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.

📣 Today is Spinal Cord Injury (SCI) Day, and we wanted to shine a light on the SCI Community – its size, scope, and the unmet needs that people with SCI face every day.      SCI Day started in 2016 by the International Spinal Cord Society (ISCoS) as a “powerful reminder of the challenges faced by individuals living with SCI” and the organization’s “commitment to prevention.” This year’s slogan for SCI Day is “End Violence – Protect Spinal Cord” to “raise awareness and inspire collective action” about the SCI cases resulting from violence.       September is also Spinal Cord Injury Awareness Month, which focuses on education. For the next few weeks, we will bring you information on the latest research, trends, and stories in the SCI Community. ✨      💡 Education is a core part of our work, and we appreciate the opportunity to share our knowledge while learning from changemakers in the SCI Community.   🔗 For more resources and education, click on the links below:      ISCoS: https://lnkd.in/gu5ZwpuU World Health Organization: https://lnkd.in/ehNqJB-F National Spinal Cord Statistical Center: https://lnkd.in/g6kgntSr United Spinal Association: https://lnkd.in/gN3TDxVv Christopher & Dana Reeve Foundation: https://lnkd.in/daYDfpdm The Miami Project to Cure Paralysis: https://lnkd.in/ge6a_bh   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 #SCIday #SCIAwarenessMonth

🛎️ We are proud to announce a grant from the Christopher & Dana Reeve Foundation to further support our research using brain-computer interface (BCI) technology!  The Reeve Foundation’s $1.1M grant to our research partner and study sponsor, .NeuroRestore, expands an ongoing early clinical feasibility study exploring the use of a BCI to restore thought-driven use of the hands and arms after SCI. The new grant from the Reeve Foundation enables up to four additional participants to be implanted with the investigational ONWARD ARC-BCI System. 🎉  This ongoing study is also supported by the European Innovation Council and SMEs Executive Agency (EISMEA) under the Reverse Paralysis project. The first study participant was implanted with the investigational ARC-BCI System in August 2023.  The ARC-BCI System combines the investigational WIMAGINE® BCI from CEA-Clinatec with our investigational ARC-IM® Therapy (implanted targeted spinal cord stimulation) to form a DigitalBridge™ that enables thought-driven movement restoration. The WIMAGINE BCI is an epidural implant with 7 years of human safety data.  We are also investigating the use of its ARC-BCI System to address lower limb mobility challenges after SCI in a separate early feasibility clinical study.  Thank you, Christopher & Dana Reeve Foundation, for your partnership and supporting our efforts as the only company exploring the potential of BCIs to address the unmet needs of people with SCI. We look forward to learning more about this transformative technology! ✨  For more details about the grant and our work with #BCI technology, click on the link below ⬇️.  #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. https://lnkd.in/ee6qJDEV

📣 The 2024 Paralympics Paris 2024 - Comité d'organisation des Jeux Olympiques et Paralympiques de 2024 are underway in Paris, and we wanted to recognize the athletes competing in this year’s Games. From paracycling to wheelchair basketball, each event demonstrates the resilience and determination of the athletes who have surmounted great challenges to reach this elite stage.   Some noteworthy details about this year’s Paralympics:     📺 For the first time in history, all 22 Paralympic sports will be broadcast live ➡️ Viewers in the US can tune into NBC News   ➡️ France Télévisions will provide 24-hour coverage in the host country   ➡️️ In the UK, Channel 4 is planning its biggest ever broadcast with more than 1,300 hours of live broadcast 🇫🇷 Athletes will compete at various iconic locations in Paris, including the Eiffel Tower, the Chateau de Versailles, and the Grand Palais.  🏅 More than 4,000 athletes are participating from a record 168 delegations, with record number of female athletes.  As a company dedicated to empowering those with spinal cord injury through movement, function, and independence, we celebrate the Paralympics for highlighting strength, innovation, and the power of possibility. ✨  To learn more about the Paralympics and how to watch, click on the link below.   #EmpoweringMovement #SCI #Paralympics2024      https://lnkd.in/gkXuHghG

Thank you, Paralyzed Veterans of America (PVA), for providing a forum to share knowledge and make connections to bring innovative therapies to our #Veterans. We honor the work that you do and are proud to collaborate with you. Congrats on another successful year for the PVA Summit and we look forward to seeing you again next year! 🎉

📣 Candy Tefertiller delivered a thoughtful podium presentation on the Up-LIFT pivotal trial* results to packed and engaged audience at the Paralyzed Veterans of America (PVA) Summit + EXPO.     Dr. 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 - led the session, which sparked interest about our therapies and how they work.      Dr. Tefertiller shared the following results from the LIFT Home** study:    ➡️ Participant dedication to the trial and therapy - participants completed all 12 investigational ARC-EX® Therapy sessions at home (3 sessions a week).    ➡️ Participant ability to quickly and easily transition to independent use of ARC-EX Therapy at home.     ➡️ Meaningful improvements in engagement in work and family activities such as typing faster, moving board game pieces, and working a TV remote.    These observations underscore the potential for additional advancement of functional recovery with home use of ARC-EX Therapy after in-clinic results of the Up-LIFT trial, which were recently published in Nature Medicine.    As we continue to work toward commercializing our therapies, education and collaboration are essential for successful outcomes. We thank those who attended the session as well as the PVA for providing a forum for collaboration and knowledge sharing. ✨     #EmpoweringMovement #SCI #PVASummit #FutureofMedicine     *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.     **Based on Dr. Tefertiller’s experience as lead PI for LIFT Home study; manuscript under review.    Note: All ONWARD® Medical devices and therapies, including but not limited to ARC-EX®, ARC-IM®, 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 will be in theaters September 21 and 25, and tickets are available now! This documentary about the life and legacy of Christopher Reeve shows the profound effect a spinal cord injury can have on people and families. Reeve confronted his injury with courage, grit, and humanity. ✨ We are proud of our partnership with the Christopher & Dana Reeve Foundation and hope you’ll watch this powerful movie which shows Reeve’s transformation into a true superhero. 🦸♂️ #EmpoweringMovement #SCI #ChristopherReeveStory

