Latest news with #ChristopheBancel
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
05-06-2025
- Business
- Yahoo
TISSIUM selected for the French Tech 120 Program
Paris, France, June 5, 2025 -- TISSIUM, a medtech company developing biomorphic programmable polymers for tissue reconstruction, confirms its selection for the sixth year in a row in the French Tech 120 Program by joining the 2025 class. Launched in 2019 by the Mission French Tech, the French Tech 120 is a program from the Government to support the 120 most promising French start-ups, who have the potential to become world-class technology leaders. TISSIUM will benefit from daily, personalized support throughout the 2025 class. The aim of the program is to provide individual and collective support on strategic issues such as international development, financing, recruitment, industrial implantation, intellectual property, and regulatory issues. Start-ups will thus be able to rely on a dedicated start-up manager within the Mission French Tech, enhanced visibility, specific support on regulatory issues, and collective support in the form of experience-sharing events and expertise contributions. 'We are delighted to once again be part of the French Tech 120 program, particularly in 2025 where we continue the expansion of our activities in each of our therapeutic indications and the achievement of important clinical and regulatory milestones in preparation for the upcoming commercialization of our first products. For the sixth consecutive year, this recognition is a validation of our ongoing commitment to innovate and grow in order to transform the field of tissue reconstruction.' said Christophe Bancel, CEO of TISSIUM. About Mission French Tech Mission French Tech is the government mission tasked, since 2013, with supporting the structuring and growth of the French start-up ecosystem, in France and internationally. Attached to the Direction Générale des Entreprises, within the Ministère de l'Économie, des Finances et de la Souveraineté Industrielle et Numérique, it federates and animates the French Tech ecosystem with a network of 17 Capitales and nearly a hundred labeled French Tech Communities, in France and in 52 countries around the world. It also supports start-ups by facilitating their interactions with the administration via a network of over 60 French Tech correspondents. Mission French Tech supports the most mature start-ups through the French Tech Next40/120 program and start-ups positioned in sectors identified as strategic within the framework of France 2030 with the French Tech 2030 program. Find all the information on the French Tech Next40/120 on the Mission French Tech website: Mission French Tech press contact: About TISSIUM TISSIUM is a MedTech company headquartered in Paris, France, with operations in Cambridge, USA, and a manufacturing site in the North of France (Ronq). The company is pioneering a proprietary platform of fully biosynthetic, biomorphic, and programmable 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 engineered to optimize tissue reconstruction through controlled and consistent application 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. *** Contact Romain Attard – Chief Financial Officer rattard@ 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
05-06-2025
- Business
- Yahoo
TISSIUM selected for the French Tech 120 Program
Paris, France, June 5, 2025 -- TISSIUM, a medtech company developing biomorphic programmable polymers for tissue reconstruction, confirms its selection for the sixth year in a row in the French Tech 120 Program by joining the 2025 class. Launched in 2019 by the Mission French Tech, the French Tech 120 is a program from the Government to support the 120 most promising French start-ups, who have the potential to become world-class technology leaders. TISSIUM will benefit from daily, personalized support throughout the 2025 class. The aim of the program is to provide individual and collective support on strategic issues such as international development, financing, recruitment, industrial implantation, intellectual property, and regulatory issues. Start-ups will thus be able to rely on a dedicated start-up manager within the Mission French Tech, enhanced visibility, specific support on regulatory issues, and collective support in the form of experience-sharing events and expertise contributions. 'We are delighted to once again be part of the French Tech 120 program, particularly in 2025 where we continue the expansion of our activities in each of our therapeutic indications and the achievement of important clinical and regulatory milestones in preparation for the upcoming commercialization of our first products. For the sixth consecutive year, this recognition is a validation of our ongoing commitment to innovate and grow in order to transform the field of tissue reconstruction.' said Christophe Bancel, CEO of TISSIUM. About Mission French Tech Mission French Tech is the government mission tasked, since 2013, with supporting the structuring and growth of the French start-up ecosystem, in France and internationally. Attached to the Direction Générale des Entreprises, within the Ministère de l'Économie, des Finances et de la Souveraineté Industrielle et Numérique, it federates and animates the French Tech ecosystem with a network of 17 Capitales and nearly a hundred labeled French Tech Communities, in France and in 52 countries around the world. It also supports start-ups by facilitating their interactions with the administration via a network of over 60 French Tech correspondents. Mission French Tech supports the most mature start-ups through the French Tech Next40/120 program and start-ups positioned in sectors identified as strategic within the framework of France 2030 with the French Tech 2030 program. Find all the information on the French Tech Next40/120 on the Mission French Tech website: Mission French Tech press contact: About TISSIUM TISSIUM is a MedTech company headquartered in Paris, France, with operations in Cambridge, USA, and a manufacturing site in the North of France (Ronq). The company is pioneering a proprietary platform of fully biosynthetic, biomorphic, and programmable 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 engineered to optimize tissue reconstruction through controlled and consistent application 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. *** Contact Romain Attard – Chief Financial Officer rattard@
