RTI Surgical (RTIX) is expanding its spine fusion portfolio with its recent acquisiton of Zyga Technology, developer of the SImmetry® Sacroiliac Joint Fusion system.
Zyga's annual revenue is ~US $4MM. The company has also developed the Glyder® Facet Restoration Device. SImmetry is commercially available, while Glyder is not.
As of 2015, Zyga had raised nearly $50MM in a variety of fundings which in part supported clinical trials. SImmetry is entered in the ongoing EVoluSIon clinical trial; recruitment is terminated in a postmarket study of SImmetry in SI joint fusion and decortication. Zyga completed the GLISSADE clinical study to evaluate the safety of Glyder in participants with facet joint pain; recruitment is suspended for DUET, a U.S. study of Glyder in subjects with lumbar facet pain syndrome.
In 2015, analysts estimated the SI joint treatment market at under $70MM. Today, RTIX leadership cites an estimated $100MM market in the U.S., slated to exceed $200MM by 2024, with SI joint fusion procedures growing 20%.
In September 2017, Highmark expanded positive coverage for minimally invasive sacroiliac joint fusion, including all FDA-cleared instrumentation for this indication including cages or screws, with or without bone graft. Previously, the insurer had only covered SI-BONE's iFuse Implant System®. Highmark represents the 4th-largest Blue Cross and Blue Shield-affiliated insurer in the U.S.
As of 2015, SI-BONE reportedly claimed 85% of the SI joint treatment market with iFuse.. Other FDA-cleared SI devices are available from Camber Spine, CoreLink, Globus Medical, Life Spine, Medtronic, SI-BONE, SICAGE, SpineFrontier, Xtant Medical, etc.
RTIX had two strategic spine announcements this past October:
- Introduced TETRAfuse® technology, reportedly the first 3D-printed polymer implant material to demonstrate trabecular bone ingrowth plus radiolucency and bone-like mechanical properties.
- Commenced commercial launch of Fortilink®-C, the first in its line of interbody fusion devices to feature TETRAfuse®.