Field Clinical Engineer

Saluda Medical expands access to first and only fda-approved closed-loop Surgical Paddle Lead with full US commercial release of CAP24(TM). Oct 06, 2026, 11:27 ET BLOOMINGTON, Minn., Oct. 6, 2026 /PRNewswire/ - Saluda Medical, Inc. (ASX: SLD, "Saluda" or the "Company") a commercial-stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed-loop neuromodulation platform, today announced the full US commercial release of the CAP24(TM) Surgical Paddle Lead following FDA approval earlier this year. CAP24 is now being made broadly available to neurosurgery and orthopedic spine practices across the US, following completion of a successful limited market release in selected centers. During the limited release, physicians provided positive feedback on the device's performance and its integration into clinical practice. CAP24 is the first and only FDA-approved surgical paddle lead purpose-built for physiologic, dose-controlled closed-loop therapy. It enables the Evoke(R) System to measure each patient's unique neural response and adapt stimulation with every pulse. Its low-profile, anatomically contoured design supports stable placement and broad coverage. "CAP24 is the first surgical paddle lead designed to support dose-controlled therapy," said Erika Petersen, MD, Professor of Neurosurgery at the University of Arkansas for Medical Sciences. "By providing real-time physiologic feedback, it allows stimulation to be adjusted as neural responses change, helping maintain consistent therapy delivery and a more predictable treatment experience." The Paddle Lead is now available to neurosurgery and orthopedic spine practices across the US, expanding access to the surgical segment, which represents approximately 30% of US spinal cord stimulation (SCS) implants. "Evoke(TM) Therapy has changed what patients and treating physicians can expect from SCS. Until recently, it has only been available through percutaneous leads," said Mike Mathias, Chief Executive Officer of Saluda Medical. "The full commercial release of CAP24 expands access to our one-of-a-kind therapy for patients who require a paddle lead. This marks an important step towards making physiologic, dose-controlled closed-loop therapy available to all appropriate patients." CAP24 is designed to deliver Evoke Therapy, which has demonstrated durable clinical outcomes in the EVOKE study. More than 90% of patients who responded at three months remained responders at 36 months.[1] 1. Mekhail NA, et al. ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Reg Anesth Pain Med. This announcement has been authorized for release by Saluda Medical's Disclosure Committee. | Investors | / | Media | | James Erickson Chief Financial Officer [email protected] | Sam Wells NWR Communications +61 (0) 427 630 152 [email protected] | Matt Wright NWR Communications +61 (0) 451 896 420 [email protected] | 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 www.saludamedical.com/us/safety/. Foreign Ownership Restriction Saluda's CHESS Depositary Interests (CDIs) are issued in reliance on Regulation S under the U.S. Securities Act of 1933, as amended (the U.S. Securities Act), and a no-action letter issued by the staff of the U.S. Securities and Exchange Commission. Accordingly, the Company's CDIs have not been, and will not be, registered under the U.S. Securities Act (except pursuant to an effective registration statement) or the securities laws of any state or other jurisdiction in the United States. The holders of Saluda's CDIs may not offer, sell, pledge, or otherwise transfer the CDIs into the United States or to, or for the account or benefit of, a "U.S. Person" (as defined in Rule 902(k) of Regulation S under the U.S. Securities Act) for a period of at least 12 months from the allotment date under the IPO, unless the resale of the CDIs is registered under the U.S. Securities Act or an exemption from registration is available. SOURCE Saluda Medical

Health Check: Biotech's version of 'Woodstock' is underway - with no leaky tents. * The annual Bioshares Summit has attracted more than 200 attendees, with more than 30 biotechs taking to the podium * Calmer Co kavas out a dominant market niche with latest supply deal * Broker tips 400% upside for Saluda Medical The finest figures of Australian biotech have gathered in Queenstown, New Zealand for the 20th Bioshares Summit. The annual love-fest is the sector's answer to Woodstock, but without the drugs (the illicit ones) and appearances from Janis Joplin, Joan Baez and The Who. More than 200 biotech execs, investors and capital market reps were due to descend on the alpine fun town, better known for bungee jumping and paragliding than earnest discourses on trial protocols and approval pathways. Dragging participants from the Hydro Shark Attack and Skyline Luge, Mayne Pharma (ASX:MYX) CEO Aaron Gray stressed the company famed for generics was more about branded drugs in the dermatology and women's health sectors. In his prezzo, he said 83% of Mayne's sales were branded in the 2025-26 year, compared