RadioGel™ device is a brachytherapy device comprising highly insoluble Yttrium-90 particles delivered by needle injection using a water-polymer composite for high-dose treatment of non-resectable
solid tumors that cannot be treated effectively by any other means. It is designed for maximum safety: to deliver a high, pure-beta radiation dose to target (tumor) tissue, with comparatively
small-to-negligible radiation doses to adjacent normal tissues, and with negligible radiation dose to any major organ or tissue in the body.
Two key design characteristics of the RadioGel™ device that influence safety and efficacy are (1) the ability to place Y-90 particles directly into tumor tissue via injection and (2) yttrium-90
containment within the tumor after injection.
Vivos Inc. has obtained an exclusive license to eight (8) patents related to RadioGel™ device technology for use in high-dose radiation therapy. The license was granted by
*Battelle pursuant to an option between Battelle and AMIC announced in February 2011. The Agreement grants Vivos an exclusive license to make, have made, use and sell RadioGel™ as a device.
Yttrium-90 is a well-established medical isotope with many applications in cancer treatment. The combination of insoluble Yttrium-90 particles and the polymer gel carrier offers physicians an
opportunity to deliver a safe, effective treatment option at a low cost.
Based upon its studies and analyses, or general application of experience with current brachytherapy devices and Yttrium-90, AMI believes that its brachytherapy products are likely to offer the
following benefits, among others, for patients and medical professionals:
•Maximizing Therapeutic Index: The short-range beta particles emitted by Y-90 deliver radiation energy within a tight range. This enables radiation to be selectively delivered to
target tissues while minimizing radiation dose to nearby normal tissues. High therapeutic indices imply that more radiation energy may be imparted to target tissues, with less radiation reaching
adjacent normal tissues.
•Half Life: Y-90 has a half-life of just 2.7 days. Many traditional brachytherapy products use isotopes with longer half-lives such as 9.7 days for cesium-131, and sixty days for
•Optimized Delivery Method: Current brachytherapy devices place permanent metal seeds in the prostate by using up to 30 large needles. By contrast, Vivos’s Y-90 RadioGel™ device
is designed to be administered in a minimally invasive procedure with small-gauge needles.
•No Permanent Seeds Remaining: Current brachytherapy devices place permanent metal seeds in the tumor. Vivos’s Y-90 RadioGel™ device utilizes a biodegradable, non-toxic polymer
that is ultimately absorbed by the body. This eliminates the possibility of a long-term seed migration or other problems that may sometimes arise when seeds remain in the body.
•Good Safety Profile: Many traditional brachytherapy devices utilize isotopes that emit x-rays (akin to gamma radiation). X-rays or gamma radiation travels within and outside of
the body and have long half-lives. Vivos’s brachytherapy products use the Yttrium-90 isotope, which is a beta-emitter. The Yttrium-90 beta-emissions travel only a short distance and has a short
half life of 2.7 days.
•Potential Lower Cost: Yttrium-90 supplies are readily accessible and are relatively inexpensive. The elimination of the metal or glass enclosures used in traditional
brachytherapy seeds greatly reduces manufacturing costs.