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OtisMed Corporation Awarded ISO 13485 Certification

10/8/2008 6:26:01 AM

ALAMEDA, Calif.--(BUSINESS WIRE)--Orthopedic technology company OtisMed Corp., a privately held company dedicated to providing new solutions for complex clinical problems in orthopedics, has been awarded ISO 13485:2003 certification for its quality management system by one of the world’s largest notified bodies, BSI Management Systems. The international standard for the medical device industry, ISO 13485:2003 verifies OtisMed’s ability to provide medical devices and related services that consistently meet customer needs and quality requirements around the world.

“The ISO 13485:2003 certification process has been a major business initiative for OtisMed and reflects our commitment to manufacturing high-quality products,” said Charlie Chi, Ph.D., co-founder and chief executive officer of OtisMed. “Achieving ISO 13485 certification demonstrates superior quality for our customers and partners.”

ISO 13485:2003 is a stringent, globally recognized standard for quality management systems for medical device manufacturers and service providers.

OtisMed’s OtisKnee is a new technique that for the first time allows surgeons to offer custom-fit knee replacement. Using OtisKnee, orthopedic surgeons can precisely match the size and placement of the knee implant to the patient’s unique and normal (non-arthritic) anatomy. Based on OtisMed’s proprietary ShapeMatch™ technology, this new tailored approach provides surgeons with patient specific-cutting guides that allow them to optimize implant fit and alignment while preserving more bone and ligaments.

Since its limited U.S. launch in June of 2007, the OtisKnee method has been performed by more than 450 surgeons on more than 8,000 patients. OtisKnee surgeons and patients have reported quicker recovery times, less pain and greater return to function than with traditional and computer-assisted total knee replacement techniques. OtisKnee surgeons have also reported reduced surgical times, simplified surgical set-up and quicker patient discharge.

About OtisMed Corporation

OtisMed Corporation is a privately held, ISO 13485:2003 certified orthopedic technology company dedicated to providing new solutions for complex clinical problems in joint replacement. OtisMed’s focus is on developing and commercializing highly accurate and cost effective surgical solutions that are customized to each patient. OtisMed’s initial offering is the OtisKnee, a groundbreaking new product that enables surgeons to offer custom-fit total knee replacement. With OtisKnee, surgeons can for the very first time match the size and placement of the implant to the patient’s unique and normal (non-diseased) knee anatomy.

Founded in 2005, the company has received funding from Kleiner Perkins Caufield & Byers. For more information, call 888-OTISMED or visit

OtisKnee® and ShapeMatch™ are registered trademarks of OtisMed Corp. U.S. and foreign patent applications are pending.


Nobles Communications Betsy Merryman, 310-560-8176

Source: OtisMed Corporation

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