News | September 21, 2008

Calypso Medical’s New PROBE Study Focuses on Prostatectomy Patients

September 22, 2008 - Calypso Medical Technologies Inc. today revealed the initiation of its latest clinical study, the PROBE clinical study (Prostatic Bed Experience with the Calypso 4D Localization System) to guide delivery of intensity modulated radiation therapy (IMRT) in prostate cancer patients following radical prostatectomy.

Certain men who have undergone a prostatectomy remain at high risk for recurrence. It is in these patients that adjuvant radiation therapy has been shown to be beneficial. In addition, some patients who have had a recurrence following surgery can benefit from salvage radiation. These patients are expected to further benefit from real-time prostate bed tracking using the Calypso System. Rajanish Singla, M.D., a radiation oncologist at Metropolitan Urological Specialists in St. Louis, MO., is the principal investigator for the PROBE study.

The Calypso 4D Localization System is FDA 510k cleared for use in post-operative prostate bed tissue. This technology provides clinicians with a new option to improve the accuracy and precision of radiation therapy treatment. The Calypso System reportedly gives the clinician the added confidence to safely deliver high-dose radiation therapy treatment.

“Patients who have had radical surgery to have the prostate removed have special needs when receiving radiation therapy,” said Steven Biggs, M.D., urologist with the Metropolitan Urologist Specialists Group. “It gives me confidence to know that the tissue target is aligned with the radiation beam during treatment delivery. It also gives the patient peace of mind that we are doing everything possible to avoid side effects of off-target irradiation to the bowel and bladder,”

Known as GPS for the Body technology, the Calypso System utilizes implanted Beacon transponders, smaller than a grain of rice, to enable continuous tracking of the targeted tissue during radiation treatment. When the prostate is removed, the Beacon transponders offer an objective method to locate the prostatic bed tissue and ensure the target is positioned correctly throughout daily treatment, all without the need of daily X-rays. If the target moves during treatment, the radiation beam may irradiate other healthy tissues nearby, including the bladder, rectum and sexual organs, therefore causing side effects.

Calypso Medical received FDA clearance to market the product for post-operative application in prostatectomy patients with recurrent cancer earlier this year.

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