Failed Back Surgery Syndrome

Closed-Loop with Precise Neural Dosing Associated with Superior Outcomes MINNEAPOLIS, Jan. 16, 2024 /PRNewswire/ -- Saluda Medical, Inc., a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies, today announced the company's data will be presented at the North American Neuromodulation Society (NANS) 2024 Annual Meeting, taking place January 18-21. The 3-Year EVOKE Study demonstrated superior pain relief in the closed-loop (SmartLoop™) arm versus the open-loop arm. In the late-breaking presentation, EVOKE Study data will be shown that SmartLoop therapy is associated with significantly better adherence to prescribed electrical dose versus the open-loop arm. This evidence may usher in a new era of objective therapy measures that enable improved long-term clinical outcomes for spinal cord stimulation (SCS). Precise neural dosing with SmartLoop is possible through real-time measurements of evoked compound action potentials (ECAPs), which are direct measures of the nerve fibers' response to stimulation. In addition to the late-breaking presentation, the 13 posters and presentations to be presented at NANS include additional data on long-term SCS clinical results and neural monitoring to optimize SCS long-term therapy efficacy as well as identify responders from non-responders during the SCS trial evaluation phase. Podium presentations include: Late Breaking Session: 3-Year Durable Outcomes and Dose-Response with ECAP Closed-Loop spinal cord stimulation (SCS) for Treatment of Chronic Pain, Dr. Nagy Mekhail (EVOKE RCT) Attaining Maximal Analgesic Effect (MAE) With Objective Neurophysiological Measurements, Dr. Robert Levy (EVOKE RCT) Increasing Treatment Response After 2 Years of Open-Loop SCS Therapy: Crossover Patient Insights Dr. Jason Pope, (EVOKE RCT) Big ECAP Data: A Novel Objective Neural Panel™ for SCS Therapy Optimization, Dr. Ajay Antony (EVOKE RCT, Avalon Study, and DR Study) "Saluda Medical has been on a journey to transform neuromodulation and solve large unmet clinical and health economic needs. The evidence presented at NANS demonstrates SmartLoop's capability to provide long-term superior outcomes for patients as well as advance SCS therapy efficiencies for clinical practices," said Jim Schuermann, President and CEO of Saluda Medical. For more information, please visit us at NANS: Saluda Medical Booth #339. About Saluda Medical Saluda Medical is a global company transforming patients' lives with disruptive neural sensing technologies designed to revolutionize the field of neuromodulation. The company's first product, the Evoke® System, is the only SmartLoop™ therapy with physiologic ECAP-controlled closed-loop spinal cord stimulation (SCS) and 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. The Evoke® System automatically reads, records, and responds to the nerves' response to stimulation 4+million times a day to provide continually optimized therapy and is proven to be superior to open-loop SCS for the treatment of overall trunk and/or limb pain. 12-month results from the EVOKE study, the first double-blind randomized controlled trial (RCT) used in support of Premarket Approval (PMA) in spinal cord stimulation history, were published in The Lancet Neurology, 24-month results have been published in JAMA Neurology, and unprecedented 36-month data, demonstrating enduring and consistent pain relief results were published in Regional Anesthesia and Pain Medicine. To learn more, including risks & important safety information, visit . Saluda and Evoke are registered trademarks owned by Saluda Medical Pty Ltd. Media Contact: Stella Kim +1 (651) 270-3084 [email protected] Investor Contact: Brian Johnston [email protected] sam@gilmartinir.com SOURCE Saluda Medical

Investing $100M over the next decade, Commons Clinic's groundbreaking spine care innovation hub will prove efficacy of new spinal care interventions, train the next generation of orthopedists, and incentivize adoption of high-value, evidence-based spine care models LOS ANGELES, Jan. 10, 2024 /PRNewswire/ -- Commons Clinic, a leading value-based physician group reinventing musculoskeletal (MSK) care, today announced the launch of the Center for Spine Economics, Outcomes & Research, accelerating the deployment of innovative care models for the treatment and management of spine conditions. The Center will introduce a center-of-excellence program for spinal restoration focusing on motion preservation, minimally invasive and ultra-minimally invasive procedures, and biologic treatments, while committing to investing $100M over the next decade to transform ambulatory spinal care delivery. Founding physicians Dr. Hyun Bae and Dr. Sanjay Khurana will lead the Center's programming and evangelize its high-value spine model with the next generation of spine specialists and ecosystem partners. Spine maladies are one of our healthcare system's largest unsolved burdens. 