In this article, EP Lab Digest speaks with Allen S. Braswell, Jr., JD, CEO of Pico-Tesla, about their Magneceutical™ Therapy, which involves the use of a very precise, extremely low-level electromagnetic field (EMF) applied by a specially designed device called the Resonator™. Recently, data from a study completed at the University of Oklahoma’s Heart Rhythm Institute suggested that extremely low-level EMFs could prevent and reverse involuntary remodeling of the heart by terminating and preventing atrial fibrillation (AF). Learn more about this promising therapy here. Tell us about the background of Pico-Tesla’s Magneceutical™ Therapy, and when the Resonator™ was created. The background of the Magneceutical Therapy emanates from Dr. Jerry Jacobson, who is our chief science officer. Some of his early work was done from the mid 80s to early 90s, when he developed a theory that would apply not high strength magnetic stimulation, but low-level magnetic stimulation to the body to improve symptoms of diseases and conditions that have afflicted people. It was really from Dr. Jacobson’s early work that this arose. Describe the components of the system. How does it work? Right now the primary configuration we are working on is a whole body emersion system. It has two separate coils and what is called a Helmholtz coil configuration. A Helmholtz coil is kind of an old, standard way of creating a homogeneous magnetic field. With two 7-ft. coils that are spaced 3.5 ft. apart, we’re able to place a person, either seated comfortably or lying on a table or bed-type configuration. The patient can be seated comfortably for a treatment session that would last typically between an hour to an hour and a half. These coils have copper wire in them, and when you push electricity through that, it creates the magnetic field. The coils are connected to an attenuator box that is then connected to a computer, that connects to our website, where our treatment protocols are accessed. A treatment protocol contains a specific amplitude and frequency that is associated with a particular disease state or molecular target that we are after. For instance, in our Parkinson’s study, we have a protocol that involves 5 different amplitudes and frequencies for a treatment session that lasts an hour and 20 minutes. That protocol would be different than the one we would use for our diabetes study or protocols for our future studies in Alzheimer’s, atrial fibrillation, or fibromyalgia. The reason for the difference is that each of these disease states is associated with different molecular targets, which then have different corresponding amplitudes and frequencies to which they may respond. How often does a patient have to utilize the Resonator in order to see benefits (for example, in Parkinson’s patients)? Our current Parkinson’s study, a pivotal study currently in phase 3, is built around an 8-week time period where the patients will come in 3 times per week for about an hour and 20 minutes per session. In a predecessor study to our current study, we saw statistically and clinically significant changes at the end of those 8 weeks. Those changes tended to last for 2 months after the last treatment. After 2 months, we started to see our 2 groups come closer together and revert back to baseline. A third study, however, involves a longer term, less intensive treatment regimen in which we still have 8 patients. We’re going into our second year, 21 months actually, where the patients come in once a week for 1 hour, and those patients are just starting to come back to their baseline scores from 2 years ago. Considering the chronic and degenerative nature of this disease, we’re hoping to show some data that suggests that we may have a decent retention of benefits with these treatment sessions. Tell us about early research using this technology to treat AF patients. What effect did the Resonator have in preventing or relieving AF symptoms? All of our AF applications have come from the University of Oklahoma, where their Heart Rhythm Institute has been the forerunner in the application of electrical or electromagnetic fields’ impact on AF. We’ve been working with a number of researchers there. The primary one is Dr. Ben Scherlag, as well as his clinical counterpart, Dr. Sonny Po. In 2004, they conducted a study where they took our low-level magnetic theory and used an invasive approach in which they utilized a small Helmholtz coil at the end of a catheter. In a dog model, they snaked it up the arteries to the heart and laid it against the ganglionated plexi, and they were able to reduce what would have induced atrial fibrillation. They have done a number of studies in low-level electrical stimulation, associated with the vagus nerves, and they were seeing that they were getting a good response in reducing AF inducibility in the dog model. So after some discussions a year and a half ago with Dr. Scherlag about some of the work with vagus nerve stimulation, he attempted to replicate in the dogs a low-level electromagnetic stimulation in a non-invasive way using our Helmholtz coil configuration (in addition to the traditional catheter approach), and he achieved the same results. What Dr. Scherlag had was a prototype version of our 7-ft. coils, a smaller configuration that uses two 19-in. coils. Essentially in this experiment, he used high-level electrical stimulation to induce atrial fibrillation in anesthetized dogs, and then used our low-level EMFs to bring them back to baseline from an AF inducibility standpoint, even while the high-level electrical stimulation was being applied. We were very excited about this outcome, and this study was the subject matter of the poster presented at Heart Rhythm 2010 in Denver. When will more research be conducted? Are there plans for research on human subjects with atrial fibrillation? Specifically we are engaged with two different cardiology groups, one in the Tampa Area and one in Denver, and we are working through the development of a human protocol right now. We are looking to put together an AF burden study, and doing an exploratory study to see if a non-invasive approach to treating AF demonstrates potential, using the information we currently have. We are very excited about this, and I would expect within a couple of months that we should be in a position to where we have gotten the appropriate approvals and are investigating our device with human subjects. Are there any complications associated with this technology? For example, is there any risk of negative effects from exposure to electromagnetic energy? No, we have not had any adverse events or significant events associated with any of our studies. We are doing studies in Parkinson’s disease and diabetes right now, so there’s not been any adverse events or significant events associated with treatment. Most magnetic stimulation devices are in the MRI strength fields, which is a trillion times stronger than the fields we use. Therapies such as rapid transcranial magnetic stimulation (rTMS) use those higher strength fields, and I think the only adverse events I have read about were headaches and a potential for people who were susceptible to seizures to have those seizures be brought on. However, we have not had any adverse events associated with our strength fields, which again are at a much lower level than MRI devices. What feedback have you received thus far? The feedback has been very exciting, especially as it relates to AF, where the current options for this patient population are just not very good. Coumadin and other drugs are about 50% effective for this population, and cardioablation surgical techniques have a 4-5% adverse event complication rate. Our technology is noninvasive, with non-significant risk, and adjunctive to standard of care; we design our studies to keep patients safe and remain on their standard of care. When you look at that from a treatment or a technology standpoint, it’s very attractive to at least go explore it to see if it works. The downside is minimal and the upside is huge, especially for a disease as big as AF or the other diseases that we are investigating. For more information, please visit: www.pico-tesla.com Note: The Resonator™ device is an Investigational Device limited by federal (or United States) law to investigational use. The Resonator™ device is not for sale, nor is the Magneceutical™ Therapy generally available outside of Investigational Review Board (IRB)- approved clinical studies.