Conducted by the Regents of the University of New Mexico
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Los Angeles, CA, April 18, 2018 (GLOBE NEWSWIRE) -- Endonovo Therapeutics, Inc. (OTCQB: ENDV) ("Endonovo" or the "Company"), a commercial-stage developer of non-invasive wearable Electroceutical™ devices, today announced an agreement to commence a clinical research study entitled Pulsed Electromagnetic Field (PEMF) Reduction of cerebrospinal fluid (CSF) and Serum Biomarkers after Traumatic Brain Injury with the University of New Mexico Health Sciences Center, School of Medicine, Department of Neurosurgery.
Pulsed electromagnetic fields (PEMF) have demonstrated anti-inflammatory and pro-regenerative effects in animals and humans. We used the FDA-approved Sofpulse to study effects of PEMF on infarct size and post-stroke inflammation following distal middle cerebral artery occlusion (dMCAO) in mice. An electromagnetic field was applied within 30-45 min after ischemic brain damage and utilized twice a day for 21 consecutive days. Ischemic infarct size was assessed using MRI and histological analysis. At 21 days after dMCAO, the infarct size was significantly (by 26%) smaller in PEMF-treated animals as compared to controls.
Neuroinflammation in these animals was evaluated using specialized cytokine/chemokine PCR array. We demonstrated PEMF significantly influenced expression profile of both pro and anti-inflammatory factors in the hemisphere ipsilateral to ischemic damage. Importantly, expression of gene encoding major pro-inflammatory cytokine IL-1a was significantly reduced, while expression of major anti-inflammatory IL-10 was significantly increased. PEMF application significantly down regulated genes encoding members of the major pro-apoptotic tumor necrosis factor (TNF) superfamily indicating the treatment could have both anti-inflammatory and anti-apoptotic effects. Both reduction of infarct size and influence on neuroinflammation could have a potentially important positive impact on the post stroke recovery process, implicating PEMF as a possible adjunctive therapy for stroke patients.
Mr. Alan Collier, Endonovo Chief Executive Officer, states, "It has always been our plan to complete a single center, prospective, controlled, clinical trial of PEMF to evaluate the effects of PEMF in patients with brain injury and external ventricular drain in an intensive care unit setting. This clinical study is an extension of a safety trial and will be open to all patients who have or are fitted with an external ventricular drain to remove excess cerebrospinal fluid.”
The Study performed under this Agreement will be under the direction of Edwin Nemoto, PhD, Principal Investigator (“PI”). Dr. Nemoto states, “Inflammation is the primary process of injury propagation after traumatic brain injury (TBI) and suppression of inflammation is the proven mechanism of action of the Endonovo Therapeutics, Inc. pulsed electromagnetic fields (PEMF) device. We are studying the effectiveness of this PEMF device in suppressing the release of brain injury, blood brain barrier and inflammatory biomarkers in the cerebrospinal fluid and blood for up to one week after severe TBI with neurologic outcome follow up at one and three months.”
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