Stanford University Orthopedic Study Collaboration with Endonovo Therapeutics SofPulse® Devices Moves Forward

Rhea-AI Summary

Endonovo Therapeutics (ENDV) announced the shipment of its SofPulse® tPEMF devices for a Stanford University study on post-operative pain management. The study aims to evaluate the efficacy of SofPulse® in reducing pain and narcotic usage after orthopedic surgeries, concluding in August 2022. Previous studies, including one at Baylor College of Medicine, showed significant reductions in pain and opioid requirements. Endonovo's CEO expressed optimism about the collaboration's potential to position SofPulse® as a standard pain management solution in orthopedic procedures.

Positive

• SofPulse® devices are being utilized in a significant Stanford University orthopedic study, potentially validating their efficacy.
• Previous studies indicated SofPulse® significantly reduced post-operative pain by 50% and opioid use by 70%.
• The CEO expressed confidence that results from the Stanford study could lead to broader commercialization opportunities.

Negative

• None.

Los Angeles, CA, May 11, 2021 (GLOBE NEWSWIRE) -- Endonovo Therapeutics, Inc. (OTCQB: ENDV) ("Endonovo" or the "Company") today announced completion of Shipment of SofPulse^® tPEMF Devices for use in a Stanford University sponsored Orthopedic Shoulder and Knee Study. The Stanford Orthopedic study titled, ‘Pulsed Electromagnetic Field (PEMF) Therapy for Post-operative Pain Following Orthopedic Surgery’ is scheduled for a final completion date of August 2022. The Orthopedic interventional (clinical trial) study is utilizing Endonovo’s SofPulse^® “Pulsed Electromagnetic Field (PEMF) Therapy which is FDA Cleared for Post-operative reduction of Pain and Edema.

Endonovo Therapeutics, as key collaborator and in support of the Stanford Orthopedic Shoulder and Knee Study, has provided Stanford University with SofPulse® PEMF working and sham devices for completion of the randomized double-blind medical study. Endonovo CEO, Alan Collier, States, “Our Executive team at Endonovo are elated to continue our collaboration with Stanford University in Palo Alto, CA and are encouraged that the Stanford Orthopedic study is continuing to advance and is on track to meet posted study deadlines. In addition to collaborating on the Stanford Orthopedic study, Endonovo’s SofPulse® device was recently utilized in a Baylor College of Medicine study on Postoperative Pain in Patients Undergoing Cardiothoracic Surgery. The Baylor Study titled ‘The Impact of Pulsed Electromagnetic Field (SofPulse^®) on Postoperative Pain in Patients Undergoing Cardiothoracic Surgery’ demonstrated by utilizing SofPulse® treatments, patients experienced significantly decreased postoperative pain VAS (Visual Analog Scale) by 50%, decreased postoperative opioid requirements (morphine equivalent dose) by 70% and resulted in a significant decrease in Length of Stay (LOS) at the hospital by a median of 2 days. The Medical and executive teams at Endonovo firmly believe that the results of the Stanford Orthopedic study will have similar pain and narcotic reduction results.”

The Stanford study titled “Pulsed Electromagnetic Field (PEMF) Therapy for Post-operative Pain Following Orthopedic Surgery”, is being overseen by principal investigator Dr. Geoffrey Abrams, MD. The Orthopedic study will determine the benefits of Endonovo's tPEMF SofPulse^® on postoperative pain, reductions of narcotic medication levels and physical function post-operatively on knee injuries, shoulder injuries and pain postoperatively. Clinical trials states that the primary outcome measures the mean change from baseline scores on the visual analog scale (VAS) at 10 days. Secondary outcome measures mean change from baseline scores in narcotic pain medics use at 10 days. Pain medication will be documented every 24 hours. The study is designed to determine, at 10 days after orthopedic shoulder or knee surgery, if pulsed electromagnetic field (PEMF) therapy is beneficial in reducing patient-reported post-operative pain, as measured by visual analog scale (VAS). The amount of pain medication taken daily and the physical function outcome scores after surgery and PEMF treatment will also be measured. Dr. Abram’s previously stated, “I am excited to collaborate with the team at Endonovo Therapeutics. Endonovo’s goal of targeting pain management has produced an encouraging level of acceptance of SofPulse^® among the medical community in such a short period of time,” For study information https://clinicaltrials.gov/ct2/show/NCT04109638

