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 at the system. Robert Trasolini, DO, a sports medicine specialist at Northwell, performed the BEAR procedure on an 18-year-old patient as an alternative to traditional ACL reconstruction.
2. Xtant Medical launched OsteoFactorPro, a naturally derived, growth factor-rich formulation for spine and orthopedics. OsteoFactorPro is designed to enhance the biologic activity and regenerative potential of any orthobiologic scaffold.
3. Medical device and regenerative medicine company TBYR Health 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.
4. The first patient was treated in ReGelTec’s Hydrafil FDA investigational device exemption trial. The Hydrafil system is for disc augmentation and is designed to treat pain without surgery. It delivers a permanent hydrogel into a degenerated disc through an injection and recruits water to restore natural biomechanics. After solidifying it distributes the load and strain in the intervertebral segment to improve function and reduce pain signals, according to the company.
5. Cerapedics’ PearlMatrix P-15 peptide enhanced bone graft for lumbar spinal fusion earned FDA premarket approval. The FDA granted it a Class III drug-device combination product for single-level transforaminal lumbar interbody fusion in adults for degenerative disc disease. PearlMatrix P-15 is the only bone graft of its kind proven to accelerate bone growth in lumbar fusions.
6. 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. Patients in the cohort are “highly complex” with an average BMI of 31.9, and most of them had at least one comorbidity. Half of the cohort had previous spine surgery.
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