Core Insights - ONWARD Medical N.V. has appointed Ali Kiboro as Chief Financial Officer effective January 2026, bringing over 25 years of financial leadership experience in the medical technology sector [1][2][3] Company Overview - ONWARD Medical is a neurotechnology company focused on spinal cord stimulation therapies aimed at restoring movement, function, and independence for individuals with spinal cord injuries and other movement disabilities [4][5] - The company has developed proprietary ARC Therapy and has received 10 Breakthrough Device Designations from the FDA, with its ARC EX System cleared for commercial sale in the US and Europe [4] - ONWARD is also working on an investigational implantable system called ARC-IM, which addresses unmet needs such as blood pressure instability after spinal cord injury and can integrate with brain-computer interfaces and artificial intelligence [4] Leadership and Strategy - CEO Dave Marver expressed confidence in Ali Kiboro's ability to drive growth and scale within the life sciences sector, highlighting the importance of Kiboro's experience at this critical stage for ONWARD [3] - Ali Kiboro holds an MBA in Finance from The Wharton School and a Bachelor of Science in Finance, summa cum laude, from Duquesne University, indicating a strong educational background in finance [3]

Core Insights - ONWARD Medical N.V. has successfully implanted its investigational ARC-BCI® Therapy in two additional individuals with spinal cord injuries, bringing the total number of human implants to seven, reinforcing its leadership in brain-computer interface (BCI) technology for restoring movement in paralyzed individuals [1][7] Company Overview - ONWARD Medical is a neurotechnology company focused on developing therapies to restore movement, function, and independence for individuals with spinal cord injuries and other movement disabilities [5] - The company has received 10 Breakthrough Device Designations from the FDA and its ARC EX® System is cleared for commercial sale in the US and Europe [5] - The company is headquartered in the Netherlands, with additional facilities in Switzerland and the US [6] Technology and Research - The ARC-BCI Therapy involves an implant placed epidurally on the motor cortex, which records brain signals related to movement intention and uses AI to decode these signals for spinal cord stimulation [3] - The latest procedures were conducted at the Centre Hospitalier Universitaire Vaudois in Switzerland, involving a 35-year-old woman and a 39-year-old man, aimed at restoring upper- and lower-limb movement, respectively [2] - The ARC-BCI System has been supported by over eight years of human safety data and has received Breakthrough Device Designation from the FDA in 2024 [3] Funding and Support - The ongoing clinical feasibility studies for ARC-BCI Therapy are supported by grants from the European Union's Horizon Europe program, the Christopher & Dana Reeve Foundation, and the Swiss State Secretariat for Education, Research and Innovation [4]

Core Insights - ONWARD Medical N.V. reported strong commercial execution and achieved significant scientific and regulatory milestones in Q3 2025, enhancing its market position in neurotechnology for spinal cord injuries [1][7] Commercial Traction - The company sold 40 ARC-EX Systems in Q3 2025, indicating robust demand for its external spinal cord stimulation technology [2][7] - ARC-EX Therapy is now available in over 60 clinics across the US, expanding access to innovative therapies for the SCI community [2] Regulatory Milestones - ONWARD Medical received CE Mark certification for the ARC-EX System, allowing for commercialization in both clinic and home settings within the European Union, with first sales expected in Q4 2025 [3] - The company obtained 510(k) clearance from the US FDA for the ARC-EX System for home use, marking it as the first FDA-cleared technology to improve hand strength and sensation in individuals with SCI [4] - The FDA also approved an investigational device exemption (IDE) for the ARC-IM System, enabling the start of the Empower BP global pivotal study to assess blood pressure management in SCI patients [5][7] Science & Technology Leadership - Two landmark articles were published in Nature and Nature Medicine, showcasing advances in blood pressure regulation after SCI and supporting the clinical evidence for the ARC-IM System [6][7] - Results from the LIFT Home Study published in Neurology: Clinical Practice demonstrated the effectiveness of continued ARC-EX Therapy at home in maintaining and extending clinical gains [8] Financial Highlights - The company reported EUR 1.7 million in revenue for Q3 2025, surpassing the EUR 1 million mark for the first time [9][7] - In October 2025, ONWARD Medical successfully raised over EUR 50 million in equity capital, providing a cash runway into Q1 2027, with a cash balance of EUR 77.7 million as of October 31, 2025 [10][7] Outlook - Continued demand for the ARC-EX System and positive user feedback suggest a strong commercial performance in 2026, supported by recent regulatory approvals [12] - The company anticipates the first patient enrollment in the Empower BP pivotal study before the end of 2025 and plans to explore additional indications for its ARC-IM and ARC-BCI Systems [13]

