Vivos Inc (RDGL)

[MikeD]

IMO its important to manage expectations. Its my understanding from the pr Vivos has simply filed a Radiogel “Application” for EFS IDE. If the “Application” has indeed already been approved and did not need resubmital and in turn the 30 day EFS has already started and goes well, it leads to more studies such as the traditional EFS or a Pivotal Study. A pivotal study can take years to complete.

“The goal of an EFS is not to prove the device performs exactly as intended and requires no changes, but rather to provide information to help you make a better, more effective device. Changes to the device design, materials, procedure, instructions, and even patient population are to be expected.”


“If the device design is near-final or final, and the results of the early feasibility study support the initial safety of the device and proof of principle, it may be more appropriate for the sponsor to pursue either a traditional feasibility study or a pivotal study. Progression to a traditional feasibility or pivotal study should be requested under an IDE supplement and should include the information needed to justify initiation of the larger study. The approval of any IDE supplement will ultimately depend on the availability of nonclinical and clinical data to justify initiation of the specific type of study requested.”

https://www.fda.gov/media/81784/download

https://mdic.org/wp-content/uploads/2018/12/MDIC-EFS-Blueprint-for-EFS-Success-2016.pdf


https://www.fda.gov/media/87603/download