Less than two years ago we were reporting the news that Apnex Medical Inc had gained CE mark approval for its Hypoglossal Nerve Stimulation HGNS® system for the treatment of obstructive sleep apnea. Now, in the blink of an eye, the company is to close, having failed to reach a primary endpoint in its pivotal clinical trial.
The Apnex HGNS System is an implantable therapy that is intended to work by activating the muscles in the upper airway to ensure that the airway remains open during sleep. During sleep, the system detects the patient’s breathing and delivers mild stimulation to the hypoglossal nerve, the nerve that controls the muscles of the tongue, to keep the airway open. The stimulation is timed to a patient’s own breathing pattern.
Our original piece, here, posted in October 2011, talked of successful studies that had generated enough clinical data to support a positive response from the European regulatory authorities. Those studies, undertaken in the U.S and Australia had demonstrated a significant reduction in obstructive sleep apnea as well as substantial improvements in the quality of patients’ sleep, quality of life, and overall health.
Buoyed by the announcements the company embarked on a larger, randomised study. But after it became clear the company was unlikely to meet a primary endpoint in that study the decision was made to close it down, according to an interview with co-founder Michael Berman in an interview with Business Journal.
The painful bit lies in the news that Apnex had, since its inception in 2006, raised over $50 million in venture capital funding.