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ONWARD Medical Publishes Closing of Bookbuild Offering
Globenewswire· 2025-10-28 16:45
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]
融资超4亿!神经修复独角兽的“闭环进化”
思宇MedTech· 2025-10-28 03:39
Core Insights - ONWARD Medical has completed a financing round exceeding €50 million (approximately 410 million RMB) to support its mission of restoring movement to spinal cord injury patients [2] - The company has transitioned from a research-focused entity to a commercial enterprise, with plans to expand its ARC-EX system and advance clinical research for the next-generation ARC-IM system [3] Product Development - ONWARD's product ecosystem includes three core products: ARC-EX, ARC-IM, and ARC-BCI, which together cover the full spectrum from non-invasive rehabilitation to closed-loop implants [5][7] - The ARC-EX system is a transcutaneous electrical nerve stimulation device approved in the U.S. for restoring upper limb function post-spinal cord injury, while ARC-IM is an implantable system for more severe motor impairments [8] Technological Framework - ONWARD is developing a closed-loop system that integrates neural stimulation, motor feedback, and brain-computer interfaces (BCI) to create a comprehensive rehabilitation solution [8] - The company has completed five successful implant surgeries of the brain-spinal cord closed-loop system, demonstrating the potential for neural plasticity to be reactivated [9] Strategic Partnerships - Ottobock, a leading prosthetics and orthotics company, has significantly invested in ONWARD, indicating a strategic shift towards neuro-rehabilitation technologies [10][12] - This partnership is seen as a critical component in Ottobock's transition towards integrating neural reconnection with prosthetic solutions [12] Market Context - In China, the spinal cord injury patient population exceeds 1 million, with approximately 60,000 new cases annually, highlighting a growing need for effective neuro-rehabilitation technologies [13] - ONWARD's approach contrasts with many Chinese BCI companies that focus on human-machine interaction rather than functional restoration, positioning ONWARD's model as a potential reference for domestic development [13] Regulatory Environment - ONWARD's ARC-BCI has received FDA breakthrough device designation, facilitating a more streamlined regulatory pathway for its neuro-rehabilitation products [14] - The company is establishing a clear validation system through multi-center clinical trials, creating a data loop that supports its commercial strategy [16] Future Outlook - The recent financing marks a significant step for ONWARD, transitioning from technical validation to building a sustainable commercial framework in the neuro-rehabilitation sector [18] - The integration of capital and engineering efforts is expected to redefine the human movement system, emphasizing the importance of restoring autonomy to patients [19]
ONWARD Medical Successfully Raises Over EUR 50 Million in Capital Increase
Globenewswire· 2025-10-24 05:30
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]
ONWARD Medical Announces the Appointment of Lucas Buchanan to its Board of Directors
Globenewswire· 2025-08-06 05:30
Core Insights - ONWARD Medical N.V. has appointed Lucas Buchanan as a non-executive member of its Board of Directors, enhancing its leadership team as it aims to grow its business and fulfill its mission to restore movement and function for individuals with spinal cord injuries and other movement disabilities [1][2] Company Overview - ONWARD Medical is a leading neurotechnology company focused on pioneering therapies to restore movement, function, and independence in individuals with spinal cord injuries (SCI) and other movement disabilities [4] - The company has developed ARC Therapy, which has received ten Breakthrough Device Designations from the US FDA, and its ARC-EX System is cleared for commercial sale in the US [4] - ONWARD is also working on an investigational implantable system called ARC-IM, which may include an implanted brain-computer interface (BCI) [4] Leadership and Expertise - Lucas Buchanan brings over 25 years of experience in commercialization, operations, business development, investing, and finance, having previously served as COO and CFO at Silk Road Medical, leading the company to its IPO in 2019 and subsequent acquisition by Boston Scientific in 2024 [2][6] - Buchanan is an active investor and currently serves on the boards of several medical technology companies, showcasing his extensive involvement in the healthcare sector [3][6] Strategic Vision - The appointment of Buchanan is seen as a strategic move to leverage his unique experiences as an operator and investor to help ONWARD Medical achieve its ambitions and deliver hope to millions affected by spinal cord injuries and movement disabilities [2][3]
ONWARD Medical Adds Entrepreneur and Neurotechnology Thought Leader Tim Denison, PhD to its Board of Directors
Globenewswire· 2025-07-07 05:30
