Vivos Inc. Receives FDA Decision on IDE Application
In a significant development for Vivos Inc. (OTCQB: RDGL), the company learned that their application for the Investigational Device Exemption (IDE) for Radiogel was not approved by the FDA. This decision came following a thorough 30-day review period by FDA officials who assessed the application for its viability and safety.
Next Steps Post-FDA Review
Vivos Inc. is now setting its sights on addressing the concerns raised by the FDA in their official correspondence. Company officials expect to hold an initial teleconference with the FDA within the next 10 days to discuss the feedback received. This proactive approach demonstrates Vivos’ commitment to rectifying the issues and moving forward.
Planning for a Pre-Submission Meeting
In addition to the initial call, Vivos intends to engage in a pre-submission meeting with the FDA review team in the coming weeks. This meeting will play a critical role in clarifying the specific aspects that need further attention and help establish a clearer path for resubmitting the IDE application.
About Radiogel®
Radiogel has been recognized with the FDA Breakthrough Device Designation. This designation indicates the product’s potential to meet unmet medical needs and facilitates expedited development and review processes. Furthermore, the therapeutic advantages that Radiogel offers—including a remarkable therapeutic ratio and a robust safety profile—underscore Vivos’ confidence in the product’s future.
Company's Commitment to Approval
Despite this setback, Vivos remains steadfast in its mission to pursue Radiogel’s approval in the competitive U.S. market. The leadership, led by President and CEO Michael K. Korenko, expresses a strong belief in the product’s capabilities and is determined to overcome the current challenges.
Continued Efforts and Innovation
Vivos Inc. is not only focused on Radiogel but continues to innovate across its product line, including its ISO robotic technology with IsoPet®. The investment in research and development, along with a commitment to regulatory compliance, positions Vivos for future opportunities in the healthcare sector.
Future Prospects for Vivos Inc.
Looking ahead, Vivos Inc. aims to leverage the insights gained from the FDA's feedback to improve its submissions and align with regulatory expectations. The collaboration with regulatory bodies, along with a firm dedication to enhancing their product offerings, will be pivotal in navigating the complexities of clinical trials and market entry.
Frequently Asked Questions
What was the reason for the FDA's decline of the IDE application?
The FDA provided feedback that indicated areas of concern which need to be addressed before approval can be achieved.
What are the next steps for Vivos Inc. after the FDA's decision?
Vivos plans to have initial discussions with the FDA and participate in a pre-submission meeting to aid in resubmission efforts.
What is Radiogel® and its significance?
Radiogel is a therapeutic product that has received FDA Breakthrough Device Designation for its significant safety and efficacy profile.
Who is leading Vivos Inc.?
Michael K. Korenko, Sc.D. serves as the President and CEO, guiding the company's strategic direction and clinical initiatives.
How can one learn more about Vivos' products?
For further information on Radiogel and IsoPet, interested parties can visit Vivos Inc.'s official website.
