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  1. Recently-Approved Devices

TheraBionic P1 – H220001

 

TheraBionic P1 handheld electromagnetic field generator and antenna

 


This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Probable Benefit and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: TheraBionic P1
HDE Applicant: Boris Pasche, MD, PhD
Address: 4108 Ryan Way
Winston-Salem, NC 27106-3567
Approval Date: September 26, 2023
Approval Letter: Approval Order

What is it?

The TheraBionic P1 System is a handheld, battery-operated, radiofrequency (RF) electromagnetic field (EMF) generator that includes an antenna on a cable that attaches to the generator.

How does it work?

The TheraBionic P1 System’s antenna is placed in the mouth. Then, the handheld generator emits EMF at specific amplitude-modulated, or AM, frequencies. The EMF frequencies may stop cancer cells from dividing and making more cancer cells.

When is it used?

The TheraBionic P1 is indicated for use in people who are 18 years old or older with advanced hepatocellular carcinoma that has not responded to other treatments.

What will it accomplish?

The use of the TheraBionic P1 shows a probable benefit of overall survival when compared to similar groups of people who receive a placebo treatment. In a clinical trial of 41 adults, 14 patients (34.1%) had stable disease for more than 6 months.

When should it not be used?

The device should not be used in people who:

  • Are under the age of 18.
  • Receive calcium channel blockers.
  • Do not have intact mucous membrane lining the mouth (oral mucosa).
  • Have intolerance or allergic reactions to the antenna.

Additional information (including warnings, precautions, and adverse events):

 

 

 
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