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First Synthetic Cartilage Product Cleared for Sale in Europe

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www.ProHealth.com • April 26, 2002




Patients suffering from arthritis or cartilage degeneration may soon have a minimally-invasive solution available to them in Europe. Medical device developer, SaluMedica™, was recently granted authorization to apply the CE mark to its SaluCartilage™ product intended for cartilage repair. A globally recognized mark of product safety, the CE mark allows the treatment to be distributed throughout the European Union.

SaluCartilage™ is the first product for use in cartilage repair applications, designed as a less invasive and more cost-effective alternative to current therapies for patients suffering from osteoarthritis, rheumatoid arthritis and sports injury.

"As a medical doctor, it has been my personal goal as well as the company's mission to provide a solution that will allow the millions of people afflicted with arthritis to lead a more active live without pain," says SaluMedica™ president and CEO David N. Ku, MD, PhD.

SaluCartilage™ is a purely synthetic implant offered in a range of sizes, made from the Company's proprietary Salubria™ biomaterial. Using standard arthroscopic techniques and instrumentation, damaged articular cartilage may be cored out and replaced with SaluCartilage™ to provide a smooth, load-bearing joint surface.

Classified as a hydrogel, Salubria™ contains water in similar proportions to human tissue and is comparable in its mechanical and physical properties. The organic polymer-based biomaterial is known to be highly biocompatible. Although it is soft and compliant like human tissue, it has proven to be exceptionally wear resistant and strong making it an ideal implant, suitable for many medical applications.

"One of the greatest benefits of the implantation is that it does not necessitate the sacrifice of healthy cartilage from the patient, although it could be used in conjunction with such a technique," explains Dr. Ku. "Even more importantly, we expect that SaluCartilage™ could provide an option to those patients requiring a total joint replacement, postponing the need for this traumatic surgery."






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