New Hope In Cancer Battle: FDA Grants Breakthrough Device Status To Vivos Inc.'s RadioGel

In a significant advancement for cancer therapy, the Food and Drug Administration (FDA) has awarded RadioGel Precision Radionuclide Therapy the coveted Breakthrough Device Designation. Developed by Vivos Inc. RDGL, this designation marks a crucial milestone in the treatment of solid metastatic tumors, particularly in lymph nodes associated with papillary thyroid cancer.

How RadioGel Works

RadioGel, a pioneering Yttrium-90-based injectable brachytherapy device, represents a groundbreaking approach to cancer treatment. It is designed for patients who are either not eligible for surgery or have chosen not to undergo the procedure, particularly those with non-radioiodine avid disease and limited burden regional nodal disease.

The therapy involves directly injecting a hydrogel containing yttrium-90 phosphate microparticles into the tumor. This method allows for a more localized and potent radiation treatment compared to traditional external-beam radiation therapies.

Dr. Mike Korenko, CEO of Vivos Inc., expressed his satisfaction with the FDA's decision, citing the thorough review process and the positive results from their Risk Management Report and animal therapy data. "The FDA did a very thorough review. The analysis in our Risk Management Report concluded that RadioGel is intrinsically safe and our animal therapy data verified its effectiveness," Korenko said.

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What's The FDA's Breakthrough Devices Program

The Breakthrough Devices Program by the FDA is designed to accelerate the development and review of innovative technologies that show potential for more effective treatment options. The program's support is instrumental in hastening patient access to promising medical advancements.

RadioGel's hydrogel technology allows for the safe delivery of higher doses necessary for treating non-resectable and radiation-resistant cancers. The product also boasts a short half-life, delivering over 90% of its therapeutic radiation within 10 days.

This feature compares favorably to other treatments that require up to six weeks for a full course of radiation therapy. Additionally, the outpatient nature of the RadioGel therapy means patients can return home without concerns about radiation exposure to family members.

With the Breakthrough Device classification, Vivos Inc. is set to expedite its Investigational Device Exemption (IDE) submission to the FDA, paving the way for human clinical trials. This collaboration with the Mayo Clinic for its initial indication marks a significant step forward in the fight against challenging cancer types, offering hope and potentially more effective treatment options to patients globally.

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Photo by National Cancer Institute on Unsplash