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💎🙌 FDA Approval Just Dropped for (NYXOAH SA) TICKER $NYXH 🌛 — Billion $ Market = Potential Rocket 🚀🚀 (DD)
Nyxoah Receives Approval from FDA for Genio® System for the Treatment of Obstructive Sleep Apnea
NYXH - Nyxoah - FDA approval expected imminently
Nyxoah's Sleep Apnea Device Awaits FDA Nod - Don't Sleep On This Stock
Sleep stocks, specifically sleep apnea stocks, will do quite well the next decade.
Sleep stocks, specifically sleep apnea stocks, will do quite well the next decade.
Sleep stocks, specifically sleep apnea stocks, will do quite well the next decade.
Sleep stocks, specifically sleep apnea stocks, will do quite well the next decade.
Mentions
NYXH looks interesting for today. Positive trial results and the stock is only up 10% right now, could easily see a second leg up.
NYXH - Nyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in the Netherlands https://www.stocktitan.net/news/NYXH/nyxoah-announces-commercial-launch-of-genio-breakthrough-therapy-in-l4glybk0sir9.html
NYXH Nyxoah Provides an Update on Expanded Middle East Presence Nyxoah SA, a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA), today announced the continued expansion of its commercial footprint in the Middle East, following the first successful Genio® implant in Abu Dhabi in September 2025. With its growing network of centers across the Middle East, Nyxoah continues to deliver on its commitment to expand patient access to Genio, the only leadless, externally powered bilateral hypoglossal nerve stimulation system for the treatment of moderate-to-severe OSA. https://finance.yahoo.com/news/nyxoah-provides-expanded-middle-east-201000949.html
Nyxoah Files Patent Infringement Lawsuit Against Inspire Medical Systems, Inc. https://finance.yahoo.com/news/nyxoah-files-patent-infringement-lawsuit-201000143.html NYXH, INSP.
NYXH - FDA approval came through Friday after close.
**Nyxoah Receives Approval from FDA for Genio® System for the Treatment of Obstructive Sleep Apnea** **U.S. Commercialization Officially Launched** **Mont-Saint-Guibert, Belgium – August 8, 2025, 10:10pm CET / 4:10pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)** (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the U.S. Food and Drug Administration (FDA) has approved the Genio system for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65.
**Nyxoah Receives Approval from FDA for Genio® System for the Treatment of Obstructive Sleep Apnea** **U.S. Commercialization Officially Launched** **Mont-Saint-Guibert, Belgium – August 8, 2025, 10:10pm CET / 4:10pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)** (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the U.S. Food and Drug Administration (FDA) has approved the Genio system for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65.
NYXH has been granted FDA approval. https://finance.yahoo.com/news/nyxoah-receives-approval-fda-genio-201000065.html INSP will take a big hit. I now await Resmed their move for a potential buy out.
NYXH was granted FDA aproval: https://finance.yahoo.com/news/nyxoah-receives-approval-fda-genio-201000065.html
NYXH taking the market away from INSP, with their superior product. INSP nervously trying to delay them with a frivolous lawsuit. Whine they admit in their filings that their revenue is threatened by Nyxoah.
NYXH will take their market away.
I think they are going down because of their competitor Nyxoah. They admitted their market share will basically be taken away by them. From their own filings they mention them as a revenue threat, and they even launched a patent lawsuit based on nothing to try and delay their product launch. NYXH's product is superior in numerous ways and they know it. (One incision in the chin, instead of 3..no internal battery that has to be replaced every 11 years, less recovery time, smaller device, working together with Resmed and even Cochlear to work with the same physicians). Personally I am tracking NYXH because they are simply waiting on the FDA site inspection to get an official approval. (Deadline sept 22th). Once that is in, they will ramp up marketing. And it's likely that Resmed buys them out. Seeing they are already partnered with them, and Resmed will help them breakthrough in the market faster.
NYXH 🚀🚀 a European medical device company that is in the final stage of U.S FDA approval (manufacturing stage) for their product, ‘Genio’ (sleep apnea, $8.8 billion market in 2024). They have already showed success with this device in Europe and are about to launch it in the states.
