ONWARD Medical

🎉 Today marks a truly historic moment – not just for our company, but for the entire spinal cord injury (SCI) community.  After more than a decade of pioneering research and unwavering dedication, we have received FDA De Novo classification and authorization to market the ARC-EX® System, the world's first non-invasive spinal cord stimulation system proven to improve strength and sensation after chronic SCI. 💫 Here are some key highlights of the ARC-EX System: ⭐️ 90% of clinical trial participants showed improved strength or function* in clinical trials ⭐️ Benefits seen up to 34 years post-injury* in clinical trials ⭐️ Named a Time Magazine Best Invention of 2024 For the first time ever, there is an approved therapy to improve hand strength and sensation for people with SCI. This recognition is particularly meaningful because it acknowledges more than just technological innovation – it validates the benefits of this therapy for the millions of people worldwide who dream of regaining movement and independence after SCI. We thank the entire SCI Community for supporting us in our journey to develop and introduce this breakthrough technology. Together, we are not just developing devices; we are reshaping what is possible after spinal cord injury. 🚀 🔗 For more details, read our press release (link in comments).  *Moritz, Chet, et al. “Non-invasive spinal cord stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial.” Nature Medicine. 2024. #EmpoweringMovement #SCI #MedicalBreakthrough #Innovation  Note: The ARC-EX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive). Please note that all other ONWARD Medical devices and therapies, including ARC-IM®, ARC-BCI®, and ARC Therapy™ with brain-computer interfaces (BCIs), are investigational and not commercially approved. Patient testimonials reflect individual experiences and outcomes, which may vary. Please review the full product label and clinical study data. 

🙏 A huge thank you to Thomas Colson and to editor Andrew Rummer for the write up in ThinQ from EQT Group 🎉    And to John de Koning, an early investor and board member, we’re grateful for your partnership as we work together to improve the lives of those affected by SCI.🚀 https://lnkd.in/e79GSN7m To be kept informed about the Company’s technologies, research studies, and the availability of therapies in your area, please complete the webform in the comments. #ThankYou #EQT #Partnership #SpinalCordInjury #HealthcareInnovation #OnwardMedical

📣 We'll be there! ONWARD Medical will be at AOTA Inspire 2025 in Philadelphia, April 3-5! Join our team at Booth #1317 to discover how the ARC-EX® System is advancing spinal cord injury (SCI) rehabilitation. Learn about our recent FDA approval and groundbreaking clinical findings from the Up-LIFT Trial. Connect with our onsite team: Mark Landman, Sarah Bogorad Mintz, PT, DPT, CPI, and Ksenia Bogdanova, to explore ONWARD Medical's vision for the future of SCI rehabilitation and discuss how our technology can enhance your practice. AOTA INSPIRE brings together 8,000+ OT professionals - don't miss this opportunity to see our innovations firsthand! To be kept informed about the Company’s technologies, research studies, and the availability of therapies in your area, please complete the webform in the comments.     #AOTAINSPIRE2025 #OccupationalTherapy #SpinalCordInjury #ONWARDMedical #EmpoweringMovement

🚀 ONWARD Medical: 2024 Year in Review & 2025 Highlights 🚀 2024 was truly transformative for ONWARD as we achieved FDA authorization and first commercial sales of our breakthrough ARC-EX® System for people with spinal cord injury. Here's a look at our incredible journey throughout 2024 and early 2025: 🏥 Commercial Achievements ✅ Received FDA De Novo authorization for our ARC-EX System in December 2024  ✅ Recorded first commercial sales to UW Medicine and Next Steps of O'Connor Foundation in Chicago   ✅ ARC-EX System named one of TIME Magazine's Best Inventions of 2024  ✅ Added to U.S. Department of Veterans Affairs procurement platforms in January 2025 🔬 Clinical and Development Milestones ✅ Received 10th FDA Breakthrough Device Designation for investigational ARC-BCI® System  ✅ Accepted into FDA's Total Product Lifecycle Advisory Program for ARC-BCI System  ✅ Published Up-LIFT pivotal trial results in Nature Medicine, meeting all endpoints  ✅ Secured exclusive license to WIMAGINE® BCI technology from the Commissariat a l'Energie Atomique et aux Energies Alternatives  ✅ First-in-human use of our investigational ARC-IM® Lumbar Lead in March 2025  ✅ Awarded grants from Christopher & Dana Reeve Foundation, EIC - European Innovation Council, The Michael J. Fox Foundation for Parkinson's Research, and United States Department of Defense 💼 Corporate Developments ✅ Secured strategic investment from Ottobock, acquiring ~10% of our share capital  ✅ Strengthened our balance sheet through EUR 70M in equity financing  ✅ Signed debt financing agreement for up to EUR 52.5M with Runway Growth Capital  ✅ Added Euronext Paris listing, highlighting our strong French connections  ✅ Welcomed Rob ten Hoedt as new Board Chairman  ✅ Added 20 patents to our IP portfolio, now totaling 150+ issued patents*  ✅ Awarded silver medal for sustainability by EcoVadis ✅ Ended 2024 with EUR 60.0M net cash Check out our 2024 Results infographic. A recording of the Full Year Results webcast held today is available on our investor website. To be kept informed about the Company’s technologies, research studies, and the availability of therapies in your area, please complete the webform in the comments.     #ONWARDMedical #SpinalCordInjury #MedicalBreakthrough #EmpoweringMovement *This does not account for country validations; the number of patents including such validations exceeds 290 Investigational products: The ONWARD ARC-IM System and ARC-BCI System are investigational and not available for commercial use. ARC-EX Indication for Use (US): The ARC-EX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).

