FDA clinical trial to begin for M6-C artificial cervical disc

Spinal Kinetics announced it has completed a $34 million private financing and will use the funds primarily to initiate a U.S. Food and Drug Administration-approved clinical trial of its M6-C artificial cervical disc.

“The entire Spinal Kinetics team is thrilled to have reached this important milestone,” Tom Afzal, president and CEO of Spinal Kinetics, said in a company press release. “Surgeons, patients and our investors have been extremely supportive of the M6 and have enabled us to take this critical step. We look forward to working with the U.S. sites to complete the clinical trial while continuing to expand M6 availability internationally.”

The M6-C is designed to help patients who have degenerative disc disease of the spine by providing an alternative to spinal fusion, according to the press release. It is designed to restore natural physiologic motion to the spine.

The clinical trial, which has already begun enrollment, will compare single-level cervical disc replacement to single-level cervical fusion.

Funds from the financing will also be used to expand international commercialization and clinical program, according to the press release.

Reference: www.spinalkinetics.com/clinicaltrial/description