With fresh funds and a pivotal trial underway, Sommetrics Inc. may be about to shed its sleeper status. Executives at the Vista, Calif.-based company hope to provide a quiet, effective solution to obstructive sleep apnea (OSA) that’s less obtrusive and better tolerated than the continuous positive airway pressure (CPAP) machines that currently dominate the market.
Newly launched startup Somne Inc. plans to give CPAP machines a run for their money by replacing CPAP masks and hoses for treating obstructive sleep apnea with a gentler collar encircling the patient’s neck. The new device uses variable negative pressure to ensure users get a good night’s sleep instead of positive airway pressure employed by companies such as Resmed Inc. and Philips Respironics Inc.
Livanova plc has launched an IDE trial of its Aura6000 sleep apnea device, following approval by the FDA to proceed with the study. The implantable pulse generator (IPG) is designed to treat patients with moderate to severe obstructive sleep apnea (OSA) who do not get relief from a traditional continuous positive airway pressure (CPAP) machine or refuse to use one.
It’s a first for Larry Miller. In his 30 years of working in pharma, he has never run a company that didn’t have a pack of near competitors scrambling to develop a therapy. “Not even close,” he told BioWorld. Miller, the CEO of Apnimed Inc., just saw the company close on a $25 million series B to help drive its lead program, a once-daily, oral obstructive sleep apnea (OSA) therapy, into a phase III registrational trial.
The U.S. FDA granted de novo authorization for Signifier Medical Technologies LLC’s ExciteOSA, the first treatment for mild obstructive sleep apnea and snoring designed for daytime use. Used for 20 minutes a day, the device improves the function of the tongue muscle to prevent airway obstruction while sleeping. ExciteOSA, previously called Snoozeal, already has a CE mark.
LONDON – Sleep disorder specialist Nyxoah SA hit the top end of its price range of €17 per share, raising €84.75 million (US$100) million in its initial public offering. Assuming full exercise of the over-allotment option, the company will have a market capitalization of €375.26 million. The shares began trading on Euronext Brussels (EBR:NYXH) on Sept. 18, and had a good first day, closing up 14.7%, at €19.50.
LONDON – Nyxoah SA reported positive clinical results for Genio, its lead-free, battery-less implantable neurostimulation device, showing it resulted in a significant reduction of the severity of obstructive sleep apnea (OSA), the world's most common sleeping disorder.
