Announcement • Jul 17
Saluda Medical, Inc. Announces First U.S. Surgical Cases Using Newly Approved CAP24 Paddle Lead Saluda Medical, Inc. announced the first U.S. surgical cases using the newly FDA-approved Evoke CAP24 paddle lead. The first procedures were performed by Erika A. Petersen, MD, Professor of Neurosurgery at the University of Arkansas for Medical Sciences (UAMS), on July 10, followed by Steven M. Falowski, MD, Director of Functional Neurosurgery at Advanced Surgery Center of Lancaster in Lancaster, PA, on July 14. CAP24 brings closed-loop neuromodulation to paddle lead cases for the first time. Paddle leads are preferred by many neurosurgeons and orthopedic spine surgeons and represent roughly 30% of U.S. SCS implants. CAP24 is the first SCS paddle lead engineered specifically for closed-loop neuromodulation, designed to sense each patient's neural signals and support precise, objective therapy. The Evoke System is supported by prospective, randomized evidence demonstrating durable outcomes through 36 months. Mekhail NA et al. ECAP-Controlled closed-loop vs open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Reg Anesthesia Pain Med 2023;0:1-9. 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. Announcement • Jul 01
Saluda Medical Receives FDA Approval For CAP24 Surgical Paddle Lead Saluda Medical, Inc. announced that the U.S. Food and Drug Administration has approved Saluda's CAP24 paddle lead, allowing it to be marketed and sold in the U.S. Paddle leads are an alternative to percutaneous leads and this approval enables the Company to target neurosurgeons and orthopedic surgeons, who generally prefer the surgical implantation of a paddle lead when performing a spinal cord stimulation procedure and who account for approximately 30% of all spinal cord stimulation implants in the U.S., meaningfully expanding Saluda's addressable market and growth profile beyond its current percutaneous lead-focused customer base. Saluda plans a phased U.S. launch beginning in the second half of calendar 2026, with broader commercial rollout commencing later in calendar 2026, as surgeon training and field inventory scale. The Company expects a gradual contribution to revenue as the surgical channel develops. The addition of a paddle lead is expected to enhance productivity within Saluda's existing U.S. commercial organization by enabling engagement with neurosurgeons and orthopedic surgeons and expanding procedural coverage within existing accounts. The CAP24 paddle lead expands Saluda Medical's spinal cord stimulation portfolio and enables use of the Evoke System with EVA Sensing Technology in surgical paddle lead procedures, extending access to the Company's physiologic closed-loop, ECAP-based therapy in the U.S. The CAP24 surgical paddle lead is the first and only spinal cord stimulation paddle lead purpose-built to deliver Evoke's physiologic closed-loop neuromodulation. Unlike traditional paddle leads originally designed for open–loop stimulation, CAP24 is the first and only spinal cord stimulation paddle engineered from the ground up for closed–loop neuromodulation, enabling therapy informed directly by each patient's unique neural signals. Its low–profile, anatomically contoured design provides stable, precise placement with broad lateral and longitudinal coverage, supporting consistent ECAP sensing and reliable therapy delivery. Featuring a unique 24-electrode, three-column configuration, the CAP24 paddle lead senses and measures evoked compound action potentials and works with the Evoke System and EVA Sensing Technology to automatically adjust stimulation to each patient's physiology, enabling objective optimization and consistent therapy delivery. The Evoke System is supported by prospective, randomized clinical evidence demonstrating durable outcomes through 36 months. New Risk • May 05
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: AU$138.6m (US$99.3m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$100m net loss in 2 years). Market cap is less than US$100m (AU$138.6m market cap, or US$99.3m). 
