Vivos Receives FDA Confirmation of RadioGel Device Classification
Vivos Inc recently announced it has been notified by the FDA that RadioGel is classified as a device for animal therapy. After 4 months of dialog with the Center for Veterinary Medicine Product Classification Group we received a ruling that RadioGel is classified as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas.
The FDA also reviewed and approved our label, which is a requirement for any device used in animals. Based on the FDA recommendation, RadioGel will be marketed as IsoPet for use by veterinarians to avoid any confusion between animal and human therapy. Vivos already has trademark protection for the IsoPet name.
The company’s feline sarcoma therapy series at Washington State University was completed in January. Those tests were designed to optimize our procedures and to determine the optimum dose. The tests demonstrated that RadioGel is safe and effective in killing cancer cells.
In February, we plan to start recruiting canine skin cancer patients to be treated at the University of Missouri, incorporating lessons learned at WSU.The animal therapy data generated from these studies will also be used in the pre-clinical data required by the FDA as part of the testing required for treating skin cancer in humans. After all the pre-clinical testing is completed we will submit an Investigational Device Exemption to obtain permission to initiate human clinical trials.
In April we plan to begin therapy at University of California Davis on canine prostate and liver cancers. Later, we will continue our testing at the University of Missouri to treat equine sarcoids. As we expand the indications for use of IsoPet™ we intend to communicate with the FDA to confirm the device designation applies. Having established a precedent for classification of skin cancer therapy as a device makes it highly likely that subsequent cancers will also be ruled similarly. Obtaining FDA approval in stages should increase the probability of success and provide the fastest path to commercializing our product in the animal sector.
We continue to communicate our progress with potential strategic partners. In the future, we anticipate interacting with their technical review teams to assess the results of our animal therapies and endorse our product. We will then determine the optimum business relationship to sell IsoPet, with the goal of leveraging the broad national presence of our strategic partner.
Dr. Mike Korenko stated “Obtaining this approval is an important step to set the stage for selling IsoPet to the private clinics for animal therapy. By being labeled a device there are no other regulatory approvals necessary for treating skin cancer, the most common cancer in animals. We chose a conservative path of obtaining FDA classification early with full and open communication on our intent in order to remove any future uncertainty in the regulatory space.”
The strategic market sector of RDGL is isotope applications. Currently, the Company is engaged in the development of RadioGel, an Yttrium-90 based brachytherapy device, for the treatment of tumors. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside the treatment area.
The company is engaging the FDA for permission to use RadioGel for the treatment of advanced basal and squamous cell skin cancers. The IsoPet Solutions division of RDGL is focused on demonstrating the safety and therapeutic effectiveness for different animal cancers in four different university veterinary hospitals. RDGL is positioning itself so that after this demonstration phase, The Company can begin to generate revenues through the sale of RadioGel to private animal clinics.
The company currently is outsourcing material aspects of manufacturing of its product in the United States and intends to enter into licensing arrangements outside of the United States for the manufacturing and distribution of RadioGelTM in other countries.
RadioGel is a hydrogel liquid containing tiny Yttrium-90 phosphate particles to be injected into a tumor. This hydrogel is a liquid at temperatures below body temperature but begins to gel, harden, upon injection as the temperature increases to normal body temperature, thereby locking the particles in place. The particles emit a very high concentrated and contained beta irradiation to kill the tumor. The beta radiation has a short penetration distance so there is minimal collateral damage to healthy tissues outside of the injected area.
RadioGel also has a short half-life – delivering more than 90% of its therapeutic radiation within 10 days. This compares favorably to other available treatment options requiring up to 6 weeks or more to deliver a full course of radiation therapy. This is an outpatient treatment much safer to the personnel treating the patient than competing brands and the patient can go home immediately with no risk to family members.
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