Episode description

Colin Kealey is the President and CEO of NeuroSigma which is commercializing the Monarch eTNS System, the first non-drug treatment for pediatric ADHD cleared by the FDA. 

Top 3 Takeaways:

• NeuroSigma is commercializing the Monarch eTNS system, a wearable medical device that stimulates the trigeminal nerve on the forehead, as a treatment for neurologic and neuropsychiatric indications.
• The Monarch eTNS System is FDA cleared as a treatment for pediatric ADHD, ages 7 – 12. Clinical trials in this population show a response rate of 50% with a only mild side effects observed in clinical trials to date.
• NeuroSigma is also developing its eTNS technology for other indications including epilepsy and depression and is currently running two large double-blind randomized controlled trials in ADHD to expand the label into adolescents, and for using the device as adjunctive therapy.
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0:45 "Do you want to introduce yourself better than I just did?"

 7:15 What is the efficacy of your device?

8:45 "What are some typical side effects of pharmaceutical ADHD treatments and what are some typical side effects of your guys' treatment?"

16:45 That was the pharmaceutical side effects, how about the neurostimulator side effects?

20:00 How does it work sleeping with a wired system?

21:45 "Were you guys able to cross-reference with any other sleep metrics to see if the quality of sleep diminished or maybe even increased?"

24:30 What's the protocol for using this device?

26:30 Could adults use this also?

28:30 Will college students use this as a study aid?

29:30 "What does your funding look like?"

35:15 How will you prevent Chinese knockoffs?

38:30 " Is there anything that we didn't talk about that you wanted to mention?"