161 0 Kommentare Vivos Inc Applies for Breakthrough Device Designation for Radiogel - Seite 2

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 six weeks or more to deliver a full course of radiation therapy. Therapy can be safely administered as an out-patient procedure and the patient may return home without subsequent concern for radiation dose to family members.

The Isopet Solutions division is using university veterinary hospitals to demonstrate the safety and therapeutic effectiveness for different animal cancers. Testing on feline sarcoma at the Washington State University was completed in 2018 and testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019.

In 2018 the Company obtained confirmation from the FDA Center for Veterinary Medicine that Isopet is classified as a medical device according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling which included canine and feline sarcomas as the initial indications for use. The FDA does not require pre-market approval for veterinary devices so no additional approval was required for treating skin cancer, which is the largest market sector. Following the demonstration phase, Vivos is able to generate revenue through the sale of Isopet to University animal hospitals and private veterinary clinics.

Isopet for treating animals uses the same technology as RadioGel for treating humans. The Food and Drug Administration advised using different product names in order to avoid confusion and cross-use.

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