AxioMed Spine Corporation
AxioMed Spine Corporation was founded to develop products for restoring native function to patients with degenerative spine conditions; thus advancing the standard of care beyond fusion and first generation artificial discs. Led by an experienced and proven management team, AxioMed has developed a next-generation technology platform for artificial disc implants that is characterized by:
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The Emergence of Total Spinal Disc Replacement
A $1 Billion+ Market Will Shift In a New Direction
Nearly 400,000 spinal fusion procedures were performed in the US in 2004, despite widespread knowledge of the disappointing outcomes of this surgery. The published data indicate that only about 75% of fusion patients get any clinical benefit, and that only half will experience major or complete relief of pain or recovery of function. Re-operation rates within ten years are reported to be between 10% and 25%. The well-documented disappointments with fusion surgery have led surgeons and patients to seek different solutions. The most promising alternative is total disc replacement with an artificial disc. This surgery has been performed in Europe for nearly twenty years, and the first artificial disc was approved in the United States in 2004. The market for artificial discs is expected to develop rapidly, exceeding $1 billion in 2008 and approaching $3 billion by the end of the decade.
Artificial Discs
First Generation Artificial Disc Technology Has Significant Shortcomings
The first discs to be approved in the US are first generation designs based upon ball-and-socket articulating bearings, modeled on hip and knee replacement prostheses. While offering some advantages over fusion such as preserving motion and reduced complications, they have significant shortcomings. An ideal prosthetic disc will replicate the native function of the natural disc, specifically; three dimensional motion, dynamic stiffness, load sharing capability, and proper maintenance of the lordotic curve. First generation discs cannot meet this standard due to:
- Limited motion that is significantly different than the motion of a natural disc,
- Lack of load sharing or passive resistance capability,
- No method to maintain the proper lordotic curve, and
- Abnormal biomechanics that can stress surrounding structures.
In addition, ball-and-socket discs present the risk of generating wear debris that, in other joints, has been known to cause tissue disease, bone loss, and prosthetic failure.
AxioMed Technology
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AxioMed Has Developed a Next-Generation Disc With Significant Advantages Based upon its viscoelastic prosthetic technology, AxioMed has designed and patented an artificial disc for use in the lumbar spine: the Freedom™ Lumbar Disc. Using a patented polymer under exclusive license, AxioMed has been able to develop an artificial disc that replicates the native function of a natural disc. The material characteristics of the polymer, in combination with the implant design, provide three-dimensional motion that functions within the natural biomechanics of the spine. The device, like the natural disc, is viscoelastic and is designed to withstand the forces during decades of use as an implant in relatively young patients. It was developed and designed by a first-class team of engineers and spine surgeon partners, along with the input of experienced and respected scientists in the fields of biomechanics, pathology, spine surgery and polymer science. |
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Freedom™ Lumbar Disc
A human clinical study of the Freedom™ Lumbar Disc started in the last quarter 2005. The company has completed extensive biomechanical and biocompatibility evaluations of the Freedom™ Lumbar Disc and has completed manufacturing process qualification and validation. A clinical study demonstrating safety and performance for the CE Mark began in Europe in late 2005. An IDE submission for a pivotal study in the US is planned for 2007. It is anticipated that AxioMed will receive a CE mark in early 2007 and proceed with commercialization in Europe in parallel with a US Pivotal Study.
