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Archus Receives FDA Green Light To Initiate First Spinal Facet Implant Trial 

This article was originally published in The Gray Sheet

Executive Summary

Archus Orthopedics' March 28 receipt of investigational device exemption approval for its Total Facet Arthroplasty System for treating spinal stenosis furthers the firm's first-to-market goal

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Archus Orthopedics

Johnson & Johnson/DePuy Spine makes the principal investment in the Redmond, Wash. firm's $35 mil. Series C financing round closed Jan. 18, establishing "a framework for future collaboration between Archus and DePuy," according to Archus. FDA granted an investigational device exemption in March for the company's Total Facet Arthroplasty System as a mobility-preserving alternative to spinal fusion following back surgery performed on patients with facet degeneration (1"The Gray Sheet" April 4, 2005, p. 19). Archus has said it will not likely launch the product in the U.S. or Europe, where it already has a CE Mark, without corporate partnership...

Archus Orthopedics

Johnson & Johnson/DePuy Spine makes the principal investment in the Redmond, Wash. firm's $35 mil. Series C financing round closed Jan. 18, establishing "a framework for future collaboration between Archus and DePuy," according to Archus. FDA granted an investigational device exemption in March for the company's Total Facet Arthroplasty System as a mobility-preserving alternative to spinal fusion following back surgery performed on patients with facet degeneration (1"The Gray Sheet" April 4, 2005, p. 19). Archus has said it will not likely launch the product in the U.S. or Europe, where it already has a CE Mark, without corporate partnership...

J&J Looks To Broaden Spine Offerings, Considers DTC Ads For Charité

Johnson & Johnson is pursuing alternate spinal technologies to address Charité artificial lumbar disc limitations, which are hindering adoption of the device as a stand-alone, total spine treatment

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