TrueRelief  

Sarasota,  FL 
United States
https://www.truerelief.com

• Booth: 2327

TrueRelief is a unique, non-invasive neuromodulation device to manage post-operative pain as an alternative to opioids. TrueRelief is a painless treatment using patented, high frequency (20,000 Hz) electrical current. Treatments are nurse or technician administered and non-sterile. The 10-minute treatments are administered three times in the first 48 hours after surgery beginning in recovery. TrueRelief just completed a 134-subject sham-controlled double-blind study on post-op cesarean section patients with morphine equivalent usage and pain scores among the primary endpoints.

 Press Releases

• High-frequency electrical stimulation helps reduce inflammation, pain in new Feinstein Institutes study. (May 12, 2023)

  MANHASSET, NY – A bump, bruise or broken bone is painful. And while pain is an important defense mechanism to protect the body and promote healing, chronic pain can be debilitating. In the United States alone, 20-50 million adults suffer from chronic pain. New research published by scientists at The Feinstein Institutes for Medical Research in the journal Bioelectronic Medicine sheds light on the molecular mechanisms that occur when high- frequency electrical stimulation (HFES) is applied transcutaneously (over the skin), which reduces inflammation and pain.

  HFES therapy, like TrueRelief’s® device, which received U.S. Food and Drug Administration clearance in 2021for acute, chronic and post-operative pain and has been shown to reduce discomfort. However, understanding the molecular reasons behind how the device works remained unknown until now. The research, led by Feinstein Institutes’ Sangeeta Chavan, PhD, showed in preclinical mice models that HFES inhibits neuroinflammatory mediator release by sensory neurons, called nociceptors, to reduce pain.

  “For your body to feel pain, neurons release molecules that kickstart the body’s immune response causing inflammation and pain. High-frequency stimulation therapies have shown to be effective in reducing pain, but the ‘how’ it works remained in question,” said Dr. Chavan, professor at the Institute of Bioelectronic Medicine at the Feinstein Institutes. “This study reveals a previously unidentified mechanism for the pain-modulating effect of HFES, which seems to reset sensory neurons by stopping the release of neuroinflammatory molecules, resulting in less inflammation and pain.”

  The team uses optogenetics – light to control the activity of neurons – along with pharmacologic and injury-related activation of nociceptors measured the release of calcitonin gene related peptide (CGRP), substance P and high mobility group box 1 (HMGB1), which are pro-inflammatory molecules. The results show that HFES lessens neuroinflammatory mediator release by activated sensory neurons, which suggests that HFES could be used as a preventative therapy for those at high-risk for chronic pain.

  “Chronic pain can limit a person’s daily activities and is associated with reduced work productivity, anxiety and depression, suicide and overall reduced quality of life. Beyond potentially addictive opioids, chronic pain sufferers struggle to find relief,” said Huan Yang, PhD, associate professor at the Institute of Bioelectronic Medicine at the Feinstein Institutes.

  “We now have a better understanding as to why high-frequency stimulation helps attenuate inflammation and associated pain.”

  “Until now, assessment of pain has been largely subjective. We now have a quantitative biomarker that correlates directly with pain symptoms and allows us to develop more effective treatments,” added Timir Datta, PhD, assistant professor at the Institute of Bioelectronic Medicine at the Feinstein Institutes. “This inflammatory biomarker released by neurons gives us new insight into the role of neuroinflammation in chronic pain.”

  Further research is needed to understand better the effect HFES has on reducing pain and inflammation, including the potential for HFES to be used as an alternative for opioids. More complete evaluations on the timing (how long, how frequently), ideal waveform and determination placement of electrodes will help advance this novel technology as a viable therapy for chronic pain.

  “The discovery that neurons produce molecules that cause inflammation represents a major advance,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes, Karches Family Distinguished Chair in Medical Research and senior author on the paper. “Now this exciting new work shows it is possible to stop inflammation by targeting these neurons with bioelectronic devices.”

  Drs. Chavan and Yang continue to advance the field of bioelectronic medicine, which combines identifying molecular targets, neuroscience and bioengineering to study how to use devices to treat diseases and injury. In a 2021 study published in Proceedings of the National Academy of Sciences of the United States of America (PNAS), the researchers showed that nerves release a molecule, HMGB1, to produce inflammation in the body, which could lead to a new strategy to develop pharmaceutical and bioelectronic therapies. This observation has been advanced in the current study utilizing HFES to target HMGB1 released by nerves.

  The research study was funded in part by TrueRelief®.

