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
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.