Calypso Medical to showcase FDA cleared Dynamic Edge Gating Technology at 52nd ASTRO

Nov 1 2010

Calypso Medical Technologies, Inc., a developer of real-time localization technology used for the precise tracking of tumor targets, today announced it will showcase Dynamic Edge^™ Gating Technology, recently cleared by the U.S. Food and Drug Administration, at the 52^nd Annual Meeting of the American Society for Radiation Oncology (ASTRO), now underway at the San Diego Convention Center. This latest innovation of the Calypso^® System automates the response to organ motion that occurs during the delivery of radiation to prostate cancer tumors in order to protect healthy tissue from unintended radiation. Demonstrations will be available at the Calypso booth (number 1236) as well as the Varian Medical Systems booth (number 201) and Siemens Medical Solutions booth (number 2715). Dynamic Edge Gating Technology extends the Calypso System's safeguard against unnecessary radiation and complements ASTRO's Target Safely initiative announced earlier this year in response to public concern over excessive radiation delivery caused by equipment and operator error.

“A hallmark of the Calypso System is its ability to accurately target the cancer and protect adjacent healthy tissue by displaying, in real-time for each moment of every patient treatment session, the type and degree of organ motion present”

Dynamic Edge Gating Technology allows therapists to set motion thresholds which disable radiation delivery if the targeted tissue moves outside the preset threshold. The Calypso System, which provides target position information in the form of objective data, previously 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. As a result, this technology may enable a further decrease in the side effects associated with prostate radiotherapy, such as bowel and bladder incontinence and sexual dysfunction, because healthy tissue is protected from receiving radiation intended for the tumor.

A May 2010 study in Urology, "Assessing the Impact of Margin Reduction (AIM)," demonstrated that patients whose radiotherapy delivery was guided by the Calypso System experienced a significant decrease in the side effects associated with prostate radiation treatment. Using Calypso's real-time tracking, physicians were able to decrease the treatment margin of irradiated healthy tissue surrounding the tumor to just a few millimeters. Because less healthy tissue received radiation, patients reported fewer side effects. Combining the decreased treatment margins of the AIM study with the automated radiation beam response of Dynamic Edge Gating has the potential to further reduce prostate radiation therapy side effects since the radiation beam will now be enabled or disabled automatically, based on objective motion threshold data, as opposed to manual intervention by the therapist.

"A hallmark of the Calypso System is its ability to accurately target the cancer and protect adjacent healthy tissue by displaying, in real-time for each moment of every patient treatment session, the type and degree of organ motion present," said Lorraine Marshall Wright, chief marketing officer and vice president of Calypso Medical. "The automatic response to organ motion of Dynamic Edge Gating should give treating physicians the confidence to decrease treatment margins, as shown in the AIM study, and ensure their patients experience the curative benefits of radiation therapy and fewer of the potential side effects."

The Calypso System, with its GPS for the Body^® technology, utilizes miniature 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. In contrast to other tumor targeting solutions, the Calypso System provides continuous tumor position information, objectively and without ionizing radiation, thereby enabling an increase in the radiation delivered to the tumor while reducing radiation misapplied to normal tissue.

In addition to showcasing Dynamic Edge Gating, Calypso technology is the topic of 17 scientific presentations and posters, including prostate SBRT, real-time couch tracking, post-operative radiotherapy to the prostatic bed and target rotation. Several presentations focus on investigational applications of the Calypso System for use in pancreatic, lung and cervical cancers.

Information about the oral presentations referenced in this news release is listed below:

• A Phase II Trial of Real-Time Target Tracking SBRT for Low-Risk Prostate Cancer Utilizing the Calypso 4D Localization System: Patient Reported Health-Related Quality of Life and Toxicity, Mantz et al., 21^st Century Oncology.
• Electromagnetic Monitoring and Real-Time DMLC Adaptation to Account for Target Rotation During Radiotherapy: First Dosimetric Results, Wu et al., Stanford University, Stanford, Calif.
• Calypso 4D Localization and CBCT Evaluation of Cervical Motion During External Beam Radiotherapy for Intact Cervix Cancer, Gatacombe et al., Emory University, Atlanta, Ga.

Information about poster presentations referenced in this news release is listed below:

• Real-Time Couch Tracking for Prostate Cancer - Towards Submillimeter Accuracy, Guckenberger et al., Julius-Maximilians University, Wuerzberg, Germany.

• Feasibility of Fiducial-Based Electromagnetic Tracking for Postoperative Radiotherapy to the Prostate Bed, Noel, Michalski, Parikh et al., Washington University School of Medicine, St. Louis, Mo.
• Accuracy of Bronchoscopic Implantation of an Anchored Beacon^® Transponder in a Cadaveric Human Lung Tumor Model, Gorden, Mayse et al., Swedish Medical Center, Seattle, Wash.; Washington University School of Medicine, St. Louis, Mo.
• The Role of Calypso 4D Beacon Transponders in Monitoring Interfraction Motion in the Definitive Treatment of Unresectable Pancreatic Cancer, Shinohara et al., University of Pennsylvania, Philadelphia, Pa.