Calypso Medical Technologies, Inc. announced that its Calypso® 4D Localization System and Beacon® electromagnetic transponder manufacturing process has been certified by the International Organization for Standardization (ISO)

Calypso® Medical Receives ISO Certification for the Calypso® 4D Localization System 

Seattle, WA – June 18, 2007 – Calypso Medical Technologies, Inc. announced that its Calypso® 4D Localization System and Beacon® electromagnetic transponder manufacturing process has been certified by the International Organization for Standardization (ISO). 

ISO 13485 sets standards ensuring a comprehensive management system is used for the design and manufacture of medical devices. The certification status by the ISO demonstrates Calypso Medical meets an international set of standards and guidelines that are becoming vital components of business transactions, global trade and regulatory requirements.

The Calypso® 4D Localization System utilizes proprietary electromagnetic technology in conjunction with implanted Beacon® electromagnetic transponders in the prostate. The system is designed to enable doctors to accurately and objectively setup radiation therapy treatment and then measure and monitor organ motion during radiation therapy delivery for cancer patients. 

“Our quality system has been in place since we started production last year,” said John Stevens, vice president, manufacturing for Calypso Medical. “It is a true measure of any company to be ISO certified -- particularly for a medical device company. We are thrilled with the designation.” 

Senior Director of Quality Systems and Regulatory Affairs, Marcia Page added, “This is a key step in our corporate development, reinforcing our commitment to product quality and customer satisfaction. Calypso Medical has built a strong foundation to develop medical devices that deliver the highest level of accuracy and precision possible in cancer therapy.” 

The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the Calypso® 4D Localization System and Beacon® electromagnetic transponders for use in the prostate in July, 2006. 

Based in Switzerland, ISO is a global network that identifies what international standards are required by business, government and society. It then develops them in conjunction with the sectors that will put them to use and delivers them to be implemented worldwide. 

The Calypso® 4D Localization System product platform is designed to provide objective, accurate and continuous, real-time tumor location information during external beam radiation therapy without adding ionizing radiation. Continuous knowledge of the tumor location is expected to provide greater confidence to clinicians and patients when they know that the radiation beam is always on target. Because the product platform does not require expertise in interpreting x-ray or ultrasound images, it greatly reduces the time to perform patient setup, a well-recognized bottleneck in the radiation department workflow. 

“This is yet another step in broadening potential markets, particularly globally,” said Eric Meier, president and CEO of Calypso Medical. “The certification reflects the countless hours of dedication by our team and associates and we are proud of this accomplishment.” 

About Calypso® Medical Technologies, Inc.
Calypso Medical Technologies, Inc. (“Calypso”) is a Seattle, WA based privately held medical device company founded in 2000. The Company’s proprietary tumor localization system utilizes miniaturized implanted devices (Beacon® electromagnetic transponders) to continuously, accurately, and objectively pinpoint the location of tumors for improved accuracy in radiation therapy. Calypso addresses two major issues in modern radiation oncology: errors in treatment set-up and tumor motion during treatment. In addition, the Calypso® 4D Localization System’s non-ionizing electromagnetic guidance has the potential to improve work flow efficiency and treatment room utilization. The technology is designed for body-wide cancers commonly treated with radiation therapy, including prostate, breast, lung, head, neck and other radiation therapy target organs. In July 2006, Calypso received 510(k) clearance from the FDA to market the product for use in the prostate only and commercialization commenced Q4 2006. 

Calypso®, Beacon® and GPS for the Body® are registered trademarks and Motion Matters™, Nothing Tracks Like the Beacon™, Calypso Within™, Beacon Within™, and
On Target, On With Living™ 

ISO 13485:2003 Certificate (2.33 MB)

20070618_isocertificate.pdf