Los Angeles, CA, July 21, 2022 (GLOBE NEWSWIRE) -- Endonovo Therapeutics Inc. (OTCQB:ENDV) today released a comparative analysis detailing how its SofPulse® medical device out-performed all pharmaceutical competitors non-opioid alternatives for surgical pain management.
Competitive post-operative pain management products compared and analyzed against Endonovo’s SofPulse® PEMF (Pulsed Electro-Magnetic Frequency) were: Pacira BioSciences, Inc. (PCRX) analgesic injectable Exparel®, Avanos Medical, Inc. (AVNS) Pain Pump On-Q® and Mallinckrodt plc (MNKPF) intravenous injection Ofirmev®. Endonovo’s comparative analysis detailed how SofPulse® has shown through clinical trials and surgical use to reduce opioid use and to directly replace injectable Exparel®, On-Q® pain pumps, Ofirmev® for patients in managing pain and/or edema post-operatively.
Endonovo’s comparative analysis identified that Exparel®; On-Q®; and Ofirmev® are FDA cleared and indicated to reduce post-operative pain. None of these pharmaceutical pain management products analyzed are FDA cleared to reduce edema, which is blood swelling in post-operative wounds. Only SofPulse® is FDA cleared to reduce both pain and edema post-operatively.
Additionally, the pharmaceutical pain management products analyzed are considered medically invasive requiring injections and/or catheter placement with numerous negative medical contraindications limiting their use. After 14 years of surgical use, SofPulse® in comparison to these pharmaceutical pain options is a superior alternative non-opioid, non-invasive, portable device with no contraindications and no known side effects.
“Results of our product and medical results comparison analysis showed that SofPulse® outperformed Exparel®, On-Q® pain pumps and Ofirmev® in non-opioid post-operative pain management. The benefits of SofPulse® treatments without the use of narcotics or opioids were more effective than our competitors’ products which helps to set it significantly above our main competitors non-opioid post-operative pain management solution,” according to Endonovo CEO Alan Collier.
There is high demand for opioid and narcotic substitutes for pain reduction in medical surgical cases. Patients’ overuse of opioids after surgical procedures is a well-known frequent cause of inadvertent opioid addiction, which impacts patient quality of life and increases cost to the hospital. This is commonly referred to as Opioid-Related Adverse Drug Events (ORADE). Opioid opponents believe that the most effective ways to way to fight the current crisis is finding and utilizing the best performing non-opioid pain relief solutions. In clinical studies, SofPulse® has shown to reduce the need for pain medication by 2.2X. Also, utilizing SofPulse® to reduce opiate use after operative procedures may reduce complications that can lead to ORADEs.
In comparing the data, Collier noted: “Currently, there is a lack of non-opioid treatments for pain and edema in the world-wide surgical market. Our SofPulse® use has been proven to be more effective than all of these competitive pharmaceutical medical products. SofPulse® has shown through clinical trials and surgical use to reduce opioid use and to be able to directly replace Exparel® and related products for patients in managing pain and edema post-operatively. Additionally, SofPulse® provides reduction of post-operative edema, blood swelling in post-operative wounds, which Exparel® and other injectable pain solution cannot claim to do.”
In completing the comparative analysis, Endonovo identified three market leading non-opioid pharmaceutical competitors available to address various degrees of post-surgical pain treatment. All competitive products literature publicly available – including competitors’ websites, product manuals, product description sheets and published medical efficacy results – were used for comparative analysis. All products analyzed provide a satisfactory alternative in varying degrees to narcotics and the inherent possibility of long-term addiction.
In a prime example, this research compares, among other things, Endonovo’s SofPulse® medical device with Exparel® injections, produced by Pacira BioSciences, Inc.:
| SofPulse® | Exparel® | |
| Indication: | Post-operative pain and edema device for superficial soft tissue | Single-dose, for post-surgical local analgesia and select nerve blocks |
| Description: | Non-invasive disposable device Using targeted Pulsed Electro- magnetic Field (tPEMF) | Injectable suspension |
| Preparation: | Ready to Use | Ready to Use |
| How Supplied: | Single and dual loop device | Choice of two single-dose vials |
| Application: | Two types of non-invasive loops above dressings | Site specific injections |
| Number/duration: | Up to 100 15-min. treatments Every 2 hrs.; up to 8 days. | Must be use immediately after open- Applicator for up to only 2 days. |
“SofPulse® is automated (15-minute treatment delivered every two hours). The device should show significant cost-savings per procedure compared to other postoperative pain options and is easy to use with demonstrated effective clinical results; such as:
- 2.2X reduction in the use of narcotics at 48 hours;
- 300% reduction in mean pain scores at 5 hours;
- 275% reduction in inflammation and swelling at 18 hours.
“In a randomized placebo-controlled study on SofPulse®, postoperative mean pain scores were reduced by 300%, which clinically relates to pain and the need for medication decrease of nearly three times faster than a sham.” Collier pointed out.
In summary, the survey of products available indicated:
- Of the opioid replacement competitive products, ONLY SofPulse® is FDA-cleared to reduce both pain and edema after surgery procedures and has no known side-effects, with no contraindication related to treatment outcomes.
- Our SofPulse® device, compared to other non-opioid solutions and competitors, provides more pain and edema reduction for patients for up to eight days of treatments, whereas our main non-opioid competitors only offer to block pain – without edema or inflammation reduction – for hours for several days.
- SofPulse® may provide significant cost-savings per procedure compared to other post-operative pain solution options.
- SofPulse® offers a superior non-invasive alternative/non-pharmacologic treatment for post-procedural pain and edema. Other competitor treatments and devices can be invasive by requiring injections or catheters, have limited pain reduction results or durations of use;
- All of the competing products in the study have multiple contraindications (some including increased risk of mortality and/or death).
The overwhelming conclusion of all factors points to the proposition that since SofPulse® addresses the biochemical root of the pain and is a superior solution to achieve optimal opiate-free, post-operative pain management.
For full resource to the 17 related scientific references regarding claims in this news release, contact Endonovo’s Investor Relations.
SofPulse® is a registered trademark of Endonovo Therapeutics, Inc. The trademarks of the products listed herein are trademarks of their respective manufacturer. Please refer to the Instructions for Use accompanying each device for further information.
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.
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.
(800) 701-1223 Ext. 108
investor@endonovo.com
www.endonovo.com
Media Contact:
Gregory A. McAndrews
Greg McAndrews & Associates
(310) 804-7037
greg@gregmcandrews.com
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