IsoRay Receives FDA Clearance For Proxcelan Cesium-131

IsoRay has received clearance from the FDA for its Premarket Notification, 510(k) for Proxcelan Cesium-131 Brachytherapy Seeds. It would enable the company to preload Cesium-131 into flexible braided strands and surgical mesh.

The FDA clearance allows IsoRay to market Cesium-131 seeds for use in the treatment of cancers well beyond the current prostate market.

Reportedly, the order clears the product for commercial distribution for treatment of lung and head and neck tumors as well as tumors in other organs.

The current 510(k) allows Cesium-131 to be delivered in a new, convenient and sterile format that can be implanted without additional seed loading by the facility. The 510(k) also clears the application of the braided strands onto a bioabsorbable mesh matrix to further facilitate implant procedures.

Dwight Babcock, CEO of IsoRay, said: “The FDA’s decision will accelerate our strategy to significantly broaden the scope of Cesium-131 cancer treatments well beyond the current major prostate market. A growing number of physicians have indicated that they believe Cs-131’s unique characteristics of shorter half life and high energy are particularly suitable for many applications beyond prostate.”