Biologics

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…

Daniel Romanelli, MD, an orthopedic sports medicine surgeon, has become the first surgeon in Texas to surpass 100 bridge-enhanced ACL restoration, or BEAR, implant procedures, according to a June 3 report from MegaDoctor News. Dr. Romanelli was also the first…

Xtant Medical launched OsteoFactorPro, a naturally derived, growth factor-rich formulation for spine and orthopedics. OsteoFactorPro is designed to enhances the biologic activity and regenerative potential of any orthobiologic scaffold, according to a May 28 news release. It’s an off-the-shelf product…

Tetrous’ EnFix implant has been used in expanded applications beyond rotator cuff repair, according to a May 20 news release. Additional uses for the biologic implant proximal/distal biceps tenodesis, insertional Achilles tendinopathy, gluteus medius and proximal hamstring reattachment, lateral epicondyle…