Nyxoah said it has won the CE Mark for its novel hypoglossal nerve stimulation therapy for treating obstructive sleep apnea (OSA).
The Genio system is a battery-free, leadless and minimally invasive neurostimulator designed to deliver bilateral hypoglossal nerve stimulation for moderate to severe obstructive sleep apnea patients who have failed conventional continuous positive airway pressure (CPAP) therapy.
The CE Mark approval was based on data from a prospective clinical study that evaluated the Genio system’s safety and performance in seven centers in France and Australia, according to the Belgian company. Results of the BLAST OSA (BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea) study will be published in a medical journal later in 2019, Nyxoah said.
“Obstructive sleep apnea is the most common sleep-disordered breathing condition,” said Nyxoah board chair Robert Taub in a prepared statement. “International sleep experts recently estimated that nearly 1 billion people worldwide suffer from sleep apnea. Existing therapeutic solutions are often not accepted or are poorly tolerated by patients.
“The sleep community is looking for alternative solutions for OSA patients who refuse currently available therapies or are not compliant,” Taub added. “The Genio system will help many OSA patients in need for a better solution. Having now received CE Mark, the Nyxoah Genio system is well on its w
Australian hearing tech developer Cochlear led a $17.1 million (EU €15 million) funding round for Nyxoah in November, investing $14.7 million (EU €13 million) and joined by several existing Nyxoah shareholders. As part of the funding round, a member of Cochlear’s board of directors has joined Nyxoah’s board. Funds from the round will be used to initiate post-CE Mark European market studies and work toward FDA investigational device exemption approval, the company said.
“Patients from the BLAST OSA study show a major improvement in their sleep apnea symptoms and their quality of life,” said Nyxoah CEO Enrique Vega. “The BLAST OSA study results and the continuous dedication of the whole Nyxoah team were instrumental in obtaining CE approval, which marks a major milestone for Nyxoah.”
