The University of Michigan in Ann Arbor has entered into a licensing agreement with Belgium-based Materialise for its biodegradable 3-D-printed splint to take it through clinical trials before being available on the marketplace. Materialise will work with Plymouth Township-based Tissue Regeneration Systems to manufacture the tracheal splints.
“This agreement is a critical step in our goal to make this treatment readily available for other children who suffer from this debilitating condition,” says Dr. Glenn Green, an otolaryngologist at the University of Michigan’s C.S. Mott Children’s Hospital.
Green says about one in 2,200 babies are born with tracheobronchomalacia, a condition that causes the trachea to periodically collapse. The tracheal splint is made with a biopolymer called polycaprolactone, a material that is gradually absorbed into the infant’s body tissue over time.
Materialise’s Mimics Innovation Suite was used to design the splint, which is constructed from a technology platform licensed to Tissue Regeneration Systems by the University of Michigan in 2007. Tissue Regeneration Systems received its first commercial product clearance from the U.S. Food and Drug Administration in 2013.
“The collaboration between Tissue Regeneration Systems and Materialise will provide production capacity for the tracheal splint, which will allow the splint to be available to a larger number of infants who are affected with tracheobronchomalacia,” says Bryan Crutchfield, managing director of Materialise USA.
C.S. Mott Children’s Hospital plans to open a clinical trial for 30 patients with similar conditions next year.