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...
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