Salvia BioElectronics

PRESS RELEASE 📢 | 𝗔 𝗻𝗲𝘄 𝗰𝗵𝗮𝗽𝘁𝗲𝗿 𝗶𝗻 𝗼𝘂𝗿 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗽𝗿𝗼𝗴𝗿𝗮𝗺 𝘀𝘁𝗮𝗿𝘁𝘀 𝘁𝗼𝗱𝗮𝘆! Today, we announce that the first patient in the U.S. has been implanted with the investigational MySalvia System in RECLAIM-II, our pivotal study in adults with resistant migraine. For people living with resistant migraine, trying multiple preventive treatments does not always mean finding sufficient relief. The burden can remain profound. RECLAIM-II will evaluate the safety and effectiveness of our purpose-built neuromodulation system in approximately 150 patients across more than 20 sites in the United States. This first implantation in the U.S. represents years of work across our clinical program, and an important next step in building the rigorous evidence needed to understand the potential role of neuromodulation in migraine care. We’re deeply grateful to the patients, investigators, clinical teams and everyone at Salvia who is making this study possible. Together, we’re moving closer to our mission of empowering people with migraine to reclaim their lives. 🔗 Read the full announcement via the link in the comments. #Migraine #Neuromodulation #ClinicalResearch #MedTech 𝘊𝘈𝘜𝘛𝘐𝘖𝘕 – 𝘐𝘯𝘷𝘦𝘴𝘵𝘪𝘨𝘢𝘵𝘪𝘰𝘯𝘢𝘭 𝘥𝘦𝘷𝘪𝘤𝘦. 𝘓𝘪𝘮𝘪𝘵𝘦𝘥 𝘣𝘺 𝘍𝘦𝘥𝘦𝘳𝘢𝘭 (𝘰𝘳 𝘜𝘯𝘪𝘵𝘦𝘥 𝘚𝘵𝘢𝘵𝘦𝘴) 𝘭𝘢𝘸 𝘵𝘰 𝘪𝘯𝘷𝘦𝘴𝘵𝘪𝘨𝘢𝘵𝘪𝘰𝘯𝘢𝘭 𝘶𝘴𝘦. Amaal Starling, MD, FAHS, FAAN Mayo Clinic Research Vista Clinical Research Group Kiran V. Patel, MD Northwell Health UC San Diego Nathaniel Schuster Queen City Clinical Research Leonardo Kapural, MD, PhD DENT Neurologic Institute MedStar Georgetown University Hospital Chicago Headache Center and Research Institute LLC Norton Neuroscience Institute Konstantin Slavin Brad Torphy, M.D. Narayan Kissoon Mark Plazier Luana Colloca Wim Pollet Hubert Martens Roni Diaz Daniel Balkcom Caaj Greebe Rob ten Hoedt Diana Saraceni Ivan Burkov Pascal Levensohn Brigit van Dijk - van de Reijt Rinke Zonneveld Hannes Kempter Manfred Ulmer-Weber Floris van Leeuwen Anja Schaeken Norman Tarazona, DVM Phyllis Kull, RN Theo Sallen Ward Yuhas Daniel Schobben Ingelou Stol Christine Swinkels Jennifer Robblee

"The majority of people living with migraine are underdiagnosed, undertreated, and underserved." — Amaal Starling, MD, FAHS, FAAN Not everyone with migraine gets the same care. Where you live, the color of your skin, and even your gender can shape how quickly you're diagnosed and how well you're treated. In a recent interview with the Migraine Science Collaborative, neurologist Dr. Amaal Starling of Mayo Clinic, Scottsdale, talked about the disparities she's worked to address throughout her career. Early on, she was struck by how often headache patients were met with dismissiveness before a clinician even saw them. Her response was to take on as many of those patients as she could. She points to several gaps: women, two to three times more likely to live with migraine, are often told to just manage their stress. The American Indian and Alaska Native population has the highest prevalence of headache disorders, by her estimate nearly double the general population. Black and Hispanic communities remain undertreated even with equal access to care, according to a Harris Poll survey. And U.S. headache specialists cluster on the coasts, far from the middle of the country, which carries a high burden of migraine disease. For Dr. Starling, closing these gaps starts with recognizing they're structural, and that real change happens through policy. She also prescribes advocacy directly to her patients, as part of the treatment plan itself. Sharing your story, she says, connects people to a community that's both inclusive and diverse, and data from other chronic conditions like cardiovascular disease and diabetes suggests it carries real therapeutic value. Read more in the article: https://lnkd.in/ejvhwPkq Photo: Headache on the Hill (Alliance for Headache Disorders Advocacy & The Headache Alliance, American Headache Society)

