Nyxoah Takes a Major Step with Genio System in U.S. Healthcare

Nyxoah's Groundbreaking Launch in U.S. Market

Nyxoah SA (NASDAQ: NYXH), a pioneering medical technology company, is thrilled to share the successful implantation of its innovative Genio® system in the United States. This achievement follows significant regulatory approval and marks a pivotal moment for the treatment of Obstructive Sleep Apnea (OSA) in the region.

Meeting a Critical Healthcare Need

The launch of the Genio system directly addresses a pressing health issue—OSA, which affects millions of individuals and is linked to serious health risks. Olivier Taelman, CEO of Nyxoah, expressed enthusiasm about the initial success, highlighting that they are not just delivering a product but a solution that enhances the quality of life for many.

Physician Demand and Training Initiatives

Several surgeons have responded with eagerness to embrace this technology, showing keen interest in training and implementation opportunities. Physicians are already identifying patients who would benefit from Genio, which indicates a strong belief in the system's potential.

Successful Procedures and Early Adoption

One of the first successful implants was conducted by Dr. Andrew T. Huang, MD FACS, Director of Sleep Surgery at Baylor College of Medicine. He recently performed five consecutive Genio implants, demonstrating the procedure's efficiency and rapid acceptance in clinical practice.

What Makes Genio Different?

The Genio system stands out for its leadless and battery-free design, providing a less invasive alternative to traditional OSA treatments. Patients can enjoy a less complicated recovery process without the need for multiple incisions or an implanted battery, making the treatment more appealing and accessible.

Metrics Driving Future Growth

Nyxoah is actively monitoring several metrics that indicate the trajectory of future growth, including:

• Surgeon training numbers
• Submissions for value analysis committees
• Prior authorization requests
• Accounts established for Genio

Pioneering a New Era in OSA Treatment

With the European CE Mark acquired in 2019 and two successful IPOs, Nyxoah is decisively expanding its portfolio. The favorable outcomes from clinical studies bolster confidence in the Genio system's ability to cater to patients with specific needs, including those with Complete Concentric Collapse (CCC).

The Vision of Nyxoah

At the core of Nyxoah's mission is the aim to ensure that OSA patients can enjoy restful sleep, significantly enhancing their overall well-being. The company's commitment to advancing medical solutions and improving patient outcomes is evident in its strategic initiatives and product innovations.

Contact Information and More

For any inquiries or further information, reach out to:

Nyxoah
John Landry, CFO
IR@nyxoah.com

Frequently Asked Questions

What is the Genio system?

The Genio system is a leadless, battery-free treatment option for Obstructive Sleep Apnea (OSA) developed by Nyxoah, aimed at simplifying the surgical procedure for better patient outcomes.

Who performed the first Genio implants?

The first implants were performed by Dr. Andrew T. Huang at Baylor College of Medicine, showcasing the technology's readiness for commercial use in the U.S.

Why is the Genio system important?

This innovative system addresses the growing need for effective OSA treatments, providing a less invasive option for patients who might not benefit from traditional methods.

What impacts will Nyxoah's entry into the U.S. market have?

Nyxoah's entry is expected to transform the landscape of OSA treatment, potentially increasing access to more patients who need innovative solutions.

How can healthcare providers get involved with Genio?

Healthcare providers interested in the Genio system can participate in training and educational initiatives set forth by Nyxoah to familiarize themselves with this groundbreaking technology.

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