Company to Conduct Larger Clinical Study to Evaluate Its Electroceutical™ Therapy in Chronic Kidney Disease
LOS ANGELES, CA, May 01, 2018 (GLOBE NEWSWIRE) -- Endonovo Therapeutics, Inc. (OTCQB: ENDV) ("Endonovo" or the "Company"), a commercial-stage developer of non-invasive Electroceutical™ therapies, today announced that it is targeting the treatment of chronic kidney disease (CKD) using its non-invasive Electroceutical™ Therapy and is currently planning a follow-up clinical study to evaluate its Electroceutical™ Therapy for reducing Proteinuria in CKD patients. Additionally, the Company highlighted positive results from an early feasibility study of its Electroceutical™ Therapy in reducing Proteinuria in 4 patients with CKD. The abstract of the early feasibility study was published in the American Journal of Kidney Diseases and has been posted by the Company on the Presentationssection of its Investor Relations website.
The feasibility study investigated the effectiveness of PEMF during a 2-week trial on reducing Proteinuria (P) in subjects with CKD, evaluating for synergy between Pulsed Electromagnetic Field Therapy (PEMF) and angiotensin receptor blockers (ARBs). Four volunteers with progressive poteinuric nephropathies applied PEMF to their lower-thoracic spine, allowing electromagnetic energy to pulse over both kidneys for 30 min, 3 times a day for 2 weeks. All medications were continued without change, including previously prescribed ARB’s. Urinary spot collections were analyzed for protein to creatinine ratio’s, expressed in grams per day.
During a two-week observational trial, the application of PEMF demonstrated reductions in protein to creatinine ratios expressed on urinary spot collections. Students paired t- test demonstrated in the four subjects, p = 0.06. There were no significant changes in the glomerular filtration rate (MDRD) or mean arterial pressures. No adverse events were reported. The reduction in proteinuria over 2 weeks was arithmetically, but not statistically significant due to small population size. This reduction in proteinuria warrants further study to determine long term effectiveness and possible synergy with RAS blockade.
Alan Collier, CEO of Endonovo Therapeutics, commented, “Proteinuria is the abnormally high presence of protein in the urine and is often a sign of chronic kidney disease. Furthermore, Proteinuria is another predictor of increased cardiovascular risk and numerous studies have shown that treating patients with diabetic/nondiabetic CKD and Proteinuria reduces Proteinuria and slows the progression of renal disease, and the greater the reduction in Proteinuria, the greater the benefit.”
“Our Electroceutical Therapies may represent a clinically-meaningful option to treat or delay the progression of kidney disease in dialysis and pre-dialysis patients. Reducing Proteinuria is important because its existence can continue to confer the well-known inflammatory, catabolic, thrombotic, and toxic effects on the endothelium during the pre-dialysis period,” concluded Mr. Collier.
The device used in this study was not the device currently marketed by the Company for treatment of post-operative pain and edema. There would be no expectation of getting similar results with the currently marketed device. FDA Approval for the device used in the feasibility study would be necessary to secure an appropriate indication for Endonovo to market such device.
About Chronic Kidney Disease:
Nearly 700,000 Americans have End Stage Renal Disease (ESRD), with approximately 500,000 of these patients on active dialysis and more than 120,000 new ESRD cases diagnosed each year. Financially, CKD represents a huge cost burden, costing Medicare nearly $65 billion a year for chronic kidney disease care, and another $34 billion directly related to dialysis patient care. Despite this high level of spending, outcomes for Medicare patients treated with in-center hemodialysis are poor with mortality rates up to 10 times higher than among the general Medicare population.
About Endonovo Therapeutics
Endonovo Therapeutics, Inc. is a commercial-stage developer of non-invasive wearable Electroceuticals™. The Company's current portfolio of commercial and clinical-stage wearable Electroceuticals™ addresses wound healing, pain, post-operative edema and Central Nervous System (CNS) Disorders, including traumatic brain injury (TBI), acute concussions, post-concussion syndrome and multiple sclerosis. The Company's non-invasive Electroceutical™ device using pulsed short-wave radiofrequency at 27.12 MHz 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 stage Electroceuticals™ addresses chronic kidney disease, liver disease, cardiovascular and peripheral artery disease. The Company's non-invasive, wearable Electroceuticals™ work by restoring key electrochemical processes that initiate anti-inflammatory and growth factor cascades necessary for healing to occur.
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.
Investors: Sign Up for Email Alerts on Endonovo