Implex Plans To Develop Spine Fusion Cage With Hedrocel Material
This article was originally published in The Gray Sheet
Executive Summary
Implex intends to explore spinal applications for the Hedrocel tantalum cellular biomaterial after reacquiring the rights from orthopedic device manufacturer Sofamor Danek.
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Strategic sales and marketing alliance between Bristol-Myers Squibb's Zimmer subsidiary and privately held Implex gives Zimmer exclusive worldwide distribution rights to Implex's Hedrocel joint reconstruction products. The alliance allows Implex to retain rights to spine and sports medicine products, although Zimmer has the sole right to acquire the entire Implex business at a later date, company reps note. Implex is in the process of submitting an investigational device exemption to FDA for a lumbar interbody fusion device. A cervical interbody fusion device was granted IDE status several months ago. Both devices have received CE marks and are being marketed overseas in a targeted release while Implex lines up distribution in Europe. Previously, Zimmer-competitor Sofamor Danek had licensed the Hedrocel technology, but that deal was scuttled (1"The Gray Sheet" March 30, 1998, p. 21)
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