Complex Regional Pain Syndromes

New delivery system, designed for Abbott's Proclaim™ DRG neurostimulation system, promotes efficient placement of neurostimulation leads on the dorsal root ganglion (DRG) Abbott's system is the only FDA-approved DRG technology for the treatment of complex regional pain syndrome (CRPS) Type 1 and Type 2 of the lower extremities, considered the world's most painful conditions1 ABBOTT PARK, Ill., April 2, 2025 – Abbott today announced the launch of its neuromodulation business’ next-generation delivery system, which will be used to streamline the implantation process for electrodes used as part of its Proclaim™ DRG neurostimulation system. The new system is intended to streamline the procedure when doctors implant the system in patients who are suffering from complex regional pain syndrome (CRPS) Type 1 and causalgia (CRPS Type 2) of the lower extremities, rare conditions that are considered more painful than childbirth or limb amputation.1 The dorsal root ganglion – or DRG – is a cluster of nerve cells found along the spine that control pain signals from specific areas of the body, including the pelvis, groin, hip, knee, ankle and foot. Abbott developed Proclaim DRG therapy specifically to target this cluster of nerves, becoming the first and only DRG technology approved to treat CRPS of the lower limbs. The DRG neurostimulation system consists of a small battery, often referred to as an implantable pulse generator (IPG), that produces the electrical stimulation, and thin wires, known as leads, that delivers the stimulation to a targeted area, in this case the DRG. Once implanted, targeted stimulation in this area can help address symptoms by disrupting pain signals before they can reach the spinal cord or brain. Four out of five people using Abbott’s Proclaim DRG neurostimulation system for their CRPS have reported significant pain relief,2 with an average 81% reported drop in pain intensity.2 The delivery system is an important part of the Proclaim DRG system because it enables physicians to carefully navigate and access the precise anatomy of the DRG when placing the system's electrodes. Designed for ease of use, the next-generation delivery system offers enhanced durability and maneuverability, which can streamline the implant procedure.2 "Because of the distinct position of the dorsal root ganglion near the spinal cord, it can be challenging to proficiently place leads there, which can limit the number of physicians who feel comfortable performing this procedure," said Timothy Deer, M.D., DABPM, president and chief executive officer of the Spine and Nerve Centers of the Virginias in Charleston, W.Va."The improved design of the new delivery system enhances maneuverability for physicians – potentially allowing more patients to experience the life-changing benefits of DRG stimulation." Placing a DRG lead involves accessing the epidural space with a needle and maneuvering the lead toward the DRG under image guidance. This cutting-edge delivery system is intended to allow physicians to implant the DRG system more efficiently. "Research shows treating CRPS with targeted DRG neurostimulation results in significantly better outcomes in terms of pain relief and functional improvements than traditional spinal cord stimulation approaches,"2,3 said Allen Burton, M.D., medical director of neuromodulation at Abbott. "Abbott is continually working to improve DRG technology to better assist physicians in improving patient outcomes. The easier the procedure, the more patients will benefit from it, helping them to live more active, fuller lives with their chronic pain under control." Considered the world's most painful chronic condition, CRPS is the result of the body overreacting to an injury or surgery and producing far greater pain signals and inflammation than is normal.4 CRPS is categorized as either Type 1 (also called reflex sympathetic dystrophy), which occurs without any detectable nerve damage, and Type 2 (also called causalgia), which happens after known nerve damage. While many affected by CRPS will have mild symptoms that can gradually improve over several months or years, some will suffer from long-term, severe pain and disability.4 For U.S. important safety information on the Abbott Proclaim DRG neurostimulation system, visit: https://bit.ly/3SheU6s 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 114,000 colleagues serve people in more than 160 countries. Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube. 1Lee 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. doi:10.4306/pi.2014.11.1.32. 2Deer 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. doi:10.1097/j.pain.0000000000000814. 3Gopal, H., Fitzgerald, J., & McCrory, C. (2016). Spinal cord stimulation for FBSS and CRPS: A review of 80 cases with on-table trial of stimulation. Journal of back and musculoskeletal rehabilitation, 29(1), 7–13. https://doi-org.sutd.idm.oclc.org/10.3233/BMR-150608. 4National Institute of Neurological Disorders and Stroke. March 8, 2023. Complex Regional Pain Syndrome. https://www.ninds.nih.gov/health-information/disorders/complex-regional-pain-syndrome. Accessed Aug. 30, 2023.

