Genio® Therapy Launch: A New Era for Sleep Apnea Treatment
Genio® Therapy Marks a New Chapter in Sleep Apnea Treatment
Nyxoah has made a significant breakthrough by introducing its innovative Genio® system, aimed at enhancing the treatment options for those suffering from Obstructive Sleep Apnea (OSA) in the Middle East. This launch was kicked off with a landmark event at the Saudi German Hospital in Dubai, where the very first patient received the Genio implant, marking a monumental milestone in the region's healthcare landscape.
The Importance of the First Implant
Dr. Ahmed Yassin Bahgat, a Consultant Otolaryngologist at the Saudi German Hospital, successfully performed the first implant of the Genio device. His enthusiasm for this advancement is palpable, as he expressed pride in being part of a team that is pioneering the offering of such a cutting-edge therapy to OSA patients. This therapy is an alternative for those who cannot tolerate conventional CPAP machines, thereby expanding treatment possibilities for this debilitating condition.
A Commitment to Innovation
Nyxoah's CEO, Olivier Taelman, emphasized the significance of bringing Genio to the UAE, identifying it as the first neurostimulation therapy available for OSA patients in the region. The introduction of Genio represents a commitment to delivering innovative, patient-focused solutions that significantly improve the quality of life for individuals battling sleep apnea. Taelman noted that with strong clinical evidence supporting the efficacy of the Genio system, the company aims to enhance accessibility and offer hope to many more patients.
Understanding Obstructive Sleep Apnea
OSA affects millions globally, leading to disrupted sleep cycles and various health issues, including cardiovascular complications. Traditional treatments such as CPAP are not suitable for everyone, highlighting the need for alternative solutions like Genio, which leverages neuromodulation technology. By gently stimulating the hypoglossal nerve, Genio enables better control of the upper airway during sleep, ultimately improving nighttime breathing and reducing apnea events.
Clinical Validation and Expansion Plans
The Genio system has undergone rigorous testing, achieving the European CE Mark in 2019 following successful outcomes in the BLAST OSA study. Nyxoah has since continued to grow, conducting two IPOs, first on Euronext Brussels in September 2020, followed by NASDAQ in July 2021. Furthermore, the positive results from the BETTER SLEEP study have allowed for an expansion of the device's indications, now catering to Complete Concentric Collapse patients, a segment overlooked by many competitors.
Future Developments and FDA Approval
Looking ahead, Nyxoah is optimistic about gaining FDA approval for U.S. market entry, fueled by positive data from the DREAM IDE pivotal study. The ability to offer Genio therapy in the United States would greatly enhance treatment availability for patients who have long awaited innovative solutions.
About Nyxoah
Nyxoah is on a mission to transform the lives of the approximately one billion individuals suffering from obstructive sleep apnea worldwide. As a medical technology company, their flagship product, Genio®, is a battery-free neuromodulation device designed for minimally invasive installation. Controlled via a wearable device, it is crafted to deliver optimal therapy while prioritizing patient comfort and efficacy.
Nyxoah's Vision for the Future
Through continued dedication to research and innovation, Nyxoah aims to further refine and expand the Genio system's applications, making strides towards broader therapeutic adoption and improved patient outcomes on a global scale.
Frequently Asked Questions
What is Genio® therapy?
Genio therapy is a neuromodulation treatment designed to help individuals with Obstructive Sleep Apnea by improving breathing through nerve stimulation.
Where was the first Genio implant performed?
The first Genio implant was successfully performed at Saudi German Hospital in Dubai.
What are the advantages of Genio therapy over CPAP?
Genio therapy is a non-invasive option for patients who cannot tolerate CPAP machines, providing an alternative method to manage sleep apnea effectively.
Is Genio® approved for use in the United States?
As of now, Genio has not received FDA approval but is in the process of seeking it after successful clinical trials.
Who is behind Nyxoah?
Nyxoah is a Belgium-based medical technology company focused on developing innovative solutions for sleep apnea through advanced neuromodulation techniques.
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