I am pleased to share with you the preliminary results of a recent study on the treatment of Type 2 diabetic patients with peripheral neuropathy. The study has confirmed the anecdotal results we have seen in the clinic.
This study is particularly significant considering that there has been a paucity of clinical evidence of the efficacy of our neurostimulator device.
Since the first FDA device was cleared in 2005, approximately 100,000 devices have been applied on patients.
We have started a program of clinical studies. The first one on treating peripheral neuropathy in Type 2 diabetics is nearing completion. The results are phenomenal, as we expected, given the anecdotal evidence gathered through the years.
We are publishing an interim paper based on an abstract that was submitted to the North American Neuromodulation Society’s annual meeting in Las Vegas in January 2019.
The paper confirms:
1. The initial treatments do not provide pain relief but make the patient sleep better.
2. Succeeding treatments provide pain relief. After treatment four, patients experience an exponential reduction of pain.
3. It takes six to eight treatments to cure the patient.
Another interesting fact emerged. Electrical stimulation also stimulates tissue regeneration. There are a few papers on this topic. In fact, the inventor of an earlier version of our neurostimulation device had treated many patients for wound care in the Viennese General Hospital. I had completely forgotten about this until I was made aware that one of the patients in our study experienced the healing of her toe during treatment. The number of treatments required to accomplish this varies depending upon the size of the wound.
We are continually amazed at the results and benefits to patients. Each study takes about 2 years from start to finish. We started the process for this current study at the beginning of the year. We have just completed treating over 66 patients (the number required for statistical significance). Now the process of final analysis and documentation begins.
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