The first-in-human study intended to evaluate the feasibility of the method, the operation of the patented device, and the safety of the injection technique
StimAire has concluded first-human-trial of its injectable stimulator. (Credit: valelopardo from Pixabay)
Neuromodulation company StimAire has concluded its first-in-human (FIH) trial in Australia of a tiny injectable stimulator for the treatment of obstructive sleep apnoea (OSA).
StimAire, which is a portfolio company of UAVenture Capital, focuses on enabling injectability for neuromodulation devices.
Its device modulates peripheral nerves, including the hypoglossal using a tiny, battery-free injectable receiver/stimulator, triggered by a tiny wearable.
The study intended to evaluate the feasibility of the method, the operation of the patented device, and the safety of the injection technique.
Additionally, the first overnight sleep studies of an OSA patient were conducted with and without the StimAire device controlling the hypoglossal nerve during the night.
Throughout the trial, there were no negative outcomes. Furthermore, the injection operations did not cause any noticeable pain or discomfort, the paradigm-shifting neuromodulation company said.
The efficacy results of OSA patient’s sleep studies’, as calculated by obstructive events, were as anticipated, said the company.
Furthermore, the patient experienced 30 minutes of REM sleep with the device compared to none without it and slept 2.5 times longer with the device than without it.
StimAire president and chief technology officer 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.”
StimAire’s device can be constructed using components that are easily accessible, which is said to hasten its production process.
A 17-gauge needle is used to inject the stimulator near the nerve while being guided by ultrasound.
UAVenture Capital managing director Fletcher McCusker said: “Of our entire portfolio we are the most excited about the progress of StimAire. Comparable devices have to be surgically implanted.
“The StimAire office-based injectable design has achieved encouraging early results for the treatment of OSA. We are honoured to invest in the world-changing technology.”