Here are 11 key updates on orthobiologics from the third quarter of 2023:
1. Creative Medical Technology Holdings got FDA clearance for its Phase 1/2 clinical trial for its StemSpine procedure using AlloStem.
2. Researchers at New York City-based Hospital for Special Surgery and Weill Cornell Medicine discovered a new stem cell that could affect spine care.
3. HippoFi and Zimmer Biomet are partnering to develop and launch a novel synthetic biomaterial for bone growth.
4. A group of lawmakers wrote a letter to Robert Califf, MD, the U.S. FDA commissioner, pushing for stricter guidance for bone grafts in light of a recent spate of tuberculosis linked to orthopedic products.
5. A Michigan woman died from tuberculosis linked to tainted bone graft.
6. Aziyo Biologics is in talks to divest its orthopedic business.
7. The first four surgeries using the EnFix RC fiber implant for rotator cuff repair were completed at Rush Oak Brook (Ill.) Surgery Center.
8. Aziyo Biologics is recalling its viable bone matrix products after two patients were infected with Mycobacterium tuberculosis following surgeries, the orthobiologics company said July 13. The CDC is investigating an outbreak realtedto the recall.
9. Orthopedic surgeon Ken Zaslav, MD, performed the first commercial case with CartiHeal's Agili-C in the U.S., the medtech company said July 26.
10. Theradaptive and 3D Systems are partneringto bolster regenerative medicine. Under the partnership, 3D Systems will be Theradaptive's exclusive 3D printing partner.
11. EpiBone named Brian Cole, MD, of Chicago-based Rush University Medical Center, as an adviser, the regenerative medicine company said Aug. 8.