Neuromodulation company StimAire has concluded the first-in-human study of an injectable stimulator for obstructive sleep apnea (OSA) in Australia.
The trial evaluated the safety of the injection procedure, the approach feasibility and the operation of the patented device.
No adverse events were observed during the study and no significant pain or discomfort was noticed from the injection procedures.
The company has also conducted the first overnight sleep studies of an OSA patient with and without the StimAire device modulating the hypoglossal nerve during the night.
StimAire president and CTO Tarek Makansi said: “We are grateful to this team for advancing non-surgical treatments that stimulate peripheral nerves. The ultimate goals are replacement of pacemaker-like devices and universal access to advanced treatments.”
The device has been designed to modulate peripheral nerves, such as the hypoglossal, utilising a tiny, battery-free, injectable receiver/stimulator that is activated by a small wearable.
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Readily available components can be used to build StimAire’s system. With the help of a 17-gauge needle, the tiny injectable is placed near the nerve under the guidance of ultrasound.
StimAire chief clinical officer Robert Dean said: “After developing this injection procedure for StimAire at the University of Arizona College of Medicine, I was delighted to see these results.
“This technology has the potential to move treatments like this from the operating room to the doctor’s office, lowering the cost of care and enabling immediate recovery.”
Through the Sponsored Research Program, StimAire collaborated with the University of Arizona College of Medicine – Tucson for its preclinical work with physiology professors Andrew Fuglevand and Fiona Bailey.