Vivos Inc (OTC: $RDGL) is nearing significant catalysts that have the potential for very high returns.
They were granted Breakthrough Device Designation in December and announced they will submit their IDE in Q2.
If accepted (which seems likely) this stock will explode upwards. Below is the full story— shares are going up fast lately.
Vivos Inc is a company that focuses on the development and commercialization of innovative medical technologies, including its lead product, RadioGel.
RadioGel is a brachytherapy product that can be used to treat solid tumors, including cancers of the prostate, breast, lung, liver, and pancreas. RadioGel is a unique treatment option because it utilizes a hydrogel-based substance that is injected directly into the tumor site. The hydrogel then solidifies, forming a biocompatible and biodegradable implant that can be loaded with a radioactive isotope. The radioactive material is then slowly released over time, providing targeted radiation therapy to the tumor while minimizing exposure to surrounding healthy tissues.
One of the key benefits of RadioGel is that it can be used as a primary or adjuvant therapy, depending on the specific cancer and patient. It has been shown to be effective in treating a range of tumor types, including those that are difficult to treat with traditional radiation therapy.
RadioGel has several potential benefits over other treatment options, including:
Precise and targeted treatment: Because the hydrogel is injected directly into the tumor site, it can provide a more precise and targeted treatment compared to other radiation therapies.
Minimally invasive: RadioGel is a minimally invasive treatment, meaning that it does not require major surgery or extensive recovery time.
Reduced side effects: RadioGel can minimize exposure to surrounding healthy tissues, which can reduce the risk of side effects and complications.
Versatile: RadioGel can be used as a primary or adjuvant therapy, depending on the specific cancer and patient.
Overall, RadioGel has the potential to be a useful treatment option for a range of solid tumors. While it is still in the clinical trial phase and has not yet received FDA approval, the initial results and potential benefits make it an exciting development in the field of cancer treatment.
The FDA IDE (Investigational Device Exemption) process is an important regulatory pathway that medical device companies must go through to conduct clinical trials on their products in the United States. An IDE is a regulatory exemption granted by the FDA that allows a medical device to be tested in a clinical study to evaluate its safety and effectiveness.
The IDE process is important for companies to obtain because it provides a mechanism for the FDA to review and evaluate the safety and effectiveness of medical devices before they can be marketed to the public. It also helps to ensure that clinical trials are conducted in a safe and ethical manner, with appropriate patient protections in place.
To obtain an IDE, a company must submit an application to the FDA that includes information about the device, the proposed clinical trial, and the study protocol. The FDA will review the application to determine whether the study meets certain safety and efficacy standards, and whether it is designed to answer the research questions posed by the company.
Once an IDE is granted, the company can begin conducting clinical trials on their device, provided they follow the study protocol and other regulatory requirements. The results of these trials will be used to support the company's marketing application to the FDA.
Overall, the IDE process is important for medical device companies because it provides a rigorous and transparent pathway for testing the safety and effectiveness of their products, and for obtaining regulatory approval to market them to the public. By following the IDE process, companies can ensure that their devices are safe and effective, and that they are backed by solid clinical evidence.
For a company like Vivos Inc (RDGL), obtaining an IDE from the FDA would be a critical step in the regulatory process for bringing their product, RadioGel, to market. Here are some of the potential benefits that Vivos Inc could experience by obtaining an IDE:
Legitimacy: By obtaining an IDE, Vivos Inc would gain credibility and legitimacy in the eyes of the FDA, investors, and the public. It would demonstrate that the company is committed to conducting rigorous clinical trials that meet high scientific standards.
Regulatory Approval: Conducting clinical trials under an IDE allows the FDA to review and evaluate the safety and effectiveness of RadioGel. If the clinical trials are successful, Vivos Inc could use the results to support a pre-market approval (PMA) application, which is required for regulatory approval to market the device in the US.
Investor Confidence: The IDE process provides a framework for conducting clinical trials that is transparent and rigorous. This can give investors confidence in the potential of the device and the company.
Competitive Advantage: If RadioGel is approved by the FDA, it could give Vivos Inc a competitive advantage in the market. It could be one of the few brachytherapy products approved for the treatment of solid tumors, which could lead to increased market share and revenue.
Overall, obtaining an IDE from the FDA is an important step for Vivos Inc to gain regulatory approval for RadioGel and bring it to market. It provides a framework for conducting rigorous clinical trials that can generate the data needed to support a PMA application. If successful, the IDE process could help to legitimize the company, increase investor confidence, and give them a competitive advantage in the market.
