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Orthopedic and Dental Industry News Complete Archive »

Management Change at Raymedica BY ROBIN R. YOUNG CFA, AUGUST 23, 2004

Tony Phillips, the long time CEO of Raymedica has left the firm to pursue other interests. Members of Raymedica's board, specifically Kent Archibald, are now running the company. John Viscogliosi, another board member and member of the Viscogliosi Brothers investment firm in New York City, is acting as the firm's "outside" representative.

Raymedica was one of the first, if not in fact, the very first company to develop a nucleus replacement implant. Founded in 1990, Raymedica took the Prosthetic Disc Nucleus technology developed by Dr. Charles Ray and began the process of developing and commercializing it.

It took nearly ten years to develop the first implantable product. In its first incarnation, the PDN was two small pillows of an inert hydrogel polymer that would osmotically absorb body fluid over time and thereby expand and support disc height. The product was extraordinary. It absorbed 80% of its weight in fluids and expanded to nearly its full height (about 2mm) in 24 hours.

Over 2,000 patients are walking around today with a PDN implant. The product design is in its third and most successful generation. Pain studies have been outstanding. Clinical success is defined as 25% reduction in patient's ODI scores. Raymedica's PDN consistently surpasses the FDA's improvement mark of 25%. In fact, the PDN routinely scores over 70%. 80-85% of PDN patients report clinical success, a percentage that compares favorably with fusions.

Raymedica's success with the FDA, however, has not been as strong as its success with patients. The company's first implant was in 1996. Its pilot IDE study of 15 patients started in 1998. In 2002, the Company received FDA approval to begin the first part of Phase III clinical studies in the United States. That was delayed when an improved, PDN-SOLO device was developed. Raymedica is hoping to be granted pivotal study approval from the FDA in early 2005.

According to our sources, Raymedica's new management has brought a team of FDA experts into the firm to try sort all the issues out and, hopefully, accelerate time to market.

For the record, we're fans of Raymedica and its product and hope that all the FDA issues can be worked out so this valuable product can be made available to surgeons.

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