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FDA Clears Calypso(R) Medical's GPS for the Body(R) for Prostatectomy Patients.

Expanded Indication Increases Potential Patient Population

SEATTLE -- Calypso[R] Medical announced today that the U.S. Food and Drug Administration (FDA) cleared a new indication for the use of implantable Beacon[R] electromagnetic transponders with the Calypso System in external beam radiation therapy. Known as GPS for the Body[R], the Calypso System utilizes transponders to setup and continuously track the position of targeted tissue during radiation treatment. In the event that the tumor site moves outside of acceptable limits, the clinician adapts therapy during daily treatment to ensure the treatment is delivered as prescribed to the cancerous tissue while avoiding adjacent healthy organs. This is the only technology platform designed to provide objective, accurate and continuous tracking information during external beam radiation therapy without adding ionizing radiation. Radiation therapy is the standard of care for patients with a high risk of prostate cancer recurrence or those in whom recurrence has been diagnosed. Previously, GPS for the Body[R] technology was cleared solely for use in patients with an intact prostate. Studies indicate up to 20% of prostatectomy patients are diagnosed with recurrent prostate cancer following surgery and require adjuvant radiation therapy.

David I. Lee, MD, University of Pennsylvania urologist, states, "Patients with high Gleason scores, extracapsular extension, positive surgical margins or seminal vesicle involvement are at risk of developing biochemical failure following radical prostatectomy." He adds, "These patients often need adjuvant radiation therapy. Having the benefit of continuous real-time tracking during radiation therapy is critical to minimizing possible complications associated with external beam radiation therapy. It is imperative to know precisely where the prostatic bed is located during radiation treatment. The objective tracking data, provided by the Calypso System, may be the key to achieving the desired outcomes for these aggressive cases."

"We are extremely pleased to receive the FDA's quick decision on this clearance for expanded indications," says Eric R. Meier, CEO and President of Calypso Medical. "Extending the clinical use of the Calypso System is vital for post-prostatectomy patients at risk or diagnosed with recurrent prostate cancer. Clinicians gain increased confidence when treating these patients. This new indication broadens the spectrum of prostate cancer patients who will benefit from continuous target tracking during radiation therapy."

About Calypso[R] Medical

Calypso 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 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[R] 4D Localization System's non-ionizing electromagnetic guidance has been found 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. The products are FDA 510(k) cleared for use in the prostate and prostatic bed.
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Publication:Business Wire
Date:May 19, 2008
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