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Tuesday, 03/18/2025 12:09:17 PM

Tuesday, March 18, 2025 12:09:17 PM

Post# of 198895
Interestingly, FDA has already approved numerous brachtherapy devices. FDA has already approved Y90 for killing tumors. Our gel, which has passed the FDA genotoxicity evaluation, has the added benefit of not including any glass, resin, or radiated metal micro beads/darts such as are used in other (approved) devices and was included in the FDA Break Through Device Designation (BDD) awarded to our product some time ago. Is the IP protected gel the real BDD component here?

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