Presentations Included First Human Data on EVA™, Saluda's Automated SCS Programming Platform MINNEAPOLIS, Feb. 5, 2025 /PRNewswire/ -- Saluda Medical, Inc., a pioneer in the development and commercialization of a novel neuromodulation platform designed to transform the lives of patients with chronic neurological conditions, today announced the presentation of new clinical data at the 2025 North American Neuromodulation Society (NANS) Annual Meeting, held from January 30 – February 1, 2025, in Orlando, FL. Data from 11 total abstracts and four oral presentations, two of which received the "Top Oral Abstract" award, underscore the significance of objective neurophysiological measurements in spinal cord stimulation (SCS) with evoked compound action potential (ECAP) dose-controlled closed-loop therapy, and the potential clinical benefits of Saluda Medical's recently FDA-approved automated patient programming platform, EVA™. Highlights from EVA™ Automated Programming Abstract: "Novel Automated Platform to Upgrade SCS Programming Experience from Subjective to Objective: Results from a Prospective, Dose-Controlled Closed-loop Clinical Study," by Ajay Anthony, MD: 94% of all programming sessions using the automated programming platform successfully generated a closed-loop program <13-minute median time to generate each patient-specific automated program ≥90% of patients were satisfied or very satisfied with the automated programming platform experience Highlights from "Top Oral Abstracts": "ECAP Study Premiere: Real-World IDE Study Showing Relationship between Physiologic ECAP Biomarkers and Pain Outcomes," by Jason Pope, MD: The ECAP IDE Study builds on the EVOKE IDE Study and represents the largest SCS study executed in a real-world cohort of 220 patients Real-world data demonstrated profound improvement (≥2 MCIDs) across all pain subgroups in the study including pain associated with Failed Back Surgery Syndrome, Non-Surgical Back Pain, Complex Regional Pain Syndrome, Diabetic Peripheral Neuropathy, and Upper Limb Pain "Characterizing Spinal Cord Neurophysiology Using ECAP Dose-Controlled Closed-Loop SCS," by Harold Nijhuis, MD: First SCS study to objectively characterize differences in cervical and thoracic spinal neurophysiology Significantly higher cervical SCS sensitivity may increase the risk of over- and under-stimulation when using open-loop SCS Precise dosing on a pulse-pulse basis using an ECAP dose-controlled closed-loop SCS may be necessary for durable long-term outcomes in the cervical spine "Saluda is driving a pivotal moment in SCS, where advanced neurophysiological data and automation are redefining the standard of care," said Jim Schuermann, President and CEO of Saluda Medical. "We believe the next generation of SCS is here, and it's built on the foundation of objective science, precision, and personalized therapy that will continue to elevate patient care for years to come." "What stands out to me about these results is the newfound clarity in understanding the relationship between ECAP biomarkers and pain outcomes," said Dr. Jason Pope, MD, Founder and CEO of Evolve Restorative Center. "This real-world data from the largest SCS IDE study gives us confidence that tailored therapy with the Evoke System can significantly improve pain relief across multiple patient etiologies we treat in our practices. This kind of personalized, biomarker-driven therapy is leading to other breakthroughs such as predicting responders and non-responders to therapy and automation of programming to achieve the best relief for our patients." The recognition of the Evoke® System at the 2025 NANS Annual Meeting highlights Saluda's commitment to advancing the field of neuromodulation through cutting-edge science and innovation. By combining real-world clinical evidence, objective biomarkers, and automation. Saluda is empowering clinicians to deliver more precise, personalized, and effective therapies for patients with chronic pain. These achievements underscore Saluda Medical's leadership in redefining SCS and its unwavering dedication to improving the lives of millions of patients. About Saluda Medical Saluda Medical is a commercial-stage medical device company focused on developing treatments for chronic neurological conditions using its novel neuromodulation platform. The Company's closed-loop, dose-control platform senses and measures neural responses to stimulation and automatically adjusts therapy based on real-time neurophysiological feedback. The Company's first product, the Evoke® System, is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain, and leg pain, and is designed to treat chronic neuropathic pain by providing spinal cord stimulation (SCS) therapy that senses and measures neural activation to optimize therapy and reduce patient and clinician burden. 