Nerve injuries affect hundreds of thousands of patients each year. Typically, they’re repaired using microsurgical stitches. However, the process is technically complex, with a risk of additional trauma to surrounding tissues and long periods of recovery and variable chances for full recovery.
TISSIUM is a medtech company headquartered in Paris and Cambridge, pioneering biomorphic programmable polymers for tissue reconstruction. This week, the US FDA granted De Novo marketing authorisation for its COAPTIUM® CONNECT with TISSIUM Light, a first-of-its-kind atraumatic sutureless solution for peripheral nerve repair.
I spoke to Christophe Bancel, co-founder and CEO of TISSIUM to learn more.
TISSIUM was founded by Christophe Bancel and Maria Pereira in 2013, after Pereira invented the polymer that is at the foundation of the company’s products while studying for a PhD in the labs of Bob Langer and Jeff Karp at MIT.
A sutureless alternative to microsurgery
According to Bancel, when a nerve is severed, it needs to be reconnected. Traditional methods use sutures, but these actually damage the tissue they're supposed to repair.
“Our approach is fundamentally different. We repair nerves from the outside without any penetration inside the tissue, allowing the nerve to grow naturally.”
TISSIUM’s medtech is built around its bioresorbable light-activated surgical polymer and its 3D-printed polymer chamber that holds the nerve ends in place throughout the healing process.
A biocompatible mix of natural compounds (e.g. glycerol and sebacic acid) is delivered directly onto the severed nerve ends via the tiny polymer chamber.
Surgeons use a visible blue light to rapidly activate the polymer (within seconds), transforming it into a soft elastomer that anchors the nerve ends, fully conforming to tissue and staying fixed.
Over time, the polymer degrades naturally, while the nerve fibres regenerate within the chamber, eliminating the need for later removal.
Bancel detailed that in a recent clinical study on 12 patients with digital nerve injuries, COAPTIUM CONNECT demonstrated significantly better functional outcomes.
“In our studies, 100 per cent of patients who had this type of trauma recovered functionality. More importantly, we observed recovery at six months, compared to the typical 12-month timeline with traditional methods.
We're continuing to investigate and provide additional data to surgeons to assess the value of this technology fully.”
TISSIUM’s polymer tech heads for global product expansion and scale
COAPTIUM CONNECT is now the only FDA-authorised system designed for atraumatic sutureless nerve coaptation.
In the US, the device is regulated as a Class II device, which allowed TISSIUM to start the regulatory process there first.
However, according to Bancel, moving from academia to clinical reality required several critical steps:
First, the team had to prove we could manufacture this polymer as a stable compound — the chemistry had never been used in this application before.
“Then we conducted extensive animal testing, followed by our first clinical trial.
Once we saw clinical success, we faced a major challenge: building manufacturing capabilities from scratch. There was no existing supply chain for this material, so we had to design and build our own equipment to produce the polymer at scale.”
Bancel explained that “now we have FDA approval, we'll generate additional clinical data to submit to European notified bodies. The regulatory pathway in Europe will take additional time, but we're committed to making this technology available to patients globally.”
How the Bancel brothers help shape modern biotech
Curiously, Bancel’s brother is Stéphane Bancel, the CEO of Moderna and he attributes their interest in biotech to several factors.
“Our mother is a medical doctor, which certainly exposed us to healthcare early on. We also came of age when molecular biology was becoming a broader industry - in the late 1990s, when the field was really gaining traction.
Perhaps most importantly, we were educated in Jesuit schools, where we were taught that it's valuable to pursue studies, but you need to use that knowledge for a greater purpose. Healthcare represents a way for me to serve others, which aligns with those early values.”
TISSIUM’S bold five-year launch plan
TISSIUM’s immediate focus is on making its technology available to patients in the US in the coming months.
Beyond that, it has an “aggressive but achievable pipeline strategy.”
The manufacturing capability now enables TISSIUM to conduct multiple studies in parallel across its seven-product pipeline across three core verticals: sutureless nerve repair, atraumatic hernia repair, and cardiovascular sealants.
Each solution is designed to help tissue heal more effectively by utilising easy-to-control procedures and specialised tools that enhance the products' performance and make them user-friendly for surgeons.
Bancel stressed:
“We're not just talking about ideas — we have products in clinical trials and late-stage development. We anticipate submitting our ventral hernia repair product in Europe in the coming months. Our ambition is to bring one new product to market every year over the next five years.”
It took the team a long time to build its platform, and it believes it has the responsibility to develop solutions where this technology can have a positive impact.
“This FDA approval represents a key milestone - our first approval, but the company has been structured so it will be the first of many.
We've engineered the company to deliver on multiple promises, and I believe we're entering a new era for patients and for TISSIUM.”
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