Amedica Partners With Chinese Orthopedic Company

Amedica Corporation has announced that it will be partnering with Shandong Weigao Orthopedic Device Company Limited, a subsidiary of Shandong Weigao Group Medical Polymer Company Limited, a medical device company in China specializing in the research and development (R&D), production and sale of spine, trauma and joint orthopedic implants.

According to the April 18, 2016 news release, “Under the distribution agreement, Weigao Orthopedic will have exclusive rights for the sale, marketing and distribution of Amedica-branded silicon nitride spinal implants in the People’s Republic of China, and will abide by minimum annual purchase requirements in Year 1 of 20, 000 units, growing annually to 50, 000 units in Year 6, following regulatory clearance by the China Food and Drug Administration (CFDA). Weigao Orthopedic will leverage its expertise in acquiring CFDA clearance of medical devices, in order to accelerate Chinese clearance of Amedica’s products.”

“With more than 50, 000 minimum unit sales to occur within the first two years following CFDA clearance, this agreement far surpasses total silicon nitride unit sales to-date, and marks a momentous time for Amedica, ” said Dr. Sonny Bal, Chairman and Chief Executive Officer. “This partnership with Weigao Orthopedic allows us to significantly increase our global sales footprint with a large-scale distribution partner who is familiar with the Chinese regulatory landscape. Weigao Orthopedic’s expertise in sales and distribution is an excellent fit for our innovative silicon nitride technology platform. We look forward to this key strategic partnership to distribute our silicon nitride technology into Asian markets that are particularly receptive to bioceramic implants.”

“We are very pleased with this exclusive distributor partnership as we plan to leverage the Amedica brand to offer a truly differentiated product to our broad network of hospitals and medical units in China, ” stated Mr. Gong Jianbo, Chief Executive Officer and Executive Director of Weigao Orthopedic. “We expect the combination of this technically advanced biomaterial with our well-established network to quickly gain significant market share. We also look forward to expanding our partnership beyond spine products and into hip and knee applications. Weigao Orthopedic is well positioned to facilitate the approval and commercial launch of Amedica’s silicon nitride spinal fusion devices in one of the world’s largest healthcare markets.”

Mike Houston, Amedica’s Vice President of Commercialization, told OTW, “A year from now, we would hope to be working with the Chinese FDA with a clear path toward clearance of our unique silicon nitride fusion devices. Furthermore, we anticipate this Chinese distribution agreement will lead to additional partnerships around the globe to aid in furthering our global sales footprint within the year.”