platform and enabling U.S. commercialization of its first product. COAPTIUM® CONNECT is now the only FDA-authorized system designed for atraumatic sutureless nerve coaptation. Christophe Bancel, Co-Founder and CEO of TISSIUM said: 'This FDA marketing authorization validates over a decade of scientific and clinical commitment to developing next-generation solutions in tissue reconstruction. COAPTIUM® CONNECT is the first demonstration of the transformative potential of our polymer platform and an important step in making atraumatic tissue repair available to patients.' Peripheral nerve injuries affect hundreds of thousands of patients annually and are typically repaired using microsurgical sutures. However, this approach presents limitations—including technical complexity, risk of additional trauma, and variable outcomes. COAPTIUM® CONNECT addresses these challenges by offering a reproducible, atraumatic sutureless alternative that preserves nerve integrity and simplifies the coaptation process1. In a recent clinical study on 12 patients with digital nerve injuries, COAPTIUM® CONNECT achieved 100% procedural success, defined as successful atraumatic sutureless coaptation using the polymer-assisted coaptation device, with all patients regaining full flexion and extension of the injured digit and reporting no pain 12 months after the procedure1. TISSIUM plans to initiate commercial rollout of COAPTIUM® CONNECT in the coming months. The COAPTIUM® CONNECT System leverages TISSIUM's unique biopolymer platform, invented by Maria Pereira, Jeffrey Karp and Robert Langer at the MIT and Brigham & Women's Hospital, using its bioresorbable light-activated surgical polymer and its 3D-printed polymer chamber. Maria Pereira, Co-Founder and Chief Innovation Officer, said: 'This first product illustrates the technical versatility and the potential of the TISSIUM polymer platform, not only in peripheral nerve repair where other solutions are currently under development, but also in other surgical applications, such as atraumatic hernia repair and cardiovascular sealing.' *** 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 seven products across three core verticals: 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 and follow us on LinkedIn: TISSIUM. *** Contacts Investor relationsRomain Attard – Chief Financial Officer rattard@ Press tissium@ A Sutureless Approach to Nerve Repair: Results from a Clinical Study in Digital Nerves, Randi Bindra, Journal of Hand Surgery, submitted 2025Attachment 20250624 - TISSIUM_FDA DeNovo announcementError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
23-06-2025
- Business
- Yahoo
TISSIUM Receives FDA De Novo Authorization for COAPTIUM® CONNECT in Atraumatic Sutureless Peripheral Nerve Repair
This regulatory milestone marks TISSIUM's entry into the U.S. market and establishes the foundation of the TISSIUM polymer platform for atraumatic tissue repairParis, France, Cambridge, USA, June 24, 2025 - TISSIUM, a MedTech company pioneering biomorphic programmable polymers for tissue reconstruction, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for COAPTIUM® CONNECT with TISSIUM Light, a first-of-its-kind atraumatic sutureless solution for peripheral nerve repair. This authorization represents a pivotal regulatory milestone for TISSIUM, further validating its biopolymer platform and enabling U.S. commercialization of its first product. COAPTIUM® CONNECT is now the only FDA-authorized system designed for atraumatic sutureless nerve coaptation. Christophe Bancel, Co-Founder and CEO of TISSIUM said: 'This FDA marketing authorization validates over a decade of scientific and clinical commitment to developing next-generation solutions in tissue reconstruction. COAPTIUM® CONNECT is the first demonstration of the transformative potential of our polymer platform and an important step in making atraumatic tissue repair available to patients.' Peripheral nerve injuries affect hundreds of thousands of patients annually and are typically repaired using microsurgical sutures. However, this approach presents limitations—including technical complexity, risk of additional trauma, and variable outcomes. COAPTIUM® CONNECT addresses these challenges by offering a reproducible, atraumatic sutureless alternative that preserves nerve integrity and simplifies the coaptation process1. In a recent clinical study on 12 patients with digital nerve injuries, COAPTIUM® CONNECT achieved 100% procedural success, defined as successful atraumatic sutureless coaptation using the polymer-assisted coaptation device, with all patients regaining full flexion and extension of the injured digit and reporting no pain 12 months after the procedure1. TISSIUM plans to initiate commercial rollout of COAPTIUM® CONNECT in the coming months. The COAPTIUM® CONNECT System leverages TISSIUM's unique biopolymer platform, invented by Maria Pereira, Jeffrey Karp and Robert Langer at the MIT and Brigham & Women's Hospital, using its bioresorbable light-activated surgical polymer and its 3D-printed polymer chamber. Maria Pereira, Co-Founder and Chief Innovation Officer, said: 'This first product illustrates the technical versatility and the potential of the TISSIUM polymer platform, not only in peripheral nerve repair where other solutions are currently under development, but also in other surgical applications, such as atraumatic hernia repair and cardiovascular sealing.' *** 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 seven products across three core verticals: 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 and follow us on LinkedIn: TISSIUM. *** Contacts Investor relationsRomain Attard – Chief Financial Officer rattard@ Press tissium@ A Sutureless Approach to Nerve Repair: Results from a Clinical Study in Digital Nerves, Randi Bindra, Journal of Hand Surgery, submitted 2025Attachment 20250624 - TISSIUM_FDA DeNovo announcementError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
