Carolinas Pain Institute PA

Five total abstracts presented at ASPN 2024CLEVELAND, July 15, 2024 (GLOBE NEWSWIRE) -- Five abstracts featuring SPR Therapeutics’ SPRINT PNS System generated interest from leading pain physicians at the American Society of Pain & Neuroscience (ASPN) Annual Conference in Miami. “Four-Year Follow Up from a Prospective, Multicenter Study of 60-day Medial Branch Nerve Stimulation for the Treatment of Chronic Axial Back Pain” was selected as an ASPN Top Abstract and featured as an oral presentation by Dr. Christopher Gilmore, MD, of the Carolinas Pain Institute and lead author, who presented long-term follow-up data from study participants who received SPRINT PNS for their low back pain. More than two-thirds (n=15/22) of participants reported clinically significant pain relief (greater than or equal to 30 percent) an average of 4.7 years after receiving 60-day PNS treatment. “The long-lasting results we are seeing from SPRINT PNS participants over four years out from the end of treatment is truly impressive and makes a strong case for 60-day PNS as it is a short-term treatment that can deliver significant, sustained relief according to these data,” said Dr. Gilmore. The abstract titled “Primary Endpoint Results From a Prospective Single-Arm Study of 60-Day Peripheral Nerve Stimulation Treatment Targeting the Occipital Nerves for Head Pain” by Dr. Jerry Gutierrez, Medical Director of The Pain Relief Surgicenter and lead author, highlights the first primary endpoint data from the MONARCH Case Series Study. The MONARCH study is the first prospective evaluation of 60-day PNS designed to learn more about relieving headache pain. Eighty-five percent of participants (n=17/20) reported greater than or equal to 50 percent reductions in pain and/or pain interference at the end of treatment (EOT). Additional abstracts featuring SPRINT PNS included- “Percutaneous PNS Used for Treatment of Chronic Shoulder Pain: A Multi-Center Retrospective Chart Review” (Aman et al.) Overall, 60-day PNS was shown to be an effective treatment for chronic shoulder pain where 75 percent of patients in this review with EOT outcomes available (n=132/176) reported greater than or equal to 50 percent pain relief. These 132 patients had a variety of shoulder pain causes and treatment histories, with patients receiving Bimodal PNS® treatment (concurrent motor and sensory stimulation targeting two nerves) reporting the highest rates of success.“Retrospective Review of 60-day Peripheral Nerve Stimulation in the Treatment of Complex Regional Pain Syndrome” (Patel et al.) This review of over 400 CRPS patients treated with PNS showed that 72 percent were responders (n=306/424), defined as reporting at least 50 percent pain relief and/or an improvement in Patient Global Impression of Change (PGIC) quality of life scores.“Percutaneous Peripheral Nerve Stimulation Relieves Chronic Postoperative Pain and Improves Function After Total Knee Arthroplasty: Holistic Responders in a Double-blind, Placebo-controlled Randomized Controlled Trial” (Goree et al.) In this analysis of holistic improvements in pain relief, function, walking ability, and/or quality of life for participants experiencing postoperative pain after knee replacement surgery, a significantly larger proportion of participants who were treated with 60-day PNS were holistic responders (with at least 30 percent improvement from baseline in pain relief and substantial improvements in at least one additional outcome) compared to those receiving placebo (sham) stimulation (n=15/20 versus n=7/20; p<0.05). Outcomes from this multicenter, randomized, double-blind, placebo-controlled trial were recently published in the journal Neuromodulation. The most common adverse events for the SPRINT PNS System in both clinical studies and real-world data include skin irritation and erythema. All three clinical studies (Goree et al., Gutierrez et al., and Aman et al.) reported no study-related serious or unanticipated adverse events. Safety was not analyzed in the long-term follow-up survey (Gilmore et al.) and the retrospective chart review (Patel et al.). See all five abstracts shared at ASPN by clicking here. Drs. Gilmore, Gutierrez, Aman, and Patel are consultants for SPR Therapeutics. About the SPRINT PNS System The SPRINT® PNS System, by SPR® Therapeutics, marks an innovative shift in the treatment of pain. Our breakthrough, 60-day treatment is a First-Line PNS™ option uniquely proposed to recondition the central nervous system to provide significant and sustained relief from chronic pain — without a permanent implant, nerve destruction or the risk of addiction. The system has been studied extensively for low back pain, knee pain, shoulder pain, post-amputation pain, and chronic and acute postoperative pain, is cleared for use up to 60 days, and is recognized by leading pain management centers. Market research indicates that this breakthrough neuromodulation