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3D Systems receives FDA approval for custom 3D printing solution to repair damaged nerves

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Additive Manufacturing company 3D Systems has partnered with TISSIUM, a French MedTech company, on the development of a bespoke 3D printing solution for the repair of damaged peripheral nerves.

A sutureless solution for peripheral nerve repair

This device, called COAPTIUM® CONNECT with TISSIUM Light, is a first-of-its-kind, atraumatic, sutureless solution for the repair of peripheral nerves. It requires the combination of 3D Systems’ bioprinting technology and TISSIUM’s biomorphic programmable polymers.

Earlier this week, TISSIUM announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for this solution. This milestone validates the polymer’s clinical potential and paves the way for its use across a broad spectrum of transformative applications. Its unique polymer characteristics enable the production of high-resolution, elastomeric biodegradable implants that are unique in the industry.

“This is a significant advancement in patient care,” said Scott Turner, vice president, advanced systems, 3D Systems. “It has been tremendously rewarding to work alongside the talented team at TISSIUM to design a complete 3D bioprinted solution that offers the potential for patients to recover from peripheral nerve damage. I truly believe this will redefine treatment paradigms and offer hope to individuals that have suffered from the effects of nerve damage in regaining their quality of life.”

The broader bioprinting programme

As a reminder, in 2017, 3D Systems entered into a joint development program with United Therapeutics Corporation. The goal of this program is to establish an unlimited supply of human lungs that require no immunosuppression. This would allow all patients with end-stage lung disease to receive transplants. This would enable them to enjoy long, active lives. 3D Systems has primarily focused on developing 3D printing technology capable of producing scaffolds. These must meet the extreme precision and resolution requirements needed for a functional human lung.

The company aims to do so in a way that ensures the physical, mechanical, and biocompatibility performance necessary to influence cell behavior and reproduction for extended use in the human body. Its Print to Perfusion™ process enables the 3D printing of high-resolution scaffolds that can be perfused with living cells to create tissues. By combining bioprinting technology, biocompatible 3D printing materials, and a wide range of cell types, including patient-derived cells, the company’s biomedical engineers can construct patient-specific living tissues.

“Over the past several years, we have made phenomenal progress building upon Chuck Hull’s invention of 3D printing, and pushing its capabilities into new frontiers,” said Dr. Jeffrey Graves, president & CEO, 3D Systems. “Whether in our medical device business through the production of patient-specific implants and surgical solutions, or through the work our regenerative medicine team is doing, 3D Systems is making a profound impact not only on how healthcare is delivered, but on the quality of patients’ lives, and continues to solidify what I believe is an unparalleled role we play in advancing medicine with additive manufacturing applications. This latest accomplishment by TISSIUM, enabled by our unique 3D printing technology, is one more example of how 3D Systems is transforming patient care for a better future.”

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