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…
Biologics
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…
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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…
Physicians at Huntington (N.Y.) Hospital, an affiliate of Northwell Health, have performed the first BEAR implant procedure and the first CartiHeal Agili-C implant procedure at the system. Robert Trasolini, DO, a sports medicine specialist at Northwell, performed the BEAR procedure…
Healthcare solutions provider Summit Products Group, based in Dallas, has launched a strategic partnership with regenerative medicine developer NovaBone Products. Summit focuses on cultivating a portfolio of products engineered for surgical applications, identifying breakthrough products and supporting their path to…
From product launches and milestones, here are five updates in orthobiologics since March 28. 1. Lenoss Medical’s OsteoPearl procedure reached its 150th case. OsteoPearl is an allograft designed to augment vertebral compression fractures. 2. Spine Wave released its Tempest demineralized…