Calypso® 4D Localization System Highlighted in Five Technical Abstracts Presented at the American Association of Physicists in Medicine (AAPM) 46th Annual Meeting 

Company Also Announces Progress in IDE Trial 

SEATTLE – July 21, 2004 — Calypso® Medical Technologies, Inc. today announced that five scientific abstracts demonstrating the accuracy and validity of the Calypso® 4D Localization System will be presented at the American Association of Physicists in Medicine 46th Annual Meeting in Pittsburgh from July 25 to July 29. Using tiny wireless markers, or Beacon® Electromagnetic Transponders, implanted in or near the tumor, the Calypso® System is designed to provide accurate and continuous confirmation of a target’s location for treatment setup and during radiation delivery. 

The abstracts are being presented by leading medical physicists and radiation oncologists from premier comprehensive cancer centers throughout the country on the clinical implantation experience, accuracy of identifying markers, accuracy and stability of the system and exploration of potential clinical utility and principles of operation. 

The Company also announced the progress of its investigational device exemption (IDE) study for the Calypso® System. In the study, investigators evaluated the feasibility of transrectal implantation techniques and positional stability of the Beacon® Electromagnetic Transponders. The Calypso® System then was used to verify the location of the target in prostate cancer patients implanted with Beacon® Electromagnetic Transponders. During an eight-minute data collection session, the patients were evaluated independent of the radiation treatment session. Calypso® Medical expects to complete the IDE study with final investigations in which the Beacon® Electromagnetic Transponders will be used to locate the target during therapy delivery in a new cohort of patients. 

Current methods of marking a tumor’s location for radiation therapy use subjective methods such as permanent tattoos on the skin, x-rays, or ultrasound images to align tumor targets for treatment and thereby lack the ability to continuously locate the target’s movement during treatment. In order to confidently deliver increasingly targeted therapy techniques, improvements in target localization are needed. 

“More than 1.2 million cancer patients receive radiation therapy in the United States each year," said Patrick Kupelian, M.D., director for clinical research, radiation oncology at M. D. Anderson Cancer Center Orlando and a principle investigator in Calypso® Medical’s IDE study. "If clinicians can know a tumor’s exact location during treatment, it will be possible to deliver radiation more effectively while protecting adjacent healthy tissues. Implanted transponders open an era in which clinicians will have significantly more information about the accuracy of radiation therapy."

“Our mission at Calypso® Medical is to address the problems associated with motion during radiation treatment by developing technology that provides accurate, objective and continuous knowledge of the target position during therapy,” said Eric Meier, president and CEO of Calypso® Medical. “The clinical study milestones bring us one step closer to fulfilling our mission and expanding the delivery options for patients undergoing radiation therapy.” 

Principal investigators in the IDE study include Howard Sandler, M.D., professor and associate chair for clinical research, radiation oncology at the University of Michigan Medical Center (Ann Arbor, MI), Mack Roach, III, M.D., professor, radiation oncology, medical oncology and urology, at the UCSF Medical Center (San Francisco) and Dr. Kupelian of M. D. Anderson Cancer Center – Orlando. 

The five technical abstracts presented at the AAPM 46th Annual Meeting in Pittsburgh, July 25-29 include:

Demonstrated Accuracy Performance Stability in Prototype AC Magnetic 4D Localization System in Radiation Therapy Environment, presented by T. Mate, MD, at “Deformable Models and Localization Techniques Scientific Session” on July 29 at 11:10 a.m. in Ballroom B 

Dynamic Accuracy of an AC Magnetic 4D Localization System Prototype, presented by D. Low, PhD, at “Motion Tracking Scientific Session” on July 26 at 4:10 p.m. in Ballroom B 

Positional Stability and Implant Experience of AC Magnetic Beacon® Electromagnetic Transponders Used to Localize Patients for External Beam Radiation Therapy, presented by J. Pouliot, PhD, at “Deformable Models and Localization Techniques Scientific Session” on July 29 at 11:20 a.m. in 
Ballroom B 

The Accuracy of Beacon® Electromagnetic Transponder Coordinate Capture From CT Images, by T. Willoughby, MS, poster on display from Sunday, July 25 to Wednesday, July 28 in Exhibit Hall 

Principles of AC Magnetic Fields for Objective and Continuous Target Localization in Radiation Therapy, by J. Wong, PhD, poster on display from Sunday, July 25 to Wednesday, July 28 in Exhibit Hall

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