Friday, May 01, 2015 1:51:50 PM
Subject to receipt of all required regulatory approvals from the FDA in the United States and analogous regulators outside of the United States, the Company plans to introduce a new Y-90-based brachytherapy product line for a range of applications for the delivery of a prescribed dose of radiation to a target site. There can be no assurance that we will obtain such approvals. Our open FDA application is a de novo for the Y-90 RadioGel™ device. If we receive FDA clearance for the Y-90 RadioGel™ device, subject to receipt of adequate financing, we will commence commercialization of that product. Also, subject to receipt of adequate financing, we intend then to seek FDA clearance for the two additional products described below, each of which also incorporates the patented technologies licensed from Battelle. Even if the FDA grants clearance for the Y-90 RadioGel™ device there can be no assurance the FDA would also grant clearance for either or both of the foregoing products.
Y-90 RadioGel™ device - combines Y-90 particles with a polymer carrier that may be injected directly into the tumor.
Y-90 Fast-Resorbable Polymer Seeds - Y-90 contained within a polymer seed, as opposed to metal or glass. This product would be used in place of treating cancers with currently marketed titanium or glass seeds.
Y-90 Polymer Topical Paste – designed to be applied directly to tissue surfaces after surgical tumor removals (also referred to as “resections”) to treat residual tumor cells.
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