Positive Clinical Trial Results Published
ORANGE COUNTY, Calif., Nov. 19, 2019 /PRNewswire/ — MediPines announces the publication of the positive clinical study results on Oxistimulator®, a breakthrough technology designed to reduce postoperative hypoxemia in patients at-risk for Obstructive Sleep Apnea (OSA). The study demonstrated that the Oxistimulator technology decreases the duration and magnitude of hypoxemia, often referred to as oxygen desaturations.
The Oxistimulator is designed to continuously monitor patient oxygenation levels and reduce desaturations automatically. Whenever dangerous oxygen levels are detected, the Oxistimulator provides an immediate therapeutic response, a mild electrical stimulation, which is just enough to reverse the deterioration without harm or discomfort to the patient.
Current pre-operative screening practices have been shown to miss nearly 50% of patients with OSA. OSA places patients at-risk for serious postoperative desaturation events such as reductions in blood oxygen levels, which can lead to complications prolonging patient hospitalization, and in some cases, even death. Currently, the burden of catching and reducing hypoxemia after surgery falls on the clinical staff, such as nurses, who manually intervene when they see a desaturation; however, this manual process has been demonstrated to be sub-optimal, resulting in patients experiencing more and longer desaturations than necessary.
The study was a randomized, double-blind, controlled trial of 106 post-operative patients at a major medical institution spanning multiple years.
The treatment group (with device) experienced a shorter duration of SpO2 <90% (median 0.0 seconds vs 19.1 seconds; p=0.01) compared to the control group (inactive placebo device), with no adverse events reported due to the mild electrical stimulation provided by the active device.
“Oxistimulator represents a breakthrough in the way that it empowers clinicians to automate their clinical response. Faster response means that patients spend less time in the hypoxemia danger zone. This is a novel solution to a serious clinical problem, and we are fortunate to be partnering with outstanding clinical partners to prove the clinical safety and efficacy as we bring this technology to market,” stated Steve Lee, CEO of MediPines.
Study results were published in the Canadian Journal of Anesthesia. Oxistimulator has not yet been approved by the FDA and is not available for commercial sale.
MediPines is based in Orange County, California and manufacturer of the FDA 510(k) cleared AGM100®. The company focuses on respiratory diagnostics and therapeutic management solutions.