Vivos Inc (RDGL)

[I-Glow]

Isn't the Radiogel™ Precision Radionuclide Therapy device a Class III Medical Device.

"The cost of clinical trials for medical devices can vary greatly depending on several factors, but estimates range from $6 million to $94 million.

Complexity

The complexity of the device and the regulatory pathway chosen can impact the cost. For example, a Class II medical device of medium complexity can cost between $2 and $5 million for research and development, and around $30 million for FDA approval."

There isn't anything on Clinicaltrials.gov about the Vivos medical advice.

From the 2014 10-K:

"Throughout 2014, the Company focused on the development of its brachytherapy products including the regulatory review of the Y-90 RadioGel™ device by the Food and Drug Administration (“FDA”)."

They have been pumping this for 10 years and still years away from generating any revenue.

IG