Company Overview - ONWARD Medical is a medical technology company focused on developing therapies to restore movement, function, and independence in individuals with spinal cord injury (SCI) and other movement disabilities [8] - The company has developed ARC Therapy, which has received ten Breakthrough Device Designations from the FDA [9] - ONWARD Medical is headquartered in the Netherlands, with a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts [10] Product Development and Milestones - The ARC-EX System, the first and only FDA-approved technology to improve hand strength and sensation in people with chronic spinal cord injury, achieved its first commercial sales in the US in late December 2024 [1][2] - The ARC-EX System was granted de novo classification by the FDA on December 19, 2024, and was named a 2024 TIME Magazine Best Invention [2] - The company anticipates authorization for home use of the ARC-EX System in 2025 and plans to seek CE Mark certification in early 2025, with a commercial launch in Europe expected in the second half of 2025 [5] - ONWARD Medical is also developing an implantable system called ARC-IM and an investigational ARC-BCI System, which uses a brain-computer interface powered by AI [5][9] Market and Industry Context - Spinal cord injury affects approximately seven million people worldwide, including over 300,000 in the US, with half of the injuries resulting in tetraplegia [7] - Lifetime treatment costs for tetraplegia exceed $5 million, highlighting the significant economic impact of SCI [7] - Historically, SCI has been considered permanent with limited options for functional recovery, particularly for those more than one-year post-injury [7] Commercialization and Partnerships - UW Medicine and Next Steps Chicago were among the first to purchase the ARC-EX System, aligning with the company's goal to provide access to this technology in both community rehabilitation clinics and major academic research centers [1][4] - The ARC-EX System is currently authorized for clinic use in the US, with plans to expand its availability for home use [5] - ONWARD Medical's partnerships with institutions like UW Medicine and Next Steps Chicago aim to redefine recovery and provide innovative care for individuals with SCI [4][5]

Greenville, South Carolina , Jan. 03, 2025 (GLOBE NEWSWIRE) -- ARCpoint Inc. (TSXV: ARC) (the “Company” or “ARCpoint”) reports that it has now completed the sale of its 68% share ownership interest in Achieve Behavioral Health Greenville LLC, (“Achieve”) as originally announced December 30, 2024. In exchange for its ownership interest in Achieve, the Company received cash of US$360,000, plus the settlement of US$120,000 in amounts owing between ARCpoint and the buyers of the Achieve interest, for total cons ...

Greenville, South Carolina, Dec. 30, 2024 (GLOBE NEWSWIRE) -- ARCpoint Inc. (TSXV: ARC) (the “Company” or “ARCpoint”) reports that it has entered into an agreement for the sale (the “Transaction”) of its 68% share ownership interest in Achieve Behavioral Health Greenville LLC, (“Achieve”) for total consideration of US$480,000. From the total consideration amount, the buyer of ARCpoint’s interest in Achieve will deduct US$120,000 in recognition of net amounts owing between the two parties and make a total ca ...

THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE (7)(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) ARC-EX System is the first and only FDA approved technology shown to improve hand strength and sensation after chronic spinal cord injury ARC-EX System is an FDA Breakthrough Device and 2024 TIME Magazine Best Invention EINDHOVEN, the Netherlands, Dec. 19, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therap ...

Nanox.ARC receives additional FDA clearance to produce tomographic images for general use, including pulmonary, intra-abdominal and paranasal indications, in addition to its previously cleared indication for the musculoskeletal systemNanox.ARC uses high voltage powered digital X-ray tubes for 3D tomosynthesis imaging that could help expand availability of medical imagingNanox.ARC now deployed at healthcare facilities across seven states in the U.S. PETACH TIKVA, Israel, Dec. 05, 2024 (GLOBE NEWSWIRE) -- NAN ...

Grant supports the first clinical trials studying the potential for brain-computer interface (BCI) and artificial intelligence (AI) technology to restore thought-driven movement after stroke Funding also supports technology development of ARC-BCI System and ARC-IM Lead Approximately 15 million people worldwide experience a stroke each year EINDHOVEN, the Netherlands, Nov. 19, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimula ...

One of the top shareholders of President-elect Donald Trump's media company has unloaded nearly his entire stake, a regulatory filing showed.The Thursday night disclosure to the U.S. Securities and Exchange Commission showed that financial firm ARC Global Investments II and its manager, Patrick Orlando, no longer own more than 5% of Trump Media stock.Orlando, the former CEO of the company that took Trump Media public in a SPAC merger, and ARC, the sponsor of that merger, now hold just 30,147 DJT shares — ab ...

About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

Oil, Gas, Energy, Metals - That's the core of my research.I am a semi-retired former engineer who switched careers in 2018 to focus on capital management. I acquired most of my knowledge about finance and valuation from NYU Professor Damodaran and books like "Margin of Safety" and "The Intelligent Investor."I specialize in fundamental analysis and require both a deep "Margin of Safety" and a "Catalyst" to consider adding a stock to my portfolio. My portfolio usually contains no more than 10 stocks.I joined ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________________________________ Emerging growth company ☐ Form 10-Q _______________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-32407 ___________ ...