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  About the Feinstein Institutes

  The Feinstein Institutes for Medical Research is the home of the research institutes of Northwell Health, the largest health care provider and private employer in New York State. Encompassing 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its five institutes of behavioral science, bioelectronic medicine, cancer, health system science, and molecular medicine. We make breakthroughs in genetics, oncology, brain research, mental health, autoimmunity, and are the global scientific leader in bioelectronic medicine – a new field of science that has the potential to revolutionize medicine. For more information about how we produce knowledge to cure disease, visit http://feinstein.northwell.edu and follow us
  on LinkedIn.

• TrueRelief engages The Ohio State University Wexner Medical Center to conduct a randomized controlled clinical trial of a bioelectronic medical device as a non- pharmacological alternative to opioids for post-operative pain relief. (May 12, 2023)

  April 8, 2022, Santa Monica, CA -- TrueRelief, LLC, a bioelectronic medical technology company offering non-opioid, non-invasive pain relief, today announced that they engaged The Ohio State University Wexner Medical Center, one of the leading teaching hospitals in the United States, to conduct a clinical trial to better understand the potential for opioid reduction and improved quality of patient care through the use of the TrueRelief bioelectronic technology as an alternative to opioids in the pain management of post-operative cesarean section patients.

  TrueRelief’s FDA-cleared device, called TrueRelief 1250, is a non-invasive technology that provides pain relief through the delivery of high frequency electrical current to the nerves. With direction from TrueRelief, physician researchers at Ohio State Wexner Medical Center will administer double-blinded treatments commencing shortly after cesarean section procedures and then throughout the patients’ hospital stay. Researchers will track and compare the morphine equivalent usage of those patients receiving actual treatments of TrueRelief vs. those who receive a sham version of the therapy. Additional endpoints will include length of hospital stay, and patient satisfaction scores.

  “Controlling postoperative pain after cesarean section is critical for a new mother and historically opioids have played a large role in this. Given the risks of opioid usage, we are very interested in exploring effective opioid-sparing alternatives for optimal post-cesarean pain management,” said Kara Rood, MD, a maternal fetal medicine specialist at Ohio State and the primary investigator of the study.

  TrueRelief’s technology was developed with a wide range of clinical applications in mind. The company is developing bioelectronic solutions to reduce inflammation and accelerate wound healing and has already received FDA clearance to market its TrueRelief 1250 for pain relief.

  “Our TrueRelief technology was created to provide a non-opioid, non-invasive solution to pain,” said John Crosson, Founder and President of TrueRelief. “We look forward to working with Dr. Rood and her team and their recognized expertise in obstetrics to evaluate and validate the potential of this technology to provide meaningful post-operative pain relief and significantly reduce opioid usage.”

  About the Research

  This will be a 134 subject, two-arm study with an active treatment group and a sham group of equal sizes randomly assigned. The sham version of the device allows for double blinding so neither the patient nor the clinician/investigator will know which subjects are receiving the real treatments. Morphine equivalent usage while in-patient will be collected, as will patient satisfaction scores. Additionally, length of hospital stay will be measured.

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  About TrueRelief, LLC

  TrueRelief, LLC is a privately held company based in Santa Monica, CA. TrueRelief develops bioelectronic medical technology to provide non-opioid, non-invasive pain relief, reduce inflammation and accelerate wound healing. The technology has both human and animal applications. TrueRelief currently holds more than a dozen U.S and foreign patents and is continuing to develop additional technology around its core business of pain, inflammation reduction and wound healing. TrueRelief’s initial product to come to market, the TrueRelief 1250 medical device, has been cleared by the FDA for the temporary symptomatic relief of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain. For more information about how we treat pain without opioids, visit www.truerelief.com.

  For Additional Information contact:

  John Crosson TrueRelief jc@TrueRelief.com

• TrueRelief to collaborate with Matthew Weiner, MD and Tucson Medical Center on a randomized controlled clinical trial of a bioelectronic medical device as a non- pharmacological alternative to opioids for post-operative pain relief. (May 12, 2023)

  May 16, 2022, Santa Monica, CA -- TrueRelief, LLC, a bioelectronic medical technology company offering non-opioid, non-invasive pain relief, today announced that they will collaborate with Matthew Weiner, MD, Medical Director of Bariatric Surgery at Tucson Medical Center on a clinical trial to better understand the potential for opioid reduction and improved quality of patient care through the use of the TrueRelief bioelectronic technology as an alternative to opioids in the pain management of post-operative bariatric surgery patients.

