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SSG Technical Developments
New-Generation SSG Gearing for Production
The new-generation Spinal Stiffness Gauge (SSG) is being designed and Mekanika has selected two companies for manufacturing operations so additional SSG units can be produced. It is projected that SSG units will be delivered to 25 leading spine surgery centers by 3rd quarter, 2020.
It is believed that the SSG can be used to create a controlled, measured displacement of the anterior vertebrae needed to implant artificial discs and interbody fusion cages and the SSG measurement will be useful input regarding the selection of implant size.
The following projects will add tremendous clinical value to the SSG and significantly increase its market potential:
Mekanika Acquires FDA Registered SafePath Bone Drill
Mekanika has acquired rights to the SafePath Bone Drill from RayMed, Inc. The SafePath Bone Drill is FDA registered, patented, production-ready, and non-aggressive (slow speed). Mekanika plans to promote SafePath for use in every SSG, Modulus implant procedure, and as an improved method of pedicle preparation in every lumbar fusion procedure. The SafePath is offered to surgeons as a safer, more reliable instrument to prepare the pedicle for screw insertion. It also serves as a bone marker for x-ray confirmation of spinal level and position within the pedicle. The SafePath bone drill bit can also serve as the anchor for connecting the SSG's joint distraction legs at a site where consistent SSG measurements can be taken pre- and post decompression.
The SafePath could replace other instruments being used for pedicle implantation. With the market potential of 800,000 spinal decompression surgeries worldwide, Mekanika anticipates a 25% market penetration.
Mekanika National Spine Care and Back Pain Forum
The Mekanika National Spine Care and Back Pain Forum will enroll over 70 physicians who will report outcomes on patients receiving either surgical, interventional pain control or nonsurgical treatments for back pain. Treatment outcomes, interesting case histories and other valuable information on spine care should be presented on the Mekanika website next year.
Additionally, Mekanika anticipates the Forum to provide a mechanism to collect SSG measurements and expand the database in the SSG software to thousands of patients divided into demographic and diagnoses subgroups. Mekanika also plans to enlist surgeons in a multi-center study designed to document the impact that the Modulus 60 will have on adjacent spine joint disease.