AxioMed Spine Corporation
AxioMed Spine Corporation was founded to advance the standard of care for patients with degenerative spine conditions by developing products 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:
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 over time to become an integral part of the surgeons´ approach to total spinal care.
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 after hip and knee replacement prostheses. While offering some advantages over fusion, such as preservation of 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 of maintaining the proper lordotic curve, and
- Abnormal biomechanics that can stress surrounding structures.
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 the next generation of artificial disc. The material characteristics of the polymer, in combination with the implant design, provide three-dimensional motion that biomechanical testing has shown functions within the natural biomechanics of the spine. The Freedom® Lumbar Disc is viscoelastic and is designed to withstand the forces and wear characterized by decades of use as an implant in relatively young patients. It was developed and designed by a first-class team of employee 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.
Freedom® Lumbar Disc
The company has completed extensive biomechanical and biocompatibility evaluations of the Freedom® Lumbar Disc and has completed manufacturing process qualification and validation. Patient enrollment in a pilot clinical study in Europe to demonstrate safety and performance for the CE Mark has been successfully completed. It is anticipated that AxioMed will receive a CE mark in late 2008 and proceed with commercialization in Europe. In addition, the US FDA has approved an IDE pivotal study for the Freedom® Lumbar Disc. The study has been initiated.