American Brachytherapy Society
2013 ABS Annual Meeting
April 18th – April 20th, 2013
Hyatt Regency New Orleans
New Orleans, LA
Visit us at Booth 308
American Association for Thoracic Surgery
2013 AATS Annual Meeting
May 4th – May 8th, 2013
Minneapolis Convention Center
Visit us at Booth 0743
American Association of Physicists in Medicine
2013 AAPM Annual Meeting
August 4th – August 8th, 2013
Indiana Convention Center
American society for Radiation Oncology
ASTRO's 55th Annual Meeting
September 22nd – 24th, 2013
Georgia World Congress Center
Visit us at Booth 2736
Congress of Neurological Surgeons
2013 CNS Annual Meeting
October 19th – October 23th, 2013
San Francisco, CA
Society for Neuro-Oncology
2013 World Federation of Neuro-Oncology Meeting
November 21th – November 24th, 2013
San Francisco, CA
IsoRay MedicalTM utilizes proprietary technologies to deliver novel brachytherapy approaches to clinicians. IsoRay’s Cesium-131 isotope has been used as primary treatment for prostate cancer in over 7,000 patients. As adjuvant radiation therapy, Cesium-131 is being employed in the management of non-small cell lung cancer, intra-cranial tumors (including meningiomas), and head & neck malignancies post-surgical resection. Additionally, Cesium-131 is currently being used as monotherapy in the management of gynecologic recurrences and ocular melanomas Customized strands, meshes, and applicators are available bearing Cesium-131 sources, and the recently reintroduced GliaSite Radiation Therapy System is available for brachytherapy of the resection bed following surgical removal of gliomas and brain metastases.
IsoRay applauds Cleveland Clinic Prostate Study Conclusions on Brachytherapy Superiority
Company's Cesium-131 Positioned As Major Beneficiary
Richland, WA (February 7, 2012) … – IsoRay Inc. (AMEX: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, said today that the findings of a Cleveland Clinic study adds to the continuing evidence supporting the efficacy of brachytherapy. The Cleveland Clinic study compared external beam radiation, prostatectomy (the surgical removal of the prostate) and brachytherapy (internal radiation therapy). The study, which examined the treatment outcomes for 137,000 men over a five year period, found brachytherapy to have the fewest number of toxicities involving genital or urinary organs and had the lowest total cost per patient per year. The Cleveland Clinic researchers are the first to examine the quality of life and financial costs of the three most common prostate cancer treatments over a prolonged period after treatment.
IsoRay CEO Dwight Babcock said the study findings are no surprise. "The results are confirmation of what we have known at IsoRay for some time. Brachytherapy low dose internal radiation is the most effective and cost efficient therapy available, along with having the fewest complications. Importantly, we are the only brachytherapy company with an isotope (Cesium-131) that has enough energy and the short half life needed to combat fast growing, aggressive cancers located anywhere in the body. Going forward, it is my hope that this study will serve to shift the focus back to brachytherapy as physicians receive further confirmation of its superiority."
IsoRay is the exclusive manufacturer of Cesium-131. The pioneering brachytherapy treatment represents one of the most important advancements in internal radiation therapy in 20 years. Cs-131 seeds deliver radiation quickly and aggressively compared to other types of internal, low dose rate radiation. Brachytherapy with Cs-131 is minimally invasive, provides higher energy, more rapidly delivers a uniform dose of radiation, and has a shorter half life (9.7 days) than other radioactive isotopes used in internal radiation therapy. The ground-breaking treatment impacts longevity and cure rates, can be performed outside a hospital setting, and results in a patient's faster return to normal activities.
Babcock says he strongly believes the expected upcoming release of IsoRay's 5 year data on the use of Cesium- 131 to treat prostate cancer will provide further compelling evidence for doctors and the patients they treat regarding the choice of Cesium-131. "While for quite some time we have known our isotope Cesium-131 has been performing better than other treatments, we now have our 5 year data being peer reviewed, providing factual evidence supporting the claims of independent medical professionals that we have the best performing brachytherapy seed for prostate cancer on the market. Current data already proves we are superior in both energy and having patients return to baseline faster following treatment." Babcock says that he also expects a number of significant developments in the months ahead regarding further progress in current initiatives and ongoing discussions relative to the application of Cesium-131 for treating cancers in other body sites including breast, pancreatic, and esophageal cancers.
