Frost & Sullivan Highlights Raymedica for its Pioneering Technology to Treat an Unaddressed Patient Market

Business Wire, April 22, 2008

PALO ALTO, Calif. -- Based on its recent analysis of the U.S. prosthetic disc nuclei market, Frost & Sullivan recognizes Raymedica, LLC, with the 2008 Frost & Sullivan Hot Investment Opportunity Award.

Raymedica is involved in the development of a nucleus replacement technology aimed at preserving the motion of the spine and is a pioneer in the field of Nucleus Arthroplasty[TM].

At present, it is estimated that approximately 30 million people in the U.S. suffer from back pain as intervertebral disc degeneration is a natural progression of the aging process. While physical therapy and medication provide a solution in most cases, a subset of approximately 15 percent of this population (about 4.5 million people) still experience back pain despite such conservative therapy. For this, the next level of treatment becomes a spinal surgery involving either total disc replacement or spinal fusion.

However, since spinal surgery is advocated only in severe cases of degenerative disc diseases, out of the 4.5 million people only 500,000 would be considered candidates for surgery. This creates a gap of about 4 million people who are currently left untreated. These patients experiencing mild to moderate degenerative disc diseases (DDD) are normally treated with conservative procedures, until the condition worsens to a degree that warrants spinal surgery.

Raymedica offers a solution to this unaddressed market by replacing only the diseased nucleus in the early stages.

"The company's technology addresses DDD through the replacement of the disc nuclei with a prosthetic device to restore and maintain height and spine motion," says Frost & Sullivan SeniorResearch Analyst Sheetal Rajani. "It uniquely addresses the category of patients who fall in the gap of being under-treated by a discectomy but over-treated by more invasive spine surgery."

Raymedica's prosthetic disc nuclei are commercially available in European Union countries and Asia, and have been implanted in over 5,000 patients worldwide. The company's current offerings are comprised of two product platforms, namely: PDN-SOLO([R]) and HydraFlex[TM] Nucleus Arthroplasty System[TM] (NAS[TM]) technology.

The prosthetic disc nuclei are comprised of an inert hydrogel core encased in an inelastic, woven polyethylene jacket. Once implanted, the device absorbs fluid and expands within the disc space, thus maintaining height. The HydraFlex NAS is the fourth iteration of the company's proprietary technology, featuring improved designs such as a more contoured implant shape for a better fit, a larger footprint, and softer core.

Raymedica's offerings are associated with positive clinical outcomes. In 2006, the 24-month preliminary results of a multi-center study conducted on 75 patients revealed that the PDN-SOLO showed an improvement both in terms of the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) scores -- validated measurements to gauge the effectiveness of spinal treatment.

"While the FDA defines clinical success to be a 25 percent reduction in patients' ODI scores, the PDN-SOLO device showed a 73 percent improvement in patients subsequent to surgical implantation," notes Ms. Rajani. "Additionally, a 10-year clinical evaluation of patients implanted with the first-generation PDN prosthetic disc nucleus technology -- the predecessor of the PDN-SOLO -- showed that nine out of ten patients were satisfied with a positive impact on the pain, function and range of motion."

To date, Raymedica has received about $60 million in financing, mainly from Viscogliosi Brothers, LLC, a leading venture capital firm specializing in the musculoskeletal industry. Viscogliosi has a portfolio of investments in spinal non-fusion products and has been responsible for two of the most successful spinal exits in the past -- Spine Solutions Inc. (sold to Synthes Inc.) and Spine Next SA (sold to Abbott Laboratories).

Viscogliosi's co-founder, John J. Viscogliosi, is also Chairman and CEO of Raymedica. A seasoned investor in the spinal non-fusion technologies area, this veteran strategist and tactician leads an experienced team who steers this promising enterprise to higher successes.

Overall, the increasing interest towards motion preservation technologies, a large unaddressed population, a highly experienced management team, and a promising technology make Raymedica the deserving recipient of the 2008 Frost & Sullivan Hot Investment Opportunity Award in the U.S. prosthetic disc nuclei market.

Each year Frost & Sullivan presents this Award to the company that displays strong investment potential, maintains a well qualified management team, and is in a position to establish a sustainable competitive advantage in an attractive market. The award recipient is well positioned in a growing market and has demonstrated the potential to obtain market leadership in the near term. Finally, clear exit paths exist, along with the potential for exceptional investment returns at an acceptable risk level for potential investors.