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ActiPatch® is a new and clinically proven drug free technology in the fight against chronic pain. Musculoskeletal pain is wide spread in society, negatively impacts quality of life and is currently inadequately treated for most people. BioElectronics Corporation, headquartered in Frederick, Maryland, USA, is the leading company in the field on non-invasive electroceutical medical devices.
Transcranial magnetic stimulation (TMS) induces transient electric fields in a small area of the cortex by using focused magnetic pulses over the skull.
That’s the potential of a revolutionary new technology known as Deep Transcranial Magnetic Stimulation, or Deep TMS, being developed by Israel-based Brainsway (TASE:BRIN). Brainsway has developed different helmets, with different patterns of coils to treat different disorders. A competing Surface TMS technology, developed by closely held Neuronetics of Pennsylvania and approved by the FDA in October 2008, achieves stimulation to a depth of only 1.5 to 2 cm.
Brainsway currently is targeting five therapeutic applications: major depression disorder (MDD), negative symptoms of schizophrenia, bi-polar disorder, Parkinson’s disease and Alzheimer’s disease.
Brainsway expects to complete recruitment of 225 patients for the trial by the end of the year, with data to be published in the second quarter of 2012. The trial’s primary endpoint is superiority of Deep TMS versus sham at the sixth week, using the Hamilton Depression Rating Scale, a commonly used questionnaire for rating depression in medical research.
There are some 15 million Americans suffering from depression, for example, of which 7.5 million are resistant to drug therapy. He says the company’s revenue opportunity is well protected, with “a strong patent portfolio” protecting the coil technology and its uses in Deep TMS and certain advances to the technology, among other things. Another advantage of Deep TMS is its mobility.  It is easy to install and perform in a hospital, medical center, clinic or private practice setting. Just today, the company announced that it has received investigational device exemption (“IDE”) from the FDA to begin a pivotal trial for the treatment of bi-polar disorder to support a premarket notification 510(k) filing with the FDA.


Other potential uses of Deep TMS include autism, multiple sclerosis, Tourette’s syndrome, pain, smoking addiction, attention deficit hyperactivity disorder, drug addiction, obesity and stroke rehabilitation.  In July, the company announced strong trial results in post-traumatic stress disorder. During TMS therapy, a device that generates a magnetic field is used to induce electrical currents in the brain. TMS treatments are an outpatient procedure, which means they are done in an office setting. BioElectronics Corporation (the manufacturer of ActiPatch®) has conducted a 7-Day trial program in the United Kingdom and Ireland.  The reported responses indicate that it is an effective pain therapy for a wide range of common conditions causing pain including osteoarthritis, rheumatoid arthritis and fibromyalgia. Sofer says that one needs to consider the fact that every idea, thought, emotion and action humans have are a result of electrical activity in some part of the brain. The non-invasive treatment has no significant side effects and no systemic effect, in contrast to drugs, and does not require hospitalization or anesthesia. If the trial is successful, the company will file a 510(k) premarket notification application with the FDA for marketing clearance, which it hopes to receive during the second half of 2012.
The multiple choice questionnaire rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss.
Sofer says Brainsway has established a “per-click” business model, where it charges a fee for each Deep TMS procedure performed by the end user. Minimal training is required and the procedure can be administered by a technician or nurse instead of a doctor, according to Mr. Sofer says Brainsway is now talking with potential marketing partners all over the world, but he expects talks to intensify after the pivotal trial results are published. Sofer says MDD, bi-polar disorder and schizophrenia have all been CE Marked in Europe, with pilot sales of Deep TMS underway in Italy and planned pilot launches in Brazil.
In fact, ActiPatch® is completely sensation free, so the only thing you are going to feel is better. Still, after 2 decades of TMS, little is known about which neurons are the primary target and which processes are induced at the level of single neurons and local networks.


That’s followed by maintenance therapy of two procedures a week for a month or two, followed by one procedure a week for 10 weeks, again depending on the type of disorder, for a total of about 46 procedures. He adds, “To reach $750 million in revenue, we need to penetrate just over 2% of the market. In Parkinson’s disease, Brainsway received CE Mark clearance in April and is planning to submit an application for IDE approval.
The typical initial treatment course consists of daily treatments over a 4-to-6-week period, for an average of 20-30 total treatments. With very recently developed TMS-responsive, patterned neuronal cultures we now have a model system that is directly accessible to restricted biophysical and electro-physiological experiments. On the other hand, with Parkinson’s disease or Alzheimer’s disease, there is hyperactivity in the motor area of the brain.
We also better understand the major role of axons over dendrites, the importance of repetitive excitation and the possible effect of drugs in the process. This project will combine those experimental studies with theoretical efforts to elucidate the cellular and synaptic mechanisms of TMS.
This efforts include simulations of direct TMS effects in 3D models of neurons in the induced fields, characterization of the field influence on axonal and dendritic morphology, and network effects in idealized balanced networks. Compartmental models of various neuron morphologies will be used to understand better the evoked potentials and results will be compared to the in vitro responses. A better comprehension of this sub-processes after stimulation can serve as a basis for a more systematic, rational design and assessment of clinical treatments with TMS protocols.




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