Complex Regional Pain Syndromes

Proclaim is an FDA-approved DRG technology that provides targeted relief for people with complex regional pain syndrome (CRPS), a rare and painful condition characterised by a continuous or intermittent burning, stinging, or tearing sensation DRG is a life-changing technology for chronic pain. (Credit: Abbott) Abbott has received the US Food and Drug Administration (FDA) approval with expanded MRI labelling for its dorsal root ganglion (DRG) stimulation therapy, Proclaim. The expanded FDA approval allows the Proclaim DRG neurostimulation system to provide full-body MRI scans of patients, while they are implanted with the device. Abbott said that its Proclaim is the only FDA-approved DRG technology to provide targeted relief for people with complex regional pain syndrome (CRPS) types 1 and 2 of the lower limbs. CRPS is a rare and painful condition characterised by a continuous or intermittent burning, stinging or tearing sensation, found to be extremely painful than childbirth or amputation. Its Proclaim DRG stimulation can be an effective option for people who suffer from CRPS and struggle to control the pain, said the medical device maker. Abbott neuromodulation vice president Pedro Malha said: “As we continue to work holistically across chronic pain care, we’re excited to see this new MRI expanded indication for our proprietary and unique Dorsal Root Ganglion Stimulation therapy become another valuable tool in the hands of treating physicians helping people get back to living a life on their terms.” In a separate development, Abbott has completed the first procedures using its new Volt Pulsed Field Ablation (PFA) System to treat abnormal heart rhythms, such as atrial fibrillation (AFib). Traditionally, patients requiring a cardiac ablation procedure to treat conditions like AFib receive radiofrequency (RF) ablation, which uses heat or cryogenic ablation. In contrast to RF, PFA leverages high-energy electrical pulses to rectify abnormal heart rhythms, without damaging adjacent tissue in patients with complex disease or anatomy. The initial-generation PFA systems required multiple ablations to effectively treat targeted tissue, with the catheter positioned in several locations. Abbott said that its Volt PFA System will address the limitations by pairing its balloon-in-basket catheter with its EnSite X EP System, a heart mapping system to position tools in the heart. The EnSite X mapping system provides clear visualisation that guides physicians to precisely identify a more accurate position where the Volt PFA Catheter is to be placed. Recently, Abbott treated more than 30 patients in Australia, as part of a pre-market clinical study to assess the safety and effectiveness of the Volt PFA System. The US medical device company anticipates a US FDA Investigational Device Exemption (IDE) approval for a clinical trial of the Volt PFA System in the first half of this year.

With this new approval, people with a Proclaim™ DRG neurostimulation system can soon receive full-body MRI scans Many doctors consider MRI labeling to be an important factor in the treatment decisions they make for people with chronic pain1 ABBOTT PARK, Ill., Jan. 18, 2024 — Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved expanded MRI labeling for its dorsal root ganglion (DRG) stimulation therapy, the Proclaim™ DRG neurostimulation system, which allows patients to receive full-body MRI scans while implanted with the device.2* The Proclaim DRG neurostimulation system is the only FDA-approved DRG technology, providing targeted relief for people with complex regional pain syndrome (CRPS) types I and II of the lower limbs by stimulating the DRG, which are clusters of nerve cells found along the spine.3 CRPS is a rare and painful condition that affects about 200,000 people in the U.S. each year.4 Characterized by a constant or intermittent burning, stinging or tearing sensation, CRPS has been found to be more excruciating than childbirth or amputation of a limb.5 For people who suffer from the syndrome and struggle to control the pain, Proclaim DRG stimulation can be an effective option, as four out of five people who receive the therapy experience significant pain relief and improved quality of life.6 MRI is one of the most widely used technologies to create detailed images of the inside of the body to inform diagnoses and treatment approaches for people with chronic pain.7 MRIs can be used to help assess the progression of CRPS.8 In these situations, an option like the Proclaim DRG therapy, which allows patients to receive MRI scans anywhere in the body within approved parameters, can be invaluable to the patient and radiologist. "The ability to do full-body MRI scans with the Proclaim DRG neurostimulation system means that, as physicians, we can ensure that people are receiving the care they need in a timely manner because they aren’t having to search for a facility that can accommodate special MRI settings for their device," said Timothy Deer, M.D., DABPM, president and chief executive officer of the Spine and Nerve Centers of the Virginias in Charleston, W.Va. "With these expanded MRI capabilities, we no longer need to sacrifice superior pain relief and quality of life outcomes in exchange for MRI needs." With the expanded MRI labeling, Abbott’s Proclaim DRG neurostimulation system will offer: Full-body scans for new and existing patients^, providing near and long-term flexibility for their imaging needs Safe scanning of any body part with standard MRI scanners^, making finding an imaging center easier and more straightforward for patients and doctors Compatibility with 50cm SlimTip™ DRG leads "As we continue to work holistically across chronic pain care, we’re excited to see this new MRI expanded indication for our proprietary and unique Dorsal Root Ganglion Stimulation therapy become another valuable tool in the hands of treating physicians helping people get back to living a life on their terms," said Pedro Malha, vice president, neuromodulation, Abbott. For U.S. important safety information on the Abbott Proclaim DRG neurostimulation system, visit: https://bit.ly/3SheU6s For U.S. important safety information on Abbott MR conditional systems, visit: https://bit.ly/3vxPs3v *When compared to traditional tonic SCS as seen in the ACCURATE clinical trial. ^Within approved conditions. Refer to the Instructions for Use for full details on the MR Conditional scan parameters. Launch pending. About Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews   1Abbott. Survey on MRI labeling. Completion date: February 1, 2023; Austin, Texas. N = 25. 2 U.S. Food and Drug Administration. See https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150004S063. 3 Abbott. Proclaim™ DRG Neurostimulation System Clinician’s Manual. Plano, TX. 2018. 4 National Organization of Rare Diseases. Feb. 8, 2023. Complex Regional Pain Syndrome. https://rarediseases.org/rare-diseases/reflex-sympathetic-dystrophy-syndrome/. Accessed Nov. 8, 2023. 5 Lee DH, Noh EC, Kim YC, et al. Risk Factors for Suicidal Ideation among Patients with Complex Regional Pain Syndrome. Psychiatry Investig. 2014;11(1):32-38. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3942549/ 6 Deer TR, Levy RM, Kramer J, et al. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain. 2017;158(4):669-681. https://pubmed.ncbi.nlm.nih.gov/28030470/ 7 Martucci, K., Ng, P., & Mackey, S. (2014). Neuroimaging chronic pain: what have we learned and where are we going?. Future neurology, 9(6), 615–626. https://doi.org/10.2217/fnl.14.57 8 Stanford Medicine. Complex Regional Pain Syndrome (CRPS). https://med.stanford.edu/pain/about/chronic-pain/crps.html Accessed. Nov. 8, 2023.