Exciting news!! 📢 Proud to announce that seasoned U.S. MedTech Executive Jill Schiaparelli, MBA will join Salvia as Board Chair! With nearly three decades of leadership across medical devices, neuromodulation, and commercial strategy, Schiaparelli brings deep U.S. market expertise and a proven track record scaling and growing innovative medical technology companies. "We are delighted to welcome Jill as Board Chair of Salvia BioElectronics. Jill has spent her career building and leading medical device companies through the full commercial journey, from development through FDA clearance and into the market", said Hubert Martens, Founder and CEO of Salvia. "Her direct experience in the neuromodulation space, combined with her depth of leadership experience, is exactly the profile we need. As we advance MySalvia Therapy through the critical phases of clinical development and toward commercialization, her leadership at the board level will be invaluable." “Migraine is one of the leading causes of disability worldwide, yet current treatments often fail to provide sufficient relief, highlighting a major unmet need,” said Jill Schiaparelli, Chair of the Board of Salvia. “The MySalvia neuromodulation platform is poised to set a new standard of care and restore quality of life to hundreds of millions of people who suffer with resistant migraine, a condition in which significant disability persists despite multiple treatments. I look forward to working with the leadership team and supporting the board to bring this vitally important solution to market.” Read the full announcement here: https://lnkd.in/ebyKZGJM #mysalviatherapy #boardannouncement #neuromodulation #migraine Jill Schiaparelli, MBA Hubert Martens Jeroen Siemes Roni Diaz Daniel Balkcom Wim Pollet Daniel Schobben Rob ten Hoedt Caaj Greebe Innovation Industries Diana Saraceni Panakes Partners Ivan Burkov Inkef SHS Capital Dolby Family Ventures Pascal Levensohn Brabantse Ontwikkelings Maatschappij (BOM) Brigit van Dijk - van de Reijt Rinke Zonneveld Invest-NL Thuja Capital Hannes Kempter Manfred Ulmer-Weber Floris van Leeuwen

At AHS 2026 in Orlando, we presented 24-month outcomes from the RELIEF early feasibility study, evaluating combined bilateral supraorbital and occipital nerve stimulation in a small group of individuals with resistant migraine. The study was conducted at AZ Delta in Belgium by Dr. Bart Billet, anesthesiologist and pain physician, and Dr. Maarten Goethals, neurologist. Eligible participants had ≥8 monthly migraine days and prior failure of ≥3 preventive pharmacological treatments (including CGRP monoclonal antibodies and/or onabotulinumtoxin A). The 24-month findings from this small first-in-human feasibility study suggest that combined nerve stimulation may provide sustained clinical benefit in some individuals with resistant migraine. The findings support continued evaluation of this implantable neurostimulation system. As with any early feasibility study, interpretation is limited by the small sample size, open-label design, and absence of a control group. Larger controlled studies are required to establish safety, durability, and effectiveness. These findings informed the design of #RECLAIM, our ongoing implantable neuromodulation study in Europe, and contributed to the design of our upcoming US #RECLAIM-II study, the first FDA IDE-approved pivotal trial of implantable neuromodulation in resistant migraine. This work was made possible by an exceptional group of co-authors: • Hsiangkuo Yuan, MD PhD FAHS, Thomas Jefferson University, Philadelphia • Maarten Goethals, AZ Delta Torhout, Belgium • Bart Billet, AZ Delta Pain Clinic, Roeselare, /Belgium • Manjit Matharu, MBChB, UCL Queen Square Institute of Neurology, University College London, and The National Hospital for Neurology and Neurosurgery Follow our page for further updates on our clinical program. #AHS2026 #Neuromodulation #ResistantMigraine #Migraine #ClinicalResearch #MedTech 𝘔𝘺𝘚𝘢𝘭𝘷𝘪𝘢 𝘛𝘩𝘦𝘳𝘢𝘱𝘺 𝘪𝘴 𝘢𝘯 𝘪𝘯𝘷𝘦𝘴𝘵𝘪𝘨𝘢𝘵𝘪𝘰𝘯𝘢𝘭 𝘥𝘦𝘷𝘪𝘤𝘦, 𝘭𝘪𝘮𝘪𝘵𝘦𝘥 𝘵𝘰 𝘪𝘯𝘷𝘦𝘴𝘵𝘪𝘨𝘢𝘵𝘪𝘰𝘯𝘢𝘭 𝘶𝘴𝘦 𝘪𝘯 𝘢𝘤𝘤𝘰𝘳𝘥𝘢𝘯𝘤𝘦 𝘸𝘪𝘵𝘩 𝘢𝘱𝘱𝘭𝘪𝘤𝘢𝘣𝘭𝘦 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘪𝘰𝘯𝘴 𝘪𝘯 𝘵𝘩𝘦 𝘜𝘯𝘪𝘵𝘦𝘥 𝘚𝘵𝘢𝘵𝘦𝘴 𝘢𝘯𝘥 𝘌𝘶𝘳𝘰𝘱𝘦.