treatment is a patient-preferred alternative to more invasive options. The SPRINT PNS System is indicated for up to 60 days for: Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; symptomatic relief of post-traumatic pain; symptomatic relief of postoperative pain. The SPRINT PNS System is not intended to be placed in the region innervated by the cranial and facial nerves. Physicians should use their best judgment when deciding when to use the SPRINT PNS System. For more information see the SPRINT PNS System IFU. Most common adverse events are skin irritation and erythema. Results may vary. Rx only. For additional information regarding safety and efficacy, visit: SPR Safety Information. About SPR Therapeutics, Inc.SPR Therapeutics is a privately held medical device company, providing patients with a non-opioid, minimally invasive pain treatment option. Our SPRINT® PNS System fulfills a critical unmet need for a drug-free, surgery-free option for millions who suffer from chronic pain. Backed by the largest body of clinical evidence in peripheral nerve stimulation for the treatment of pain, SPR has demonstrated commercial demand in untapped peripheral (shoulder and knee) and back pain markets and built an incredibly strong foundation for commercial growth. Headquartered in Cleveland, OH with satellite offices in Chapel Hill, NC and Minneapolis, MN, SPR’s Senior Management team includes experienced industry veterans with nearly 200 years of collective pain market and MedTech expertise, all driven by our purpose – to improve the quality of patients’ lives by providing them with a minimally-invasive, drug-free, surgery-free solution to manage their acute and chronic pain. More information can be found at www.SPRTherapeutics.com. SPR Contacts:Michelle McDonaldVice President – Marketingmmcdonald@sprtherapeutics.com 844.378.9108 Dave FolkensPublic Relations dfolkens@sprtherapeutics.com 612.978.6547

Presentations review clinical results of 10 kHz Therapy™ for the treatment of chronic back and leg pain, non-surgical back pain (NSBP), and painful diabetic neuropathy (PDN) REDWOOD CITY, Calif., Jan. 17, 2024 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced a series of data presentations supporting the use of the company's HFX™ 10 kHz Therapy for patients with chronic pain. Results will be presented at the 2024 North American Neuromodulation Society (NANS) Annual Meeting held from January 18-21, 2024 at Caesars Palace Las Vegas. A total of 25 scientific abstracts reviewing clinical results for 10 kHz Therapy™, including four podium presentations and 21 posters, will be presented at the conference. Nevro will also host a Lunch Symposium showcasing the benefits of the company's AI-enabled HFX iQ™ system in a presentation titled "HFX iQ Accelerating Outcomes with Real-Time, Proactive Care" on Saturday, January 20, from 12:00 – 1:00 p.m. PST, in the Augustus Ballroom. The company will also unveil its new sacroiliac (SI) joint fusion portfolio at exhibit booth #0238. "Our strong presence at NANS underscores Nevro's dedication to continuously improving the chronic pain field and providing the best possible pain management solutions to patients," said Kevin Thornal, Nevro's CEO and President. "The growing body of clinical evidence from our 25 scientific abstracts displays the substantial benefits of 10 kHz Therapy and we look forward to continuing to treat underserved patient populations suffering from debilitating chronic pain." Key presentations are highlighted below (all times PST): Painful Diabetic Neuropathy (PDN) and 10 kHz Therapy™ Main Session: "Scientific Advances in Neuromodulation Session 1" - Saturday, January 20, 2024, 10:30 - 12:00 p.m., Emperors Ballroom Concurrent Session: "10 kHz SCS Treatment of Painful Diabetic Neuropathy: Results Combining Dermatomal Dysesthesias and Lower Limb Sensory Assessments," presented by David Caraway, M.D., Ph.D., Senior Vice President and Chief Medical Officer, Nevro - Saturday, January 20, 2024, 10:40 - 10:48 a.m., Emperors Ballroom Concurrent Session: "Quantifying the Neural Response to Kilohertz Spinal Cord Stimulation Using Calcium-Sensitive Imaging," presented by Dongchul Lee, Director of Theoretical Research, Nevro - Saturday, January 20, 2024, 11:12 - 11:20 a.m., Emperors Ballroom Main Session: "The Future is NOW: Late Breaking Science Updates" - Saturday, January 20, 2024, 1:30 - 3:30 p.m., Octavius Ballroom Plenary Session: "10 kHz SCS Treatment of Painful Diabetic Neuropathy: Significant Reductions in HbA1c, Weight, and Pain," presented by Johnathan Goree, M.D., University of Arkansas for Medical Sciences - Saturday, January 20, 2024, 2:15 - 2:23 p.m., Octavius Ballroom Non-Surgical Back Pain (NSBP) Main Session: "Neuromodulation and Athletics. Parallels and Lesson" - Saturday, January 20, 2024, 4:00 - 5:30 p.m., Neapolitan Ballroom Concurrent Session: "Comparing 10 kHz Spinal Cord Stimulation Efficacy in Persistent Spinal Pain with and without Previous Spine Surgery," presented by Leonardo Kapural, M.D., Carolinas Pain Institute - Saturday, January 20, 2024, 5:14 - 5:22 p.m., Neapolitan Ballroom For more information, please visit . Internet Posting of Information Nevro routinely posts information that may be important to investors in the "Investor Relations" section of its website at . The company encourages investors and potential investors to consult the Nevro website regularly for important information about Nevro. About Nevro Headquartered in Redwood City, California, Nevro is a global medical device company focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy™, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 100,000 patients globally. Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes the SenzaR SCS system and support services for the treatment of chronic pain of the trunk and limb and painful diabetic neuropathy. Nevro recently added a minimally invasive treatment option for patients suffering from chronic sacroiliac joint ("SI joint") pain and now provides the most comprehensive portfolio of products in the SI joint fusion space, designed to meet the preferences of physicians and varying patient needs in order to improve outcomes and quality of life for patients. Senza®, Senza II®, Senza OmniaR, and HFX iQ™ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Nevro's unique support services provide every patient with HFX Coach™ support throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management. SENZA, SENZA II, SENZA OMNIA, OMNIA, HF10, the HF10 logo, 10 kHz Therapy, HFX, the HFX logo, HFX iQ, the HFX iQ logo, HFX Algorithm, HFX CONNECT, the HFX Connect logo, HFX ACCESS, the HFX Access logo, HFX COACH, the HFX Coach logo, HFX CLOUD, the HFX Cloud logo, RELIEF MULTIPLIED, the X logo, NEVRO, and the NEVRO logo are trademarks or registered trademarks of Nevro Corp. Patents covering Senza HFX iQ and other Nevro products are listed at Nevro.com/patents. To learn more about Nevro, connect with us on  LinkedIn, X (Twitter), Facebook, and Instagram. Investors and Media: Angie McCabe Vice President, Investor Relations & Corporate Communications [email protected] SOURCE Nevro Corp.

Data Published in Journal of Neurosurgery: Spine Highlight Lasting Pain Relief, Enhanced Function, Quality of Life, and Reduced Opioid Dependency with High-Frequency SCS Therapy REDWOOD CITY, Calif., Nov. 20, 2023 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced the publication of new 24-month data from the SENZA Nonsurgical Refractory Back Pain (NSRBP) multicenter randomized controlled trial (RCT) in the Journal of Neurosurgery: Spine. Acute back pain causes more disability around the world than any other condition1 and a quarter of adults in the U.S. report they have experienced back pain within the past three months2 More than 500,000 Americans3 are living with back pain and either aren't good candidates for it or don't want to have spine surgery4 to treat it, leaving them with few treatment options. The published 24-month data evaluated outcomes for NSRBP patients treated with Nevro's high-frequency (10 kHz) spinal cord stimulation (SCS) system plus conventional medical management (CMM) versus CMM alone. The data show that patients in the high-frequency SCS arm experienced profound improvements in pain, function, and quality of life, plus reduced opioid use compared to the CMM arm at 24 months. The long-term data provides further evidence of the benefits of high-frequency SCS in managing patients with NSRBP. "People with NSRBP live with pain that can be both physically and emotionally debilitating, affecting their ability to manage their everyday lives," said principal investigator Dr. Leonardo Kapural, physician and researcher at the Carolinas Pain Institute and Center for Clinical Research. "Patients often turn to unproven treatments – some with potentially significant harms, like opioids – when they feel they've run out of options to reduce their pain. We can see through these data that high-frequency SCS is capable of giving patients the relief, function, and quality of life improvements that many are desperate to find." The 24-month data demonstrated the following benefits for the 125 patients who received 10 kHz Therapy™ within the RCT: Pain Relief 81.6% of all patients who received a permanent implant were classified as pain responders (achieved ≥50% pain relief) at 24 months, with 58.4% of patients classified as profound responders who achieved ≥80% pain relief. The mean back pain (as measured by the visual analog scale VAS) significantly decreased from 7.4 at baseline to 1.9, representing a 5.5-point (74%) decrease from baseline. Function Patients reporting a severe level of disability (based on the Oswestry Disability Index, ODI) decreased from 73% at baseline to 26% of patients at 24 months. 