3D Systems Advances Regenerative Medical Solutions

3D Systems announced that its 3D bioprinting technologies have enabled FDA approval for the regenerative repair of peripheral nerve damage. For the last several years, 3D Systems has partnered with TISSIUM, a French MedTech company that is a pioneer in the development of biomorphic programmable polymers for tissue reconstruction, to develop a bespoke 3D printing solution for the repair of damaged peripheral nerves. Combining TISSIUM’s expertise and proprietary biomorphic programable polymers with 3D Systems’ ground-breaking regenerative medicine bioprinting technologies has resulted in the successful development of a fully bioabsorbable 3D-printed medical device for nerve repair utilizing a unique photopolymer. This device, called COAPTIUM^® CONNECT with TISSIUM Light, is a first-of-its-kind, atraumatic, sutureless solution for the repair of peripheral nerves.

TISSIUM recently 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 milestone is yet another proof point of 3D Systems’ nearly decade-long leadership position in bioprinting. In 2017, 3D Systems entered into a joint development program with United Therapeutics Corporation, the goal of which is to establish an unlimited supply of human lungs, requiring no immunosuppression, allowing all patients with end-stage lung disease to receive transplants which will enable them to enjoy long and active lives. 3D Systems has focused primarily on establishing the 3D printing technology to produce scaffolds meeting the extreme precision and resolution requirements for a functional human lung and to do so in a manner that yields the physical, mechanical, and biocompatibility performance to influence cell behaviour and reproduction required for extended use in the human body. Its Print to Perfusion™ process enables 3D printing of high-resolution scaffolds, which can be perfused with living cells to create tissues. Through the combination of bioprinting technology, biocompatible 3D printing materials, and a broad range of cell types including patient-derived cells, the Company’s biomedical engineers can construct patient-specific living tissues.