Richland WA, April 30, 2019 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCPINK: RDGL), provides an update on the progress towards commercialization of Y-90 IsoPet® for animal therapy.
Animal Testing
This week we will be treating our last dog in the test series for soft tissue sarcoma therapy at the University of Missouri (“Missouri”). Missouri will write up the test report, which we will review and forward to the FDA. The primary purpose of the testing was to answer key FDA questions regarding the Radiogel™/ IsoPet® technology and to confirm our claims related to the safety and effectiveness in treating solid tumors. Following completion of the canine sarcoma study, we plan to expand our contract with Missouri to begin testing for treatment of equine sarcoids.
Dr. Mike Korenko, Vivos Inc. CEO stated, “I am encouraged by the outstanding preliminary results of the canine sarcoma treatments with Isopet®. All of the test subjects are alive and well and are showing objective evidence of tumor destruction. We will continue to track their progress based on their follow-up examinations. Dr. Charlie Maitz, the principal investigator at Missouri, did an excellent job demonstrating proficiency in administering IsoPet according to the procedures on our Label. The new state-of-the-art PET/CT equipment at Missouri provided objective evidence of IsoPet® near-uniform dose distribution via perfusion within the tumor. These results confirm precise delivery of a high dose of therapeutic radiation and address multiple questions the FDA has previously asked regarding the product.”
Pilot Clinic for Commercial Sale of Isopet®
We have been placing a high priority on obtaining the Radioactive Material License for our pilot clinic, Vista Veterinary Hospital. This process has taken longer than expected in part because Vista has not previously been licensed to handle any radiopharmaceutical material and because this is the first experience in the country that regulators have had with Isopet®. To address this, we agreed to additional oversight for the first few treatments to demonstrate safety of the procedures for handling and administering the product. This will help establish standard permit conditions for other clinics that to use IsoPet® in the future.
The Washington Department of Health conducted a pre-licensing inspection at Vista in the first week of April. They provided a list of actions that they wanted completed and decided to do a final inspection prior to issuing the license. Washington is an Agreement State, i.e. the State has been granted authority to implement US Nuclear Regulatory Commission regulations for medical uses of radioactive materials. When an Agreement State issues a license for a new product it sets a precedent for all other Agreement States. This will have a benefit when we begin expanding IsoPet® therapy to regional clinics across the country, since all but twelve states are agreement states.
Within this regulatory framework, we have decided to sell IsoPet® as part of a development effort wherein new users agree to provide data on the safety and efficiency of IsoPet administration procedures and report on the overall effectiveness of the therapy. This is consistent with the licensing practices of new products and guarantees that we harvest data which we will share with the FDA and other clinics.