75.2% of patients were classified as ODI responders, achieving a ≥10-point improvement in ODI score. This signals improvements in the ability to perform daily living activities. Quality of Life Mean EuroQoL-5 Dimension-5 Level (EQ-5D-5L) instrument index score was significantly increased from 0.570 at baseline to 0.766 at three months after implantation. This 0.19-point improvement was maintained at 6, 12, 18, and 24 months after implantation. This score represents ≥2.5 times the minimal clinically important improvement. High levels of patient satisfaction were recorded at 24 months, with 76% of patients reporting their condition was "better" or "a great deal better" on Patient-Reported Global Impression of Change (PGIC). Opioid usage was decreased or stopped in 62% percent of patients who were using opioids at baseline, with the mean dose decreasing from 35±39 morphine milligram equivalent (MME) at baseline to 15±35 MME at 24 months. Safety No new safety signals were identified during the 24-month follow-up, with most study-related adverse events occurring in the first six months after permanent implantation and no additional serious adverse events beyond the six reported at 12 months.5,6 The observed safety profile is consistent with types and rates of real-world adverse events reported for high-frequency SCS, as well as safety outcomes generally associated with SCS.7 "When patients with chronic low back pain don't improve with conventional therapies and aren't good candidates for spine surgery, it can leave both the patient and their care team feeling frustrated by the lack of options," said study investigator Dr. Naresh P. Patel, associate professor of Neurosurgery and vice chair of the Department of Neurological Surgery at Mayo Clinic in Arizona. "This research demonstrates that high-frequency SCS can address an unmet need to treat the challenging NSRBP patient population, and to see results sustained at 24 months is very encouraging." Internet Posting of Information Nevro routinely posts information that may be important to investors in the "Investor Relations" section of its website at . The company encourages investors and potential investors to consult the Nevro website regularly for important information about Nevro. About Nevro Headquartered in Redwood City, California, Nevro is a global medical device company focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy™, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 100,000 patients globally. Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic pain of the trunk and limb and painful diabetic neuropathy. Senza®, Senza II®, Senza Omnia™, and HFX iQ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Nevro's unique support services provide every patient with an HFX Coach™ throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management. SENZA, SENZA II, SENZA OMNIA, OMNIA, HF10, the HF10 logo, 10 kHz Therapy, HFX, the HFX logo, HFX iQ, the HFX iQ logo, HFX Algorithm, HFX CONNECT, the HFX Connect logo, HFX ACCESS, the HFX Access logo, HFX COACH, the HFX Coach logo, HFX CLOUD, the HFX Cloud logo, RELIEF MULTIPLIED, the X logo, NEVRO, and the NEVRO logo are trademarks or registered trademarks of Nevro Corp. Patents covering Senza HFX iQ and other Nevro products are listed at Nevro.com/patents. To learn more about Nevro, connect with us on LinkedIn, Twitter, Facebook and Instagram. *Senza HFX iQ™ uses a fixed set of instructions to provide optimized treatment recommendations that utilize direct patient input from assessments on pain and quality of life measures. Investors and Media: Nevro Corp. [email protected] 1 Hoy D, March L, Brooks P et al. The Global Burden of Low Back Pain: Estimates from the Global Burden of Disease 2010 Study. Ann Rheum Dis. 2014; 73(6): 968–74. 2 Deyo R A, Mirza S K, Martin B I. Back Pain Prevalence and Visit Rates: Estimates from U.S. National Surveys, 2002. Spine (Phila Pa 1976). 2006; 31(23): 2724–7. 3 Sources: US Census Bureau; CLBP Market Research; CMS OP Hospital SAF Data 2012–2018. . 4 Chronic back pain patients who are refractory to conventional medical management, have no history of and are not candidates for surgery based on individual preference or surgeon consult 5 Kapural L, Jameson J, Johnson C, et al. Treatment of nonsurgical refractory back pain with high-frequency spinal cord stimulation at 10 kHz: 12-month results of a pragmatic, multicenter, randomized controlled trial. J Neurosurg Spine. Feb 11 2022:1-12. doi:10.3171/2021.12.SPINE211301 6 Eldabe S, Buchser E, Duarte RV. Complications of Spinal Cord Stimulation and Peripheral Nerve Stimulation Techniques: A Review of the Literature. Pain Med. Feb 2016;17(2):325-36. doi:10.1093/pm/pnv025 7 D'Souza RS, Olatoye OO, Butler CS, Barman RA, Ashmore ZM, Hagedorn JM. Adverse Events Associated With 10-kHz Dorsal Column Spinal Cord Stimulation: A 5-Year Analysis of the Manufacturer and User Facility Device Experience (MAUDE) Database. Clin J Pain. Feb 8 2022;38(5):320-327. doi:10.1097/AJP.0000000000001026 SOURCE Nevro Corp.