Core Insights - ONWARD Medical N.V. has received FDA 510(k) clearance to expand the ARC-EX System for home use, significantly enhancing market opportunities for spinal cord injury (SCI) therapies [2][4][6] - The ARC-EX System is designed to improve hand strength and sensation in adults with chronic, non-progressive neurological deficits due to incomplete SCI, and can be used both in clinics and at home [3][11] Company Overview - ONWARD Medical is a leading neurotechnology company focused on developing therapies to restore movement and independence for individuals with spinal cord injuries and other movement disabilities [7][8] - The company has received 10 Breakthrough Device Designations from the FDA and is also developing an investigational implantable system called ARC-IM [7] Product Details - The ARC-EX System utilizes non-invasive, programmed transcutaneous electrical spinal cord stimulation and is intended for use by rehabilitation professionals in medical centers and by patients at home [3][11] - Clinical studies supporting ARC-EX Therapy show that 90% of participants improved strength or function, and 87% reported enhanced quality of life, with benefits observed up to 34 years post-injury [4][5] Market Impact - The FDA clearance for home use of the ARC-EX System is expected to broaden access to innovative therapies for individuals with SCI, potentially improving their quality of life [4][6] - The system is currently available in over 60 clinics across the US and has been recognized as one of TIME magazine's Best Inventions [5][6]

Core Insights - ONWARD Medical N.V. has successfully closed a private placement with institutional investors, raising gross proceeds of EUR 50,850,000 [1] - The new shares from the private placement are now listed and trading on Euronext Brussels, Euronext Amsterdam, and Euronext Paris [1] Company Overview - ONWARD Medical is a leading neurotechnology company focused on developing therapies to restore movement and independence for individuals with spinal cord injuries and other movement disabilities [3] - The company has developed ARC Therapy, which has received 10 Breakthrough Device Designations from the FDA [3] - The ARC-EX System is commercially available in the US and Europe, while the investigational ARC-IM system is under development to address unmet needs such as blood pressure instability after spinal cord injury [3] Locations and Listings - The company is headquartered in the Netherlands, with a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts [4] - ONWARD Medical is listed on Euronext Paris, Brussels, and Amsterdam under the ticker ONWD, and its US ADRs are traded on OTCQX under the ticker ONWRY [4]

Core Insights - ONWARD Medical N.V. successfully raised EUR 50.85 million through an accelerated bookbuild offering, issuing 11.3 million new ordinary shares at an issue price of EUR 4.50 per share [1][2][3] Group 1: Financial Details - The private placement was supported by existing and new investors, including Ottobock SE & Co. KGaA as a cornerstone investor and healthcare specialist investor Invus [2][6] - The net proceeds from the private placement are expected to provide cash runway through at least the end of 2026, assuming no drawdown of the company's debt facility [4][6] Group 2: Use of Proceeds - The company plans to allocate the net proceeds as follows: 40% for development initiatives including product development and clinical studies for the investigational ARC-IM® System, 30% to expand sales and operations for the ARC-EX® System, 20% to support quality and administrative activities, 5% for working capital, and 5% to cover financing costs [7] Group 3: Market Position and Future Plans - ONWARD Medical is transitioning to a commercial-stage company, validated by strong demand for its ARC-EX® System, and plans to use the raised capital to expand commercial activities and advance its pipeline [3][10] - The new shares are expected to be listed on Euronext Brussels, Euronext Amsterdam, and Euronext Paris on October 28, 2025 [8]

Core Insights - ONWARD Medical N.V. successfully raised EUR 50.85 million through an accelerated bookbuild offering, issuing 11.3 million new ordinary shares at an issue price of EUR 4.50 per share [1][2][5] Company Overview - ONWARD Medical is a leading neurotechnology company focused on therapies to restore movement and function in individuals with spinal cord injuries and other movement disabilities [10][11] - The company has developed the ARC Therapy and has received 10 Breakthrough Device designations from the FDA for its technologies [10] Investment Details - The private placement was supported by existing and new investors, including Ottobock SE & Co. KGaA as a cornerstone investor and healthcare specialist investor Invus [2][5] - The net proceeds from the private placement are expected to extend the company's cash runway through at least the end of 2026 [4][5] Use of Proceeds - The funds will be allocated as follows: - 40% for product development, clinical studies, and regulatory activities for the investigational ARC-IM System - 30% to expand sales and operations for the commercialization of the ARC-EX System - 20% to support quality and administrative activities - 5% for working capital and general corporate purposes - 5% to cover financing costs, including existing debt obligations [6] Market Activity - Trading of ONWARD Medical's shares was temporarily suspended during the bookbuilding period and is set to resume on October 24, 2025 [7] - The new shares are expected to be listed on Euronext Brussels, Euronext Amsterdam, and Euronext Paris on October 28, 2025 [8]

