Vivos Inc. Provides IDE Submission Status Update – Conversion to Pre-Sub Filing Accepted by the FDA
Vivos Inc. (OTCQB: RDGL), a company at the forefront of innovative cancer treatment technologies, has announced a significant update regarding their Investigational Device Exemption (IDE) submission. The FDA has accepted their request to convert the IDE submission to a Pre-Submission (Pre-Sub) filing.
This strategic decision aims to allow Vivos Inc. to provide comprehensive responses to the FDA’s feedback, ensuring a thorough review process for their breakthrough Radiogel® technology. This move highlights Vivos’ commitment to regulatory compliance and effective communication with the FDA, paving the way for future advancements in cancer treatment.
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For an in-depth exploration of Vivos Inc.’s groundbreaking advancements with RadioGel™ and IsoPet®, including recent FDA designations, executive leadership updates, please refer to our previous article. Vivos Inc. Innovation in Precision Radionuclide Therapy ‣ TradersQue covers the comprehensive developments that have positioned Vivos Inc. at the cutting edge of medical and veterinary oncology innovation.
Comprehensive Review with the FDA
Vivos Inc. has been in regular communication with the FDA, responding to five sets of Interactive Review Requests. The FDA has been diligently reviewing the extensive materials submitted in the IDE application within the 30-day statutory time limit. However, due to the time constraints, Vivos and the FDA agreed to convert the IDE submission (G240159) to a Pre-Sub filing (Q241925). This strategic move allows for more thorough addressing of the FDA’s feedback while maintaining open communication through quick review sessions.
Next Steps in the Review Process
This week, Vivos anticipates follow-up questions from the FDA to further analyze the risk/benefit assessment of Radiogel®. The company is confident that 90-95% of the required information has already been provided. Vivos aims to resubmit the refined IDE application with high-quality responses, demonstrating a compelling risk/benefit analysis to the FDA within the next 45 days.
Collaboration with Mayo Clinic
Vivos has been in consistent contact with collaboration partners at the Mayo Clinic. Following FDA approval of the IDE, Vivos will promptly submit their treatment plan to Mayo Clinic’s Independent Review Board (IRB). The initial treatment target for Radiogel® will be solid metastatic tumors in lymph nodes associated with papillary thyroid cancer. Vivos remains dedicated to achieving full compliance and demonstrating a compelling risk/benefit profile to the FDA.
Final Thoughts and Future Directions
Vivos Inc. is making strategic moves to ensure the successful review and approval of Radiogel® by the FDA. With the conversion to a Pre-Sub filing, the company can comprehensively address the FDA’s feedback. The collaboration with the Mayo Clinic further solidifies their commitment to advancing treatment for papillary thyroid cancer. Stay tuned for more updates as Vivos progresses towards their goals.
About Vivos Inc.
Vivos Inc. has developed an Yttrium-90-based injectable Precision Radionuclide Therapy™ medical device to treat tumors in animals (IsoPet®) and humans (RadioGel®). Using the company’s proprietary hydrogel technology, PRnT™ uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area. This allows the safe delivery of higher doses needed for treating non-resectable and radiation-resistant cancers.
RadioGel® Technology
RadioGel® is a hydrogel liquid containing yttrium-90 phosphate microparticles, administered directly into a tumor. After injection, it gels within the tumor interstitial spaces to keep the radiation sources in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area, minimizing adverse effects on normal organs and tissues. The short half-life of RadioGel® ensures that more than 90% of its therapeutic radiation is delivered within 10 days, allowing for outpatient procedures without risk to family members.
IsoPet® for Veterinary Use
IsoPet® uses the same technology as RadioGel® for treating animals. It has been tested successfully on feline sarcoma at Washington State University and on canine soft tissue sarcomas at the University of Missouri. The FDA has classified IsoPet® as a medical device and does not require pre-market approval for veterinary use, allowing for revenue generation through sales to university hospitals and private clinics.
Vivos Inc. | RadioGel™ | IsoPet® – (OTCMKTS: RDGL)
Meet the Visionaries Behind Vivos Inc.
Meet the innovative minds driving Vivos Inc. forward in the fight against cancer. Our dedicated team combines expertise, passion, and cutting-edge technology to revolutionize cancer treatment. Learn more about our leaders and their groundbreaking work by visiting Meet The Team | RadioGel™
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