Real-time Technology that Stops Prostate Radiation Therapy When Tumor Moves Outside Target Zone to be Highlighted

SEATTLE—July 15, 2010—Calypso Medical Technologies, Inc., a developer of real-time localization technology used for the precise tracking of tumor targets, today announced it will demonstrate radiation safeguard features of the Calypso System at the 52nd Annual Meeting of the American Association of Physicists in Medicine (AAPM). The conference will take place July 18-22 at the Philadelphia Convention Center (booth #545).  

Dynamic Edge™ Gating Technology*, the latest innovation of the Calypso System, allows therapists to set motion thresholds which disable radiation delivery if the targeted tissue moves outside the preset threshold.  Previously the Calypso System, which provides target position information in the form of objective data, relied upon the therapist to manually intervene and halt radiation delivery when healthy tissue was in danger of receiving unintended radiation.  Dynamic Edge Gating Technology automates this function and provides an immediate response so the radiation beam is automatically disabled or re-enabled in response to organ motion.  The Company expects to submit its application for regulatory clearance for this feature to the U.S. Food and Drug Administration during the third quarter.  Following regulatory clearance, the Dynamic Edge Gating feature will be compatible with Siemens and Varian linear accelerators.

“Dynamic Edge Gating Technology leverages the real-time data output of the Calypso System to automate and further improve the precision of radiation therapy delivery,” said Lorraine Marshall Wright, vice president and chief marketing officer of Calypso Medical. “By automating the response to target motion with a signal to disable the radiation beam, our system safeguards patients against overdosing healthy tissue and underdosing the cancer.”

The Calypso System, with its GPS for the Body® technology, utilizes implanted Beacon® transponders to provide precise, continuous information on the location of the tumor during external beam radiation therapy. Any movement by the patient, including internal movement of the tumor, may cause the radiation to miss its intended target and hit adjacent healthy tissue. The real-time position information provided by the Calypso System allows physicians to deliver maximum radiation directly to the tumor while sparing the surrounding healthy tissues and organs from exposure.

In contrast to other guidance techniques, Calypso’s electromagnetic technology is the only non-ionizing guidance solution to keep the treatment precisely focused on the target without adding unnecessary radiation.  Calypso technology is designed for body-wide applications and is currently cleared by the U.S. Food & Drug Administration (FDA) for use in radiation therapy for the prostate and prostatic bed.

The Calypso Medical booth will also highlight a recent clinical outcomes study published in the May issue of Urology, entitled, “Assessing the Impact of Margin Reduction (AIM),” which  demonstrated that prostate tumor tracking utilizing the Calypso System during high-dose intensity-modulated radiotherapy (IMRT) allowed physicians to deliver high dose radiation therapy within a smaller planning target volume (PTV) margin.  During the study, patients treated with reduced margins and Calypso real-time tracking had a significant reduction in treatment-related side effects.   

Data from ten additional scientific studies will be presented at the AAPM Annual Meeting that demonstrate the value of Calypso’s real-time tracking of the prostate during external beam radiation therapy. Information about selected studies featuring Calypso technology is listed below.

* This technology is currently in development and not available for sale.

AAPM Booth #545

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Patient-Specific Rotational Tolerances and Margins Based On Prostate Shape
D. Litzenberg, et al., University of Michigan, Ann Arbor, Mich.

Accurate Modeling of Calypso KVue Couch for Pinnacle SmartArc Based Elekta VMAT Prostate Treatments
C. Wu, et al., Radiological Associates of Sacramento, Sacramento, Calif.

Electromagnetic Detection and Real-Time DMLC Correction of Rotation During Radiotherapy
J. Wu, et al., Stanford University, Palo Alto, Calif.

A Single Phantom Study for the Evaluation of Accuracy of Three IGRT Techniques
T. Djemil, Ph.D., et al., Cleveland Clinic Foundation, Cleveland, Ohio

Motion Pattern of Electromagnetic Transponders Implanted in the Prostate Gland
T. He, Ph.D., et al., Oregon Health & Science University, Portland, Ore.

Effective Tracking of Intrafractional Organ Motion Due to Breathing Using a Siemens 160 MLC
A. Krauss, et al., German Cancer Research Center (DKFZ), Heidelberg, Germany

Direct Investigation of Geometric Coincidence Among Calypso System, Onboard KV Imaging, and MV Treatment Beam Imaging
W. Mao, et al., UT Southwestern Medical Center, Dallas, Texas

A Comparative Study for Daily Localization with 3D Ultrasound, Cone Beam CT, Implanted Prostate Fiducial Markers and Calypso 4D Localization System for Patients Undergoing IGRT for Prostate Cancer
T. Neicu, et al., Henry Ford Health System, Detroit, Mich.

Failure Mode and Effect Analysis (FMEA)-Based Quality Assurance for Dynamic MLC Tracking Systems
A. Sawant, et al., Stanford University Cancer Center, Palo Alto, Calif.

Electromagnetic Transponders Indicate Prostate Size Increase Followed by Decrease During and After a Course of External Beam Radiation Therapy
W. Butler, et al., Wheeling Hospital, Wheeling, W. Va.

AAPM FINAL 07 14 10.pdf