FDA approves light-activated polymer for nerve repair without stitches

The US Food and Drug Administration has approved a new system for nerve repair based on light-activated polymers rather than surgical stitches. The flexible polymer system was developed by the medical technology company Tissium, which was founded over a decade ago to commercialize research from the laboratories of Jeffrey M. Karp and Bob Langer at the Massachusetts Institute of Technology.

Christophe Bancel, who is now Tissium’s CEO, recalls meeting the firm’s eventual cofounder, Maria Pereira, back when she was finishing up her PhD work in Karp’s lab. She impressed him with both the quality of her work and the poly(glycerol sebacate acrylate) material that she had developed for surgical use.

After spending a few days with Pereira in the lab, Bancel returned to France and spoke to numerous surgeons to understand what it would mean to have a biocompatible, light-activated polymer system that could stick cells and tissues together. Convinced the material could have multiple applications in surgery, he founded Tissium with Pereira, and the hard work really began.

Although Tissium first demonstrated its polymer material as a cardiovascular sealant, the application that the FDA just approved it for is the repair of nerve damage. Currently, Bancel explains, this is a highly complex surgery in which doctors stitch together extremely delicate tissues under a microscope.

Tissium’s solution uses its polymer to make a 3D-printed chamber that can be fitted around the damaged nerve like a cuff. Liquid prepolymer is then squeezed around the edges and cured to create a flexible seal that holds the damaged nerve in place inside the cuff so that it can knit itself back together. before the implant is absorbed into the body.

“This first approval is, in fact, the beginning of a journey,” Bancel says. Following today’s approval of the nerve-repair product, Bancel says the company hopes to expand into new treatment areas, possibly through codevelopment partnerships. It has built a manufacturing site in France that can produce complete kits for applications such as fixing nerves, sealing blood vessels, and repairing gastrointestinal hernias.

“Chemistry is central. No chemistry, no Tissium,” Bancel says. “But we decided to go beyond the chemistry . . . combining the polymer with the right accessories, because we believe we are not here to provide a component to the surgeons. We are here to provide a solution for their patients.”