Healthcare Industry News:  Calypso Medical 

Devices Oncology

 News Release - September 21, 2008

Calypso Medical Announces First Post-Operative Prostatectomy Patient Implanted in Clinical Study to Track Tissue Motion during Radiation Therapy

SEATTLE & BOSTON--(HSMN NewsFeed)--Calypso Medical Technologies, Inc. today announced 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 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. 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,” notes Dr. Steven Bigg, urologist with the Metropolitan Urologist Specialists Group.

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. Cancer centers with the Calypso System immediately began to offer this innovative treatment guidance option to patients with recurrent prostate cancer. Eric Horwitz, MD, radiation oncologist at Fox Chase Cancer Center in Philadelphia, Pa., states, "At Fox Chase, real-time tracking during every fraction for our prostate and now post-prostatectomy patients is the standard of care. The Calypso® System is the only technology that gives us the ability to identify the target every second of every treatment."

Leading cancer institutions have reported on the value that highly targeted radiation therapy provides for post-operative prostate cancer patients. Improved targeting can further reduce toxicity and allow for the potential of higher doses to be delivered safely. Recent studies reveal that a significant dose response exists for post-operative salvage radiation therapy to the prostate bed. These studies show that salvage radiation therapy should receive a prostate bed dose of at least 70 Gy.

“The FDA clearance of this indication broadens the clinical utilization of our platform and benefits even more prostate cancer patients. Calypso Medical actively supports clinical researchers to assist in the development of new applications for our innovative platform. We are pleased that cancer centers throughout the country can now offer improved targeting to their post-operative patients with recurrent prostate cancer,” states Eric R. Meier, president & chief executive officer, Calypso Medical, Inc.

Clinical use of the GPS for the Body® technology will be highlighted in the Calypso Medical Booth 1418 at ASTRO’s 50th Annual Scientific Meeting in Boston, Mass.

About Calypso® 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® 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® 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.

Source: Calypso Medical Technologies

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