8.2% of U.S. adults experience chronic, severe back pain, adversely impacting quality of life and livelihood. Approximately 40% of back surgeries are low value, offering only temporary solutions or resulting in serious complications such as "failed back syndrome" that require long-term, costly care. These problems can leave consumers with persistent pain. Although low back pain can often be more effectively treated with conservative interventions like physical and behavioral health therapy, it's all too often addressed with high-cost, low value procedural interventions like a spinal fusion, which can cost more than $100,000, according to hospital price transparency data from Turquoise Health. Implementing a 'full stack' approach, inclusive of comprehensive physician-driven clinical programs, cutting-edge surgery center capabilities, rigorous application of evidenced-based research, modern care management technology, and transparent payment models, Commons Clinic's Center for Spine Economics, Outcomes & Research is dedicated to igniting the transition of MSK care away from low-value traditional hospital systems to community-based accountable care networks. "Spine patients are habitually advised to undergo surgery to resolve their pain, after which they discover they'll need more surgery and more injections over time, eroding their quality of life," said Dr. Hyun Bae, Co-Chair, Center for Spine Economics, Outcomes & Research. "The Center for Spine Economics, Outcomes & Research will illuminate the path forward from obsolete hospital-based spine care models, equipping physicians with the latest spine care research, state-of-the art facilities and technology, and evidence-based, high-value care delivery models." The Center will share resources with the Commons Clinic physician group, which rearchitects the core of an integrated delivery network. With premiere orthopedic physicians, care centers, virtual services, and ambulatory surgical centers, Commons Clinic offers patients all-inclusive care programs for various musculoskeletal episodes, including total joint replacements, artificial disc replacements, non-surgical treatment of low back pain, and more. Its vertically integrated operating model provides unparalleled control over care, experience, and costs, supporting the success of its value-based care model and earning the loyalty of patients, providers, and health plans. 2024 Center for SEOR programming will center on five pillars: Center-of-Excellence for Spinal Restoration that convenes collaborative care teams capable of delivering the best outcomes for spine restoration & motion preservation interventions such as disc replacements, minimally invasive and ultra-minimally invasive procedures, biologic treatment, and non-surgical care, all at state-of-the-art surgery centers and community clinics to reduce overall cost & improve patient-reported outcomes. Technology Lab that builds, adopts, tests, and proves the efficacy of new surgical techniques, devices, implants, biologics, virtual intervention, robotics, and software applications. Payment Innovation Coalition dedicated to developing new payment models & consumer advocacy policies for spinal surgery and low back pain, including prospective, full-risk bundled payments and consumer price transparency standards, to incentivize nationwide adoption within partnered orthopedic physician platforms, value-focused health plans, and the Center for Medicare and Medicaid Innovation. Research Institute aimed at publishing real-world evidence and open sourced data demonstrating the efficacy of unique new interventions developed internally and in collaboration with industry partners (e.g. health plans, device manufactures, and technology partners). Post-Fellowship Training Program to equip the next generation of MSK physicians (spine surgeons, pain/PM&R, and more) with the skills to thrive in and advance a modernized, revamped approach to spinal health. "Affordable spinal care outcomes are possible with the right delivery network and care model, but change will not come from within, as hospital-based systems and the orthodoxy of academic medicine lack incentive to innovate," said Nick Aubin, CEO and Co-Founder, Commons Clinic. "With the Center for Spine Economics, Outcomes & Research, Commons Clinic is committing to a multi-decade investment with the