02-04-2025
- Health
- Yahoo
TISSIUM Announces Clinical Results of COAPTIUM® CONNECT System for Atraumatic Sutureless Nerve Repair
Paris, France, Cambridge, USA, April 2nd, 2025 - TISSIUM, a privately-owned medtech company developing biomorphic programmable polymers for tissue reconstruction, is proud to unveil clinical data which were presented at the IFSSH Congress in Washington, D.C. on March 27, 2025, demonstrating the potential of its COAPTIUM® CONNECT System, an innovative atraumatic sutureless solution for peripheral nerve repair. Peripheral nerve injuries pose a significant burden, often resulting in impaired nerve function, reduced dexterity, and decreased quality of life. Traditional microsurgical repair with sutures, while effective, presents challenges such as inconsistent functional recovery and the potential for additional nerve trauma. The need for disruptive technologies in nerve repair is clear—TISSIUM's COAPTIUM® CONNECT System offers an innovative atraumatic sutureless method for coaptation of severed nerves. Study Overview & Key Findings A prospective, single-arm study was conducted in patients with digital nerve injuries to assess the COAPTIUM® CONNECT System. The trial enrolled 12 patients, of whom 10 completed the entire 1-year follow-up duration. 100% procedural success was achieved, defined as successful atraumatic sutureless coaptation using the polymer-assisted coaptation device ; All patients regained full flexion and extension of the injured digit ; All patients reported no pain (VAS pain score) at 12 months ; No study device-related complications were reported for the complete 12-month follow-up ; No neuromas occurred. TISSIUM would like to thank our study investigators Professor Randy Bindra, MD at the Gold Coast University Hospital and Dr. Michael Wagels at the Princess Alexandra Hospital and their study teams for their commitment to atraumatic treatment of digital nerve injuries. The COAPTIUM® CONNECT System has been designed for atraumatic sutureless consistent nerve repair. It leverages TISSIUM's unique biopolymer platform and is comprised of a bioresorbable light-activated surgical polymer and a protective coaptation chamber. When asked about his experience in this study, Dr. Randy Bindra, Professor of Orthopedic Surgery and principal trial investigator at the Gold Coast University Hospital and Griffith University School of Medicine said 'In my 30 years of experience of repairing nerves, this is one product where the clinical trial results have surpassed my expectation. All patients were pain free and had excellent outcomes.' 'I am optimistic this new technology can bring us a step closer to better nerve repair outcomes in the future. Removing the need for sutures will allow improved regeneration of the nerve, benefiting the patient long term,' said Dr. Michael Wagels, Director of the Australian Centre for Complex Integrated Surgical Solutions, Department of Plastic and Reconstructive Surgery, Princess Alexandra Hospital. The COAPTIUM® CONNECT System represents a meaningful advancement in nerve surgery, offering an innovative atraumatic sutureless method for coaptation of severed nerves. By eliminating the need for microsutures, this technology streamlines nerve repair while preserving nerve integrity and function. TISSIUM remains committed to advancing innovation in tissue reconstruction and is actively exploring the expansion of the COAPTIUM® platform for broader applications in nerve repair. The COAPTIUM® CONNECT System is not approved or cleared by the U.S. FDA or other regulatory authorities. *** About TISSIUM TISSIUM, a privately-owned MedTech company based in Paris, France and Cambridge, USA, is dedicated to the development and commercialization of products derived from its unique proprietary family of fully biosynthetic, biomorphic, and programmable polymers platform. The company's products will address multiple unmet clinical needs, including atraumatic tissue repair and tissue reconstruction. Currently, the Company has a pipeline of seven products across three verticals, including atraumatic sutureless nerve repair, atraumatic hernia repair and cardiovascular sealants. Each product is designed to enhance the tissue reconstruction process in a unique way. In addition, the company develops complementary delivery and activation devices for enhanced performance and usability of its products. TISSIUM's technology is based on world-class research and intellectual property from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Women's Hospital), who co-founded the company in 2013. For more information, please visit: and follow us on LinkedIn: TISSIUM. *** Contact Romain Attard – Chief Financial Officer rattard@ in to access your portfolio
