CLINICAL TRIALS, APPROVALS & SAFETY
Currently, our machines are engaged in two clinical trials in the United States. These studies are for submission to the FDA for U.S. FDA clearance, and for adding human use approval in other countries.
To our knowledge, PEMF Systems Inc is the only manufacturer conducting clinical trials in the USA to demonstrate the health benefits and safety of our product. MagnaWave offers the longest most comprehensive warranty available, we also stand behind our PEMF equipment use and safety.
Currently, PEMF Solutions products are not regulated under the FDA. They are to be used as massage like instruments, there is no medical benefit claim currently assigned to their use. In general, PEMF is designed to support overall health and well-being in humans and animals.
In other countries, PEMF has been a mainstream therapy for over 30 years. There have been over 2800 clinical trials completed using many different PEMF devices in many different countries, all with positive results.
Electromagnetic stimulation of bone repair: A Histomorphometric Study
Published by Kansas State University
The results show that PEMF therapy is the most technically and operationally feasible option of the aforementioned modalities for a mobile business model due to its variety of applications, ability for use before and after performances, reasonable startup cost and lack of veterinary oversight required.
Veterinary applications of pulsed electromagnetic field therapy
Published by Science Direct
In an effort to unravel the confusion surrounding PEMF devices, this article reviews important PEMF history, device taxonomy, mechanisms of action, basic science and clinical evidence, and relevant trends in veterinary medicine. The data reviewed underscore the usefulness of PEMF treatment as a safe, non-invasive treatment modality that has the potential to become an important stand-alone or adjunctive treatment modality in veterinary care.
NASA ON STIMULATING GROWTH AND REPAIR
NASA4-YEAR COLLABORATIVE STUDY ON THE EFFICACY OF ELECTROMAGNETIC FIELDS TO STIMULATE GROWTH AND REPAIR IN MAMMALIAN TISSUES NASA/TP-2003-212054*
Robert Dennis Ph.D. of the University of Michigan, and Thomas J Goodwin Ph.D. of the Lynden B Johnson Space Center
This four year study used human donors “to define the most effective electromagnetic fields for enhancing growth and repair in mammalian tissues.” To utilize “nerve tissue which has been refractory to efforts to stimulate growth or enhance its repair regardless of the energy used.” (all other tissues have demonstrated growth and repair stimulation with appropriate PEMF). To define a PEMF technology that would “duplicate mature, three dimensional morphology between neuronal cells and feeder (glial) cells, which has not been previously accomplished.”
The PEMF used in the study “caused accelerated growth rate and better organized morphology over controls”, and resulted in “greater cell viability” (85% vs. 65%). In the gene discovery array (chip technology that surveyed 10,000 human genes),the investigators found up-regulation of 150 genes associated with growth and cell restoration. T. Goodwin (personal communication) “PEMF shut down each dis-regulatory gene we studied.”