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.

🙏 Thanks to Lineage Cell Therapeutics and our strategic partner, the Christopher & Dana Reeve Foundation for hosting the 2nd Annual SCI Symposium, which aims to boost investment in breakthrough therapies for those with spinal cord injury (SCI). We were thrilled to participate in this event, which brings together neuroscientists, clinicians, company leaders, investors, and people with SCI to share key learnings and best practices to fuel innovation to address the unmet needs of those with SCI. Our own VP Communications, Aditi Roy and Candy Tefertiller PT, DPT, PhD, NC, principal investigator of our Up-LIFT pivotal trial and Executive Director of Research and Evaluation at Craig Hospital, shared insights about our Up-LIFT trial results, provided an overview of our investigational therapies, and outlined our goals for 2024 and beyond. Collaboration and capital are critical components of developing disruptive technologies. We are grateful to Lineage and the Reeve Foundation for bringing investors together with some of the brightest minds working in the SCI to progress towards solutions for the SCI Community. 🚀 #EmpoweringMovement #SCI #investing *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 our research partners, .NeuroRestore co-directors G. Courtine and Jocelyne Bloch, for delivering the closing plenary lecture at the #FENS2024 Forum in Vienna, Austria. The duo spoke to the enthusiastic audience at the Federation of European Neuroscience Societies - FENS conference about the therapies they have developed to address the unmet needs of people with spinal cord injury (SCI). The FENS Forum is Europe’s largest #neuroscience congress, covering all areas of the field, from basic to translational research, and highlighting the most up-to-date research discoveries in neuroscience. FENS represents 40 neuroscience societies and more than 20K member scientists, and conference participants gather to listen, learn, and share.   We appreciate FENS for showcasing the latest breakthroughs in neurotechnology and the work that Professor Courtine and Dr. Bloch are doing to develop innovative solutions for those with SCI. ✨   *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.   #EmpoweringMovement #SCI #Neuroscience #FENS2024

Building stronger partnerships is paramount for success! 🌟   We recently hosted a gathering for our valued suppliers to discuss transitioning from traditional supplier relationships to strategic partnerships. 🔑 Key topics discussed: • Strengthening collaboration and communication • Mutual growth and long-term success • How best to support the SCI Community together This event underscored our commitment to working closely with our suppliers, ensuring that we grow and innovate together. Thank you to everyone who participated and contributed to the vibrant discussions! Together, we’re not just suppliers and buyers—we’re partners. Working towards building a better future for those with a spinal cord injury. #EmpoweringMovement #SCI #SupplierDay

Wishing our US employees, partners, and friends a happy Independence Day!   #EmpoweringMovement #JulyFourth #IndependenceDay

🎙️ Thanks to Matthew Henriksson, CFA for a thoughtful and well-researched discussion with our CEO, Dave Marver on the Bloomberg Intelligence “Vanguards of Health Care” podcast. The episode, “ONWARD Medical Data Promising for SCI,” takes a deep dive into our Up-LIFT pivotal trial results, which were published in a Nature Portfolio publication.     Key questions answered in the podcast:     ⭐️ How investigational ARC-EX® Therapy may help people with spinal cord injury (SCI) improve upper extremity mobility with rehab      ⭐️ Why we decided to address upper extremity mobility as an initial recovery target    ⭐️ Why we are pursuing blood pressure instability for our ARC-IM® platform and our path to launching our Empower BP pivotal trial     ⭐️ How our use of BCI technology is unique compared to that of other BCI companies, including Neuralink   🎤 To listen to the full episode, click on the link below ⬇️ #EmpoweringMovement #SCI #digitalhealth   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. https://lnkd.in/gAvReAK2

