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Brainsway Receives FDA Approval

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 seal of approval 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 approval 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 approval 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 approved by the U.S. FDA – is a great source of pride."

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