Dr. Geoffrey Abram’s MD the principal investigator for the Stanford Orthopedic study is a Board Certified Orthopedic Surgeon and is an assistant professor of Orthopedic surgery at the Stanford University School of Medicine and the Director of Sports Medicine for Stanford’s varsity athletes. His credentials include: Member of the American Academy of Orthopedic Surgeons (AAOS) and the American Orthopedic Society for Sports Medicine (AOSSM). He currently serves as assistant team physician for the NFL’s San Francisco 49ers as well as head team physician for a number of Stanford University varsity athletic teams. Dr. Abrams specializes in orthopedic sports medicine and arthroscopy of the shoulder, knee and elbow as well as upper extremity joint replacement surgery. Collier continues, “We believe this is a unique opportunity for SofPulse^® devices to be evaluated by Stanford University’s Orthopedic division. Upon completion, to be used as a proven pain and edema reduction option for becoming the standard of healthcare for Orthopedic surgical cases nationwide. Endonovo is pleased to be collaborating with Dr. Abrams who has authored or co-authored over 60 peer-reviewed scientific articles, over 20 book chapters, has presented original research at numerous national and international scientific meetings.” fortunebusinessinsights.com states “The global orthopedic device market size was USD $53.44 billion in 2019 and is projected to reach USD $68.51 billion by 2027, exhibiting a CAGR of 6.6% during the forecast period.” Additionally Global News Wire states” The "Orthopedic Surgery - Global Trends & Opportunities" report has been added to ResearchAndMarkets.com's offering. In 2017, the number of Orthopedic surgery procedures performed worldwide totaled approximately 22.3 million. The number of procedures per year is forecast to grow at a 4.9% compound annual rate over the 2017-2022 interval, approaching 28.3 million by 2022 and making this one of the most rapidly growing surgical procedure categories.”. Fortunebusinessinsights.com concludes, “…joint reconstruction segment held the dominate share of the market in 2019. Increasing number of procedures such as knee and hip replacements, shoulder and extremities reconstructions, and other musculoskeletal procedures related to these joints are contributing to the growth of the segment. The arthroscopy device (sport medicine/soft tissue repair) segment is projected to expand at a significantly high growth rate during the forecast period owing to increasing sports-related soft tissue injuries and the growing introduction of new products in this area.”

Endonovo CEO, Alan Collier continues, The Orthopedic market segment for joint reconstruction devices is looking for new and innovative products to help expand to meet the projected USD $66.51 billion by 2027. Endonovo firmly believes SofPulse® devices are positioned to capitalize on the expanded need to reduce opioid use and proven efficacy shown to reduce pain and edema in postoperatively in surgical procedures. As the Stanford study advances and initial results are available, we will be able to utilize those results to advance our commercialization initiatives to expand uses throughout the Orthopedic Surgery market. Proving efficacy by reducing pain and edema while significantly reducing opioid use postoperatively in Orthopedic procedures, will allow Endonovo to further expand the use of SofPulse® devices to service the entire Multi-Billion-dollar Orthopedic surgical market. SofPulse^® is Endonovo’s FDA-Cleared, non-invasive device utilized for the reduction of postoperative pain and edema. SofPulse^® represents a low-cost drug-free solution for reducing opioid usage, accelerating patient recovery and preventing opioid addiction following surgical procedures. This non-invasive and non-pharmacologic therapy has no known side effects and presents no potential for overdose or dependency as SofPulse^® is not reliant on any narcotic to produce pain and edema reduction. SofPulse^® has been effectively utilized and studied extensively in soft tissue postoperative pain management showing significant clinically proven results for the reduction of postoperative pain and edema. Learn more at www.sofpulse.com. “Past published clinical efficacy studies for tPEMF SofPulse^® have shown 2.2X reduction of post-op use of narcotics at 48 hours, 300% reduction of pain scores which relates to nearly a three times faster reduction in the need for pain medication post-op and 275% reduction in inflammation and swelling at 18 hours postoperatively.

About Endonovo Therapeutics

Endonovo Therapeutics, Inc. is a commercial-stage developer of noninvasive wearable Electroceuticals^® therapeutic devices. 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 and 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. 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.
Mr. Steven Barnes
Senior Vice President
(800) 701-1223, Ext. 108
Sbarnes@endonovo.com

FAQ

What is the goal of the Stanford University study involving Endonovo Therapeutics (ENDV)?

The study aims to evaluate the effectiveness of SofPulse® in reducing post-operative pain and narcotic medication levels following orthopedic surgeries.

When is the Stanford orthopedic study expected to be completed?

The study is scheduled for completion in August 2022.

What were the results of the previous Baylor College of Medicine study on SofPulse®?

The study found that SofPulse® led to a 50% reduction in post-operative pain and a 70% decrease in opioid requirements.

What does the SofPulse® device do?

SofPulse® is a non-invasive device that uses pulsed electromagnetic field therapy to reduce post-operative pain and edema.

How does Endonovo Therapeutics (ENDV) plan to leverage the results from the Stanford study?

Endonovo aims to use the study results to advance commercialization initiatives for SofPulse® throughout the orthopedic surgery market.