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| 3-D printed bioresorbable tracheal splint--Courtesy of the University of Michigan |
3-D printer Materialise ($MTLS) announced last week that it's expanding its production of medical models. Now it's taken a step even further in its commitment to medical applications of 3-D printing. The Belgian company has partnered with Plymouth, MI, upstart Tissue Regeneration Systems (TRS) to manufacture 3-D printed bioresorbable tracheal splints for clinical trials.
Materialise also licensed technology from the University of Michigan for the project, in addition to the 2007 deal that TRS already had in place with that academic institution.
In 2013, TRS nabbed the first FDA clearance for a 3-D printed, coated, bioresorbable skeletal reconstruction implant with its Cranial Bone Void Filler product to fill holes drilled into the skull during neurosurgery. Last year, Johnson & Johnson ($JNJ) also selected TRS as part of a lineup of a dozen startup partnerships selected to stake out the conglomerate's 3-D printing territory.
In the new trial, 3-D printed splints will be used to treat infants with tracheobronchomalacia (TBM), a condition in roughly 1 in 2,220 babies that can cause the airway to collapse spontaneously. The FDA has granted Expanded Access for devices treating TBM.
"The collaboration between TRS 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 TBM," said Materialise USA Managing Director Bryan Crutchfield in a statement.
University of Michigan professors Glenn Green and Scott Hollister used Materialise's Mimics Innovation Suite to model and construct these splints based on CT scans of a specific patient's anatomy. The team expects to start a clinical trial in 30 patients next year at C.S. Mott Children's Hospital.
"It was the possibility to realize 3D-printing enabled medical applications that, in part, motivated me to start Materialise 25 years ago," said Materialise founder and CEO Fried Vancraen in a statement. "Today, we are proud to offer an entire range of software and services that can help universities, research centers, medical device companies, and hospitals develop solutions that result in a better and healthier world, such as the treatment developed for children diagnosed with TBM."
- here is the TRS announcement and a statement on licensing