Los Angeles, CA, April 11, 2022 (GLOBE NEWSWIRE) -- Endonovo Therapeutics, Inc. (OTCQB: ENDV) today announced significant advancement in the of process to obtain medical reimbursements for its SofPulse® devices with its SEC filing of a $5 million Regulation A+ common stock offering currently in registration.
Endonovo management and reimbursement consultants have completed extensive market research in the hospital and private payment sectors regarding the correct path to pursue medical reimbursement for SofPulse® in the United States. Such reimbursements are important for hospital buyers and can serve as a key factor in making its devices more readily available. Management’s objective is to make these devices the standard of care for surgical cases in U.S. hospitals.
“Since 2005, the SofPulse® PEMF device has demonstrated through clinical studies and surgical use to be one of the best drug-free, non-opioid solutions for post-operative surgical pain and edema reduction management available in the medical market,” according to CEO Alan Collier. “The device has shown no known adverse effects in almost 18 years of use, which is one of the last major hurdles to overcome to obtain large scale surgical adoption of SofPulse® by hospitals and surgical clinics,” he pointed out
Collier also noted: “Significant and proven pain and edema reduction results have been demonstrated post-operatively. So, in our estimation, there is little reason – except lacking medical reimbursement – for the SofPulse® not to be the standard of care for surgical cases in U.S. hospitals.
Published clinical studies demonstrate SofPulse®’s outstanding clinical results with:
- postoperative pain, edema, and opioid reduction with a 2.2X reduction in post-op use of narcotics at 48 hours;
- 300% reduction of mean pain scores at 5 hours;
- 275% reduction in inflammation and swelling at 18 hours post-op;
- published peer reviewed results demonstrating significant advantages of SofPulse® as a non-opioid post-operative pain management device.”
“SofPulse® continues to perform at a high level of efficacy and success to combat post-op surgical pain and edema,” Collier pointed out. “Recent results from a Baylor College of Medicine cardiothoracic surgery study, presented at the 44th Annual meeting of the Association of VA Surgeons in 2020, further demonstrated the SofPulse® to be an effective post-operative pain and edema reduction treatment,” he said.
The Baylor College of Medicine study entitled “The Impact of Pulsed Electromagnetic Field (SofPulse®) on Postoperative Pain in Patients Undergoing Cardiothoracic Surgery” presented by Samir Awad, M.D. at the Annual meeting of the Association of VA Surgeon further demonstrated it to be an effective non-opioid pain and edema reduction treatment. Results showed use of SofPulse® PEMF devices verified:
- decreased postoperative opioid requirements (morphine equivalent dose) by 70%;
- significantly decreased postoperative pain VAS (Visual Analog Scale) by 50%;
- significant decreased Length of Stay (LOS) at the hospital by a median of two days.
Endonovo medical reimbursement consultants believe two current clinical trials should allow the Company to apply for and obtain medical reimbursement for its devices. One of the studies is at Columbia University and the other at Stanford University. Publication of results from either study will be used to apply for medical reimbursement and the completion of a new billing code for SofPulse® devices. The two current clinical trials to be utilized are listed and updated on clinicaltrials.gov
The Columbia University study is being completed by the Chief of Division of Plastic Surgery at Columbia, Christine Hsu Rohde, MD, and is titled “PEMF and PEC Blocks in Mastectomy Reconstruction Patients”. The actual study completion date was March 7,2022.
https://clinicaltrials.gov/ct2/show/NCT03360214?term=sofpulse&draw=2&rank=7
The Stanford University Clinical trial is being completed by Board Certified Orthopedic surgeon Geoffrey Abrams, MD and is titled, “Pulsed Electromagnetic Field (PEMF) Therapy for Postoperative Pain”. It is in the recruitment stage with a scheduled completion date in August 2023.
SofPulse® has a proven efficacy to manage surgical post-op pain and edema has shown that it can be a significant drug-free pain management treatment that can be a key factor in helping to combat the prescription opioid crisis gripping the U.S.
SofPulse also has medical CE Mark (CE518057), which allows it to be marketed in the European Union for: “the manufacture of electroceutical therapy systems for the promotion of wound healing, reduction of pain and post-operative edema”.
Endonovo owns multiple patents surrounding SofPulse® technology that can be developed easily and expanded in bringing new products to the medical market. The Company looks to expand sales and marketing efforts in all areas of SofPulse® including international growth in Taiwan and other Asian countries as well as efforts to explore EU distribution models.
About Endonovo Therapeutics Inc.
Endonovo Therapeutics is a commercial-stage developer of noninvasive wearable Electroceuticals® therapeutic devices for pain relief, general wellness and wound curatives. The Company's current portfolio of commercial and clinical-stage wearable Electroceuticals® therapeutic devices addresses wound healing, pain, post-surgical pain and edema, cardiovascular disease, chronic kidney disease, and central nervous system (CNS) disorders, including traumatic brain injury (TBI), acute concussions, post-concussion syndrome and multiple sclerosis. The Company's noninvasive Electroceutical® therapeutic device, SofPulse®, which uses 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. It also has CMS national coverage for the treatment of chronic wounds. The Company's current portfolio of preclinical-stage Electroceuticals® therapeutic devices addresses chronic kidney disease, liver disease, non-alcoholic steatohepatitis (NASH), cardiovascular and peripheral artery disease (PAD), and ischemic stroke. The Company's noninvasive, wearable Electroceuticals® therapeutic devices work by restoring key electrochemical processes that initiate anti-inflammatory and growth factor cascades necessary for healing to occur.
Website: www.endonovo.com
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.
Steve Barnes
800-701-1223 X108
sbarnes@endonovo.com
