WIRE)–IsoRay, Inc. announced it has shipped its first GliaSite® radiation therapy system. The Company initiated
sales after receiving final approval this week from the State of Washington
Department of Health to manufacture its GliaSite® radiation therapy system. The
GliaSite® radiation therapy system is a balloon catheter device used in the
treatment of brain cancer. Having already received FDA clearance, the Washington State
regulatory approval opened the door for sales of IsoRay’s GliaSite® brain
cancer treatment in the United
IsoRay CEO Dwight Babcock says inquiries are on the rise,
“News of final regulatory approval has generated a great deal of interest
throughout the medical community in the U.S. and internationally. We are
hearing from physicians as well as brain cancer patients who are seeking treatment
options for Glioblastomas and metastasized brain cancers.”
The GliaSite® radiation system offers an innovative
alternative that presents an important advance over previous brain cancer
treatments. Doctors are able to use the system to directly place a specified
dosage of liquid radiation in areas where cancer is most likely to still remain
after completion of brain tumor removal. The ability to precisely place a
specified dosage of this form of radiation means there is less likelihood for
damage to occur to healthy brain tissue compared to other alternative
treatments. Importantly, the GliaSite® radiation treatment diminishes the
ability of the tumor to recur which means important benefits for patients in
longevity as well as quality of life.
The news comes as the Company is moving forward to achieve
FDA clearance of liquid Cesium-131 for use with the GliaSite® radiation system.
IsoRay is the exclusive manufacturer of Cesium-131 for cancer treatment. In its current form, the
pioneering brachytherapy treatment represents one of the most
important advancements in internal radiation therapy in 20 years. In other
developments, CEO Babcock revealed that discussions are already underway
regarding the application of Cesium-131 for treating cancers in other body
sites including breast and esophageal cancers.
Babcock says he views the latest developments as just the
beginning of important benefits from GliaSite® for the company, too. “We
expect GliaSite® to be a tremendous revenue generator. It is my sense that it
will fuel other important opportunities for IsoRay’s growth and
IsoRay holds exclusive worldwide distribution rights for the
GliaSite® radiation therapy system as well as exclusive worldwide licensing
rights to Iotrex®, a liquid iodine radiation for use in brain cancer treatment.
Prior to the Company’s acquisition of the GliaSite® technology, approximately
500 GliaSite® cases were performed annually at some 40 hospitals worldwide.
The GliaSite® system has established reimbursement for both
in-patient and out-patient settings. In addition to its CMS codes, Cesium-131
is FDA-cleared in seed form for the treatment of prostate cancer, lung cancer, ocular melanoma cancer, brain cancer, colorectal cancer,
gynecologic cancer, and head and neck cancer and other cancers throughout the body.
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc., is the sole
producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy
options throughout the body. Learn more about this innovative Richland, Washington
company and explore the many benefits and uses of Cesium-131 by visiting www.isoray.com.
Posted by Sean Fenske, Editor-in-Chief, MDT