Our injectable is one of the smallest and least invasive neuromodulation devices. The platform has the potential to treat bladder urgency, gastrointestinal diseases, autoimmune disorders, depression, pain, cluster headaches and more.
Some neuromodulation treatments do not require the injectable at all with StimAire’s technology — just the wearable.
News:
October 2023 – Press release highlighting StimAire’s recent accomplishments.
September 2023 – StimAire was selected to present at the Innovation Summit hosted by Medtech Strategist November 14-16 in San Francisco. https://www.medtechstrategist.com/overview-sf23
August 2023 – StimAire completes its first-in-human clinical trial of its injectable hyposglossal nerve stimulator for Obstructive Sleep Apnea. There were no adverse events and efficacy results were as expected. 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 study was conducted of an OSA patient with the StimAire device modulating the hypoglossal nerve throughout the night.
October 2022 – StimAire is seeing positive results in first-in-human clinical trial of its injectable hypoglossal nerve stimulator device for Obstructive Sleep Apnea.
February 2022 – StimAire achieves regulatory approval for first human study and signs a clinical trial agreement with principal investigators and host hospital.
December 2021 – StimAire completes manufacturing of clinical units for first human study.
February 2021 – StimAire signs agreement with a Clinical Research Organization (CRO) to conduct a human study of its Obstructive Sleep Apnea treatment.
July 2020 – StimAire develops an ultrasound-guided needle path for the injectable to treat Obstructive Sleep Apnea.
June 2020 – Robert Dean MD, Otolaryngologist and ENT surgeon, joins StimAire’s leadership team as Chief Clinical Officer.
May 2020 – StimAire develops technology that eliminates the tingling feeling, a side effect and efficacy-limiter of TENS devices. The technology can be applied to TENS treatments for migraine, essential tremor, and opioid withdrawal. This breakthrough is expected to increase acceptance of exisitng TENS devices as well as increase efficacy by enabling stronger stimulation that is easily tolerated.
February 2020 – Tony Arnold, former CEO of Setpoint Medical is appointed to the StimAire Board of Directors.
November 2019 – StimAire closes its Series A Financing that paves the way for clinical testing of its sub-millimeter injectable neural stimulation devices. The funding round was led by UA Venture Capital, with participation from Desert Angels and Sonoran Mavericks angel investment groups.
July 2019 – Daniel Root MD, founder and President of Oregon Sleep Associates and founder of sleepdirect.com, is added to StimAire’s Scientific Advisory Board.
April 2019 – StimAire completes first form-factor prototype of wearable stimulator for treating Obstructive Sleep Apnea. The prototype hardware is ~2 cm in diameter and ~1 cm thick, and is powered by rechargeable button batteries.
March 2019 – Abhay Sanan MD/Neurosurgeon, is named Chief Medical Officer of StimAire.
November 2018 – Deep Transmission Demonstration StimAire achieved a 10 centimeter transmission depth for its non-surgical, wearable, wireless neural stimulation system. The injectable was placed in a saline bath 10 centimeters deep. The amplitude at the injectable was sufficient for almost all neural stimulation therapies, including for incontinence, pain, and mental illness.
October 2018 – First Human OSA Therapy Demonstration StimAire achieved its first human therapy demonstration of its wearable, wireless, non-surgical neural stimulation system. Guided by ultrasound imaging, StimAire’s injectable was connected to a two-electrode needle and placed extraneurally at the hypoglossal nerve. During Stage 2 sleep, a sleep apnea subject experienced a 4X reduction in obstructive events when the stimulation was turned on. Obstructive events were determined by nasal airflow measurements. No changes in systemic indictors, such as blood pressure and heart rate, were recorded during stimulation, and the patient experienced no pain or discomfort.
September 2018 – First-in-Human Demonstration StimAire achieved its first human demonstration of its wearable, wireless neural stimulation system. Two needle electrodes were placed via ultrasound imaging near the hypoglossal nerve and were connected electrically to an (uncommitted) StimAire injectable. The subject’s tongue moved out of the airway during stimulation, effectively achieving sleep apnea treatment. As in prior animal trials, all critical measurements followed precisely that of invasive, wired stimulation, showing that this technology is ready to eliminate surgery for proven neurostimulation treatments.
August 2018 – First-in-Animal Demonstration StimAire achieved a successful proof-of-concept of its wearable and non-surgical neurostimulation technology in a small animal. The sciatic nerve of a rat was stimulated by a tiny injectable to produce muscle contractions in the hind leg with indistinguishable characteristics vs. invasive wired stimulation. All key parameters tested successfully including muscle force, response delay, long-term stability, robustness, and consistency.
StimAire Inc 