StimAire Completes First-In-Human Study of Injectable Stimulator for Obstructive Sleep Apnea (OSA)

UAVenture Capital Portfolio Company StimAire Completes First-In-Human Study of Injectable Stimulator for Obstructive Sleep Apnea (OSA)

TUCSON, Ariz., Oct. 11, 2023 -- Paradigm-shifting neuromodulation company, StimAire, has completed its first clinical trial in Australia. The first-in-human study tested a tiny injectable stimulator 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 of 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. Furthermore, this patient slept 2.5 times longer with our device than without it and enjoyed 30 minutes of REM sleep vs. none without it.

Robert Dean PhD MD/ENT, StimAire Chief Clinical Officer, 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." 

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. The tiny injectable is placed in close proximity to the nerve through a 17-gauge needle under ultrasound guidance... UAVenture Capital's Press Release -

Signifier Medical Technologies Announces Upcoming Publication of Randomized Controlled Trial Results Examining High-Intensity (Active) Vs. Low-Intensity (Sham) Neuromuscular Electrical Stimulation in Patients for 6 Weeks

Signifier Medical Technologies LLC, a Boston-based medical technology company, is pleased to announce that the publication of AEGIS clinical trial results is in press at the ERJ Open Research. The objective of the trial was to determine whether patients with mild obstructive sleep apnea (OSA) would adhere to eXciteOSA, a daytime neuromuscular electrical stimulation (NMES) therapy. Results showed high adherence, with approximately 90% of participants in each arm adherent to NMES. This trial demonstrates the potential of Signifier Medical’s innovative medical technology to significantly improve the lives of individuals suffering from obstructive sleep apnea (OSA).

“The encouraging results from our first randomized controlled trial further validate the data from our previous studies, and we’re thrilled to see how well patients accept the therapy,” says Co-founder and Director, Akhil Tripathi.

The current standard of care for treating mild OSA, positive airway pressure (PAP), has long been plagued with low adherence and low patient satisfaction. Clinical trials and observational studies indicate 25-46% of patients are not adherent to PAP.1-3 There is also evidence that those with mild OSA are 34% less likely to adhere to PAP than those with moderate/severe OSA.4 Given that adherence to positive airway pressure (PAP) therapy in OSA is suboptimal, alternative strategies are needed, particularly for patients with mild OSA.

The AEGIS clinical trial was a randomized, double-masked, sham-controlled study to assess the adherence and overall impact of Signifier Medical’s innovative medical device, eXciteOSA, in managing and treating obstructive sleep apnea. Using NMES to “exercise” the upper airway muscles, eXciteOSA improves tongue muscle endurance and reduces the occurrence of airway collapse during sleep. The trial involved 40 patients and was conducted in collaboration with a network of renowned medical institutions and healthcare professionals....Signifier Medical Technologies' Press Release -