fiercebiotechJanuary 17, 2019
Tag: Magnetic therapy , Brainsway , depression , obsessive-compulsive
Brainsway, developer of magnetic device treatments for depression and obsessive-compulsive disorder, plans to raise $30 million through an initial public offering on the Nasdaq under the symbol "BWAY."
Currently listed on the Tel Aviv Stock Exchange under the symbol "BRIN," the Jerusalem-based company confidentially filed in November 2018, according to Renaissance Capital. Pricing terms were not disclosed.
The company obtained a de novo clearance from the FDA last August for the use of its noninvasive, deep transcranial stimulation system in treating OCD through about 20-minute-long sessions. That authorization was the second for Brainsway in the U.S., following a 2013 clearance for treatment-resistant major depressive disorder.
Brainsway’s device has received CE marks for stimulating nerve cells in different regions of the brain to treat multiple disorders, including chronic pain, autism, bipolar disorder, schizophrenia and others, as well as for Alzheimer’s and Parkinson’s diseases.
According to its prospectus, the company is currently conducting clinical trials to support FDA clearance of its technology for smoking cessation and post-traumatic stress disorder. Future studies could explore opioid addiction, fatigue in multiple sclerosis and post-stroke rehabilitation.
The U.S. represents Brainsway’s primary market, providing about 89% of its revenues in 2017. Currently, the company is ramping up its commercialization efforts in OCD, although it has yet to secure reimbursement coverage in the indication. Still, it aims to generate review from flexible pricing models and the out-of-pocket market.
The company brought in $11.6 million in revenues over the first nine months of 2018, a 54% increase compared to the same nine months the year before, and more than the $11.1 million it raised through all of 2017.
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