Vivos Inc. Submits IDE Application for RadioGel™ and Collaborates with Mayo Clinic for Clinical Trials
June 28, 2024 – Vivos Inc. (OTCQB: RDGL) has officially submitted an amended Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for its groundbreaking RadioGel™ technology. This IDE Submission | RadioGel™ marks the company’s first filing with the FDA since receiving the FDA Breakthrough Device Designation for RadioGel™ Precision Radionuclide Therapy.
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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, and detailed share structure information, 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.
Dr. Michael Korenko, CEO of Vivos Inc., stated:
“We are pleased to announce the submission of the IDE application to the FDA. This is a significant achievement for Vivos Inc. and represents years of dedicated research and development. Our innovative RadioGel™ technology offers a new therapeutic option for patients with solid metastatic tumors in lymph nodes associated with papillary thyroid cancer, particularly those who are not surgical candidates or have declined surgery, and for those with non-radioiodine avid disease and limited regional nodal disease.”
Understanding the IDE Submission Process and FDA Review Timeline
This IDE filing addressed 63 FDA comments from previous correspondences, including reports on two complex studies: RadioGel® genotoxicity and the retention of RadioGel® at the injection site in VX2 tumors in rabbits.
The Investigational Device Exemption (IDE) submission is a crucial step in gaining FDA approval to conduct human clinical trials for new medical devices. When a company submits an IDE application, it includes detailed reports, studies, and data demonstrating the device’s safety and efficacy. Once the application is submitted, the FDA has a 30-day review period to evaluate the information provided. During this time, the FDA can respond with one of three possible outcomes
- Approval: Full authorization to proceed with the clinical trials.
- Approval with Conditions: Authorization to proceed with specific conditions or modifications required.
- Disapproval: Denial of the application, requiring further data or changes.
Collaboration with Mayo Clinic
In anticipation of FDA approval, Vivos Inc. is collaborating with the Mayo Clinic to prepare the necessary documentation for submission to their Institutional Review Board (IRB). This partnership aims to facilitate the initiation of clinical trials at Mayo Clinic, leveraging their extensive expertise in oncology and clinical research.
The clinical trial will focus on delivering therapeutic radiation to solid metastatic tumors in lymph nodes associated with papillary thyroid cancer through percutaneous direct needle injection. This trial is designed for patients who are not surgical candidates, have declined surgery, or have non-radioiodine avid disease with limited regional nodal disease.
Patient Recruitment and Trial Launch
Patient recruitment will commence following IRB approval, marking the beginning of this pivotal study. The outcomes of these trials will be instrumental in determining the future availability of RadioGel™ as a treatment option for thyroid cancer patients.
Setting the Strategic Compass
Vivos Inc.’s trajectory over the past year showcases a dynamic and forward-thinking approach to cancer treatment and veterinary care. Underpinned by steadfast leadership, groundbreaking technological advancements, and an expanding network of IsoPet® clinics, the company is actively reshaping the landscape of medical and veterinary oncology. In alignment with these achievements, Vivos Inc. has set forth strategic objectives to further its impact:
- Accelerating Human Clinical Trials: At the forefront of its agenda is to expedite human clinical trials for RadioGel™, capitalizing on the FDA’s Breakthrough Device Program to bring this innovative treatment to the forefront of cancer care swiftly.
- Expanding the IsoPet® Network: A key goal involves widening the reach of the IsoPet® network, not only domestically but also by exploring international market opportunities, thereby extending its revolutionary veterinary care globally.
- Enhancing Professional Awareness: Vivos Inc. is committed to deepening its engagement within the professional veterinary community through targeted conference participation, aiming to elevate awareness and adoption of its pioneering treatments.
These strategic endeavors are meticulously designed to propel Vivos Inc. forward, driving transformative impacts in both medical and veterinary oncology, and underscoring the company’s commitment to excellence and innovation in healthcare.
Conclusion
Vivos Inc. is clearly focused on enhancing product quality, ensuring regulatory compliance, and strengthening its market position through strategic reconfiguration and active marketing efforts. As the FDA IDE application progresses and clinical studies advance, the company’s future looks promising.
Vivos is dedicated to marketing its IsoPet® division in an effort to save more animals, while continuing on the regulatory pathway for the first human use of RadioGel®. This dual focus not only underscores their commitment to innovation but also highlights their dedication to improving lives, both human and animal. By actively promoting IsoPet® at veterinary conferences and engaging with regional clinics, Vivos is working to ensure that more animals benefit from their advanced therapies.
At the same time, the progress with the FDA IDE application for RadioGel® represents a significant milestone in bringing this groundbreaking treatment to human patients. As Vivos Inc. continues to navigate the complexities of regulatory approval and market expansion, their strategic initiatives and relentless pursuit of excellence position them well for sustained growth and success in the biotech industry.
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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