Lung Cancer Tumors Successfully Tracked in Real-Time With Calypso System During Daily Radiation Treatment

SEATTLE, WA--(Marketwire - Sep 28, 2011) - ASTRO Booth #2425 -- Calypso Medical Technologies, Inc., the developer of real-time localization technology used for precise tracking of cancerous tumors, today announced two new clinical abstracts substantiating the safety and viability of the Calypso® System and implantation of its proprietary anchored Beacon® transponders in lung cancer patients for enhanced radiation treatment. Results from one abstract -- the first report on results of a prospective clinical study -- indicate that use of Calypso's electromagnetic anchored transponders can be safely and successfully used in patients' lung tumors, which should permit highly accurate delivery of daily radiation to the cancer while minimizing exposure of surrounding healthy tissue.

These abstracts, as well as research on the clinical use of Dynamic Edge™ Gating for managing intra-fraction motion in patients who had a radical prostatectomy prior to prostate cancer radiotherapy, and the first in-human use of linear accelerator gating with electromagnetic tracking are among several clinical posters highlighting the feasibility and safety of Calypso's GPS for the Body® technology at the 53^rd Annual Meeting of the American Society for Radiation Oncology (ASTRO), October 2-6, in Miami Beach, Fla.

"Our research indicates that implantation of Calypso's electromagnetic anchored transponders in lung tumors is feasible and safe," said Professor C.T. Bolliger, director of Respiratory Research and co-chairman of the Division of Pulmonology at the University of Stellenbosch in South Africa, located outside of Cape Town. "It took just 15-20 minutes to successfully implant three anchored transponders in each of the nine patients enrolled in the prospective clinical study, and not one of the patients experienced adverse pulmonary symptoms following the procedure. Furthermore, this technology should enable highly accurate delivery of daily radiation, as well as provide the opportunity to design and deliver more conformal radiation plans for lung cancer patients."

In addition to data on implantation of Calypso's anchored Beacon transponders in lung cancer patients, separate research was performed to characterize free-breathing respiratory motion using Calypso's real-time tracking system. The results are illuminating, as not only was the expected periodic respiratory motion captured, but irregular intrafraction motion was also observed, with use of an external compression device. The presence of this day-to-day variability has not been visible with conventional external monitoring methods and underscores the need for continuous daily monitoring during radiation therapy.

"These findings have important implications for the design of target volumes and margins, and for monitoring daily treatments, which may ultimately lead to safer outcomes for lung cancer patients," said Ed Vertatschitsch, Ph.D., president and chief executive officer of Calypso Medical. "Calypso's non-ionizing ability to track high-velocity target motion during routine daily radiation may expand treatment options for lung cancer patients to include earlier and more aggressive radiation treatment plans."

According to the American Cancer Society, an estimated 221,130 new cases of lung cancer will be diagnosed this year (115,060 among men and 106,070 among women), and the associated mortality at 156,940 will be higher than that of breast, prostate and colorectal cancers combined.

"The growing research and studies underway utilizing the Calypso System during radiation treatment for prostate and lung cancer exemplifies the significance of our real-time localization and tumor tracking technology," said Lorraine Marshall Wright, chief marketing officer and vice president of Calypso Medical. "The early research using real-time tracking during lung cancer radiotherapy is particularly promising, and continuing data underscoring the value of real-time tracking for prostate and prostate SBRT patients is testament to why more than 10,000 patients have opted for radiation therapy with Calypso tracking."

Calypso technology is the topic of several scientific presentations and posters during the ASTRO annual meeting. The company will showcase the Calypso System and Dynamic Edge Gating, as well as host in-booth presentations by industry experts on the use of Calypso with prostate SBRT (stereotactic body radiotherapy). ASTRO is the largest radiation oncology society, with members who specialize in treating patients with radiation therapies. As the world's leading organization in radiation oncology, biology and physics, the Society is dedicated to improving patient care through education, clinical practice and the advancement of science and advocacy.

About the Calypso System
The Calypso System uses GPS for the Body technology to safely guide radiation delivery. The Beacon transponders, currently cleared by the FDA for permanent implantation in the prostate and prostatic bed to provide precise, continuous information on the tumor location during radiation therapy, have been engineered to allow for safe implantation in the lung using a standard bronchoscope and proprietary delivery catheter. Calypso's electromagnetic technology is the only non-ionizing guidance solution that uses internal markers to keep the radiation beam precisely focused on the tumor in real-time, without adding unnecessary radiation. Dynamic Edge Gating technology allows therapists to set motion thresholds that disable radiation delivery if the targeted tissue moves outside of a clinician-defined preset threshold. If healthy tissue is in danger of receiving unintended radiation, the Dynamic Edge Gating technology provides an automated response so the radiation beam can be disabled or re-enabled in response to organ motion. The Calypso System has been used to treat more than 10,000 patients worldwide during prostate cancer radiation therapy.

About Calypso Medical Technologies, Inc.
Calypso Medical is a privately held medical device company headquartered in Seattle. Its proprietary tumor localization system is designed for body-wide cancers commonly treated with radiation. Utilizing miniaturized, non-ionizing implanted devices called Beacon® electromagnetic transponders, the Calypso System continuously and accurately tracks the location of cancerous tumors for the improved precision and safe management of radiation for cancer treatment. The real-time position and motion information provided by the Calypso System offers objective reassurance that radiation treatment is delivered precisely to the prescribed target and not to surrounding healthy tissue, thereby improving safety and eliminating unnecessary radiation exposure to patients. The Calypso System was cleared by the U.S. Food & Drug Administration (FDA) for use in radiation therapy for the prostate and post-operative prostatic bed. Additional information can be found at www.calypsomedical.com.

Calypso, GPS for the Body and Beacon are registered trademarks and Dynamic Edge is a trademark of Calypso Medical Technologies, Inc.