BrainsWay Deep TMS Receives FDA Clearance

BrainsWay Receives FDA Clearance

JERUSALEM, Thursday 10, 2013 BrainsWay® Ltd. (TASE: BRIN)

 is proud to announce that the U.S. Food and Drug Administration (“FDA”) has cleared 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. It should be noted that this indication for the use of BrainsWay’s device, as cleared by the FDA, is broad, both in general terms as it relates to depression therapy and compared to the FDA-cleared indications for the use of competing TMS therapy.

The scope of the FDA-cleared indication for the use of the BrainsWay device provides 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 and could fundamentally alter the way in which depression is treated worldwide. Furthermore, this clearance 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.

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 clearance 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 clearance 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.”

Prof. Zangen commented, “This is exciting news for the world of medicine in general and the field of psychiatric research in particular, which is ever in pursuit of the progress which recent decades have brought other fields of medical research. This clearance status from the FDA is a testament to the effectiveness of the technology that I first started to develop with Dr. Roth more than ten years ago, and is likely to pave the way for affordable and accessible treatment for depression all over the world.”

Ronen Segal, CTO of BrainsWay, commented,  “This broad-scope clearance clearly demonstrates that Deep TMS is a game-changing technology in the field of treatment for neurological and psychiatric brain disorders. Today, we have entered a new age, in which BrainsWay is standing at the helm of a global technological revolution in the medical device industry. An industry once primarily involved in the development of diagnostic measures now possesses the capability to effectively treat disorders, and offers a real alternative to treatment thus far dominated by the drug industry.”

Dr. Yiftach Roth, BrainsWay’s Chief Scientist and one of the developers of the Deep TMS technology, said, “The FDA’s clearance is great news for the Company, of course, but more importantly, for millions of people in the U.S. and worldwide who suffer from depression. These individuals, who have failed to find relief for their condition using existing treatments, may finally find therapeutic relief for their affliction. The safety and efficacy of depression therapy with BrainsWay’s device have been demonstrated extensively, and patients now have the option of receiving comfortable, noninvasive treatment without the need for anesthesia or hospitalization, and without any significant side effects that might affect their quality of life.”

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 cleared by the U.S. FDA – is a great source of pride.”