Calypso Medical Technologies, Inc., Announces AIM Clinical Study for Prostate Cancer Patients.

Study Underway to Assess the Impact of Treatment Margin Reduction and Motion Management on Clinical Outcomes with Calypso System

SEATTLE -- Calypso Medical announced the launch of the AIM Clinical Study (Assessing the Impact of Margin Reduction) using Calypso Medical's GPS for the Body[R] technology for patients receiving radiation therapy for prostate cancer. The primary objectives of the study are to evaluate acute and chronic quality-of-life assessments and complications related to external beam radiation therapy in prostate cancer patients when the Calypso[R] 4D Localization System is used for managing motion.

The study protocol recommends the delivery of high doses of radiation (81 Gy) to the prostate during 45 treatment sessions with tighter treatment margins while using the Calypso System to manage prostate motion. 21st Century Oncology is one of the first cancer centers to participate in the study at their locations in Cape Coral and Plantation, Fla.(Principal Investigator Constantine Mantz, MD), Santa Monica, Calif. (Co-Investigator David C. Khan, MD), and Scottsdale, Ariz., (Co-Investigator Scott Tropper, MD).

Patient enrollment is already underway in the 300-patient study. "Calypso Medical's technology allows clinicians to manage motion as it occurs and adapt treatment, ensuring that the tumor target is always aligned with the radiation beam. With the higher doses and tighter treatment margins used in the AIM Study, motion management becomes even more essential," says Eric Meier, CEO and President of Calypso Medical.

Earlier clinical studies using the Calypso System revealed important new information about prostate motion, which was found to be variable and unpredictable, patient-to-patient, day-to-day and even moment-to-moment. If motion goes unchecked during treatment, complications can result from off-target irradiation. The most common complications associated with prostate radiation therapy include urinary, rectal and sexual complications, which can be both acute and chronic.

"The data from this study will reinforce the importance of the management of prostate motion during daily treatment with tight treatment margins. Calypso's technology enables radiation oncologists to treat patients with confidence that the tumor target is continuously aligned with the radiation beam throughout each treatment session. Since we treat patients with tight margins daily for 40 to 45 days, it is critical we know where the prostate is at all times. The clinical goal is to achieve the best control of the cancer while minimizing side effects," notes Constantine Mantz, MD, 21st Century Radiation Oncology, Radiation Oncologist and Principal Investigator.

Criteria for patient eligibility in the clinical study may be found on the National Institutes of Health clinical trial Web site registry: www.clinicaltrials.gov. Inquiries for information about the study are directed to Calypso Medical at 1-888-48-TRACK or [e-mail].

About Calypso[R] Medical

Calypso[R] Medical Technologies, Inc. ("Calypso") is a Seattle, WA-based privately held medical device company. The Company's proprietary tumor localization system utilizes miniaturized implanted devices (Beacon[R] electromagnetic transponders) to continuously, accurately, and objectively pinpoint and track the location of tumors for improved accuracy and management of radiation therapy delivery. Calypso addresses two major issues in modern radiation oncology: errors in treatment set-up and tumor motion management during treatment. In addition, the Calypso[R] 4D Localization System's non-ionizing electromagnetic guidance has been found to improve workflow 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. The products are FDA 510(k) cleared for use in the prostate and post-operative prostatic bed.