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…
Biologics
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…
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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…
CGBIO, a South Korea-based company, earned the FDA’s investigational device exemption approval for its Novosis putty for spinal fusions. The bone graft incorporates rhBMP-2 and is designed to enhance high-density bone formation and minimize ectopic bone growth, according to a…
A study reporting on DiscGenics’ cell therapy phase 1 and 2 study has been selected as one of three of the best and most influential articles published in the International Journal of Spine Surgery in 2024. Here are four things…