IsoRay, a medical technology company, has received a five year extension to its CE mark covering its entire product offering of Cesium-131 seeds, permitting sale in the European market of these products into 2018.
When combined with a previous enhanced CE mark received in August 2013 extending the useful life for our GliaSite radiation therapy system and the Iotrex isotope used in the system, this five year extension gives us the ability to continue to sell our entire product line in the European market.
As reported in the company’s Form 10-K filed with the SEC on 30 September 2013, the GliaSite radiation therapy system, the world’s only balloon catheter device used in the treatment of brain cancer, and the Iotrex isotope used with the system received an enhanced European CE mark providing for longer shelf life, extended isotope usage and an additional second source isotope manufacturer.
The system’s balloon catheter is a landmark technology that allows physicians to treat more patients with brachytherapy or internal radiation, and provides important benefits over other radiation treatment options for brain cancer.
The CE mark designates that the manufacturer conforms with the essential product requirements of the applicable European Commission directives. Granted after a rigorous evaluation process, the CE mark allows a product to be legally marketed in the European Free Trade Association member states as well as the EU.
IsoRay chairman and CEO Dwight Babcock noted the five year extension is a clear indication of the quality and care IsoRay places on producing a truly superior product, and when combined with the enhanced CE mark received several months ago, helps to ensure our future internationally.
"Specifically, the enhanced CE mark for GliaSite® and Iotrex provides several major product improvements: first, an extended shelf life for our catheter from 12 months to now 36 months; second, our Iotrex isotope has had its useful life extended from 19 days to 30 days giving IsoRay the opportunity to utilize more of the product produced within a single batch, and finally, a second source manufacturer for Iotrex was approved giving more production capability and increasing potential batch sizes.
"These enhancements improve our ability to pursue additional distribution opportunities in numerous European countries due to the extended product life cycle.
"These European developments are consistent with the Company’s primary strategic objective of creating groundbreaking products proving to be vital weapons in the treatment of numerous cancers throughout the body, and creating value for our stockholders," Babcock added.
The GliaSite radiation therapy is exclusively marketed worldwide by IsoRay, which is also the exclusive manufacturer of Cesium-131 in seed form. With the recently announced FDA clearance for liquid cesium-131, IsoRay can now offer multiple isotope options for use within the GliaSite catheter.
Cesium-131 allows for the internal radiation treatment of many different cancers because of its unique combination of high energy and unrivaled speed in providing therapeutic radiation (9.7 day half-life).