Vivos Inc. (OTCQB: RDGL), a pioneer in Precision Radionuclide Therapy™ (PRnT) solutions, announced the submission of its Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for RadioGel®, a novel hydrogel-based radioactive therapy designed to deliver targeted radiation to solid tumors. This comprehensive submission, supported by extensive animal and human data, marks a significant milestone in the company's mission to provide innovative cancer treatments.
Novel Hydrogel Technology for Targeted Cancer Treatment
RadioGel® represents a novel medical device that enables precise radiation delivery to tumors while minimizing damage to surrounding healthy tissue. The technology addresses a critical need in cancer treatment by providing targeted therapeutic radiation directly to tumor sites through a hydrogel-based delivery system.
The IDE application was developed through months of close collaboration with the FDA under the Breakthrough Device sprint process, which addresses regulatory concerns with robust evidence of RadioGel's safety and promising efficacy. The Breakthrough Device designation expedites development for devices that address life-threatening conditions with unmet medical needs.
Regulatory Milestone and Clinical Development
"This is our most comprehensive IDE submission to date, backed by both animal and human data and months of productive dialogue with the FDA," said Dr. Michael Korenko, CEO of Vivos Inc. "The strong evidence of RadioGel's safety and efficacy brings us closer to delivering a transformative therapy to cancer patients in need."
The submission represents a significant regulatory milestone for Vivos Inc., positioning the company to advance RadioGel® into human clinical trials. The comprehensive nature of the application, supported by both preclinical animal studies and human data, demonstrates the company's commitment to meeting FDA regulatory standards for medical device approval.
Precision Radionuclide Therapy Platform
As a pioneer in Precision Radionuclide Therapy™ solutions, Vivos Inc. has developed RadioGel® as part of its broader therapeutic platform targeting solid tumors. The hydrogel-based approach represents an innovative method for delivering radioactive therapy with enhanced precision compared to traditional radiation treatment methods.
The company's focus on precision delivery systems addresses the ongoing challenge in oncology of maximizing therapeutic efficacy while minimizing toxicity to healthy tissues. This targeted approach could potentially improve treatment outcomes for cancer patients while reducing the side effects associated with conventional radiation therapy.