We just announced a financing with Runway Growth Capital that gives us access to up to EUR 52.5M in additional capital over the next few years. The first EUR 16M will be used to pay off our existing debt; the rest will be available to help fund upcoming business milestones, such as our planned commercialization of our investigational ARC-EX® System later this year.     ⭐️ Runway is a leading US-based specialty finance lender ⭐️ The funding further strengthens our balance sheet ahead of pending FDA approval and planned Q4 launch of our ARC-EX System in the US ⭐️ The new loan replaces our existing debt with a larger, more flexible instrument that can support our expected growth “ONWARD is pleased to enter this long-term relationship with one of the top U.S. lenders providing growth capital to innovative life science companies,” said ONWARD Medical CEO Dave Marver. “This relationship will diversify our capital structure and help to fund many of our upcoming milestones, including expected launch of our ARC-EX System later this year and commencement of our pivotal study for ARC-IM, called Empower BP. We look forward to working closely with Runway to provide fuel to our effort to bring solutions to the profound unmet needs of people with spinal cord injury.” Special thanks to our banking and legal advisors Stifel Bank and Skadden Law Firm for working tirelessly to help us complete this transaction.  For more information on the financing, see the press release below ⬇️.  #EmpoweringMovement #SCI #Financing *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. https://lnkd.in/eUbt-xsM

🎉 Congratulations to Neurokinex for presenting results from its investigator-initiated clinical study using investigational ARC-EX® Therapy at the 2024 AMERICAN SPINAL INJURY ASSOCIATION (ASIA) Annual Scientific Meeting last month. The poster was presented by our very own Jenny Suggitt, who was the lead investigator for the Neurokinex study* before joining ONWARD Medical in 2022. The poster focused on five participants with thoracic spinal cord injuries who began the study with lower limb mobility and function challenges, including trunk stability, walking, and standing independently.  Study participants used ARC-EX Therapy – non-invasive spinal cord stimulation designed to aid in functional recovery after spinal cord injury (SCI) – while performing activity-based therapy three times per week for two hours a session for a total of 120 sessions spanning one year.  As we plan to launch our ARC-EX System to address upper limb function in the US later this year pending FDA clearance, we are enthusiastic about our clinical partners and celebrate the ways they share their research to the clinical community.  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.  *The Neurokinex study was an investigator-initiated trial. #EmpoweringMovement #SCI #ClinicalTrials

🎉 Congratulations to our friend and investor Adrien Cohen for launching SCI Ventures, a first-of-its-kind venture philanthropy fund dedicated to investing in innovative therapies for spinal cord injury (SCI).     The venture philanthropy fund model was pioneered in SCI by Christopher & Dana Reeve Foundation, a key investor in our company. SCI Ventures is now building on the progress they’ve made and scaling the model. We are proud to be one of SCI Ventures’ first portfolio companies. 🌟    Adrien is a serial tech entrepreneur who became interested in cutting-edge therapies addressing SCI after his brother suffered an injury. Upon identifying the lack of funding for companies working toward solutions for the SCI Community, Adrien sprang into action, bringing together the most influential SCI advocacy groups in the world. 🌎    The launch of SCI Ventures marks the first time that five of the leading foundations addressing spinal cord injury in the US, the UK, and the EU have come together in support of a novel investment vehicle. Co-founders are the Christopher & Dana Reeve Foundation, Wings for Life - Spinal Cord Research Foundation, Spinal Research, the Promobilia Foundation and the Shepherd Center.     To learn more about SCI Ventures and its vision, watch this interview with Adrien and our CEO Dave Marver as they discuss the importance of investment to drive groundbreaking solutions for those with SCI ⬇️    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.    #EmpoweringMovement #SCI #SCIVentures    https://lnkd.in/gex9b9aE

We are grateful for opportunities to collaborate with researchers, scientists, clinicians, and other thought-leaders at the cutting-edge of #neuroscience.💡    Our research partners and co-founders, G. Courtine and Jocelyne Bloch, recently gave a lecture at the American Academy of Neurology Frontiers in Neuroscience Plenary Session in Denver. 🎤    Professor Courtine and Dr. Bloch, who are co-directors at .NeuroRestore, spoke about the development of their breakthrough therapy that restores communication between the brain and the spinal cord after spinal cord injury (SCI) and is key to the design of our ARC-BCI™ System to create thought-driven movement.     ✨ Thank you, American Association of Neurology, for bringing together important stakeholders in the world of neuroscience to share breakthroughs, progress, and best practices to create solutions for those in the SCI Community.  #EmpoweringMovement #SCI #BCI 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.