12-month results from the EVOKE study, the first and only prospective, multi-center, parallel-arm, double-blind, randomized controlled pivotal study with a voluntary crossover arm in SCS, that demonstrated clinically superior pain relief to open-loop therapy, were published in The Lancet Neurology, 24-month results were published in JAMA Neurology, and 36-month data, that demonstrated sustained pain relief, were published in Regional Anesthesia and Pain Medicine. To learn more, including risks and important safety information, visit . Saluda and Evoke are registered trademarks owned by Saluda Medical Pty Ltd. Investor Contacts: Brian Johnston or Sam Bentzinger [email protected] [email protected] SOURCE Saluda Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Safety and efficacy of two candidates are currently being assessed in investigator-initiated clinical trials. BRC is planning to commence enrollment for Phase 2 and 3 trials by mid 2026. MONTEREY, Calif., Jan. 29, 2025 /PRNewswire/ -- Biopharmaceutical Research Company (BRC), a pharmaceutical company developing proprietary cannabinoid therapeutics, announced today that the U.S. Food and Drug Administration (FDA) reviewed the company's procedures for the Chemistry, Manufacture and Controls (CMC) of their candidates for clinical use and development. Two of BRC's therapeutics are currently being assessed in investigator-initiated Phase 1 and Phase 2 clinical trials for Complex Regional Pain Syndrome (CRPS) and Aromatase Inhibitor Induced Arthralgia (AIIA), respectively. "BRC has established and implemented CMC procedures for clinical use within a short time frame", said George Hodgin, CEO and founder of BRC. "Engaging with the FDA regarding our clinical and commercialization manufacturing pathways represents yet another milestone for our company and is critical towards advancing our candidates through further clinical development and ultimately commercialization." "Over the course of less than two years, we committed ourselves to establishing our CMC procedures and having two of our candidates enter the clinic," said Lucas Zumstein, VP of Operations. "BRC now has a manufacturing facility with full cGMP capabilities for clinical use. This accomplishment is a testament to the strength of our team." BRC's novel botanically derived cannabinoid therapeutics contain major and minor cannabinoids at defined and proprietary ratios. CMC requires the development of specific processes for manufacturing, stability and other product testing. Like any drug, BRC's candidates follow defined specifications throughout the various steps of product development towards their later-stage clinical development and eventual marketing approval. BRC is planning to commence enrollment for Phase 2 and 3 clinical trials by mid 2026 following investigational new drug (IND) application clearance. The FDA's input on the company's manufacturing investigational product is essential for further development and will set the company on an accelerated path towards marketing approval of medicines in critical need. About Biopharmaceutical Research Company (BRC) Biopharmaceutical Research Company (BRC) is a pharmaceutical company focused on developing proprietary cannabinoid therapeutics to address high unmet medical needs. BRC's therapeutics are polymodal and contain major and minor cannabinoids at defined ratios. BRC has developed a pipeline of treatments addressing pain and neurological and inflammatory conditions. BRC is registered with the Drug Enforcement Administration and is based in Monterey, CA. To learn more about BRC, visit . Forward-Looking Statements This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks, uncertainties and assumptions, including without limitation statements about the development, use, benefits and effects of Biopharmaceutical Research Company's (BRC) therapeutic product candidate and related technology, future plans for the BRC's business and growth, expected plans with respect to clinical trials, including the number of patients enrolled and timing of patient enrollment. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "design," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management's current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements. The forward-looking statements made herein speak only as of the date of this press release and, unless otherwise required by law, BRC does not undertake any obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. SOURCE Biopharmaceutical Research Company WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED