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.”

In Network

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.

“It’s always been our plan to have insurance coverage and credentialing,” said Heal Chief Executive Dr. Renee Dua, who co-founded the startup in February with her husband, serial entrepreneur Nick Desai. “Becoming in-network takes time.”

Though Dua couldn’t provide concrete examples of how the insurers’ varying reimbursement rates compare with Heal’s flat $99 fee for the uninsured, she said sometimes it’s a great opportunity from a financial perspective and other times not as much.

But going in-network with insurance providers was attractive, Dua said, mostly because it opens the door to more patients. She pointed out that Heal has now served more than 1,000 customers and expanded its coverage beyond the Westside to most of Los Angeles and Orange counties, San Francisco and Palo Alto.

She plans on having Heal in 15 markets by the end of next year and working with more health plans.

“Anthem (and other insurers) want their customers to be happy and I think everyone else will follow suit,” she said.

Sticking to Plan

Brentwood digital health firm h2 wellness recently launched a customized version of its online health-engagement platform for Denver weight loss company Atkins Nutritionals Inc.

H2 develops cloud-based health portals that crunch data to coach users toward wellness goals. The firm’s sweet spot is effecting behavioral change by helping other firms improve their customers’ adherence to health-related plans, such as an Atkins diet, or by keeping them engaged in a company’s wellness-related services.

For example, h2’s algorithm can ping a person’s smartphone at lunch time, recognizing he or she is near a certain restaurant and offer advice on which menu item to choose. Or it might log visits to the gym, congratulating a user when they’ve worked out.

The firm offers a few different versions of its platform. There’s a standard noncustomizable version for health clubs that costs the gym a few hundred dollars a month. A highly customizable portal, which Atkins uses, runs hundreds of thousands of dollars a year. Costs vary depending on how many locations and number of users a portal is serving.

Co-founder and Chief Executive Hooman Fakki said h2 has learned that such programs need to be highly sensitive to each user’s specific situation.

“Just gaining data from someone is important but not enough,” Fakki said. “Five different diabetics could be on a similar program but each has a different motivation level.”

Staff reporter Marni Usheroff can be reached at musheroff@labusinessjournal.com or (323) 549-5225, ext. 229.

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