MEKANIKA

Mekanika, Inc.

History

Mekanika, founded by David Holmes, Chairman and Chief Science Officer, has invested over 20 years of R&D on the Mekanika Spinal Restabilization System, a revolutionary advancement in the diagnosis and treatment of spinal instability. The company was founded within the renowned University of Miami's Orthopaedic Surgery Department, where Mr. Holmes was Director of the Spine Biomechanics Research Lab. The Spinal Stiffness Gauge (SSG) was patented and developed to allow an accurate, objective, intra-operative, computer-based measurement of spine joint instability before and after spinal decompression. The SSG was used at the University of Miami in over 300 patients undergoing spine surgery to demonstrate the accuracy and value of the measurement, which may become the needed, essential definition of spinal instability used to guide and document the necessity for fusion, restabilization or just the decompression. A database of SSG measurements has been developed from the test results in 300 patients, and can be reviewed in the May 2002 issue of SPINE.

Further research in the area of spinal instability led Mr. Holmes to realize that fusion was not the optimum method of spinal stabilization. He designed and patented the Modulus™ Spinal Reconstruction System. Not only is this device capable of being used in fusion, but it is the first, posterior, intrasegmental arthroplasty system on the market designed to restabilize the spine joint while maintaining segmental motion and normal biomechanical function. FDA IDE studies are anticipated to begin in 2004. Spine arthroplasty has been cited as the new frontier of orthopedics.

A realized goal of market introduction began in July 2002 with the introduction of the SafePath™ Bone Drill System. The SafePath is an FDA-registered, patented disposable drill designed to facilitate a safe, fast, accurate and reliable nucleation within the pedicle.

In addition, Mekanika has now completed the development of an advanced diagnostic and therapeutic spinal restabilization system that will be the first to offer the spine surgeon the following:
1) increased diagnostic capability with the SSG
2) a choice of either arthrodesis or arthroplasty with the Modulus System
3) a significant potential to improve surgical spine care outcomes and reduce spine surgery costs.
The SSG, which is FDA-cleared, will be released in a multi-centered clinical study in the USA in 2011. A full product line is anticipated in the US and European markets in 2012. Modulus System clinical studies for arthroplasty indications are anticipated to commence in 2012.

One of the major strengths built into Mekanika since the company's inception is its strategic alliances. The company has completed product development and licensing through the University of Miami School of Medicine's sponsored research and patent license agreements, which has allowed Mekanika to access the University's tremendous research and clinical testing capabilities.

Additionally, early developmental work was completed with Sparta, Inc., a $150 million aerospace and advanced composites materials company, which is a world leader in the research, development and manufacturing of carbon fiber composite products. Sparta and Mekanika have invested six years of research, development and testing of the company's Modulus Spinal System, which is constructed from a proprietary, carbon-fiber composite architecture that has tested stronger and more biomechanically compatible than titanium.