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Carticept Medical Receives 510(k) Clearance for Navigator(TM) Delivery System


7/20/2011 7:16:31 AM

ALPHARETTA, Ga.--(BUSINESS WIRE)-- Carticept Medical, Inc., a developer of innovative products for the treatment of cartilage injuries and osteoarthritis, today announced that it has received clearance from the Food and Drug Administration to market its Navigator Delivery System (Navigator DS) in the United States.

The Navigator DS is a computer-controlled, drug delivery system designed to automate preparation and delivery of pain relieving medications for joint pain. The system prepares physician-prescribed injections from standard multi-dose anesthetic and steroid drug vials. In addition to eliminating multiple needle exposures to health care workers and minimizing the potential for contamination of the medication, automating this procedure ensures accurate dose preparation and saves significant labor for a busy physician practice. The injection is then delivered into the painful joint under precise computer control. The Navigator DS automates accurate medical record keeping by recording the treatment data for transfer to an electronic record management system or direct print-out.

“The Navigator DS is the first injection system of its kind,” said Timothy J. Patrick, President and Chief Executive Officer of Carticept. “Receiving FDA clearance is an important milestone for Carticept Medical that will allow us to launch this proprietary technology to the U.S. orthopedic and sports medicine market.”

“This technology can be a valuable tool for the accurate and efficient delivery of injections,” said John Reach, MD, Director, Yale Foot and Ankle Service, Department of Orthopaedic Surgery, Yale University School of Medicine. “This system can significantly enhance practice logistics and increase patient throughput in orthopedic and sports medicine clinics.”

About Carticept Medical™, Inc.

Based in Alpharetta, Ga., Carticept Medical, Inc. is a privately held medical device company established in 2005 to develop innovative solutions for patients with osteoarthritis or cartilage damage. Major investors include Domain Associates, New Enterprise Associates and SonoSite, Inc. Additional information is available on the company's web site at www.carticept.com.

Contact:

Carticept Medical, Inc.Barry Hassett, 770-754-3800Vice President, Marketing


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