A magnetic brain stimulation device for depressive disorders has received CE Mark approval from European regulators, according to a statement from the company. The move paves the way for the global expansion of the device to markets in Europe, the Middle East and ultimately, Asia.
Neuronetics‘ Neurostar TMS Therapy known as transcranial magnetic stimulation had been approved by the U.S. Food and Drug Administration in 2008, but now that it has established a market for the device in the U.S., it is forging ahead with its commercialization plans in other parts of the world, according to a spokeswoman for the company.
The device is approved in the U.S. for people with major depressive depressive disorders for whom antidepressants have not produced satisfying results. The device stimulates the brain using low level electrical currents. The company estimates the market size in the U.S. alone at 3 million to 4 million people.
The Malvern, Pennsylvania company is in the midst of securing partnerships in key Asian and Middle Eastern markets and is about to embark on commercial partnerships for Europe. In the run-up to the expansion, it has raised $30 millionin its latest financing round in the past year co-led by Pfizer. The company was founded by The Innovation Factory, an Atlanta-based medical technology incubator. Since its inception in 2003, it has raised more than $100 million.
Trancranial stimulation has been a closely watched area of neuroscience for some years, including for more invasive applications. St Jude’s is studying a neurostimulation device as a therapy for severe depression, but it involves an implant. Boston Scientific’s $78 million acquisition of Cleveland Clinic spinoff Intelect Medical in 2011 moved the company into the deep brain stimulation treatment area.
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