Healthcare Industry News:  Calypso Medical 

Devices Oncology FDA

 News Release - August 8, 2006

Calypso Medical Receives FDA 510(k) Clearance for the Calypso(R) 4D Localization System

First Continuous, Real-Time Method to Locate and Continuously Track Tumor Motion During Cancer Treatment

SEATTLE, Aug. 8 (HSMN NewsFeed) -- Calypso Medical Technologies, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CalypsoŽ 4D Localization System, which utilizes proprietary electromagnetic technology in conjunction with implanted BeaconŽ transponders, in the prostate. The product platform is designed to provide objective, accurate and continuous tumor location information during external beam radiation therapy without adding ionizing radiation.

The American Cancer Society estimates 233,000 new cases of prostate cancer will be diagnosed in 2006 and it is the most diagnosed cancer among men in the United States. The Calypso System offers the only available means to continuously and objectively monitor prostate organ motion during radiation therapy, a primary treatment for the majority of prostate cancer patients.

The Calypso System is designed to enable clinicians to measure and monitor organ motion during radiation therapy for cancer patients. Continuous knowledge of the tumor location is expected to provide greater confidence to clinicians and patients 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.

The Calypso System was evaluated in clinical studies in patients undergoing prostate radiation treatment between 2003 and 2006 at leading cancer centers including M. D. Anderson Cancer Center Orlando, Cleveland Clinic, The Nebraska Medical Center, Virginia G. Piper Cancer Center at Scottsdale Healthcare, Sharp Memorial Hospital, University of Michigan Comprehensive Cancer Center, and University of California at San Francisco Medical Center. In these studies, investigators documented that clinically-relevant prostate motion was present during the delivery of radiation and could be responded to in real-time, ensuring that the radiation beam remained on target.

"The product is easy to use and provides important information regarding the location of the tumor," said Patrick J. Kupelian, MD, director of clinical research for radiation oncology at the M. D. Anderson Cancer Center Orlando. "This is exciting technology that could have a significant impact on the management of a number of diseases that we treat with radiation therapy."

Charles Enke, MD, radiation oncologist of the Nebraska Medical Center, said, "We have been pleased with the Calypso System. Our radiation therapists found it easy to use, and it provides significant peace of mind for both physicians and patients because now I always know where the tumor target is located. With its continuous monitoring capabilities, I have greater confidence in the precision of the radiation treatment as well as the ability to act upon prostate motion when it exists."

Clinical results from the company's recently completed clinical study will be presented at the American Society for Therapeutic Radiology and Oncology (ASTRO) in November.

"One of the key limitations in the advancement of radiation therapy has been identifying precisely where the tumor target is at all times," said Timothy P. Mate, MD, radiation oncologist of the Seattle Prostate Institute at the Swedish Medical Center, a well-recognized leader in prostate cancer treatment. "The Calypso System is world's first truly continuous, real-time method available to locate and internally track tumors during radiation delivery. It provides a level of knowledge that has only been hoped for in the past and will significantly contribute to future treatment advances." Swedish Medical Center participated in pilot evaluations of the product and continues to be a key advisory group for Calypso Medical.

Eric Meier, president and CEO of Calypso Medical, said, "We have received a great deal of interest in the Calypso System based on its ability to increase clinical confidence while improving workflow efficiency in the radiation therapy department. Given its unique continuous monitoring capability, this platform has the potential to enhance the utility of radiation therapy techniques such as intensity modulated radiation treatment (IMRT) and other technologies such as volumetric imaging. We look forward to launching the platform later this year and continuing to work with clinicians to enable them to better manage their response to organ motion with guidance from the Calypso System."

About CalypsoŽ Medical Technologies, Inc.

Calypso Medical was founded in 2000 and is a privately held medical device company located in Seattle, Washington. The Company and its employees are dedicated to enabling organ motion monitoring solutions that improve the delivery of radiation therapy throughout the body. Calypso Medical is a pioneer in solutions designed to accurately, objectively and continuously locate and align targets from inside the body without the addition of ionizing radiation. Its AC electromagnetic localization platform, the CalypsoŽ 4D Localization System with implanted BeaconŽ transponders, received FDA 510(k) clearance July 28, 2006. Additional information can be found at

Source: Calypso Medical Technologies

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