I just heard about a new treatment device for advanced hepatocellular carcinoma (liver cancer) and wanted to share the news with my readers. This bioelectromagnetic device is called TheraBionic, and according to some friends whose child has liver cancer, it
has successfully completed Phase I & II trials, and will soon undergo Phase III. The device itself is very non-invasive—a small box about the size of a pencil case with a spoon-like attachment. Patients turn it on, put the spoon into their mouths, and sit for an hour while it sends low-level electromagnetic waves through the body. Patients do this three times a day and experience virtually no side effects.
It’s not so easy for people living in the United States to join the trials for TheraBionic, however, as they have been conducted in Brazil. So my friends, with help from doctors at MD Anderson in Houston and Northwestern in Chicago and a patient advocate at the University of California at San Diego, applied to the Food and Drug Administration to use the device on a compassionate basis.
They started this process in December and just received approval. They gave me permission to publicize the device on this website.
I was not aware that individuals could set up their own trial with approval from the FDA. That’s good to know.
Here is some information from the website:
TheraBionic has solved a central problem in the treatment of hepatocellular carcinoma. Because most drugs are metabolized by the liver, many patients do not tolerate therapy for this disease as they have severely impaired liver function. With current treatments on the market, patients with hepatocellular carcinoma have a very limited life expectancy, ranging from 6-12 months.
In contrast to current treatments, no significant side effects have been observed with the use of the TheraBionic device in the treatment of 41 study patients with advanced hepatocellular carcinoma and severely impaired liver function. TheraBionic treatment showed clear benefit in 20 of the 41 (49.8%) patients who experienced either significant tumor shrinkage (4) or stable disease for more than three months (16). Seven of the 11 (63.6%) patients who experienced pain prior to TheraBionic treatment initiation reported either complete or partial disappearance of pain. There were several very long-term responders to TheraBionic treatment, which suggests that TheraBionic treatment may offer control of advanced cancer for several years.
So, TheraBionic shrank the tumor in 4 out of 41 patients, and 16 others lived three months longer than they would have otherwise.
The overview page on the website also mentioned a 2012 Phase II trial for advanced breast cancer.
The TheraBionic P1 device received the CE mark as a Class IIa medical device according to Annex II of the Medical Devices Directive (MDD) 93/42/EEC guidelines and in compliance with the EN ISO 13485:2016 quality management systems regulatory requirements for medical devices. Class IIa medical devices are considered low risk and this class includes hearing aids and dental implants. The TheraBionic P1 device was approved as a breakthrough medical product for unmet medical needs, specifically for patients with advanced hepatocellular carcinoma who have exhausted all curative treatment options. The intended use of the TheraBionic P1 device is the systemic treatment of patients with advanced hepatocellular carcinoma who have either failed or are intolerant to first line and second line therapies. More information is available at therabionic.com