with 17% generic. That's a flip from two years ago, when 68% of sales derived from the low-margin generic stuff. The CEO of kidney disease specialist Dimerix (ASX:DXB), Dr Nina Webster highlighted up to $1.9 billion of development and sales milestones and royalties the company could pocket from five separate distribution deals. These pertain to the company's lead asset DMX-200, for the rare disease focal segmental glomerulosclerosis. Dimerix has since picked up DMX-652, a phase II-ready asset for acute kidney injury. With no other approved treatment available for the disorder, Dimerix estimates a current addressable market of US$3.5 billion, rising to US$7.5bn by 2036. Hope for Alzheimer's breakthrough. Also today, Actinogen Medical (ASX:ACW) reminded the audience that topline results from its phase IIb/III Alzheimer's disease trial were due to lob in November. Dubbed Xanamia, the 247-patient trial targets brain cortisol, "a well-established risk factor in Alzheimer's disease and depression". In doing so, Actinogen's lead compound Xanamem pursues a novel mechanism of action. The company hopes that if successful, the results will support a "registration package", with the US and/or European regulators. If the biotech gods shine, Actinogen may require only one more additional trial. Star-studded lineup. More than 30 companies are due to perform - er, present - over the two-day fiesta. What the brokers say. Following Saluda Medical's (ASX:SLD) upbeat June quarter results, broker Morgans values the device maker at $2.94 a share - much higher than the current 58 cents. Saluda has a commercialised spinal cord stimulation platform called Evoke. Spinal cord stimulation works by suppressing pain using electrical pulses generated by electrodes, to activate the spinal cord's dorsal columns. This inhibits the body's pain signals before they travel up the spinal cord to the brain. Subscribers to Saluda's December IPO have only felt hip pocket pain, with the stock well adrift of the $2.65/sh listing price. However, Saluda shares have zipped up almost 50% this week, following the July 29 quarterly showing a 28% revenue boost, to US$27 million. "We view Saluda as a high-growth, execution-led opportunity offering first-in-class, clinically differentiated closed-loop technology in the global spinal cord stimulation market," Morgans says. "Following a weak post-IPO performance, the stock trades at a material discount to neuromodulation peers." Meanwhile, Macquarie Equities ascribes an outperform to Neuren Pharmaceuticals (ASX:NEU), following the rare neurological disease specialist's stellar quarterly update yesterday. More precisely, Neuren's global distribution partner Acadia disclosed record sales of the parties' Rett Syndrome drug, Daybue. Macquarie ascribes a $23 price target, which implies only modest upside following the stock's 30% spurt over the last month. Chill out! Calmer Co secures kava supply. Kava supplier The Calmer Co International (ASX:CCO) has secured a key deal to access supply of the mildly intoxicating root from parties in Papua New Guinea and Vanuatu. With an indicative annual supply value of around $8.65 million for up to ten tonnes per month, the deal pertains to noble kava. Noble kava is higher quality and arguably produces more predictable and safer results. The company says the arrangement bolsters its existing Pacific sourcing network - notably from the kava capital of Fiji. "Securing reliable, long-term access to premium noble kava is fundamental to our growth strategy," Calmer CEO Zane Yoshida says. The deal supports Calmer's existing manufacturing capacity of around five tonnes of dried kava per week, with more facilities coming online. Osteopore 'turban charges' its Middle East prospects. The Singapore-based Osteopore (ASX:OSX) might not have curried investor favour - its market cap is a mere $3 million - but the company hasn't been short of commercialisation updates. The latest involves the bone healing specialist signing a three-year distribution agreement with Al-Umnia Medical LLC (Al-Umnia). This is to sell Osteopore's orthopaedic products in Saudi Arabia, United Arab Emirates, Oman, Qatar and Bahrain. The Dubai-based Al-Umnia builds partnerships with "leading international medical technology suppliers" in the region. Osteopore's patented tech revolves around 3D-printed, bioresorbable "micro-structured" scaffolds for bone regeneration. The company says the Middle East is a "compelling growth opportunity" for orthopaedic bone regeneration, with a high rate of lower extremity fractures that defies the downward global trend. Saudi Arabia tops the fracture league ladder, with the mishaps "driven substantially by road trauma in a young, working-age population." The oil-rich state recorded 63,737 road traffic accidents between 2016 and 2020, mainly in the key cities of Riyadh and Makkah. At Stockhead, Stockhead tell it as it is. While Dimerix and Calmer Co are Stockhead advertisers, the companies did not sponsor this article. Investor Guide: Health & Biotech 2026 featuring Tim Boreham