Sleep stocks, specifically sleep apnea stocks, will do quite well the next decade. I'm bullish on sleep apnea stocks. Over a billion people have sleep apnea worldwide, it goes undiagnosed in 80% of cases, and increases the risk of the leading causes of death such as heart attack, stroke, cancer, accidents, and diabetes. I personally believe this sector will do well as millennials age and awareness increases on social media. The sleep apnea devices market is expected to have a [CAGR of 6.2% from 2021 to 2028](https://markets.businessinsider.com/news/stocks/sleep-apnea-devices-market-size-worth-6-1-billion-by-2028-cagr-6-2-grand-view-research-inc-1030292947). Resmed is the world’s top CPAP manufacturer. CPAPs are the most effective treatment for sleep apnea. Resmed (RMD) is my number one holding in my portfolio. I think they have a decent chance of growing to be as large as a company like Eli Lilly within the next 10-20 years. It all depends on whether or not the US Government decides to pursue a mass screening approach for sleep apnea. This is currently being debated in the [US Preventative Services Task Force](https://www.uspreventiveservicestaskforce.org/uspstf/draft-update-summary/obstructive-sleep-apnea-adults-screening). To reiterate, about a billion people worldwide have sleep apnea and it goes undiagnosed in about 80% of cases. [Check](https://pubmed.ncbi.nlm.nih.gov/31300334/) this article on pub med. My mid cap holdings: 1) Resmed (RMD). 2) Koninklijke Phillips (PHG). Also a CPAP manufacturer. My higher risk growth plays are below: 1) Inspire Medical (INSP). They created an implant for sleep apnea, analogous to a pacemaker, to keep airways open at night. I think they have a good shot long term. 2) LivaNova (LIVN). UK equivalent of Inspire Medical, but their business is more diversified. 3) Nyxoah (NYXH). Super risky and less proven than Inspire, but less invasive of a product. Some of their startup capital came from Resmed. 4) Vivos Therapeutics (VVOS). Ultra small cap and could go bankrupt, but more risk more reward if their business pays off. They have a product that’s like a mouth guard, that expands airways to help prevent sleep apnea. They rely on dentists to diagnose and sell the product. 5) Sleep Number (SNBR). There’s some press that the company will develop more sleep tech to help with sleep apnea. My hope is that the company tries to acquire #3 or #4 to have a more integrated sleep solution. I own all these companies with Resmed and Inspire being the bulk of my portfolio. I’m bullish on the space, but recognize that some of the small caps could have issues if not out right bankruptcies. *Not financial advice. This is for entertainment/educational purposes only. Do your own research and consult with a financial professional if necessary. Be skeptical of everything that you read online.
Resmed (RMD) is my number one holding in my portfolio. I think they have a decent chance of growing to be as large as a company like Eli Lilly within the next 10-20 years. It all depends on whether or not the US Government decides to pursue a mass screening approach for sleep apnea. This is currently being debated in the US Preventative Services Task Force. To reiterate, about a billion people worldwide have sleep apnea and it goes undiagnosed in about 80% of cases. Check this article on pub med. My mid cap holdings: Resmed (RMD). Koninklijke Phillips (PHG). Also a CPAP manufacturer. My higher risk growth plays are below: Inspire Medical (INSP). They created an implant for sleep apnea, analogous to a pacemaker, to keep airways open at night. I think they have a good shot long term. LivaNova (LIVN). UK equivalent of Inspire Medical, but their business is more diversified. Nyxoah (NYXH). Super risky and less proven than Inspire, but less invasive of a product. Some of their startup capital came from Resmed. Vivos Therapeutics (VVOS). Ultra small cap and could go bankrupt, but more risk more reward if their business pays off. They have a product that’s like a mouth guard, that expands airways to help prevent sleep apnea. They rely on dentists to diagnose and sell the product. Sleep Number (SNBR). There’s some press that the company will develop more sleep tech to help with sleep apnea. My hope is that the company tries to acquire #3 or #4 to have a more integrated sleep solution. I own all these companies with Resmed and Inspire being the bulk of my portfolio. I’m bullish on the space, but recognize that some of the small caps could have issues if not out right bankruptcies. \*Not financial advice. This is for entertainment/educational purposes only. Do your own research and consult with a financial professional if necessary. Be skeptical of everything that you read online.