Failed Back Surgery Syndrome

For millions suffering from chronic pain, relief often comes with a host of complications. But a new generation of spinal cord stimulators aims to change that. BackStop Neural is developing thin, softening epidural leads for chronic arm and neck pain and won a two-year, $485k Phase I Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support continued development. A softer touch for spinal cord stimulation Founded in 2018, BackStop Neural specializes in spinal cord stimulation systems. The company’s recent NIH funding will back the development of stimulators that use tiny electrodes to interrupt pain signals before they hit the brain. The company’s website describes them as “stable, high charge-injection capacity titanium nitride electrodes.” One novel element in the design is the lead, the component that delivers the electrical stimulation. The company said its paddle-type epidural stimulation lead is 10 times thinner than commercially available products. “This lead is made with a proprietary polymer that is stiff for implantation but softens once implanted, ensuring close contact with the spinal cord for stable and efficient stimulation and insertion into the narrower cervical space,” the company said in a news release. “Spinal cord stimulation (SCS) is effective in the treatment of chronic, intractable pain of the trunk and/or limbs due to a variety of neuropathic pain conditions including failed back surgery syndrome, complex regional pain syndrome, and painful diabetic neuropathy,” the company later continued. “However, it is still underutilized as a therapy partly due to SCS leads not being well suited to placement in the cervical epidural space. BackStop Neural’s softening lead may improve the risk profile of placement in regions with less epidural space, such as the cervical region, to increase patient eligibility and expand the use of SCS in the current standard of care for chronic pain patients.” Balancing rigidity and flexibility “Our team has worked tirelessly to develop a lead that combines the best of both worlds—rigidity for implantation and flexibility for long-term use,” Chief Medical Officer Dr. Jason Carmel said in the news release, adding that the lead has “the potential to reduce the risk of the surgical procedure but also enhances the overall effectiveness of the therapy.” Neurosurgeon Dr. Steven Falowski, a member of BackStop Neural’s advisory board, said the technology “could transform how we approach chronic pain management.” “The ability to maintain consistent contact with the spinal cord could lead to more reliable pain relief and potentially reduce the need for repeated adjustments or revisions,” he said in the release. The NIH grant will enable BackStop Neural to conduct testing of the new lead, including evaluating its mechanical and electrical stability, biocompatibility, and effectiveness in a pre-clinical animal study. BackStop is eligible for Phase II of the grant, which would provide an additional $2 to $3 million if granted. The company was founded by experts with diverse backgrounds. CEO Connie Manz previously conducted research at MIT, Draper and UT Dallas. President Walter Voit is a serial entrepreneur and tenured professor at UT Dallas. Carmel is a neurologist and motor systems neuroscientist at Columbia University.

ASPN Top Abstract awarded for analysis demonstrating benefits associated with the Evoke® System's utilization of objective measurements to achieve maximum analgesic effect for SCS Separate analysis suggests 98% positive predictive value of long-term SCS therapy success on day zero of trial period MINNEAPOLIS, July 18, 2024 /PRNewswire/ -- Saluda Medical, Inc., a commercial-stage medical device company focused on developing treatments for chronic neurological conditions driven by a novel closed-loop, dose-control neuromodulation platform, today announced the recent presentations of two abstracts analyzing biomarker-based spinal cord stimulation (SCS) data at the American Society of Pain and Neuroscience (ASPN) 2024 Annual Conference, held July 11-14, 2024, in Miami, FL. The abstracts, which were among 10 total abstracts with Saluda Medical clinical data presented at ASPN, relied on evidence from patients treated with the Evoke System in clinical studies. Key takeaways from these two abstracts demonstrate the significance of objective neurophysiological measurements in SCS with evoked compound action potential (ECAP) dose-controlled closed-loop therapy. Key Abstracts Presented: "Maximal Analgesic Effect Attained by the Use of Objective Neurophysiological Measurements with ECAP Dose-Controlled Closed-Loop SCS": Authored by Dr. Robert Levy, MD, PhD, and based on a paper accepted for recent publication in the journal Neuromodulation, this abstract was awarded "Top Abstract" out of more than 300 clinical abstracts, and was also featured as an oral presentation; the abstract sought to characterize the biomarker-based dose-response relationship that produced a patient's maximal analgesic effect. The analysis showed a statistically significant relationship between usage over ECAP threshold, ECAP dose and pain relief across the patient population. In addition, the analysis demonstrated that the clinical benefit observed in the trial period was reproduced following permanent implantation when the neurophysiological metrics remained consistent. "Identifying SCS Trial Responders Immediately after Postoperative Programming with ECAP Dose-Controlled Closed-Loop Therapy": Authored by Dr. Jason Pope, MD and based on the recent published paper by Pope, Antony, Petersen, et al., this abstract was also featured in an oral presentation; the abstract sought to analyze the benefits of closed-loop, dose-control SCS as it relates to trial outcomes and the predictability of long-term success. The analysis compared neurophysiological and certain patient reported metrics between the day of the trial procedure, or day 0, and the end of the trial. Success criteria included confirmation of neural activation and dose-controlled closed-loop therapy, patient reported pain relief, functional improvement and willingness to proceed. The analysis measured patients who passed all success criteria on day 0 and demonstrated that these success criteria had a 98% positive predictive value for being responsive to therapy at the end of the trial period. "Saluda's scientific presence at this year's ASPN conference is reflective of our commitment to elevate SCS therapy with best-in-class clinical evidence grounded in real world data and our double-blinded EVOKE RCT, and we sincerely thank our clinical investigators and their patients," said Jim Schuermann, President and CEO of Saluda Medical. "These two abstracts, highlighting biomarker-based measurements, in particular are significant to the field of SCS. We believe that the Evoke System's ability to objectively measure and respond to these neurophysiological metrics allows it to improve the reliability and reproducibility of patient outcomes from the trial period through the long-term follow-up." About Saluda Medical Saluda Medical is a commercial-stage medical device company focused on developing treatments for chronic neurological conditions driven by a novel neuromodulation platform. The Company's closed-loop, dose-control platform is designed to sense and measure neural responses to stimulation and automatically adjust 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 and can sense and measure neural activation to optimize and adjust therapy in real time with every stimulation pulse, up to 250 times per second. 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. Investor Contact: Brian Johnston or Sam Bentzinger [email protected] [email protected] SOURCE Saluda Medical

The Evoke® SCS System is now covered by all major commercial payers and Medicare, providing broad patient access for this important therapy to over 200 million lives. MINNEAPOLIS, April 10, 2024 /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 that key US commercial payers, including Cigna and EviCore (including several Blue Cross Blue Shield plans), have updated their policies to include coverage for the use of the Evoke® closed-loop spinal cord stimulation (SCS) System. 20 pain societies pledged their support and advocacy, including 11 societies as part of the Multisociety Pain Workgroup (MPW). The MPW letter to Cigna stated, "The scientific community at large recognizes closed-loop SCS as an evolutionary and proven advancement, offering patients a level of personalized care that was once unimaginable." Cigna and EviCore coverage decisions become active on May 1, 2024. Dr. Peter Staats, past president of the World Institute of Pain (WIP), the North American Neuromodulation Society (NANS) and the American Society of Interventional Pain Physicians (ASIPP), states, "This robust payer coverage for The Evoke SCS System is a result of the therapy's significant clinical and economic advantage over current standard of care, supported by published evidence in respected journals such as Lancet Neurology and JAMA Neurology. It is gratifying to know that more patients now have access to this lifechanging therapy." 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 Gilmartin Group [email protected] SOURCE Saluda Medical