Spinal Kinetics designed the M6-C cervical disc for patients needing an artificial disc replacement as an alternative to spinal fusion. Orthofix acquired Spinal Kinetics in April 2018 and has since been focusing on rolling out the new technology for patients suffering from cervical disc degeneration.
Here are seven key developments on the M6-C cervical disc this year:
1. Orthofix received FDA approval for the M6-C in February. The device received the CE Mark in Europe in 2014, where there have been more than 45,000 implantations.
2. In March, the FDA granted premarket approval for the M6-C for procedures to correct single-level cervical disc degeneration.
3. A U.S. Investigational Device Exemption study reported in April that patients treated with the M6-C disc reported higher pain, function and quality of life scores than patients who underwent anterior cervical discectomy and fusion.
4. Todd Lanman, MD, announced in April that he will be incorporating the M6-C into his practice at Beverly Hills, Calif.-based Lanman Spinal Neurosurgery and he performed his first three-level artificial disc replacement with the device in August.
5. Orthofix reported that the company trained 50 surgeons to use the M6-C in August. The company's training program has six people devoted to it and is continuing to ramp up efforts.
6. The company reported achieving the No. 1 spot in the cellular allograft market, conducting $100 million-plus in hospital sales in the past year.
7. Orthofix CEO Brad Mason said in the company's second quarter earnings conference call that the company is continuing to train surgeons and roll out the M6-C, and is on course to exceed its $3 million to $4 million revenue target for 2019.