The Results of the Animal Safety Trial Explained
I have been waiting to write this post until the animal safety trial was finished and all the results had been reviewed. As a scientist, I was very impatient to share this information. As an officer of EMF Disturbance Monitors, Inc., I also have an obligation to only share information with the public that is valid and reproducible. I can now say that our animal safety trial was an unqualified success! Not only are we moving forward with our planned human volunteer trial, we have attracted additional capital investment in the company.
The most important outcome of an FDA animal safety trial is to document whether the tests we performed caused any injury (Adverse Events) to the animals tested. They did not. The Rhesus macaque monkeys wore our sensor vest for 30-45 minutes and returned to their enclosures with the other monkeys. The staff at the Biomedical Imaging Research Center at the University of North Carolina at Chapel Hill observed animal behavior before and after the tests. They reported no Adverse Events, confirming that the test is safe. Our thanks go out to the UNC staff who were incredibly professional.
The secondary outcome of an animal safety trial is to determine whether the technology was able to estimate the electromagnetic field produced by the monkey hearts. This was also successful. In each test, the animal was compared both to its own baseline (the EMF generator turned OFF) and to our control animal (Reese, the stuffed animal resembling a Rhesus monkey). The EMF disturbance data obtained from the tests animals was significantly different than the controls and estimated the electromagnetic field created by the heart of the animals. The tests were performed on different days with different sensor vests, and the results were reproducible.
The innovation that EMF Disturbance Monitors, Inc. has patented is the ability to indirectly estimate the electromagnetic field created by the muscles (such as the heart) and nerves. Based on published estimates of the heart’s electromagnetic field (EMF) strength, our technology appears to have magnified the weak EMF of the heart by a billion times (10 to the 9th power)! This allowed us not only to create “normal” cardiac EMF disturbance values for Rhesus monkeys, but also to show that the individual monkeys had subtle differences in their cardiac EMF studies.
In 2009, EMF Disturbance Monitors, Inc. completed our first “Proof-of-Concept” at GA Tech for a sports medicine application. Now, in 2024, our UNC animal safety trial has again confirmed this “Proof-of-Concept” for a cardiac application. Our plan as a company is to continue to move forward with FDA approval by testing human volunteers, hopefully this fall at UNC. You can follow our progress on our Web site or on our Linkedin page.
