Endonovo® Therapeutics (OTC:ENDV), a biotech company, announces use of their SofPulse® device in a recent investigator-initiated study which evaluated the impact of SofPulse® post-operative pain and opioid usage for patients undergoing cardiothoracic surgery. Study results demonstrated that the use of SofPulse® significantly decreased post-operative pain as measured by the VAS (Visual Analog Scale) by 50%, decreased opioid requirements (morphine equivalent dose) by 70%, and showed a significant decrease in the median length of stay (LOS) at the hospital by 2 days.
The study, authored by Samir Awad, Professor of Surgery at Baylor College of Medicine and accepted for presentation at the 44th Annual meeting of the Association of VA Surgeons, evaluated thirty-one patients who underwent open cardiac and thoracic procedures. Sixteen patients had SofPulse® applied to their chest incisions in addition to the standardized enhanced recovery after surgery (ERAS) pathway, and fifteen patients only had the ERAS. All patients were well matched for demographics, patient comorbidities, and type of procedure performed.
Coronary artery bypass graft (CABG) surgery is the most common type of open-heart surgery, and up to 500,000 CABG surgeries are performed in the US yearly with patient hospitalization averaging one week or 7 days. Healthgrades.com, in August 2019, stated, “The cost of CABG surgery varies greatly across the US with an average cost for CABG surgeries being $40,000.” A two-day reduction in the median length of stay (LOS) for CABG surgeries equates to a daily savings of $5,714, and a cumulative average realized savings to hospitals of $11,428 for each surgery performed. Cost savings related to the reduction of opioid use and an overall improvement to the patient standard of care should be noted as well. It is simply too hard to ignore the overall savings to hospitals if they simply added SofPulse® as a standard of care for all CABG cases yearly. With 500,000 cases performed yearly in the US, the potential cost savings realized by hospitals could result in overall cost savings to in-patient and hospital care of $5,714,000,000.
As the US Opioid crisis continues to worsen, hospitals and MD’s search for solutions to reduce opioid use while mitigating costs. The financial outcome from the Baylor Hospital study and the cost savings of up to $11,428 per CABG surgery are groundbreaking. The conclusions indicate a more efficient and cost-effective solution for surgeons and hospitals to treat post-surgical pain, inflammation, and edema than currently prescribed. SofPulse® Electroceutical® technology makes an overwhelmingly strong case to be the standard of care for every surgery performed in the US. In addition to offering true cost savings, a reduction of patient length of stay will allow hospital beds to be available sooner and will result in a decrease in costs, and an increase in bottom-line profitability.
The use of SofPulse® for the reduction of opioid use and reduction in median length of stay of 2 days after Open Heart Surgery (CABG and VATS) is a significant finding for all US hospitals to consider. Results of the Baylor College of Medicine study using SofPulse® could be a significant factor towards eliminating the opioid issue currently running rampant in the United States. Many Americans suffer from post-surgical pain, and opioid prescriptions remain a staple of the post-surgical pain management regime. However, the dangers of misuse, opioid use disorder, ORADES (Opioid-Related Adverse Drug Effects), and opioid-related overdoses have been a growing problem throughout the United States. The Drug Enforcement Agency (DEA) cites that 80% (4 out of 5 people) addicted to opioids were introduced to opioids through medical prescriptions. From 1999 to 2018, more than 232,000 people died in the United States from overdoses involving addiction to prescription opioids. Overdose deaths involving prescription opioids were more than four times higher in 2018 than in 1999.
In addition, the COVID-19 Pandemic has unleashed a spike in opioid overdose deaths nationwide. Current large pharmaceutical producers of pain medications and reduction solutions include Pfizer (PFE), Johnson & Johnson (JNJ), AstraZeneca (AZN), Sanofi (SNY), GlaxoSmithKline (GSK) and Merck (MRK). As production of opioids continues with no indications of slowing the need for opioid alternatives, opioid reducing devices and pain management replacements remains a constantly growing market.
Endonovo’s SofPulse® device offers a true non-invasive, non-pharmacological replacement not only to opioids, which have been associated with prolonged hospitalizations, increase in post-operative complications and potential addiction, but also to other modalities such as Exparel® (bupivacaine liposome) produced by Pacira BioSciences, Inc. (PCRX). Exparel, which is injected prior to making the incision, is currently used to offer prolonged analgesia post-operatively for CABG in US hospitals and requires additional prescribed opioids to control patient post-operative pain. Exparel® is an invasive pharmaceutical injection and can induce side effects such as Nausea, Constipation, Vomiting, Drowsiness, Dizziness, Headache, Back Pain, Anxiety, Depression, and worse in some patients. SofPulse® pain and edema reduction lasts up to 8 days, while Exparel® pain reduction at best lasts only up to 72 hours. When Exparel® pain injection wears off, the surgeon and patient are right back in the dilemma of needing large doses of opioids to effectively manage pain in many cases. In contrast, SofPulse® pain and edema reduction has no known side effects and has shown to significantly reduce or eliminate the need to use opioids thus reducing the potential for addiction and death in patients. SofPulse® is FDA cleared to work adjunctively with any pain management option and has shown no known side effects in thousands of completed surgical procedures.
SofPulse® PEMF (Pulsed Electro Magnetic Therapy) Electroceutical® Technology by Endonovo Therapeutics (ENDV), is FDA cleared for the reduction of post-operative pain and edema and has shown in clinical studies the reduction of post-surgical mean pain scores by 300% at the 5-hour post-surgical mark. This clinically relates to pain and shows a need for medication decrease nearly three times faster than sham. Studies show a 275% reduction of inflammation at the 18-hour post-surgical mark. SofPulse® has consistently delivered opioid reducing post-surgical results and has been helpful in reducing opioid use post-surgically in the US. SofPulse® studies indicate increased hospital profitability, faster and improved patient recovery experience, and a pathway to helping patients get back to their lives faster without the worry of addiction or death from opioids.
If you are interested in learning more about SofPulse® and Dr. Awad’s findings, email inquiries to [email protected].
Company Name: Endonovo Therapeutics (OTC:ENDV)
Email: [email protected]
Media Contact: Regal Consulting, LLC. (702-742-8991)