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Oct 17, 2011

Calypso Medical Technologies : FDA Grants Calypso Medical IDE Approval for Pivotal Lung Cancer Study

Calypso Medical Technologies
Sept. 27, 2011—Calypso Medical Technologies, Inc., developer of real-time localization technology used for precise tumor tracking, announced that the U.S. Food and Drug Administration (FDA) granted Investigational Device Exemption (IDE) approval for its clinical study evaluating real-time tracking of lung cancer tumors during radiation delivery. Patient enrollment is planned at Washington University in St. Louis, and the Cancer Treatment Centers of America in Tulsa, Oklahoma. Investigators in the United States will implant three anchored Beacon® transponders in patients’ lungs and use the Calypso® System to precisely track tumor location and movement during lung cancer radiation therapy.

“We are very pleased to see Calypso begin the U.S. portion of this important clinical study to assess the clinical experience and safety of anchored transponders in the small airways of patients with lung cancer,” said Daniel Nader, DO, FCCP, national clinical director, pulmonary/critical care and interventional pulmonologist at the Cancer Treatment Centers of America at Southwestern Regional Medical Center in Tulsa, Okla. “The five-year survival rate for lung cancer is grim at just 16 percent; however, with the Calypso System’s ability to track this high-velocity repetitive motion, treatment options for lung cancer patients may expand to include earlier and more aggressive radiation treatment.”

Calypso began the pivotal study in October 2010 at Tygerberg Hospital, affiliated with the University of Stellenbosch, in South Africa, located outside of Cape Town. The multi-center study is also underway at the University of Heidelberg in Germany, and the University Hospital Basel in Switzerland. Early data on the implantation of the electromagnetic transponders in lung cancer patients, and the use of the Calypso System for real-time tracking in these patients will be presented at the upcoming American Society of Radiation Oncology (ASTRO) meeting in Miami... Calypso Medical Technologies' Press Release -