Core Viewpoint - ONWARD Medical N.V. is launching a capital increase through a private placement aimed at raising approximately EUR 50 million to support its operations and development initiatives in neurotechnology for spinal cord injuries and movement disabilities [1][2]. Summary by Sections Private Placement Overview - The private placement will involve the issuance of new ordinary shares with a nominal value of EUR 0.12 each, offered to qualified institutional investors [1][3]. - The final number of shares and the issue price will be determined through a bookbuilding process, which is expected to last one business day [4][5]. Use of Proceeds - The net proceeds from the private placement will be allocated as follows: - 40% for product development, clinical studies, and regulatory activities for the ARC-IM System - 30% to expand sales and operations for the ARC-EX System - 20% to support quality and administrative activities - 5% for working capital and general corporate purposes - 5% to cover financing costs, including existing debt obligations [2][6]. Trading and Regulatory Aspects - Trading of ONWARD Medical's shares will be temporarily suspended on Euronext Brussels, Amsterdam, and Paris during the bookbuilding period to facilitate broader investor participation [5][7]. - The new shares are expected to be listed and admitted to trading on October 28, 2025, with payment and delivery occurring on the same day [9]. Company Background - ONWARD Medical is a leading neurotechnology company focused on therapies to restore movement and independence in individuals with spinal cord injuries and other movement disabilities [11]. - The company has developed the ARC Therapy and has received multiple Breakthrough Device Designations from the FDA for its products [11].

Core Insights - ONWARD Medical N.V. has reported strong execution in Q3 2025, with the ARC-EX System now available in over 50 US clinics, indicating accelerating adoption of its neurotechnology solutions [1][4] - The company will provide a comprehensive business and financial update on November 11, 2025 [1] Company Overview - ONWARD Medical is a leading neurotechnology company focused on therapies to restore movement and independence for individuals with spinal cord injuries and other movement disabilities [2] - The company has developed ARC Therapy, receiving 10 Breakthrough Device Designations from the FDA, and its ARC-EX System is cleared for commercial sale in the US and Europe [2] Commercial Performance - In Q3 2025, ONWARD Medical sold 40 ARC-EX Systems, demonstrating strong commercial traction [4] - The company has surpassed EUR 1 million in quarterly revenue for the first time [4] Regulatory Milestones - The ARC-EX System received CE Mark certification for improving hand strength and sensation after spinal cord injury [4] - The FDA approved an investigational device exemption for the ARC-IM System, allowing the initiation of the Empower BP global pivotal study [4] Scientific Contributions - The company announced the publication of two articles in Nature and Nature Medicine, highlighting advances in blood pressure regulation after spinal cord injury [4]

Core Viewpoint - ONWARD Medical N.V. has received FDA approval for an investigational device exemption for its ARC-IM System, enabling the initiation of the Empower BP pivotal study to evaluate the safety and efficacy of its implantable spinal stimulation system for managing blood pressure instability after spinal cord injury (SCI) [2][7]. Group 1: Study Details - The Empower BP study is the second global pivotal study for ONWARD and the first to assess the ARC-IM System, involving approximately 20 leading neurorehabilitation and neurosurgical centers across the US, Canada, and Europe, with patient enrollment expected by year-end [3][7]. - The study will focus on participants with spinal cord injuries at levels C2-T6, with injury severities of AIS A-D, and those experiencing chronic orthostatic hypotension and episodes of autonomic dysreflexia [3]. Group 2: Market Need and Impact - Over 50% of individuals with SCI experience blood pressure instability, affecting nearly 350,000 people in the US and Europe, which can threaten neurological recovery and negatively impact cardiovascular health and quality of life [4][5]. - Addressing blood pressure instability is critical for improving long-term outcomes for SCI patients, as it is a significant but often unrecognized complication that can lead to increased cardiovascular disease risk [5][8]. Group 3: Technology Overview - The ARC-IM System is an implanted neuromodulation platform designed to deliver targeted spinal cord stimulation, specifically aimed at managing blood pressure instability in SCI patients [5][9]. - The system includes the ONWARD Neurostimulator and the ARC-IM Thoracic Lead, which is optimized for placement in the thoracic spinal cord's "Hemodynamic Hotspot," a location identified through research partnerships [5][6]. Group 4: Previous Results and Future Outlook - In December 2022, ONWARD announced positive interim clinical results from feasibility studies showing improved blood pressure regulation and hemodynamic stability after SCI, with participants reporting enhanced well-being and reduced symptoms of orthostatic hypotension [6]. - The FDA has awarded ONWARD one of its 10 Breakthrough Device Designations for the ARC-IM System, indicating its potential to address significant unmet medical needs and providing regulatory and reimbursement advantages [8].