This is BrainsWay’s global website. The website includes information on clinical indications that were not cleared by the FDA and are considered investigational by the U.S. medical device regulations. BrainsWay D treatment is FDA cleared for patients with MDD who failed to respond to one or more anti-depressants in the current episode.
JERUSALEM, Sept. 14, 2016 (GLOBE NEWSWIRE) — Brainsway Ltd. (TASE:BRIN), the leader in the development of advanced noninvasive treatments for brain disorders, announced that it has received local regulatory approval for the marketing and distribution of Brainsway Deep TMS (Transcranial Magnetic Stimulation) in Mexico. The company entered an exclusive distribution and marketing agreement with Moksha8, a leading specialty pharmaceutical company in Latin America, who has exclusive rights to distribute Deep TMS in Mexico.
“At least 15 million Mexicans suffer from a mental illness, many of whom do not have access to quality care,” said David Zacut, chief executive officer of Brainsway. “Our technology has been well-received globally, and we are confident that together with Moksha8 we will be able to provide hope to the people of Mexico.”
The partnership between Brainsway and Moksha8 is a long-term one, including specified sales objectives for each year, as well as a commitment to purchase 10 devices within a year from attaining the regulatory approval. Brainsway’s penetration into the Mexican market creates an opportunity for gaining a competitive advantage in this market, as it marks the first time the Deep TMS technology has been approved for clinical use in Mexico.
Brainsway’s Deep TMS solution is used throughout the world and is FDA cleared for the treatment of clinical depression in the United States.
Brainsway Ltd./ Brainsway USA is a leader in noninvasive treatments for brain disorders utilizing Deep Transcranial Magnetic Stimulation (Deep TMS). Our unique patented technology was developed in collaboration with the National Institute of Health (NIH) and is FDA and CE cleared to treat patients with depression who are not currently responding to medication. The treatment has been enthusiastically supported by many academic communities and is widely covered by most insurance payers. For more information, please visit brainsway.com.