Vivos Inc (RDGL)

[Diggnun21]

The old "traditional" Brachytherapy devices are now all approved as Class II devices, i.e. using metal or glass seeds with 1-3 month turn-around times. It's the Radiogel that is taking longer. Essentially, the FDA is approving a predicate device. Here's a bunch of quick turn-around approvals from the FDA on Brachytherapy devices using old glass/metal seeds and various radioisotopes.

http://www.accessdata.fda.gov/cdrh_docs/pdf14/K140856.pdf
http://www.accessdata.fda.gov/cdrh_docs/pdf7/K070468.pdf
http://www.accessdata.fda.gov/cdrh_docs/pdf/k994317.pdf
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093663.pdf

The 510(k) rejection was part of the process; Radiogel is unique in the Brachytherapy market and is not substantially equivalent (NSE) to any predicate device, thus the 510K rejection.

But, the Radiogel Y-90 technology has been shown in tests at Pacific Northwest Laboratory to be safe and effective, even more so than these existing traditional Brachytherapy devices. And that is what we need for Class II de novo approval. The Radiogel approval is a safety-risk approval, and nothing more than that. Straight up clean DD.