Neuromodulation company StimAire has completed its first-in-human clinical trial in Australia testing an injectable neurostimulator to treat obstructive sleep apnea (OSA).
This study assessed the safety of the injection procedure, the operation of the patented device, and the feasibility of the approach. In addition, the first overnight sleep studies were conducted on an OSA patient with and without the StimAire device modulating the hypoglossal nerve throughout the night.
There were no adverse events during the study. Furthermore, no significant pain or discomfort was experienced from the injection procedures.
Efficacy results from the sleep studies of the OSA patient, as measured by obstructive events, were as expected. The patient slept 2.5 times longer with the device than without it and experienced 30 minutes of REM sleep versus none without it.
“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,” says Robert Dean, PhD, MD, StimAire chief clinical officer, in a release.
StimAire’s device modulates peripheral nerves, like the hypoglossal, using a tiny, battery-free, injectable receiver/stimulator activated by a small wearable. StimAire’s system can be built with readily available components, expediting the path to production, according to a release from the company. The injectable is placed in close proximity to the nerve through a 17-gauge needle under ultrasound guidance.
“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,” says Tarek Makansi, PhD, president and chief technology office of StimAire, in a release.
Fletcher McCusker, managing director of UAVenture Capital, StimAire’s lead investor, adds in a release, “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 honored to invest in the world-changing technology.”
StimAire is a venture-backed medical device company located in Tucson, Ariz. StimAire’s efforts are focused on enabling injectability for neuromodulation devices in order to make “electricity as medicine” readily available and reimbursable worldwide.
Photo caption: StimAire device
Photo credit: StimAire