Core Insights - ONWARD Medical N.V. reported strong demand for its ARC-EX System in the US and achieved FDA IDE approval for the Empower BP study, indicating positive commercial and regulatory momentum [2][6]. Commercial Traction - The company successfully sold 30 ARC-EX Systems to US clinics in the first half of 2025, meeting its sales targets and demonstrating strong demand [3][7]. - Access to US government procurement platforms was secured, allowing Veterans Affairs and other government buyers to purchase the ARC-EX System [4]. Regulatory Milestones - ONWARD submitted a 510(k) application to the FDA for home use of the ARC-EX System and filed for CE Mark certification in the EU [5][7]. - The FDA approved an investigational device exemption (IDE) for the ARC-IM System, enabling the start of the Empower BP study [6][7]. Science & Technology Leadership - The Pathfinder2 study showed that sustained access to ARC-EX Therapy leads to continued functional improvements after one year of treatment [9]. - The first human implant of the investigational ARC-IM Lumbar Lead was successfully completed, aimed at restoring mobility [11]. Financial Highlights - The company reported EUR 1.2 million in revenue for the first half of 2025, with an operating loss of EUR 20.0 million [15][17]. - The cash position at the end of June 2025 was EUR 40.9 million, up from EUR 32.1 million at the end of 2024 [17]. Outlook - Continued strong demand for the ARC-EX System and positive user feedback suggest the company is on track to meet its sales targets for Q3 2025 [18]. - The company anticipates first patient enrollment in the Empower BP study before the end of the year and plans additional implants of its ARC-IM and ARC-BCI systems [19].

Core Insights - Longeviti Neuro Solutions has appointed Tim Scannell, former President & COO of Stryker Corporation, as Chair of its Board of Directors, aiming to enhance its strategic direction in neurotechnology [1][6] - The company has established a $10 million strategic capital partnership with Soleus Capital to support hiring, product development, and medical education initiatives [1][5] Company Overview - Longeviti Neuro Solutions focuses on innovative platform solutions for complex brain disorders, with a mission to improve patient care during and after surgery [8][9] - The company has full in-house capabilities for manufacturing, packaging, designing, and sterilizing, along with multiple FDA clearances and ISO 13485 Certifications [8] - Longeviti's products are approved for use in over 120 hospitals globally and have assisted over 4,000 patients to date [9] Leadership and Strategic Direction - Tim Scannell brings over thirty years of experience in the medical device market, having held various leadership roles at Stryker Corporation, including Group President of MedSurg & Neurotechnology [2][4] - As Chair, Scannell will help formulate strategic plans and provide oversight, leveraging his extensive experience in scaling MedTech businesses [4][6] - Scannell expressed confidence in Longeviti's leadership and technology, emphasizing the potential for significant advancements in patient care within the neuro industry [7] Investment Partnership - Soleus Capital, a healthcare investment firm with approximately $2 billion in assets under management, has committed $10 million in structured financing to Longeviti [10] - The partnership aims to enable Longeviti to scale its team, enhance its market presence, and amplify its impact on patients with complex brain disorders [5][7]

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]

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]

"The next Neuralink product is BlindSight which will enable people who have lost both eyes or have no eye sight to see."Elon Muskhttps://t.co/uv8ExkuGrU ...

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]

Company Overview - ONWARD Medical N.V. is a leading neurotechnology company focused on therapies to restore movement, function, and independence in 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 implantable system ARC-IM is under development [3][9] Upcoming Events - ONWARD Medical will host a webcast on June 17, 2025, at 2:00 PM CET / 08:00 AM ET to discuss its Q1 2025 business update and year-to-date highlights [2] Research and Development - The company has conducted over a decade of scientific discovery, preclinical research, and clinical studies at leading hospitals and neuroscience laboratories [3] - The ARC-EX System is intended to improve hand sensation and strength in individuals aged 18 to 75 with chronic, non-progressive neurological deficits due to incomplete spinal cord injuries [8]