In addition to its CMS codes, Cesium-131 is FDA-cleared for the treatment of prostate, lung, ocular melanoma, brain, colorectal, gynecological, and head and neck cancer and other cancers throughout the body.
IsoRay Ships First GliaSite® Brain Cancer Treatment
Groundbreaking Cancer Therapy Drawing Widespread Interest From Physicians and Patients
Richland, WA (November 28, 2011) - - IsoRay, Inc. (Amex: ISR) announced today 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 States.
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 expansion."
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.
MD Anderson Cancer Center Initiates Orders of IsoRay's Cesium-131 for Intermediate Risk Prostate Cancer Study
Brachytherapy Study Focuses on Cesium-131 Compared to Previously Used Isotopes
Richland, WA (October 10, 2011) … – IsoRay Inc. (AMEX: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, announced today that MD Anderson Cancer Center has initiated orders of Cesium-131 brachytherapy (internal radiation therapy) seeds as it continues its clinical research study investigating brachytherapy's ability to help control intermediate risk prostate cancer. “Intermediate risk” is a classification of early stage prostate cancer that has shown a tendency to recur following standard treatments including surgery and radiation therapy.
The current phase of the study will compare Cesium-131 to other, previously used isotopes. With other centers' prior successes using Cesium-131 in treating prostate cancer, principal investigator Dr. Steven J. Frank hopes to evaluate Cesium-131's effectiveness in addressing intermediate risk prostate cancer and its quality of life benefits. The study will also evaluate PSA response and the patient's return to urinary function baseline as well as normal lifestyle activities. High levels of PSA typically indicate the presence of prostate cancer. Cesium-131 has a higher average energy than any other commonly used brachytherapy isotope and results in a more homogeneous dose. Other cancer centers' studies have demonstrated Cesium-131's ability to deliver the required radiation dose with excellent homogeneity across the entire prostate gland, while limiting damage to other tissue and body structures including the urethra and rectum.
IsoRay CEO Dwight Babcock says he believes this study will add to the growing recognition of Cesium-131's significant role as a powerful weapon in the fight against cancer. "Cesium-131 is already proving its essential value in fighting prostate cancers. My expectation is that this research study will be significant in identifying Cesium-131's improved cancer control for intermediate risk prostate cancer. I feel strongly that it will demonstrate Cesium-131's superiority over other isotopes and its ability to provide a faster return to urinary function baseline and normal daily activities." Babcock says that Cesium-131's full potential is just beginning to be realized as thought leaders seek solutions for treating cancers in other body sites. He pointed to its growing adoption in treating cancers throughout the body including recent exciting applications in treating Glioblastomas and metastasized brain cancer as well as lung cancers.
The MD Anderson Cancer Center is one of the nation's original three comprehensive cancer centers established by the National Cancer Act of 1971. The prestigious degree-granting academic institution and cancer treatment and research center has ranked No.1 for eight of the past 10 years (including 2011) in cancer care in the "America's Best Hospitals" survey published by U.S. News & World Report.
IsoRay is the exclusive manufacturer of Cesium-131 which represents one of the most important isotope advancements in internal radiation therapy in the last 20 years. Cesium-131 allows for the internal radiation treatment of many different cancers because of its unique combination of high energy (its distinctive tissue penetrating capability reaching just far enough to treat the cancer) and its 9.7 day half-life (its matchless speed in giving off therapeutic radiation). The treatment can be deployed using several delivery methods including single seed applicators, implantable strands and mesh, and several new implantable devices. In addition to its CMS codes, Cesium-131 is FDA-cleared for the treatment of prostate cancer, lung cancer, ocular melanoma cancer, brain cancer, colorectal cancer, and head and neck cancer as well as 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.
Safe Harbor Statement
Statements in these news releases about IsoRay's future expectations, including: the advantages of our Cesium-131 seed, the expected outcomes from the 5 year Cs-131 study, whether IsoRay will be able to continue to expand its base beyond prostate cancer to treat additional cancers and malignant disease, whether the use of Cesium-131 to treat other cancers will be successful in the initial and any future implants, and all other statements in this release, other than historical facts, are "forwardlooking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of our products, our ability to successfully manufacture, market and sell our products, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, our ability to enforce our intellectual property rights, whether additional studies are released and support the conclusions of early clinical studies, patient results achieved when Cesium-131 is used for the treatment of cancers and malignant diseases beyond prostate cancer, successful completion of future research and development activities, and other risks detailed from time to time in IsoRay's reports filed with the SEC.