MEKANIKA

Mekanika Success at North American Spine Society Meeting

press release: Mekanika Joins with FAU - Moves to New Headquarters

News Briefs

• SSG in Production and undergoing Beta Site evaluations
• SSG Technical Development
• Mekanika Acquires FDA registered patented Safe Path Bone Drill
• Mekanika National Spine Care and Back Pain Forum Expands
• Distributors Established in U.S., Europe, Pacific Rim

New-Generation SSG Gearing for Production

The new-generation Spinal Stiffness Gauge (SSG) has been 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 first quarter, 2008. Beta-site testing has begun in 3 South Florida hospitals: University of Miami, Miami Baptist, and Boca Raton Community Hospital.

SSG Technical Developments
The following projects will add tremendous clinical value to the SSG and significantly increase its market potential:

• Frank Cammisa, M.D., Chief of the Spine Service at Hospital for Special Surgery, and the HSS Biomechanics Research Lab have agreed to consult on the anterior SSG applications. 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.

• 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.

• The Mekanika National Spine Care and Back Pain Forum has enrolled more than 100 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.

• Distribution

  Distribution efforts both in the domestic and international markets have increased significantly. Committments have have been established with leading companies in the orthopaedic and neurosurgical spine markets. Distributors have been selected as follows:

  • Europe: U.K., Spain, Italy, Germany, Scandinavia and Belgium
  
  
  • Pacific Rim: Australia
  • United States: So. California, Arizona, New Mexico, Idaho, Minnesota, North Dakota, South Dakota, Utah, Wyoming, Nevada, Colorado, Florida, Georgia and Rhode Island with further discussions to be completed by NASS.