sole mission of reversing the societal burden of low back pain and spine maladies. If we succeed, we will pioneer novel approaches for spinal care, train a new generation of physician-leaders, and catalyze a multi-billion dollar savings opportunity for one of the most egregious failures of the US healthcare system." Those interested in participating in Commons Clinic's Center for Spine Economics, Outcomes & Research can visit: commonsclinic.com. About Commons Clinic Commons Clinic is a Los Angeles-based specialty health system offering Center-of-Excellence programs for spinal restoration, total joint replacements, and sports medicine. The platform converges value-based care, elite physicians, and a portfolio of state-of-the-art ambulatory facilities and surgical centers to offer an end-to-end service that delivers a phenomenal experience to patients. The company has raised more than $33M in venture capital from RA Capital Management, Floating Point, Time BioVentures, and Courtside Ventures, among others. Founded in 2021 by Nick Aubin and Paulo da Costa, Commons Clinic is based in Los Angeles. Media Contact [email protected] SOURCE Commons Clinic

MINNEAPOLIS, Dec. 14, 2023 /PRNewswire/ -- Saluda Medical, Inc. ("Saluda Medical"), a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies, today announced the appointment of Jim Erickson as Chief Financial Officer (CFO). "I am thrilled to welcome Jim to Saluda and believe his proven track record across several financial leadership roles and broad medical device industry experience will add significant value to our organization as we continue to build our innovative platform and grow commercial operations for our first indication," said Jim Schuermann, President & CEO of Saluda Medical. In conjunction with Mr. Erickson's appointment, Greg Plamondon, the Company's prior CFO, will transition to the role of Chief Operations Officer (COO) based in Sydney, Australia. "Saluda has an exciting future ahead and I am pleased to join such a remarkable team at this important juncture," said Jim Erickson, CFO of Saluda Medical. "The company is well positioned fundamentally and strategically to further establish Saluda as a leader in neuromodulation and I look forward to contributing to efforts to accelerate already encouraging momentum." Mr. Erickson brings more than 20 years of finance, accounting, and leadership experience to his new role at Saluda Medical. Most recently, he served as CFO and Head of Marketing at Monteris Medical, a medical device company focused on developing neurosurgical laser ablation capital and disposable systems. Prior to joining Monteris, Mr. Erickson held various roles of increasing responsibility at Tornier, including Vice President, Global Controller and Vice President, Global Finance. Following the announcement of Tornier's merger with Wright Medical in 2015, he also served as Vice President, Integration, where he was a member of the senior executive management team of the combined company and led the global Integration Management Office. He began his career in the assurance and advisory services practice with Ernst & Young, LLP and holds a Bachelor of Business Administration degree in accounting from the University of Iowa. About Saluda Medical Saluda Medical is a global company transforming patients' lives with disruptive neural sensing technologies designed to revolutionize the field of neuromodulation. The company's first product, the Evoke® System, is the only SmartLoop™ therapy with physiologic ECAP-controlled closed-loop spinal cord stimulation (SCS) and 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. The Evoke® System automatically reads, records, and responds to the nerves' response to stimulation 4+million times a day to provide continually optimized therapy and is proven to be superior to open-loop SCS for the treatment of overall trunk and/or limb pain. 12-month results from the EVOKE study, the first double-blind randomized controlled trial (RCT) used in support of Premarket Approval (PMA) in spinal cord stimulation history, were published in The Lancet Neurology, 24-month results have been published in JAMA Neurology, and unprecedented 36-month data, demonstrating enduring and consistent pain relief results were published in Regional Anesthesia and Pain Medicine. To learn more, including risks & important safety information, visit . Saluda and Evoke are registered trademarks owned by Saluda Medical Pty Ltd. Media Contact: Stella Kim +1 (651) 270-3084 [email protected] Investor Contact: Brian Johnston or Sam Bentzinger Gilmartin Group [email protected] [email protected] SOURCE Saluda Medical