Biologics

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…

Spine surgeon Daniel Park, MD, completed the first U.S. case using Kuros Biosciences’ MagnetOs minimally invasive surgery delivery system, according to an Aug. 5 news release. MagnetOs MIS, a bone graft delivery system, was cleared by the FDA in May.…

Alafair Biosciences earned FDA 510(k) clearance for the VersaCoat tendon protector and VersaCoat nerve protector, according to a July 30 news release. VersaCoat is a syringe-deliverable gel that offers a protective, gliding surface to limit post-operative tethering in surgical procedures…

SurGenTec earned additional FDA clearance for its OsteoFlo HydroFiber, according to a July 22 news release. The new 510(k) clearance adds indications for use as a bone void filler for the treatment of tumors, cysts, trauma, and osteomyelitis. “Treating tumors…

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…

Bone Biologics filed a patent application with the U.S. Patent and Trademark Office for its NELL-1 protein, according to a June 27 news release.  The patent applies to rhNELL-1 polypeptide and its use for treating bone conditions. The protein is…

From new FDA nods to debuts, here are six key developments in spine and orthopedic biologics. 1. Physicians at Huntington (N.Y.) Hospital, an affiliate of Northwell Health, performed the first BEAR implant procedure and the first CartiHeal Agili-C implant procedure…

OssDesign’s Catalyst nanosynthetic bone graft putty saw an 88.4% fusion rate in highly complex spine patients, according to results from its Propel study. The data comes from the first 108 patients in its Propel study, according to a June 26…

Cerapedics’ PearlMatrix P-15 peptide enhanced bone graft for lumbar spinal fusion earned FDA premarket approval, the company said June 23. The FDA granted it a Class III drug-device combination product for single-level transforaminal lumbar interbody fusion in adults for degenerative…

Medical device and regenerative medicine company TBYR Health has earned FDA clearance for its B3 gel system, a bioresorbable gel barrier that protects healing tissue planes and preserves mobility following tendon, ligament and skeletal muscle surgeries.  The gel, which is…