PR: Nemechek Tech Seeks FDA Emergency Use Authorization, July 20, 2020

OVERLAND PARK, KS, July 20, 2020  — Nemechek Technologies has applied to the FDA for an Emergency Use Authorization (EUA) for its Vitality Smartcable device. Originally sold as a wellness device, the Vitality Smartcable is currently being used in a COVID-19 clinical trial to assess the therapeutic effect of transcutaneous auricular vagus nerve stimulation (taVNS). The study will measure the clinical impact on ICU admissions, intubations, and mortality in patients with pneumonia from coronavirus infection. We are confident the trial will show that taVNS can improve outcomes by its effect in suppressing the uncontrolled surge of inflammation-signaling molecules known as a “cytokine storm”. It’s the same excessive inflammatory reaction associated with septic shock. A cytokine storm response triggers Acute Respiratory Distress Syndrome, the reason so many coronavirus-infected patients need mechanical ventilation. Stimulation of vagus nerve fibers in the ear with a barely perceptible electronic current activates what is known as the “inflammatory reflex”. Much like the baroreflex that controls blood pressure, the inflammatory reflex signals the body to naturally regulate an immune response. This form of stimulation is safe, inexpensive, easy to administer, and does not interfere with existing standard of care therapies. Importantly, a single Vitality Smartcable can be used among many patients with minimum sterilization. Nemechek Technologies has offered to donate devices for use in clinical studies to evaluate its potential for mitigating the progress of COVID-19 disease. The Vitality Smartcable may become an ideal therapy for under-resourced healthcare systems struggling to treat hospitalized patients. About Nemechek Technologies, LLC Nemechek Technologies, LLC is a privately held manufacturer of bio-electronic medicine products. The Vitality Smartcable, is the first taVNS neuromodulator that runs on your smartphone, iPod or tablet. Nemechek Technologies has offered to supply Vitality Smartcable devices for investigator-initiated clinical trials of taVNS therapy for COVID-19. With 20 years’ experience as an HIV physician and researcher, Dr. Nemechek was awarded U.S. Patent No. 10,335,396 for his method of using vagus nerve stimulation to lower inflammation and reversing autonomic nervous system damage. The Nemechek Protocol®, which focuses on the reduction of chronic inflammation, includes the use of transcutaneous vagus nerve stimulation. Dr. Nemechek has treated more than 1,000 patients with vagus nerve stimulation therapy over the past ten years at his clinic near Phoenix, Ariz. Media Contact: Mike Nemechek Nemechek Technologies, LLC
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