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Colin Kealey on the non-pharmaceutical adolescent ADHD treatment with NeuroSIgma

Neural Implant podcast - the people behind Brain-Machine Interface revolutions

Release Date: 02/13/2023

Nathan Piland of Nunex: From Medtech Concept to Commercialization show art Nathan Piland of Nunex: From Medtech Concept to Commercialization

Neural Implant podcast - the people behind Brain-Machine Interface revolutions

In this episode of the Neural Implant Podcast, we’re joined by , CEO of , a consulting firm that specializes in helping MedTech companies navigate the complex journey from concept to commercialization. With over two decades of experience across regulatory strategy, product development, and market access, Nathan shares invaluable insights into the critical steps for MedTech startups and established companies looking to succeed in today’s competitive landscape. Tune in as we discuss the unique challenges of the neurotech industry, strategic consulting for MedTech ventures, and how Nunex is...

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Neural Implant podcast - the people behind Brain-Machine Interface revolutions

In this episode of the Neural Implant Podcast, we welcome Dr. Eugene Daneshvar, founder of Black Swan Intellectual Property (BSIP), a boutique law firm specializing in intellectual property for neurotech and medtech innovations. With a background in biomedical engineering and law, Eugene has a unique perspective on protecting the cutting-edge ideas that drive the future of healthcare technology. After years of working at a larger firm, Eugene founded BSIP to provide more accessible, fair, and transparent pricing for IP services, moving away from the traditional hourly billing model. In...

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Maurits Ortmanns: Advancements in ASIC Design for Neurotech Implants show art Maurits Ortmanns: Advancements in ASIC Design for Neurotech Implants

Neural Implant podcast - the people behind Brain-Machine Interface revolutions

In this episode, we welcome , a leading expert in ASIC design and professor at the , Germany. With a distinguished career in microelectronics, Dr. Ortmanns has contributed extensively to the development of integrated circuits for biomedical applications. He shares insights into the critical role of ASIC (Application-Specific Integrated Circuit) design in advancing neurotech implants, focusing on low-power, high-speed circuits that are essential for optimizing the performance and reliability of these devices. Dr. Ortmanns also discusses the challenges and future of circuit integration in...

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Neural Implant podcast - the people behind Brain-Machine Interface revolutions

In this episode of the Neural Implant Podcast, host Ladan Jiracek engages in an insightful dialogue with , founder and CEO of . The discussion covers Cognixion's pioneering augmented reality headset with EEG sensing, designed to enhance communication for individuals with speech and motor challenges. Andreas describes the journey from creating a speech augmentation device to developing a versatile platform, the Axon-R, which is now being utilized by health systems and researchers for various clinical applications. They explore the platform's form factor, capabilities, and its role in empowering...

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Neural Implant podcast - the people behind Brain-Machine Interface revolutions

In this episode of the Neural Implant Podcast, host Ladan speaks with , the Director of Education Outreach for the and a Research Assistant Professor in the Department of Neurological Surgery at the University of Miami. They discuss the Miami Project's work, particularly in spinal cord injury research and neuroprosthetics. Topics include clinical trials, combining therapies, regulatory challenges, and the importance of rehabilitation in conjunction with therapeutic technologies. 00:00 Introduction to the Neural Implant Podcast 00:16 Meet David McMillan: Director of Education...

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Neural Implant podcast - the people behind Brain-Machine Interface revolutions

I n this episode of the Neural Implant Podcast, host Ladan welcomes and from , an engineering services company based in Uruguay. They discuss their work in firmware, hardware, and software development for medical devices, emphasizing their specialization in wireless communications and test automation.  They also explain the benefits of contract engineering, the challenges they face, and highlight an exciting project involving an injectable neurostimulator. The conversation covers the history of neurotechnology development in Uruguay, the process and dynamics of working with clients, and...

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Neural Implant podcast - the people behind Brain-Machine Interface revolutions

Today's guest is from Blackrock Microsystems. While we've featured Blackrock guests before, Stephen's appearance today is driven by his podcast, , where neurotech-inspired movies are reviewed and discussed.     Top 3 Takeaways: "Our goal for the podcast isn't necessarily to be overly technical, requiring a neuroscience degree to understand. We're often deep in the subject matter and may get a bit jargony, but broadly, we aim to be accessible without pretending to be accomplished neuroscience researchers." “Due to the subject's nature, movies dealing with neuroscience themes...

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Neural Implant podcast - the people behind Brain-Machine Interface revolutions

is a University of Michigan PhD graduate working on thin film neural implants but has since transitioned into the legal side of things having passed his bar exam and working with . This interview took almost 2 years to get done but we're glad we were able to do it!     Top 3 Takeaways: "I think the main thing I'll say is you don't undermine your valuation by not having an informed and intentional patent strategy, and you don't have to go cheap. You know, I feel that you have to bootstrap, but if you work with certain law firms that are very entrepreneurial friendly, and my...

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Neural Implant podcast - the people behind Brain-Machine Interface revolutions

 "Welcome to today's episode! Our guest, , co-founder and CEO of , brings innovation to neural implants. With roots in France and a Harvard PhD, he's leading groundbreaking work. Welcome, Paul!"  Top 3 Takeaways: "It's a good time to ask the question: What if we could develop solutions tailored for this problem instead of borrowing from the semiconductor industry? That's what Axsoft is about. We emphasize developing soft materials that offer better long-term biocompatibility. Additionally, these materials are suitable for micro and nano fabrication and remain stable inside the...

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Neural Implant podcast - the people behind Brain-Machine Interface revolutions

Today’s guest is who is a share who works in regenerative neural tissue engineering. Top 3 Takeaways: "We're trying to create scaffolds that can be templates for the body to repair itself, to grow around, and ultimately become natural tissue, seamlessly integrating with the body's own." "Other faculty were discouraging. This is because academia tends to prioritize scholarly pursuits such as papers and grants, often undervaluing applied work and its real-world applications."  "Our clinical collaborator actively participated in the lab alongside Sarah. Together, they would work on...

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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?"