- Data presented features nerve targets throughout the body, highlighting the versatility of the SPRINT® PNS System -CLEVELAND, Jan. 16, 2024 (GLOBE NEWSWIRE) -- SPR Therapeutics, Inc. will be featured prominently at the North American Neuromodulation Society (NANS) Annual Meeting January 18-21 in Las Vegas. A total of 11 abstracts highlighting applications of the SPRINT® PNS System will be featured at the meeting including four posters never before presented to the industry. Oral and poster presentations include reviews of data on numerous regions of pain where SPRINT PNS has been widely used with demonstrated efficacy to reduce pain including the low back, knee, shoulder, and groin, along with evaluation of outcomes in specific patient populations including a Medicare-eligible cohort. The continuing adoption of SPRINT PNS and ongoing efforts of the company to retrospectively review real-world patient outcomes have generated significant data allowing physicians the opportunity to review how they may be able to apply the 60-day treatment to patient pain throughout the body, and potentially consider SPRINT treatment earlier in the care continuum based on consistent outcomes in clinical trials and real-world patient treatment. Data being featured for the first time include: Cost Benefits of Medicare Patients Receiving 60-day PNS Treatment Prior To Other Forms of Permanent PNS, which will be presented as an oral session (Saturday, January 20 4:02 - 4:10 p.m. during Scientific Advances in Neuromodulation Session 2) and featured as an ePoster by Dr. David Dickerson, Section Chief for Pain Medicine, Endeavor Health Medical Group and SPR Consultant. The presentation reviews treatment costs for patients in two cohorts who started treatment either with SPRINT PNS or with a conventional brief PNS trial. Cost Savings Associated with 60-day PNS in the Treatment of Chronic Low Back Pain, which will be featured as an ePoster by Dr. Samir Sheth, Assistant Professor of Pain Medicine and Co-Director of Neuromodulation at Sutter Health and SPR Consultant. The poster reviews health economics and outcomes research to explore the economic implications of the use of SPRINT PNS in chronic low back pain. This analysis of the per patient costs of two hypothetical cohorts demonstrates the potential cost savings with the use of SPRINT PNS early in the treatment continuum. A Single-Center, Retrospective Chart Review of 60-Day PNS Used for Shoulder Pain, which will be presented as a poster (Friday, January 19 5:30 – 7:00 p.m. during Paper Posters: Group 6 - Nerve III) by Dr. Jerry Gutierrez, Medical Director of The Pain Relief Surgicenter and SPR Consultant. The chart review highlights experience using PNS for the treatment of chronic shoulder pain in over 50 patients, including many patients who received Bimodal PNS® treatment. Sustained Relief of CRPS Pain Following 60-Day Peripheral Nerve Stimulation: Review of Three Cases, which will be featured as an ePoster also by Dr. Jerry Gutierrez. This is a retrospective review of three patients treated for complex regional pain syndrome (CRPS) in the foot and ankle via stimulation of the tibial and common peroneal nerves. A full list of the posters featuring SPRINT PNS and when they will be available can be viewed here. “There continues to be significant interest from physicians in evaluating SPRINT PNS for treating various types of pain and the results seen both in clinical trials and in real-world evidence provide hope for patients,” said Maria Bennett, President, CEO and Founder of SPR Therapeutics. “We are encouraged by the clinically meaningful outcomes and believe that SPRINT PNS can be the first-line treatment for many patients given its short-term treatment duration with demonstrated potential to provide long-lasting pain relief.” 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, shoulder pain, post-amputation pain, and chronic and acute post-operative 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 post-operative 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