Bioresorbable plastics star in new tissue engineering technology

(Kirkland, WA) received 510K approval from the U.S. Food and Drug Administration to use its Cranial Bone Void Filler product in the repair of neurosurgical burr holes.  It wll be the first use of the technology licensed from the Universities of Michigan and Wisconsin.

"This is a significant milestone for the company," said CEO Jim Fitzsimmons.  "With our base material and manufacturing processes now cleared by FDA, the approval pathway for future products can be streamlined." Other submissions are in the pipeline.

Porous scaffolds made of polycaprolactone (PCL) are bioresorbable and are replaced over time with natural bone. That's a big advantage over metal, which requires a second surgery for removal. Other techniques, such as bone grafts are also falling out of favor.

 The polycaprolactone is coated with a proprietary, osteoconductive material that promotes adhesion and local, controlled release of growth factors to enhance bone regeneration. The scaffold is strong enough to bear load until new bone can be grown. Metal screws are not required for attachment.

"To our knowledge, this is first FDA approval of a coated bioresorbable skeletal reconstruction implant fabricated by means of 3D printing," said Fitzsimmons.  "This technology is definitely the wave of the future."

Target applications include complex joints such as the temporo-mandibular joint (TMJ).

Tissue Regeneration Systems uses selective laser sintering to additively manufacturing complex internal structures that facilitate bone growth. Scaffolds can be exactly matched to the required space with designs generated with use of three-dimensional scanning of the surgical area.

The company's researchers say they can use virtually any powdered bioplastic that will fuse but not decompose under a laser beam. PCL is used because it is more stable and "significantly less expensive" than PLA (polylactic acid).