🛎️ We are thrilled to participate in the 2024 Paralyzed Veterans of America (PVA) Summit + EXPO next week in Anaheim, California!     This event for the spinal cord injury (SCI) community brings together scientists, clinicians, caregivers, and people with SCI to fuel breakthrough solutions. For more than a decade, Paralyzed Veterans of America (PVA), which serves US Veterans with SCI, has brought together critical stakeholders in this one-of-a-kind health-care summit to support new therapies, treatments, and potential cures for SCI. This year, the annual event is expected to showcase more than 100 speakers and 50 sessions highlighting the latest development in SCI care.     🙏 We embrace the opportunity to connect with those working toward advancements in care for the SCI Community. We also look forward to sharing our knowledge and answering questions about our innovative therapies.    Here’s how to connect with us at the PVA Summit ⬇️    ⭐️ Join our Expert Session and Live Q&A Tuesday, August 27th at 7:00am PT. This session is hosted by Candy Tefertiller, PT, DPT, PhD, NC, principal investigator of our Up-LIFT pivotal trial and Executive Director of Research and Evaluation at Craig Hospital. Dr. Tefertiller will discuss our Up-LIFT pivotal trial results, which were recently published in Nature Medicine, and answer questions about our investigational ARC-EX® Therapy.     ⭐️ Visit us at Booth #113, where you can meet company leaders to learn more about our mission and our progress towards bringing breakthrough solutions to the SCI Community.   ⭐️ Set up a 1:1 meeting with us by emailing us at support@onwd.com. We’d love to share more information about our work.     See you next week! ✨    All ONWARD® Medical devices and therapies, including but not limited to ARC-EX®, ARC-IM®, 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 #PVASummit

🎙️ Thank you, U2FP CureCast, the podcast from Unite 2 Fight Paralysis (U2FP), for shining a light on the potential for investigational ARC-EX Therapy to address upper limb mobility and strength challenges after spinal cord injury (SCI).    In “ONWARD to Recovery,” U2FP CureCast co-host Matthew Roderick interviewed our CEO, Dave Marver, in an illuminating conversation about our company, our research, our therapies, and our Up-LIFT pivotal trial results. Matthew’s thoughtful questions and observations made for a robust conversation.     Some questions addressed in the episode:    ⭐️ What makes our therapies unique?     ⭐️ How did we decide upon which indications to pursue first?     ⭐️ What were the results of our Up-LIFT pivotal trial involving ARC-EX Therapy?     ⭐️ What role does funding play in bringing these therapies to market?    The mission of Unite 2 Fight Paralysis is to “empower the international spinal cord injury community to cure paralysis through advocacy, education, and support for research.” We applaud U2FP and CureCast for empowering the SCI Community by asking tough questions, diving deep beyond the headlines, and bringing important information to those with SCI and their caregivers.     🎤 Link to podcast in comments ⬇️    #EmpoweringMovement #SCI #Paralysis #Education    *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 recent 2024 NYC Neuromodulation Conference from Neuromodec provided an exciting opportunity to hear about the ONWARD Medical Up-LIFT pivotal trial. Principle Investigator Chet Moritz presented the results, which evaluated investigational non-invasive ARC-EX® Therapy spinal cord stimulation to improve hand function for people with chronic spinal cord injury (SCI). “We know that restoring hand and arm function is the highest treatment priority for people with tetraplegia due to spinal cord injury, rated as five times more important than all other functions surveyed. The Up-LIFT trial may represent the first successful clinical trial in chronic spinal cord injury to restore significant function to the hands.” Prof. Moritz shared. The trial included 65 participants across 14 leading SCI rehabilitation centers in North America and Europe and met all primary and secondary endpoints. Here are some highlights shared: ⭐️ ARC-EX Therapy was shown to be safe and effective.* ⭐️ 90% of ARC-EX Therapy users experienced clinically meaningful improvements in at least one primary strength or function assessment – up to 34 years post injury.* ⭐️ 87% of ARC-EX Therapy users reported improvements in overall quality of life.* ⭐️ Self-care ability improved statistically significantly with ARC-EX Therapy.* In May, the results of the trial were published in Nature Medicine. Learn more here: 🔗 https://lnkd.in/dY2XEhcp 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 2025. #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. Nature Medicine Highlights Significant Improvement in Hand and Arm Function After Spinal Cord Injury with Use of ONWARD® ARC-EX® Therapy