ONWARD Medical

🎉 Today, the results from our Up-LIFT pivotal trial were published in Nature Medicine, one of the world’s preeminent scientific journals.     This Nature Portfolio publication is a key milestone advancing our mission to address the unmet needs of the spinal cord injury (SCI) community. 📑 The Up-LIFT study was designed to evaluate the safety and effectiveness of our investigational ARC-EX® Therapy to improve upper limb mobility in people with chronic incomplete tetraplegia. The global study was conducted with 65 participants at 14 leading SCI centers in the United States, Europe, and Canada.   Here are the headlines: ⭐️ ARC-EX Therapy was shown to be safe and effective*     ⭐️ 90% of participants improved either strength or function of their upper limbs*    ⭐️ 87% of participants reported improvement in quality of life*    ⭐️ Improvement was demonstrated in participants up to 34 years post-injury*    Study participants also reported reduced spasm frequency, improved sleep, and improved upper body sensation, including the sense of touch*. Self-care, a key component of independence after SCI, also improved statistically significantly*.     💡 These are remarkable results. Finally, there is a therapy to restore strength, function, and sensation after chronic spinal cord injury.  We have submitted an application to the US Food and Drug Administration for US regulatory clearance of the ARC-EX System. We hope to be able to offer ARC-EX Therapy to people with SCI in the US later this year and in Europe in mid-2025. ✨ This achievement reflects intense collaboration. We are deeply grateful for the research teams at the 14 leading SCI centers for examining this breakthrough therapy in the hopes of making it available to the SCI Community. We appreciate the intellectual rigor, clinical expertise, and discipline that our esteemed roster of principal investigators brought to this study. We honor our trial participants, the trailblazers who signed up for the study in the name of furthering solutions to address unmet needs of the SCI Community. Finally, we thank our clinical team for the long hours, dedication, and mission-driven passion they bring to their work.  Let’s keep the momentum going. 🚀 Special thanks to Up-LIFT Clinical Trial Principal Investigators: Drs. Edelle Field-Fote, Jim Guest, Thomas Janssen, Dr. Sukhvinder Kalsi-Ryan, Andrei Krassioukov, Ralph Marino, Chet Moritz, Leslie Morse, Lynda Murray, Margaret Purcell, Candy Tefertiller, Randy Trumbower, Ilse van Nes, and Kristin Zhao, PhD. #EmpoweringMovement #SCI #ClinicalTrials *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. Note: All ONWARD® Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.

🎬 Super/Man: The Christopher Reeve Story is now playing in theaters nationwide! We were thrilled to see one of our pioneering trial participants in this documentary about the life and legacy of iconic actor, Christopher Reeve.     Gert-Jan Oskam is the first person in the world to use our investigational ARC-BCI™ Therapy to walk again using the power of thought. His study was featured in a groundbreaking publication in Nature Magazine, and covered by media all over the world.🌍    The documentary references Gert-Jan’s milestone achievement as one example of the wide-ranging impact Reeve had in his advocacy work after his spinal cord injury (SCI) from a horseback riding accident.     Our strategic partnership with Christopher & Dana Reeve Foundation has enabled us to work closely with the SCI Community to develop our therapies. We are grateful for our ties to those with SCI, and we know that many advances in this space can be attributed to the work that Christoper and Dana did to find solutions for the unmet needs of this community. 💫    To celebrate the release of Super/Man and in recognition of Christopher Reeve’s legacy, we are highlighting what Reeve meant to some of our own trailblazers, starting with Gert-Jan.     🎥 To watch Gert-Jan’s cameo in the SuperMan trailer, click on the link in comments (Gert-Jan appears around 2:36). 🔗    #EmpoweringMovement #SCI #BCI #SuperMan    Note: All ONWARD® Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.    

