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Article: Curis' OP-1 Receives HDE Status in the United States; Third Major Market Approval for Regenerative Product.
- Article from:
- Business Wire
- Article date:
- October 18, 2001
CopyrightCOPYRIGHT 2001 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Attention Business & Science Editors
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 18, 2001
Curis, Inc. (NASDAQ: CRIS) today reported that the U.S. Food and Drug Administration (FDA) has granted Stryker Corporation (NYSE: SYK) Humanitarian Device Exemption (HDE) status for Curis' regenerative product OP-1. The approved indication is for use as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. Stryker reported that commercial launch of the OP-1 Implant in the U.S. is expected to commence later this quarter.
The approval marks the third regulatory clearance for ...