Israeli company Brainsway Ltd. has announced U.S. FDA approval of its proprietary Deep TMS device for the treatment of depression in patients who have failed to respond to antidepressant medications in their current episode of depression.
We’ve followed Brainsway for some time, notably last year (2012) when it received CE mark approval for treating chronic pain to add to its approval for so-called refractory (non responsive) depression. The company’s device was conceived for the noninvasive treatment of common brain disorders. It is based on a uniquely shaped electromagnetic coil connected to a rapidly changing current supply, which produces magnetic fields capable of affecting different areas of the brain. Deep brain areas can be either excited or inhibited, depending on the frequency of the magnetic field.
This indication for the use of Brainsway’s device, as approved by the FDA, is broad, both in general terms as it relates to depression therapy and compared to the FDA-approved indications for the use of competing TMS therapy.
Brainsway sees the scope of the FDA-approved indications as further confirmation of the safety and efficacy of the Deep TMS technology, developed by Prof. Abraham Zangen at the U.S. National Institutes of Health, in the treatment of depression patients. It believes the technology could fundamentally alter the way in which depression is treated worldwide.
Another reason to be cheerful is that the approval represents a major breakthrough for the Company, inasmuch as it grants it access to the U.S. market for depression therapy, which is valued at tens of billions of dollars per year.
Brainsway is currently exploring various avenues for the marketing and distribution of treatments using its Deep TMS device in the U.S. and across the globe, including collaborations with well-known and experienced companies in the industry.
This news follows release of clinical study information in November 2012, which suggested the therapy may have a place in treatment of patients with multiple sclerosis. While some of the results of the study were not statistically significant it seems there may be some effect in alleviation of tiredness and depression in these patients. Further information here.
Prof. Hilik Levkovitch, Director at the Shalvata Mental Health Center, one of the two Principal Investigators of the Clinical Trial and a pioneer of TMS in Israel, remarked, “Brainsway’s depression therapy is a breakthrough and a credit to the clinical research efforts that have been made in order to combat depression. This innovative treatment – developed here in Israel and now approved by the U.S. FDA — is a great source of pride.”
Uzi Sofer, CEO of Brainsway, took this occasion to say, “‘Give thanks to the LORD, for he is good. For his mercy endures forever’ (Psalms 136:1). We have worked tirelessly for almost ten years to make it to this blessed day. These are glad tidings not only for Brainsway, but also for depression patients and their doctors. The broad scope of the FDA’s clearance proves conclusively that our device is both safe and effective. I believe this approval will boost awareness and acceptance of Brainsway’s Deep TMS technology not only in the U.S., but the world over, as we continue to also work towards achieving regulatory approval from healthcare authorities in Canada and other countries. This is a very happy day for me personally and for every one of the Company’s employees who have all contributed to our achievements. I am hopeful that we will have the wisdom to steer Brainsway onto ever-greater achievements moving forward. CNS is a difficult and challenging field and few companies have any projects in their pipelines in this field. We have dozens of products ready to be released, and we hope to obtain clearance for these in the future.”
Source: Brainsway Ltd., Globe Newswire