Healthtech company Nyxoah SA reported on Tuesday the receipt of the CE Mark approval for the Genio system in Europe, for treating obstructive sleep apnea.
Headquartered in Mont-Saint-Guibert, Belgium, the company said the Genio system is the world's first and only battery-free, leadless and minimally invasive neurostimulator, which delivers bilateral hypoglossal nerve stimulation for moderate to severe OSA patients who have failed Positive Airway Pressure (PAP) therapy.
This CE Mark approval was based on data from the company's BLAST OSA (BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea) clinical study. The BLAST OSA trial is a prospective study that evaluated the safety and performance of the Genio system in seven centres in France and Australia.
In conjunction, the BLAST OSA study results will be published in a leading medical journal later in 2019.
Currently, the company is focusing on gathering additional clinical evidence on the Genio system, initiating European market development activities and working toward gaining approval by the US Food and Drug Administration (FDA).
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Illumina's GRAIL divestment plan receives EC approval
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Ondine Biomedical's Steriwave approved for use by HCA UK
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial
Syros receives Fast Track Designation from FDA for tamibarotene in AML