TISSIUM Receives FDA De Novo Authorization for First Atraumatic Sutureless Peripheral Nerve Repair System
核心洞察
TISSIUM's COAPTIUM® CONNECT (搜索) with TISSIUM Light (搜索) has received FDA De Novo marketing authorization, becoming the first and only FDA-authorized system designed for atraumatic sutureless nerve coaptation.
The system addresses limitations of traditional microsurgical sutures by offering a reproducible, atraumatic alternative that preserves nerve integrity and simplifies the coaptation process for peripheral nerve injuries (搜索).
In a clinical study of 12 patients with digital nerve injuries (搜索), COAPTIUM® CONNECT (搜索) achieved 100% procedural success with all patients regaining full digit function and reporting no pain at 12 months.
TISSIUM, a MedTech company pioneering biomorphic programmable polymers for tissue reconstruction, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for COAPTIUM® CONNECT (搜索) with TISSIUM Light (搜索), marking a significant breakthrough in peripheral nerve repair. This first-of-its-kind atraumatic sutureless solution represents the only FDA-authorized system designed for atraumatic sutureless nerve coaptation.
The regulatory milestone establishes TISSIUM's entry into the U.S. market and validates over a decade of scientific and clinical development in next-generation tissue reconstruction solutions. "This FDA marketing authorization validates over a decade of scientific and clinical commitment to developing next-generation solutions in tissue reconstruction," said Christophe Bancel, Co-Founder and CEO of TISSIUM. "COAPTIUM® CONNECT (搜索) is the first demonstration of the transformative potential of our polymer platform and an important step in making atraumatic tissue repair available to patients."
Addressing Critical Unmet Medical Need
Peripheral nerve injuries (搜索) affect hundreds of thousands of patients annually and are typically repaired using microsurgical sutures. However, this traditional approach presents significant limitations including technical complexity, risk of additional trauma, and variable outcomes. COAPTIUM® CONNECT (搜索) addresses these challenges by offering a reproducible, atraumatic sutureless alternative that preserves nerve integrity and simplifies the coaptation process.
The system leverages TISSIUM's unique biopolymer platform, invented by Maria Pereira, Jeffrey Karp and Robert Langer at MIT and Brigham & Women's Hospital (搜索), utilizing a bioresorbable light-activated surgical polymer and 3D-printed polymer chamber.
Clinical Evidence Demonstrates Strong Efficacy
In a recent clinical study involving 12 patients with digital nerve injuries (搜索), COAPTIUM® CONNECT (搜索) achieved 100% procedural success, defined as successful atraumatic sutureless coaptation using the polymer-assisted coaptation device. All patients regained full flexion and extension of the injured digit and reported no pain 12 months after the procedure, according to results submitted to the Journal of Hand Surgery.
Platform Technology with Broader Applications
Maria Pereira, Co-Founder and Chief Innovation Officer, emphasized the broader potential of the technology: "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."
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.
Commercial Launch and Market Entry
TISSIUM plans to initiate commercial rollout of COAPTIUM® CONNECT (搜索) in the coming months, marking the company's entry into the U.S. medical device market. The clinical and commercial stage MedTech company, founded in 2013, operates from locations in Paris, France, Cambridge, USA, and maintains a manufacturing site in Roncq, France.
The company's proprietary platform of fully biosynthetic, biomorphic, programmable, elastomeric polymers is designed to address critical unmet needs in atraumatic tissue repair and tissue reconstruction, built on breakthrough research and intellectual property from the laboratories of Professor Robert Langer at MIT and Professor Jeffrey M. Karp at Brigham and Women's Hospital.