Many parents of children suffering from attention deficit hyperactivity disorder wrestle with whether or not to medicate their kids. But Westwood medical device maker NeuroSigma Inc. has developed an alternative, which just got the European Union’s stamp of approval to treat ADHD in adults as well as children ages 7 and older.
NeuroSigma’s Monarch eTNS System wires a pulse generator to a Band-Aid-like patch placed on a patient’s forehead. Usually worn overnight, the noninvasive system gently stimulates a large cranial nerve through the skin, targeting and altering activity in specific brain regions involved with disorders such as epilepsy and depression.
Though the E.U. had already authorized it to treat epilepsy and depression, NeuroSigma considers this latest blessing a big deal because the system was approved for use on its own and not in combination with another therapy.
“This is a major event for the company,” said Chief Executive Leon Ekchian. “We’re delighted we … can move forward commercializing eTNS.”
NeuroSigma had been focusing on selling its technology to major medical centers, but it’s now ready to concentrate more on commercialization, establishing supply chains and building a sales force.
Though only cleared for investigational use in the United States, clinical trials are underway with an eye toward Food and Drug Administration approval in certain cases. The firm has already submitted an application to be used in combination with other treatment for the symptoms of Lennox-Gastaut Syndrome, a rare neurological condition in children. If granted, this could be the company’s first U.S. approval for any of its products.
NeuroSigma had remained relatively mum about much of its progress for the past year while it was under a Securities and Exchange Commission registration for an initial public offering. But that’s been pushed off due to market conditions.
“Timing is important,” Ekchian said. “Right now the general perspective of the banking community is market conditions are not ideal.”
Doctor house-call app Heal recently achieved its own milestone; getting the nod from two major insurers to cover its physician home visits under certain health insurance plans.
The Santa Monica company announced earlier this month that it’s now in-network with many large-group and small-group PPO plans offered by Anthem Blue Cross of California and Blue Shield of California. In other words, Heal’s app-arranged house calls, arriving in an hour or less, are now covered for those members at the same rate as traditional office visits for services such as physician and wellness exams.
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