nyxoah fda approval genio impact

💎🙌 FDA Approval Just Out for $NYXH 🌛 — Billion $ Market = Potential Rocket 🚀🚀 (DD)
This is my non-financial advice, just speculation DD on $NYXH (Nyxoah SA). It dropped on August 8 and I haven't seen anyone mention it here yet.
📰 The Big News
Nyxoah got full FDA approval for Genio, a leadless nerve stimulator for sleep apnea. The FDA says it's safe, effective, and ready for the U.S. market.
📊 Why This Is Big
30M+ Americans have sleep apnea, making the U.S. market worth billions annually. Nyxoah's tech works in all sleep positions, a major advantage over Inspire Medical ($INSP), the main player, which is a ~$5B company. Plus, Genio is less invasive, with no leads, making it simpler and safer for patients and doctors, potentially leading to faster adoption and a bigger market share.
📈 The Chart
Already moved from $4 to $20 on news before
Monday could see a lot of movement if this hits the scanners
🧠 Some Extra Info
15.04% owned by Cochlear Investments, 10.62% by Robert Taub (Founder), 7.85% by TOGETHER Partnership, 7.84% by Coöperatieve Gilde Healthcare III Sub-Holding U.A., 4.83% by Vestal Point Capital, 4.61% by ResMed Inc., and 3.59% by Jürgen Hambrecht (including JH Capital GmbH)
🧪 Dream Study Results
63.5% of patients showed significant AHI reduction
70.8% median AHI drop: big improvement in sleep apnea
82% of patients: AHI under 15, moving from moderate/severe to mild OSA
Position-specific results: 66.6% median AHI drop in supine position and 71.0% in non-supine positions, showing consistent effectiveness
TL;DR
$NYXH went from "some Belgian medtech" to FDA-approved player in a huge market. Small public float, big news, Monday could be wild, either way, this seems like a legit and promising company (compared to some of the junk posted here) 😉
I've been in since May btw, Plenty of articles here, including the Yahoo one: https://uk.finance.yahoo.com/news/nyxoah-receives-approval-fda-genio-201000193.html