  TrueRelief’s FDA-cleared device, called TrueRelief 1250, is a non-invasive technology that provides pain relief through the delivery of high frequency electrical current to the nerves. In collaboration with TrueRelief, Dr. Weiner and his clinical research team will administer TrueRelief treatments commencing shortly after bariatric surgery procedures and then throughout the patients’ hospital stay. Researchers will track and compare the morphine equivalent usage of those patients receiving actual treatments of TrueRelief vs. those who receive a sham version of the therapy. Additional endpoints will include length of hospital stay, patient satisfaction scores, and opioid usage at home following release from the hospital.

  “When I first saw the pain-relieving performance and patient outcomes of the TrueRelief technology, I immediately wanted to explore usage for my post-surgical patients,” said Matthew Weiner, MD. “Successfully managing post-operative pain after bariatric surgery is critical to patient recovery and having a technology option that could significantly reduce the need for opioids would be a huge benefit to patients.”

  TrueRelief’s technology was developed with a wide range of clinical applications in mind. The company is developing bioelectronic solutions to reduce inflammation and accelerate wound healing and has already received FDA clearance to market its TrueRelief 1250 for pain relief.

  “Our TrueRelief technology was created to offer clinicians and their patients an effective non-opioid, non-invasive solution to pain,” said John Crosson, Founder and President of TrueRelief. “TrueRelief has a wide range of clinical applications and this particular study with Dr. Weiner and his clinical research team at TMC will be an important step for us to collect evidence that quantifies the impact of TrueRelief in post-surgical pain management application.”

  About the Research

  Over 250,000 bariatric procedures are performed in the United States annually1, making it one of the most common elective surgeries performed. Opioids are commonly used to manage pain after bariatric surgery, but post-bariatric patients have a 19% higher incidence of chronic opioid use compared to those who have not had bariatric surgery2. The psychological and emotional journey of a post-operative patient is complex and fragile and new chronic opioid use presents significant morbidity to post-operative patients who are otherwise experiencing significant improvements in their health. Reduction in perioperative opioid use after bariatric surgery would result in a decrease in post-operative chronic opioid use.

  This will be a 156 subject, two-arm study with an active treatment group and a sham group of equal sizes randomly assigned. The sham version of the device allows for double blinding so neither the patient nor the clinician/investigator will know which subjects are receiving the real treatments. Morphine equivalent usage, both while in-patient and after discharge at home will be collected, as will patient satisfaction scores. Additionally, length of hospital stay will be measured.

  ###

  About TrueRelief, LLC

  TrueRelief, LLC is a privately held company based in Santa Monica, CA. TrueRelief develops bioelectronic medical technology to provide non-opioid, non-invasive pain relief, reduce inflammation and accelerate wound healing. The technology has both human and animal applications. TrueRelief currently holds more than a dozen U.S and foreign patents and is continuing to develop additional technology around its core business of pain, inflammation reduction and wound healing. TrueRelief’s initial product to come to market, the TrueRelief 1250 medical device, has been cleared by the FDA for the temporary symptomatic relief of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain. For more information about how we treat pain without opioids, visit www.truerelief.com.

  About Matthew Weiner, MD and Tucson Medical Center

  Matthew Weiner, MD is a board certified general surgeon and Fellow of the American College of Surgeons.

  Dr. Weiner is the Medical Director of Bariatric Surgery at Tucson Medical Center. TMC has been Tucson’s locally governed nonprofit hospital for more than 75 years and is Southern Arizona’s leading provider for emergency care and pediatric care as well as specialty areas including women’s, maternity, cardiac care, orthopedic, neuroscience, hospice, surgical, vascular, geropsychiatric care and senior services. TMC is a member of The Mayo Clinic Care Network and is rated the top hospital in Tucson by US New & World Report.

  ____________________________
  1 “Estimate of Bariatric Surgery Numbers, 2011-2019.” American Society for Metabolic and Bariatric

  Surgery, 8 Mar. 2021, https://asmbs.org/resources/estimate-of-bariatric-surgery-numbers. 2

  Dr. Weiner is an active member of the American Society of Metabolic and Bariatric

  Surgeons (ASMBS) and is a past president of the Michigan state chapter of the ASMBS. He has

  performed more than 2,000 bariatric surgeries and frequently does complicated revision surgery. Dr.

  Weiner is the author of two books that focus on bariatric surgery and weight loss. He has created

  and published over 40 videos.

  Maciejewski, Matthew L., et al. "Long-term opioid use after bariatric surgery." Surgery for Obesity and

  Related Diseases 16.8 (2020): 1100-1110.

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