Core Insights - ONWARD Medical N.V. announces changes to its Board of Directors, highlighting the appointment of Professor Tim Denison and the departure of Professor Gregoire Courtine [2][5][7] Company Overview - ONWARD Medical is a leading neurotechnology company focused on developing therapies to restore movement and function in individuals with spinal cord injuries (SCI) and other movement disabilities [10][11] - The company has developed ARC Therapy, which has received 10 Breakthrough Device Designations from the US FDA, and its ARC-EX System is cleared for commercial sale in the US [10] Board Changes - Professor Tim Denison has been appointed to the Board, taking over the seat previously held by Professor Gregoire Courtine, who will continue as Co-Founder and Science Advisor [3][5][8] - Denison brings extensive experience in neurotechnology, having previously served as Vice President of Research & Core Technology at Medtronic and is a co-founder of Amber Therapeutics [4][8] Research and Development Focus - The Neuro-X Institute, directed by Courtine, is a multidisciplinary research hub aimed at accelerating therapies for neurological disorders, while NeuroRestore focuses on recovery therapies for SCI, Parkinson's disease, and stroke [6][10] - ONWARD Medical's commitment to innovation is underscored by its ongoing development of investigational products, including the ARC-IM system [10][18]
ONWARD Medical Announces Results of its Annual General Meeting of Shareholders
Globenewswire· 2025-06-11 17:00
Company Overview - ONWARD Medical N.V. is a leading neurotechnology company focused on developing therapies to restore movement, function, and independence for individuals with spinal cord injuries and other movement disabilities [3][4] - The company has developed ARC Therapy, which has received ten Breakthrough Device Designations from the US FDA [3] - The ARC-EX System is cleared for commercial sale in the US, while the investigational ARC-IM system is under development [3][9] Recent Developments - All proposed resolutions at the Annual General Meeting of Shareholders (AGM) held on June 11, 2025, in Amsterdam were approved [1][2] - The meeting took place at 4:00 PM CET, and details of the resolutions can be found on the company's Investor Relations website [2] Corporate Structure - ONWARD Medical is headquartered in the Netherlands, with a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts [4] - The company 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]
ONWARD Medical Convocation of the 2025 Annual General Meeting of Shareholders and Proposed Resolutions
Globenewswire· 2025-04-30 15:35
Core Points - ONWARD Medical N.V. is a medical technology company focused on developing spinal cord stimulation therapies to restore movement and independence for individuals with spinal cord injuries and other movement disabilities [1][3] - The company will hold its 2025 Annual General Meeting of Shareholders (AGM) on June 11, 2025, in Amsterdam, with a record date for participation set for May 14, 2025 [1][2] Company Overview - ONWARD Medical has developed ARC Therapy, which has received ten Breakthrough Device Designations from the US FDA, and its ARC-EX System is cleared for commercial sale in the US [3] - The company is also working on an investigational implantable system called ARC-IM, which may include a brain-computer interface [3] - The company is headquartered in the Netherlands, with additional facilities in Switzerland and a US office in Boston, Massachusetts [4] AGM Resolutions - Key resolutions proposed for the AGM include the adoption of annual accounts for the financial year 2024, implementation of the compensation policy for 2024, and the appointment of new non-executive directors [4] - The board seeks authorization to issue ordinary shares and acquire shares in the company's capital, with specific limits on the percentage of issued share capital [4]
ONWARD Medical Announces Release of 2024 Annual Report
Globenewswire· 2025-04-28 06:30
Core Insights - ONWARD Medical N.V. has filed its Annual Report for the fiscal year ended December 31, 2024, with the Dutch Authority for the Financial Markets (AFM) [1] - The company has also released its 2024 Sustainability Report and received a silver medal from EcoVadis for business sustainability ratings [2] - CEO Dave Marver highlighted that 2024 was transformative for ONWARD, emphasizing the company's mission to restore movement and independence for individuals with spinal cord injuries [2] Company Overview - ONWARD Medical is focused on creating therapies aimed at restoring movement, function, and independence for people with spinal cord injuries and other movement disabilities [3] - The company has developed ARC Therapy, which has received ten Breakthrough Device Designations from the US FDA, and its ARC-EX System is cleared for commercial sale in the US [3] - ONWARD is also working on an investigational implantable system called ARC-IM, which may include a brain-computer interface [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 can be traded on OTCQX under the ticker ONWRY [4]