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Health Unlocked: The Power of SalutogenesisAuthor: TopHealth Media
"Health Unlocked: The Power of Salutogenesis" explores how shifting the focus from disease to health creation can transform our lives. Join us with our host: Jasen Petersen, Founder at Ionic Alliance Foundation and Eudaimonia HFC, as we uncover the secrets of salutogenesis, the science behind building resilience and vitality from within. Through expert opinions, scientific insights, and real-world stories, we reveal how you can unlock the full potential of your health. Language: en-us Genres: Alternative Health, Health & Fitness, Life Sciences, Science Contact email: Get it Feed URL: Get it iTunes ID: Get it |
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From 510k to Class 1: A New Pathway for US Market Entry
Episode 6
Friday, 3 April, 2026
Welcome back to Health Unlocked: The Power of Salutogenesis, where we explore cutting-edge ideas shaping the future of healthcare. In this episode, Jasen Petersen discusses how Ion Biotechnology is pivoting its US market entry strategy amidst shifting crypto and DeSci (Decentralized Science) market conditions. Instead of pursuing the costly and complex 510k regulatory pathway immediately, he reveals a new plan centered on launching the Ion Gel as a Class 1 medical device or even as a cosmetic product, leveraging the terrain support concept. This approach not only allows faster access to the US market and clinical data generation but also provides a foundation for stronger future regulatory submissions. Along the way, he covers the importance of academic publication, community involvement via token funding, and maintaining transparency as the project evolves. Tune in to get a real-time look at how innovation, regulation, and community engagement intersect in biotech.Timestamps:00:00 Finding a cost-effective FDA strategy06:17 FDA classification and product function09:33 Understanding product claims and regulations12:51 Preventing diabetic foot ulcers17:15 Overview of the research papers21:30 Launching token before DAO24:50 Presenting research and generating interest27:22 FDA reclassification and strategy31:37 Using real-world data for strategy35:26 Navigating FDA classification challenges38:09 Connecting with Jason and updates39:50 Wrapping up the episode“Disclaimer: Informational only. Not medical advice. Consult your doctor for guidance.”Show Website - https://powerofsalutogenesis.com/ Ionic Alliance Foundation Website - https://iaf.care/Jasen Petersen's LinkedIn - https://www.linkedin.com/in/jasenepetersen/TopHealth Media Website - https://tophealth.care/
