Raymedica Inc has signed an agreement with Medtronic Inc, under which Medtronic Sofamor Danek will distribute the PDN Prosthetic Disc Nucleus in Europe and India. Raymedica expects Medtronic to begin actively marketing the PDN device in the third quarter of 2002. Raymedica also announced that Medtronic has made an equity investment in the company. The PDN device is an implant designed to treat low-back pain in patients that have not responded to conservative care.

Medtronic has retained negotiation rights for additional international territories and will collaborate with Raymedica on new instrumentation development. Further financial details were not disclosed.

The PDN device is comprised of a hydrogel material designed to replace the function of a failed spinal disc nucleus. To treat low-back pain, a pair of PDN devices is implanted in the center of the spinal disc. The devices are designed to support the bones of a patient's spine while allowing for more normal flexibility and movement than spinal fusion, the current established surgical treatment, in which adjacent vertebrae are fused together.

The PDN device is commercially available in Europe and other international regions, but is not yet approved in the United States. More than 600 patients worldwide have received PDN implants. Raymedica is pursuing marketing approval from the U.S. Food and Drug Administration and recently received approval to begin a second round of U.S. clinical evaluations.