“We believe the positive feedback and robust interest we are getting from surgeons for our innovative Sagittae Lateral Lumbar Interbody Fusion (LLIF) device validates our technology, while the operational progress we continue to make positions SpineEX for long term sustainable growth and success,” commented Roy Chin, Chairman and CEO. “We expect, in the very near future, to announce the first procedure using our innovative Sagittae device to be performed by a leading orthopedic surgeon and complete our transition from a development stage to a commercial stage and revenue generating company.”
The additional 510(k) clearance for the company’s Sagittae Lateral Lumbar Interbody Fusion (LLIF) covers:
The addition of new system instrumentation along with an updated surgical technique.
Enables surgeons to better streamline the implant sizing process along with giving surgeons the ability to adjust the anterior and posterior side of the implant independently of one another.
The clinical end goal of Sagittae is to help achieve optimal lordosis, vertebral endplate contact, and posterior column decompression to give each patient the best personalized implant configuration possible.
Since receiving the initial FDA clearance, the company has been working with several long-term suppliers to manufacture the Sagittae cages and instrumentation, in preparation for the company’s commercialization efforts, which are expected to commence later this month.