Since the beginning of the year, Becker's Spine Review has reported on eight orthobiologic and regenerative medicine companies that have launched new products, received FDA clearances and demonstrated favorable outcomes in clinical trials:
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1. Cerapedics received FDA approval in July to reduce the number of patients required for its P-15L bone graft clinical trial. In May, The Spine Journal published data from Cerapedic's clinical trial examining the fusion rate of its i-Factor bone graft in noninstrumented lumbar fusion.
2. Bioventus invested $15 million in CartiHeal in July and agreed on an option structure to acquire the company pending approval of its Agili-C implant. Bioventus also launched its Signafuse bioactive bone graft in a strip format in June.
3. In July, Spine Wave launched its Tempest Allograft Bone Matrix, which features cancellous and partially demineralized cortical bone.
4. Baxter received FDA clearance for its Altapore Shape Bioactive Bone Graft for spine surgery in July.
5. Aziyo Biologics launched OsteoGro V in June, a viable cell bone matrix to assist with bone repair.
6. In May, SpineOvations reported favorable results at the midpoint of its clinical trial for DiscSeal, a viscous material injected percutaneously into the intervertebral diseased disc of patients with lumbar pain.
7. Carmell Therapeutics was granted fast track designation in April for its debut product, a plasma-based bone-healing accelerant.
8. Onkos Surgical launched its GenVie Magnesium Bone Scaffold in February, a magnesium-based bone void filler for orthopedic conditions.