ONWARD Medical is hosting the Full Year 2024 Financial Results and Business Update. Make sure to attend it at 2pm CET / 8am ET, April 1st.

🚀 Erika Ross Ellison, our VP for Global Clinical, Regulatory, and Quality, spoke at the Emerge Americas event in Miami this month, sharing her expertise on the intersection of AI and robotics in paralysis recovery. The event unites the tech industry’s top leaders, sharing visionary insights that will drive the future of technology. ✨ 💡 In her session, “Breaking Barriers: Innovations in AI and Robotics Transforming Paralysis Recovery”, Erika shared how groundbreaking technologies are revolutionizing rehabilitation, including the regulatory challenges and quality benchmarks needed to bring therapies from the lab into clinics and homes where they can impact people’s lives. Fellow panelists included @Melanie Orell of Jackson Memorial Hospital, Brianne Neuburger Simon of University of Miami Health System, Dr. Leslie Morse of University of Miami, and Alan T. Brown of the Christopher & Dana Reeve Foundation. To be kept informed about the Company’s technologies, research studies, and the availability of therapies in your area, please complete this webform.   #ParalysisRecovery #AI #Robotics #MedTech #HealthcareInnovation #ONWARD #MedicalInnovation #Rehabilitation #eMergeAmericas #TechLeadership #FutureOfHealthcare #BreakingBarriers 

🚀 Milestone Alert from ONWARD Medical! 🚀 We're thrilled to announce the successful first human implant of our investigational ARC-IM Lumbar Lead! This procedure, performed last week by neurosurgeon, Jocelyne Bloch, at CHUV | Lausanne university hospital in Switzerland, marks a major step forward in our mission to restore movement, function, and independence for individuals with spinal cord injuries (SCI). 🔬 This implant follows the successful first-in-human use of the ARC-IM Thoracic Lead in May 2023. The ARC-IM Thoracic Lead will be part of our planned Empower BP pivotal study targeting blood pressure instability after SCI. 💡 The ARC-IM Lumbar Lead is designed to stimulate the lumbar region of the spinal cord, unlocking the potential to restore standing, stepping, and improved mobility for SCI patients. We’re expanding our ARC-IM Lead portfolio to address a variety of indications, including mobility, blood pressure stability, upper extremity function, and bladder control—potentially impacting both the SCI and Parkinson's disease populations. To be kept informed about the Company’s technologies, research studies, and the availability of therapies in your area, please complete the webform in the comments below.    #onwdempowered #SpinalCordInjury #Innovation #MedTech #HealthTech #NeuroTech #empoweringmovement Investigational products: The ONWARD ARC-IM Lead and ARC-IM System are investigational and not available for commercial use.

We are deeply grateful to Erica Coulston and the team at Walk The Line to SCI Recovery for being one of the first to offer the ARC-EX System. These folks are dedicated to rehabilitation and support for the Spinal Cord Injury community using cutting-edge technologies. Thank you for all you do! To be kept informed about ONWARD’s technologies, research studies, and the availability of therapies in your area, please complete the webform in the comments. #ONWARDMedical #Gratitude #ARCEX #SpinalCordInjury #ChangingLives #Innovation #ThankYou #EmpoweringMovement ARC-EX Indication for Use (US): The ARC-EX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).

🌟 Grateful for Chicago Tribune's Spotlight on ARC-EX System Breakthrough 🌟 Thank you Lisa Schencker and the Chicago Tribune for the recent write-up on the FDA approval of our ARC-EX System, the first of its kind technology to improve hand strength and sensation after spinal cord injury (SCI).🙏 Lisa’s story captures the reason we developed this technology, to provide a renewed sense of hope and progress for the millions of people living with SCI. ✨ We are also deeply grateful to Mary Jones and NextSteps Chicago, one of the first US clinics offering the ARC-EX System, for the team’s dedication and commitment to rehabilitation for the SCI community using cutting-edge technologies. 🦾 A special thanks to Dr. Arun Jayaraman of Shirley Ryan AbilityLab for his comments in the article, and Marco Baptista of The Christopher & Dana Reeve Foundation for his support of cutting-edge research in the space. 🙌 To be kept informed about ONWARD’s technologies, research studies, and the availability of therapies in your area, please complete the webform in the comments.    #OnwardMedical #ChicagoTribune #Gratitude #ARCEX #SpinalCordInjury #ChangingLives #Innovation #ThankYou #EmpoweringMovement ARC-EX Indication for Use (US): The ARC-EX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).

Save the date! Join our CEO, Dave Marver for the webcast of our Full Year 2024 Financial Results and business highlights on April 1st at 2pm CET. To join the webcast via Zoom, please register using the link provided below. A recording of the webcast will be available on the Company’s website following the live event. #empoweringmovement #ONWD #ONWARDMedical #MedTech