Vivos announced the successful validation of a new electron beam (E-Beam) sterilisation process for our hydrogel, marking a culmination of nearly a year of testing and validation of a process that was only viable because of the unique characteristics of our hydrogel. The validation was carried out under ISO 11137 by an international medical device accredited organisation. Vivos applies these same high standards to both human (Radiogel) and animal (Isopet) therapies.

The E-Beam sterilization process is reproduceable and more reliable than our current filtration process, achieving a sterility assurance level of 10-6, which is the most rigorous sterility level; meaning there is a one in a million chance of a viable microorganism surviving, and it is the standard for critical medical devices that enter the body or compromised tissues, ensuring patient safety by minimizing infection risk.

Beyond the clinical advantages, the process is more cost-effective, improves production yield, and meaningfully enhances scalability as we prepare for commercial growth. The ability to efficiently produce and distribute sterile hydrogel and PrecisionGel for therapeutic agent dispersal worldwide supports Vivos’ strategic path toward broader market penetration.

Importantly, the process will also drive greater manufacturing efficiency for IsoPet, our animal health therapy, enabling more consistent supply and cost-effective production to meet growing veterinary demand. This dual benefit—advancing both human and animal health divisions—positions Vivos for stronger revenue opportunities while reinforcing our competitive differentiator through intellectual property protection.