Xtant Medical's Certex Spinal Fixation System received FDA clearance for the posterior cervical screw indication.
Here are five takeaways:
1. The cleared indication expands the use of the Certex screws for use in the posterior cervical spine. It is now indicated for implantation using a posterior approach at the craniocervical junction, the cervical spine and the thoracic spine.
2. The system is intended to treat patients with advanced stage tumors involving the cervical spine.
3. The Certex Spinal Fixation System can be linked to the Fortex Pedicle Screw System and the Xpress Minimally Invasive Pedicle Screw System with rod-to-rod connectors and transition rods.
4. Xtant Medical recently reported its first quarter 2016 financial results. The company's quarterly revenues hit $21 million, a 3 percent decrease from the same period in 2015.
5. Additionally, Xtant Medical received two Montana Department of Commerce grants totaling $155,000. The funds will help Bacterin International, a Xtant wholly-owned subsidiary, expand its orthobiologic process facility.