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Current Legal Status in the U.S.
The BPT machine, meaning the Knott Hemo-Irradiator
or its direct linear descendent currently has Pre-Amendment and R&D
status (because it was in use before May 10, 1976) and is manufactured
for us by the elected company working with the FDA to secure 510K status
and will be funded by our investors.
Because its legal status in the U.S. is still at RD, we are only
allowed 2 RD clinics for now. However, we are currently setting up
to use the BPT machines in hospitals & clinics in Canada, Israel,
Dominican Republic, and Panama. A clinic in New York City is also in the
works (pending proper funding).
Legal Status in other Countries
It is approved for use in Canada, Russia, Germany and parts of Eastern
Europe. Countries with pending approval are Israel, Panama, and the
Dominican Republic. Additional countries will be added as funding
becomes available.
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