Congrats, Christopher & Dana Reeve Foundation, for the beautiful tribute to Christopher Reeve and his enduring legacy. 💫

Congrats, Christopher & Dana Reeve Foundation, for the beautiful tribute to Christopher Reeve and his enduring legacy. 💫

🛎️ As you may know, we recently listed our shares on Euronext Paris. 🇫🇷 We pursued this additional listing to increase liquidity and trading volume in our shares. Our Company has significant ties to France, exemplified by our relationship with French biomedical research institute Commissariat a l'Energie Atomique et aux Energies Alternatives (CEA-Clinatec) in #braincomputerinterface research. We are hopeful this new listing provides French investors with a greater opportunity to participate in our growth story. 💫    📹 You can watch highlights from the listing ceremony in the post below issued by Euronext. ⬇️    The Euronext Paris listing further fuels our mission to restore movement, function, and independence for people with spinal cord injury around the world. 🌏    #EmpoweringMovement #SCI #EuronextParis   

✨ Thanks to MassDevice and Sean Whooley for an informative piece detailing our work with brain-computer interface (BCI) technology.     The article covered our recent announcement of a third successful implant of our investigational ARC-BCI™ Therapy to restore thought-driven movement after spinal cord injury (SCI).     This milestone event, which involved the use of our investigational ARC-BCI System to restore lower limb mobility after SCI, is part of an ongoing clinical feasibility study supported by grants from the Christopher & Dana Reeve Foundation and the European Innovation Council and SMEs Executive Agency (EISMEA) and in coordination with our research collaborators, neuroscientists Professor G. Courtine and Dr. Jocelyne Bloch of .NeuroRestore, and Commissariat a l'Energie Atomique et aux Energies Alternatives (CEA-Clinatec).    In the rapidly evolving field of BCI technology, education is key to keeping the public updated. We appreciate Sean’s informed reporting and MassDevice’s commitment to providing accurate information and thoughtful context about breakthroughs in #BCI. 🙏    🔗 Link to article in comments    #EmpoweringMovement #SCI #BCI     Note: All ONWARD® Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.    

🎉 Kudos to Unite 2 Fight Paralysis (U2FP) for the success of its 19th Annual Science & Advocacy Symposium in Atlanta despite special weather challenges this year! 💨   We were thrilled to sponsor this event, and we joined scientists, clinicians, investors, those with spinal cord injury (SCI), and their caregivers over the weekend to share the work we are doing to address the unmet needs of the SCI Community.   Our CEO Dave Marver and Jim Guest - MD, PhD, FAANS, Professor at the University of Miami and the Miami Project to Cure Paralysis, and principal investigator of our Up-LIFT pivotal study – spoke during a special session on translation (due to the travel impact of Hurricane Helene).    🎤 The presentation, titled “Translation, Is ‘Five Years’ Finally Here?” covered the following:   ⭐️ The SCI Community has been waiting a long time for new therapies to become available. Dave Marver spoke about our commitment to the SCI Community, and why we are well-positioned to deliver on our mission to improve the lives of those with SCI.   ⭐️ Dave explained how investigational ARC Therapy™ works and spoke about our plans to bring the investigational ARC-EX® System to the SCI Community.   ⭐️ Dr. Guest covered the results of the Up-LIFT pivotal trial, which were published in Nature Medicine, and achieved all primary safety and effectiveness endpoints. *You can find more details about the study from the link in the comments. 🔗   ⭐️ The pair answered questions from clinicians, caregivers, and people with SCI about the study, our therapies and pipeline of potential solutions.   In addition, Blake Pokress, our VP US Sales, met with conference participants to answer their questions about our mission and technologies.   💫 Special thanks to U2FP for providing a forum to share our breakthroughs with members of the SCI Community. We look forward to continuing the conversation!   #EmpoweringMovement #SCI #U2FP   *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.   Note: All ONWARD® Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use. 

