Raymedica Announces Marketing Approval in China

Marketing approval from the State Drug Administration of China (SDAC) to begin commercialization of the company's PDN prosthetic disc nucleus in China has been announced by Raymedica, Inc. (Minneapolis, MN, USA), the manufacturer of the PDN device.

The PDN device is designed to treat patients with chronic lower back pain due to degenerative disc disease that have not responded to nonsurgical alternatives. It is made of a hydrogel material intended to support the bones of a patient's spine while allowing for more normal flexibility and movement than spinal fusion.

Raymedica has worked closely with two medical device distributors in China to obtain the marketing approval. The company also held surgical technique workshops in Beijing, Shanghai, and Guangzhou, where its medical directors lectured and demonstrated the PDN implant technology. In addition, 12 surgeons from China have been trained on PDN implant techniques through seminars and workshops in Vienna (Austria) and Memphis (TN, USA). Raymedica states that China is the second-largest market in Asia for medical device exports from the United States, after Japan.

"Our recently introduced PDN-SOLO device is especially well-suited for patients with smaller bone structures and the Asian market,” said Tony Phillips, president and CEO of Raymedica. "Both distributors have extensive experience importing spinal implant technology and have deep relationships with key spine surgeons throughout China.”




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