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Vivos Inc. - RDGL STOCK NEWS

Welcome to our dedicated page for Vivos news (Ticker: RDGL), a resource for investors and traders seeking the latest updates and insights on Vivos stock.

VIVOS INC (RDGL) is a company focused on advanced medical technologies, specifically in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic use. Their flagship product, Yttrium-90 Radiogel™, is pending FDA clearance, with plans for additional related products in the pipeline. Brachytherapy, a radiation-based treatment, is a billion-dollar industry, and VIVOS INC aims to tap into this market by outsourcing manufacturing and distribution in the US while considering licensing abroad.

Rhea-AI Summary

Vivos Inc. (OTCQB: RDGL) has submitted an Investigational Device Exemption (IDE) application to the FDA, following amendments addressing previous FDA comments (Q211938/S001). This marks their first filing post the FDA Breakthrough Device Designation for their Radiogel™ Precision Radionuclide Therapy. The application includes studies on RadioGel® genotoxicity and retention at injection sites in VX2 tumors in rabbits. Dr. Korenko noted the readiness to address any comments from the FDA's twelve reviewers. Approval of this IDE will allow Vivos to seek clearance from the Mayo Clinic's Independent Review Board (IRB) to initiate human clinical trials targeting metastatic tumors in lymph nodes from papillary thyroid cancer.

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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.
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FAQ

What is VIVOS INC (RDGL) focused on?

VIVOS INC is focused on advanced medical technologies, specifically in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications.

What is Yttrium-90 Radiogel™?

Yttrium-90 Radiogel™ is VIVOS INC's flagship product awaiting FDA clearance, designed for brachytherapy cancer treatment using radioactive isotopes.

What is the market potential for brachytherapy products?

The annual sales of brachytherapy products exceed $1 billion, with about half of the market in the United States.

How does brachytherapy work?

Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area.

What are VIVOS INC's plans for manufacturing and distribution?

VIVOS INC plans to outsource material aspects of manufacturing, distribution, sales, and marketing for their products in the United States while evaluating licensing arrangements outside the country.

What stage is VIVOS INC in currently?

VIVOS INC is in a late-stage development phase, awaiting FDA clearance for their brachytherapy cancer product, Yttrium-90 Radiogel™.

Who is the CEO of VIVOS INC?

Michael K. Korenko, Sc.D. is the President and CEO of VIVOS INC.

What is the primary goal of VIVOS INC?

The primary goal of VIVOS INC is to transition to full operations upon receiving FDA clearance for their patented brachytherapy cancer product.

What are the future plans for VIVOS INC products?

VIVOS INC intends to file FDA premarket notifications for two related Yttrium-90 brachytherapy products, expanding their product portfolio.

How does VIVOS INC plan to enter international markets?

VIVOS INC plans to enter into licensing arrangements outside of the United States, exploring various alternatives before finalizing their international strategy.

Vivos Inc.

OTC:RDGL

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82.57M
381.87M
4.85%
Surgical and Medical Instrument Manufacturing
Manufacturing
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United States of America
Richland