Biologics

The FDA is ramping up enforcement activities against companies developing unapproved stem cell therapies, particularly for spine and orthopedic indications, according to the Regulatory Affairs Professional Society.

Ortho Regenerative Technologies received a clinical hold letter from the FDA related to its trial for its hybrid implant, Ortho-R, the company said June 4.

Adipose cells, commonly known as fat, could be a useful source of stem cells to promote bone growth in spinal fusion, according to researchers from Johns Hopkins Medicine in Baltimore.

The FDA has granted breakthrough device designation for Cerapedics' P-15L bone graft for the treatment of degenerative disc disease.

DiscGenics, a biopharmaceutical company focused on regenerative therapies for spinal conditions, has finished enrolling patients in its Japanese study of  IDCT, an allogeneic, injectable disc cell therapy for lumbar disc degeneration.

Pacira Biosciences invested $3 million in Spine BioPharma.

Rishi Wadhwa, MD, of Shreveport, La.-based Specialists Hospital, completed the first implantation of Ventris Medical's Allocell AF allograft.

Orthobiologics company Kuros Biosciences has treated the first patient in a clinical trial comparing MagnetOs Putty to autograft for posterolateral spinal fusion.

The first two spinal surgery cases with TheraCell's TheraFuze DBF Fiber Bag were completed in Illinois and Texas.

Two professors from West Lafayette, Ind.-based Purdue University developed a shoulder implant that uses a patient's stem cells to help repair the rotator cuff.