Here are five updates in spine and orthopedic biologics since June 27.
1. Bone Biologics filed a patent application with the U.S. Patent and Trademark Office for its NELL-1 protein. The patent applies to rhNELL-1 polypeptide and its use for treating bone conditions. The protein is used for spinal fusions.
2. Sharad Rajpal, MD, performed the first U.S. case using Cerapedics’ PearlMatrix P-15 bone graft for lumbar spinal fusion since its FDA approval. The bone graft, the first of its kind for lumbar spinal fusion, was approved by the FDA in June and is proven to accelerate bone growth.
3. SurGenTec earned additional FDA clearance for its OsteoFlo HydroFiber. The new 510(k) clearance adds indications for use as a bone void filler for the treatment of tumors, cysts, trauma, and osteomyelitis.
4. Alafair Biosciences earned FDA 510(k) clearance for the VersaCoat tendon protector and VersaCoat nerve protector. VersaCoat is a syringe-deliverable gel that offers a protective, gliding surface to limit post-operative tethering in surgical procedures involving tendons, ligaments, skeletal muscles and peripheral nerves in patients of all ages. The gel bioresorbs without any residual.
5. Spine surgeon Daniel Park, MD, completed the first U.S. case using Kuros Biosciences’ MagnetOs minimally invasive surgery delivery system. MagnetOs MIS, a bone graft delivery system, was cleared by the FDA in May. Compared to a traditional funnel-based system, Magnet OS MIS completed graft placement three times faster.