🎉 Congratulations to The International Spinal Cord Society - ISCOS for its memorable 63rd ISCoS Annual Scientific Meeting in Antwerp, Belgium. 🇧🇪   This recent gathering brought together the world’s top scientists, physicians, innovators, and thought leaders to discuss the latest research breakthroughs with the potential to address the needs of those with spinal cord injury (SCI).   We were a proud sponsor of the event, and several of our leaders, including our VP, Clinical, Regulatory, and Quality Erika Ross Ellison and our VP, Engineering Julien Camisani attended this influential conference.   Our highlights included:   ⭐️ Dr. Candy Tefertiller, DPT, PhD, principal investigator (PI) of our Up-LIFT pivotal trial*, lead PI for our LIFT Home study**, and Executive Director of Research and Evaluation at Craig Hospital of Denver, Colorado, USA, presented results from the LIFT Home study, which investigated the use of investigational ARC-EX® Therapy in the home setting.   ⭐️ Dr. Ilse van Nes, PI of the HemON NL study and rehabilitation physician at Sint Maartenskliniek of Nijmegen, the Netherlands, presented a poster on the first participant in the trial, which is investigating the safety and effectiveness of investigational ARC-IM® Therapy to improve blood pressure regulation after SCI.   ⭐️ We held a dinner with several key opinion leaders to share learnings and collaborate on future clinical trial strategies for ARC-EX and ARC-IM.   ⭐️ Our team met with clinicians, people with SCI, and their caregivers at our booth, which gave us a chance to share information about our mission, our research, and our therapies.   Collaboration and learning are essential parts of innovating, and we appreciate ISCoS for facilitating the exchange of ideas, best practices, and key learnings to fuel the next generation of innovative solutions for the SCI Community. ✨   #EmpoweringMovement #SCI #spinalcordresearch #innovation    Note: All ONWARD® Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.   

🛎️ We are pleased to announce that over the summer, we retired our 2016 innovation loan from the Netherlands Enterprise Agency (RVO). This loan helped us start our business and achieve many important milestones over the past several years. Thank you, RVO!!! ✨ In June, we announced a new debt financing agreement with Runway Growth Capital, which replaces the RVO loan and gives us access to more flexible capital as we approach upcoming milestones. Here are some notable milestones since the 2016 RVO loan: Clinical ✅ Submitted a De Novo application to the US Food and Drug Administration (FDA) for our ARC-EX System ✅ Published results of our Up-LIFT pivotal trial for ARC-EX Therapy in Nature Medicine ✅ Conducted several clinical feasibility studies for our investigational ARC-IM® Therapy, exploring the use of our ARC-IM System to restore movement and autonomic function after SCI and Parkinson’s disease ✅ Initiated clinical feasibility studies with our investigational ARC-BCI™ platform, pairing our ARC-IM System with an implanted brain-computer interface (BCI) to enable thought-driven movement Technological ✅ Completed initial development of the ARC-IM Neurostimulator, which has been implanted in humans in clinical feasibility studies since May 2022 ✅ Completed initial development of the ARC-IM Lead, which has been implanted in humans in clinical feasibility studies since May 2023 ✅ Completed initial development of the ARC-BCI System, which has been implanted in humans in clinical feasibility studies since late 2023 Corporate ✅ Secured investment from the Christopher & Dana Reeve Foundation in October 2019, continuing its long-standing support for spinal cord stimulation R&D ✅ Completed the largest pre-revenue MedTech IPO in European history, raising net EUR 80M on Euronext in October 2021 on top of a EUR 30M convertible note raised in early 2021 ✅ Completed a capital raise of 20M Euros in March 2024 and a financing agreement with Runway Growth Capital in June 2024, providing up to EUR 52.5M in additional capital over the next few years to fund upcoming milestones ✅ Gained equity research coverage from Stifel Bank, Bryan, Garnier & Co, KBC Securities, Degroof Petercam, and Kepler Cheuvreux Innovation ✅ Accrued more than 270 issued patents, strengthening and protecting our first-mover advantage ✅ Awarded 10 US FDA Breakthrough Device Designations across our ARC-EX, ARC-IM, and ARC-BCI platforms ✨ We are grateful to RVO for providing the financing in 2016 which helped us get started and moved us closer toward our goal to serve the spinal cord injury (SCI) community with breakthrough solutions. RVO’s belief in our vision demonstrates the importance of investment to drive innovation. 🚀 Hartelijk dank, RVO, voor het Innovatiekrediet! 🙏 🇳🇱 #EmpoweringMovement #SCI #Innovation https://lnkd.in/gjzx4arp

💫 We honor the life and legacy of Christopher Reeve and the work that the Christopher & Dana Reeve Foundation is doing to continue his mission. We are proud to partner with the Reeve Foundation as we work together to bring innovative solutions to serve the spinal cord injury (SCI) community. #EmpoweringMovement #SCI #ChristopherReeveBirthday