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.

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 [email protected]. 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

🛎️ Only a few days left to vote for our proposed panel with the Christopher & Dana Reeve Foundation at SXSW 2025!! Please follow the instructions below to vote for our panel, called “SCI Research: One Small Movement Can Change Lives.” ⬇️    #EmpoweringMovement #SCI #SXSW #PanelPicker

🛎️  We just reached the “Panel Picker” phase of the SXSW submission process, and we NEED your votes to bring our proposed panel to SXSW’s iconic gathering of innovators and creatives!      Please vote for our proposed panel, in partnership with the Christopher & Dana Reeve Foundation, called “SCI Research: One Small Movement Can Change Lives.”    This exciting conversation will feature the Reeve Foundation’s Chief Scientific Officer, Marco Baptista, our own CEO Dave Marver, and Neurotech Network Founder and CEO Jennifer French. The discussion will be moderated by NBC News correspondent Ellison Barber.    Here’s how to vote for our submission:     ➡️  Click on the session name: https://lnkd.in/eMU8XhYb     ➡️  If you haven’t already signed up, get a PanelPicker login (you only have to do it once)     ➡️  Vote “thumbs up” for the session and comment on why you think it will be amazing!     Voting is open until August 18. Thank you for the support! 🙏     #EmpoweringMovement #SCI #SXSW #PanelPicker

This week, we reaffirmed our 2024 strategic priorities, and we have an exciting 2H ahead! Our top priority remains preparing for commercialization, and we look forward to bringing the investigational ARC-EX® System to the Spinal Cord Injury (SCI) Community in the US later this year. *   Here’s more detail:  ➡️ ARC-EX® commercial launch. We intend to launch our ARC-EX Therapy for people with SCI in the US in Q4 2024, pending Food and Drug Administration (FDA) clearance.   ➡️ ARC-IM ® interim data publication. We expect a peer-reviewed publication in a top-tier medical journal detailing the results of the first 10+ patients implanted with investigational ARC-IM Therapy to address blood pressure instability after SCI. ➡️ ARC-IM pivotal study commencement. We are preparing to launch our global pivotal study, called Empower BP, for investigational ARC-IM Therapy to address blood pressure instability after SCI, pending FDA Investigational Device Exemption approval.  ➡️ ARC-BCI™ Therapy advancement. Clinical and development activities for our investigational ARC-BCI System continue and several additional ARC-BCI System implants are expected in 2H 2024 and 1H 2025 as part of the ongoing clinical feasibility study with partners at .NeuroRestore and @CEA-Clinatec.  Here are our unaudited Q2 2024 financial highlights: ✅ We plan to publish our Half Year 2024 financial statements on September 10, 2024.  ✅ The net cash balance on June 30, 2024, was EUR 32.1 million.   To learn more about ONWARD Medical’s commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit www.ONWD.com    *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 #StrategicPriorities d4871b2d-3d8c-4e4b-99fd-2774a1714fb6 (onwd.com)