Nyxoah's Genio® System: A Breakthrough in U.S. Sleep Apnea Treatment

Nyxoah Aims to Revolutionize Sleep Apnea Treatment in the U.S. with Genio® System

Overview

Nyxoah, a pioneering medical technology company, is making strides in treating obstructive sleep apnea (OSA) with its innovative Genio® system. This battery-free hypoglossal neuromodulation device, inserted through a single incision under the chin, offers a breakthrough alternative for OSA patients. Following successful studies and European CE Mark approval, Nyxoah is now targeting the U.S. market.

Innovative Solutions for Sleep Apnea

Nyxoah is dedicated to transforming the lives of over a billion people suffering from obstructive sleep apnea globally. Their Genio® system stands out as a cutting-edge solution, utilizing neuromodulation to effectively manage OSA symptoms. This device, which is controlled by a wearable, has demonstrated exceptional outcomes in reducing the burden of OSA.

Regulatory Milestones and Market Expansion

The Genio® system received its European CE Mark in 2019 after the successful BLAST OSA study. Nyxoah further expanded its market presence with IPOs on Euronext Brussels in 2020 and NASDAQ in 2021. The company's recent BETTER SLEEP study led to CE mark approval for treating Complete Concentric Collapse (CCC) patients, a group previously contraindicated by competitors' therapies.

In the U.S., the Genio® system is currently an investigational device, with Nyxoah actively pursuing FDA approval following positive results from the DREAM IDE pivotal study. This approval would mark a significant step towards making Genio® available to U.S. patients.

Forward-Looking Statements and Risk Factors

Nyxoah's forward-looking statements reflect its commitment to innovation and regulatory advancement. However, these statements are subject to risks and uncertainties that could impact actual outcomes. The company has outlined these potential risks in its annual report and SEC filings.

For more details, Nyxoah encourages stakeholders to review its financial reports and visit nyxoah.com.

Contact Information

• Nyxoah

  • Loïc Moreau, Chief Financial Officer
  • Email: IR@nyxoah.com

• Media Contacts

  • United States: Glenn Silver, FINN Partners (glenn.silver@finnpartners.com)
  • Belgium/France: Gunther De Backer, Backstage Communication (gunther@backstagecom.be)
  • International/Germany: Anne Hennecke, MC Services (nyxoah@mc-services.eu)