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Endonovo Therapeutics Announces Enrollment of First Patient in Clinical Study at the University of New Mexico for Treating Traumatic Brain Injury Using Its Electroceutical™ Therapy

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LOS ANGELES, CA, June 14, 2018 (GLOBE NEWSWIRE) -- Endonovo Therapeutics, Inc. (OTCQB: ENDV) ("Endonovo" or the "Company"), a commercial-stage developer of Electroceutical™ Therapies, today announced that the first patient has been enrolled in a clinical study at the University of New Mexico Health Sciences Center that will evaluate the effects of Pulsed Electromagnetic Fields (PEMF) on reducing brain injury, blood-brain-barrier and inflammation biomarkers in the cerebrospinal fluid and blood in patients with brain injury who are or have been fitted to an external ventricular drain. Funding for the study has been secured via the Company's senior secured Series C Preferred Stock financing.

"The initiation of this study represents a significant milestone for Endonovo," said Endonovo CEO, Alan Collier. "We believe our technology, whose proven mechanism of action is the suppression of inflammation, has the potential to change the treatment of central nervous system disorders where neuroinflammation propagates injury such as ischemic stroke, Alzheimer's disease and Multiple Sclerosis."

"After completing two PEMF safety studies on volunteers and patients with brain injury currently submitted for publication, we have consented and studied our first severe traumatic brain injury patient for the PEMF study and collected brain fluid and serum samples for four days post-injury," said Edwin Nemoto, PhD, University of New Mexico Health Sciences Center, School of Medicine, Department of Neurosurgery.

About the Study

The randomized, double-blind, placebo-controlled, clinical study is an extension of a safety trial that will be open to all patients who have or are fitted with an external ventricular drain (EVD) to remove excess cerebrospinal fluid (CSF). The study will enroll 48 patients with brain injury and will assess the effects of PEMF on 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. CSF will be collected at baseline and then every 8 hours until EVD is removed. CSF samples will be analyzed for biomarkers, such as IL-1β, IL-10 and S100 and other outcomes such as ICP, tissue oxygenation, blood flow, vital signs, and variables specific to individual diagnoses will be measured. Patient outcomes will be compared within and between groups.

About Traumatic Brain Injury

Traumatic brain injury (TBI) can happen when a sudden, violent blow or jolt to the head results in damage to the brain. As the brain collides with the inside of the skull, there may be bruising of the brain, tearing of nerve fibers and bleeding. If the skull fractures, a broken piece of skull may penetrate the brain tissue. Causes include falls, sports injuries, gunshot wounds, physical aggression, and road traffic accidents. Primary brain injury is irreversible as it occurs at the moment of impact and involves immediate neuronal damage from axonal shearing. After the initial injury, secondary injury may result from hypoxia, hypotension, and intracranial hypertension, all of which cause cerebral ischemia and neuroinflammation. Therefore, treatment of TBI is concentrated on preventing or attenuating secondary injury by appropriate medical intervention or therapeutics. Chronic traumatic brain injury (cTBI) represents one of the largest unmet medical needs in the U.S. healthcare market today, with a current pool of approximately 5.3 million patients incurring costs estimated at more than $60 billion per year. Furthermore, each year an estimated 1.7 million people in the United States suffer a traumatic brain injury. In the United States and elsewhere, it is a major cause of disability and death. Yet, despite its cost and clear lack of treatment, not a single drug has been approved for traumatic brain injury.

About Endonovo Therapeutics

Endonovo Therapeutics, Inc. is a commercial-stage developer of Electroceutical™ Therapies. The Company's current portfolio of commercial and clinical-stage Electroceutical™ Therapies addresses post-surgical pain and edema, cardiovascular disease, chronic kidney disease, and Central Nervous System (CNS) disorders, including traumatic brain injury (TBI). The Company's non-invasive Electroceutical™ System, SofPulse®, has been FDA-Cleared and CE Marked for the palliative treatment of soft tissue injuries and post-operative pain and edema, and has CMS National Coverage for the treatment of chronic wounds. The Company's current portfolio of pre-clinical Electroceuticals™ addresses non-alcoholic steatohepatitis (NASH), peripheral artery disease (PAD), and ischemic stroke.

Safe Harbor Statement

This press release contains information that constitutes forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, trends, analysis, and other information contained in this press release including words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," and other similar expressions of opinion, constitute forward-looking statements. Any such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from any future results described within the forward-looking statements. Risk factors that could contribute to such differences include those matters more fully disclosed in the Company's reports filed with the Securities and Exchange Commission. The forward-looking information provided herein represents the Company's estimates as of the date of the press release, and subsequent events and developments may cause the Company's estimates to change. The Company specifically disclaims any obligation to update the forward-looking information in the future. Therefore, this forward-looking information should not be relied upon as representing the Company's estimates of its future financial performance as of any date subsequent to the date of this press release.

Investor Relations Contact: 
Endonovo Therapeutics, Inc. 
Mr. Andrew Barwicki

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Source: Endonovo Therapeutics, Inc.