Vivos Inc. announced the filing of a provisional patent (No.: 63/873,014 - STERILE THERMOGELS) for a new electron beam (E-Beam) sterilization process for its proprietary hydrogel. This validation, achieved under ISO 11137 by an international medical device accredited organization, marks a culmination of nearly a year of testing. The process is viable due to the unique characteristics of Vivos's hydrogel.
The E-Beam sterilization process is reproducible and more reliable than the company's current filtration method, achieving a sterility assurance level of 10^-6. This is the most rigorous sterility level, standard for critical medical devices, ensuring patient safety by minimizing infection risk. The process applies to both human (RadioGel) and animal (IsoPet) therapies.
Beyond clinical advantages, the new process is more cost-effective, improves production yield, and enhances scalability, which is crucial for commercial growth. This operational improvement supports Vivos's strategic path toward broader market penetration and reinforces its competitive differentiator through intellectual property protection for both its human and animal health divisions.
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