Vivos Inc (RDGL)

[kayak_wench]

Radiogel "provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions" than existing treatment methods (for a given application of course) currently available.

That is an amazing statement to be able to make as a company to investors, doctors, and patients!!!
Not only has the FDA declared that to be true, they did it when they had previous said it wasn't true. This speaks volumes to Korenko's management of the company and the IDE process! Being able to say we are a better technology than anything else you can get (or our application areas) certainly makes the potential market larger.

We can safely conclude the FDA believes Radiogel is a better treatment option because to get BDD status you have to meet only two criteria. The first being criteria that every single BDD product must meet (see https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program#s3):

1. The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions

The second being that the device must also meets at least one of the following:

2.a. Represents Breakthrough Technology
2.b. No Approved or Cleared Alternatives Exist
2.c. Offers Significant Advantages over Existing Approved or Cleared Alternatives
2.e. Device Availability is in the Best Interest of Patients

As longs will recall Radiogel was declared to represent breakthrough technology back in 2021 (from PR date Jan 19, 2021 Vivos)

“The FDA does believe that RadioGel™ meets criterion #2a: Device represents breakthrough technology. Your device does meet this criterion because it is a novel application of a brachytherapy device outside of the liver.”