Nyxoah SA announced that the first patient has been implanted in BREATHE, the Company’s U.S. post-approval study of the Genio® system. The procedure was performed by Rolando Molina, MD, otolaryngologist at South Florida ENT Associates. Edward Mezerhane, MD, FAASM, FACP, DABOM, CPI, sleep medicine physician at PharmaDev Clinical Research Institute (Miami, Florida), serves as the BREATHE Site Principal Investigator.
BREATHE is a multicenter, prospective, single-arm post-approval study designed to assess the long-term safety and effectiveness of the Genio system in adults with moderate to severe OSA. Up to 229 patients will be implanted at up to 25 clinical centers across the United States and followed for up to five years after implantation. The co-primary effectiveness endpoints are the Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) responder rates at 12 months. Safety endpoints assess device- and procedure-related serious adverse events at 12 months and annually thereafter.
BREATHE will generate real-world evidence on how Genio performs in routine clinical practice across a broad set of U.S. centers bringing together sleep medicine physicians and ENT surgeons and will contribute to the ongoing evaluation of long-term patient outcomes.
“As an otolaryngologist dedicated to the treatment of sleep-disordered breathing, I have seen firsthand the significant impact obstructive sleep apnea has on patients’ health and quality of life. The BREATHE study represents an exciting milestone in the evolution of sleep surgery and neurostimulation therapy. By performing the first implant in this study, we have the opportunity to help shape the future of sleep apnea treatment while offering eligible patients access to an additional therapeutic approach. Advancing innovation through clinical research remains central to our mission of improving outcomes for patients with obstructive sleep apnea,” said Rolando Molina, MD, South Florida ENT Associates, implanting surgeon.
“Obstructive sleep apnea affects millions of people, yet many patients continue to struggle despite available therapies. The launch of the BREATHE study marks an exciting step forward in the evolution of sleep medicine, allowing us to evaluate an innovative bilateral hypoglossal nerve stimulation therapy in a real-world setting. Being the first site to implant a patient in this study reflects our commitment to bringing cutting-edge research and new treatment possibilities to patients who need alternatives,” said Edward Mezerhane, MD, PharmaDev Clinical Research Institute.
“The first BREATHE implant marks the start of the largest prospective study of Genio to date and the next step in building the long-term, real-world evidence base for bilateral hypoglossal nerve stimulation in the United States,” said Olivier Taelman, Chief Executive Officer of Nyxoah. “As adoption of Genio accelerates across U.S. centers, BREATHE will document how the therapy performs in everyday practice, in the hands of both sleep physicians and surgeons, over five years. This is the evidence that patients, physicians and payors expect, and it reflects our commitment to clinical rigor beyond approval.”
Source: GlobeNewswire