𝗙𝗿𝗼𝗺 𝗙𝗲𝗮𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗢𝘂𝘁𝗰𝗼𝗺𝗲𝘀 𝘁𝗼 𝗣𝗶𝘃𝗼𝘁𝗮𝗹 𝗦𝘁𝘂𝗱𝘆 𝗗𝗲𝘀𝗶𝗴𝗻 At the 68th Annual Scientific Meeting of the American Headache Society in Orlando, a poster is presented on the design and evidence base behind our upcoming RECLAIM-II study in the U.S. The first FDA IDE-approved pivotal trial of implantable neuromodulation in resistant migraine. Three ongoing prospective feasibility studies demonstrating procedural success, device safety, durability of effect, and high compliance informed the pivotal study design. A key focus was the study methodology, building on prior learnings to ensure a robust and scientifically rigorous trial design. Targeting resistant migraine, a condition in which significant disability persists despite multiple preventive treatments, RECLAIM-II represents an important step toward evaluating a potential new treatment option. This work was made possible by an exceptional group of co-authors: • Amaal Starling, MD, FAHS, FAAN, Mayo Clinic Arizona • Manjit Matharu, MBChB, UCL Queen Square Institute of Neurology, University College London, and The National Hospital for Neurology and Neurosurgery • Hsiangkuo Yuan, MD PhD FAHS, Thomas Jefferson University, Philadelphia • Robert Dworkin, PhD, University of Rochester School of Medicine and Dentistry • Luana Colloca, MD, PhD, University of Maryland, Baltimore • Ulrike Bingel, MD, University Hospital Essen, Germany • Roni Diaz, Salvia BioElectronics • Wim Pollet, MD, Salvia BioElectronics • Todd Schwedt, MD, Mayo Clinic Arizona Follow our page for further updates on our clinical program. #AHS2026 #Neuromodulation #ResistantMigraine #Migraine #ClinicalResearch #MedTech 𝘊𝘈𝘜𝘛𝘐𝘖𝘕 - 𝘐𝘯𝘷𝘦𝘴𝘵𝘪𝘨𝘢𝘵𝘪𝘰𝘯𝘢𝘭 𝘥𝘦𝘷𝘪𝘤𝘦. 𝘓𝘪𝘮𝘪𝘵𝘦𝘥 𝘣𝘺 𝘍𝘦𝘥𝘦𝘳𝘢𝘭 (𝘰𝘳 𝘜𝘯𝘪𝘵𝘦𝘥 𝘚𝘵𝘢𝘵𝘦𝘴) 𝘭𝘢𝘸 𝘵𝘰 𝘪𝘯𝘷𝘦𝘴𝘵𝘪𝘨𝘢𝘵𝘪𝘰𝘯𝘢𝘭 𝘶𝘴𝘦.

𝐏𝐢𝐨𝐧𝐞𝐞𝐫𝐢𝐧𝐠 𝐚 𝐧𝐨𝐯𝐞𝐥 𝐧𝐞𝐮𝐫𝐨𝐦𝐨𝐝𝐮𝐥𝐚𝐭𝐢𝐨𝐧 𝐭𝐡𝐞𝐫𝐚𝐩𝐲 𝐟𝐨𝐫 𝐦𝐢𝐠𝐫𝐚𝐢𝐧𝐞 Today, Salvia BioElectronics celebrates 9 years. Salvia was born from a strong personal drive combined with a clear and urgent medical need. Chronic migraine is not “just a headache.” It is a debilitating neurological condition that forces people out of their social lives, their work, and the life they want to live. Nine years ago, our three founders Hubert Martens, Wim Pollet and Daniel Schobben turned that urgency into action. What began as a bold vision has grown into a multidisciplinary team of more than 60 scientists, engineers, and innovators, all driven by the same mission to empower people with migraine to reclaim their lives. Today, we are advancing our investigational therapy in clinical studies, marking an important milestone in our journey to bring a new treatment option to patients who need better solutions. We are proud of how far we have come. And we know this is just the beginning. Thank you to our team, (clinical) partners, investors, participating hospitals, and especially the patients who inspire us every day. 𝘔𝘺𝘚𝘢𝘭𝘷𝘪𝘢 𝘛𝘩𝘦𝘳𝘢𝘱𝘺 𝘪𝘴 𝘤𝘶𝘳𝘳𝘦𝘯𝘵𝘭𝘺 𝘣𝘦𝘪𝘯𝘨 𝘦𝘷𝘢𝘭𝘶𝘢𝘵𝘦𝘥 𝘪𝘯 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘴𝘵𝘶𝘥𝘪𝘦𝘴. 𝘐𝘵 𝘩𝘢𝘴 𝘯𝘰𝘵 𝘺𝘦𝘵 𝘣𝘦𝘦𝘯 𝘢𝘱𝘱𝘳𝘰𝘷𝘦𝘥 𝘧𝘰𝘳 𝘤𝘰𝘮𝘮𝘦𝘳𝘤𝘪𝘢𝘭 𝘶𝘴𝘦. 𝘕𝘰 𝘤𝘭𝘢𝘪𝘮𝘴 𝘢𝘳𝘦 𝘮𝘢𝘥𝘦 𝘳𝘦𝘨𝘢𝘳𝘥𝘪𝘯𝘨 𝘪𝘵𝘴 𝘴𝘢𝘧𝘦𝘵𝘺 𝘰𝘳 𝘦𝘧𝘧𝘦𝘤𝘵𝘪𝘷𝘦𝘯𝘦𝘴𝘴.