Radiogel™ Precision Radionuclide Therapy™ Receives FDA Breakthrough Device Designation
Vivos Inc. (OTCQB: RDGL) receives Breakthrough Device designation from the FDA for RadioGel Precision Radionuclide Therapy, accelerating the development and review process for potential human clinical trials.
12/20/2023 - 10:08 AM
Richland WA, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc is pleased to announce that the Food and Drug Administration has granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device pursuant to the FDA’s Breakthrough Devices Program.
Dr. Mike Korenko stated “We are pleased with the FDA’s decision to grant Breakthrough Device Designation following our recent data submissions. 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. We are currently working closely with Mayo Clinic for our initial indication for use of Radiogel for delivering “therapeutic radiation to solid metastatic tumors in lymph nodes associated with papillary thyroid cancer, accessible by percutaneous direct needle injection, in patients who are not surgical candidates or have declined surgery, had non-radioiodine avid disease and had limited burden regional nodal disease.” The Breakthrough Device classification will enhance the schedule priority for our upcoming IDE submission seeking authorization to begin human clinical trials.
The FDA’s Breakthrough Devices program facilitates accelerated development and expedites the review of breakthrough technologies to help patients potentially gain timely access to technologies that can provide more effective treatment options.
Contact for journalists: MKorenko@RadioGel.com
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About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. has developed an Yttrium-90-based injectable Precision Radionuclide Therapy brachytherapy device to treat tumors in animals (IsoPet® ) and humans (RadioGel™ ). Using the company's proprietary hydrogel technology, Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows the safe delivery of higher doses needed for treating non-resectable and radiation-resistant cancers.
RadioGel™ is a hydrogel liquid containing tiny yttrium-90 phosphate microparticles that may be administered directly into a tumor. The hydrogel is a yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
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 outpatient procedure, and the patient may return home without subsequent concern for radiation dose to family members.
University veterinary hospitals use the IsoPet® Solutions division to demonstrate animal cancers' safety and therapeutic effectiveness. Testing on feline sarcoma at Washington State University was completed in 2018, and testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019. The Company has 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 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 to avoid confusion and cross-use.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners, and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
CONTACT:MKorenko@VivosInc.co
What is the significance of the FDA granting Breakthrough Device designation to Vivos Inc. (OTCQB: RDGL) for RadioGel Precision Radionuclide Therapy?
The designation accelerates the development and review process for potential human clinical trials, allowing for more effective treatment options for patients.
What is the initial indication for use of Radiogel for delivering therapeutic radiation?
The initial indication is for delivering therapeutic radiation to solid metastatic tumors in lymph nodes associated with papillary thyroid cancer, accessible by percutaneous direct needle injection, in patients who are not surgical candidates or have declined surgery, had non-radioiodine avid disease and had limited burden regional nodal disease.
How does the Breakthrough Device classification benefit Vivos Inc. (OTCQB: RDGL)?
The classification enhances the schedule priority for the upcoming IDE submission seeking authorization to begin human clinical trials, facilitating accelerated development and expediting the review of breakthrough technologies.
Who is the contact person for journalists at Vivos Inc. (OTCQB: RDGL)?
The contact person for journalists is Dr. Mike Korenko, reachable via email at MKorenko@RadioGel.com.
