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ONWARD Medical's ARC-EX System Now Available on US Veterans Affairs Online Procurement Platforms
GlobeNewswire News Room· 2025-01-29 06:30
Core Points - ONWARD Medical has secured approvals for the ARC-EX System to be purchased through US government procurement platforms, enhancing access for Veterans with spinal cord injuries [1][2] - The partnership with Lovell Government Services is pivotal in facilitating the purchase of the ARC-EX System, which is now available through the VA Federal Supply Schedule and GSA Advantage platforms [1][3] - The ARC-EX System, authorized for commercial sale by the FDA in December 2024, offers a significant advancement in spinal cord injury treatment by delivering targeted stimulation to restore upper extremity function [4][8] Group 1 - The ARC-EX System is now accessible to US government clinics and healthcare facilities, ensuring rapid access for the VA, Military Health System, and other agencies [2][4] - The collaboration with Lovell Government Services aims to improve access to care for Veterans and expand the distribution of the ARC-EX System through additional channels like the Defense Logistics Agency's Electronic Catalog [3][4] - ONWARD Medical is committed to developing innovative solutions for restoring movement and function in individuals with spinal cord injuries, building on extensive scientific research and clinical studies [8] Group 2 - The ARC-EX System is designed for individuals aged 18 to 75 with chronic, non-progressive neurological deficits due to incomplete spinal cord injuries, focusing on improving hand sensation and strength [10] - Lovell Government Services has a strong track record in federal contracting and aims to enhance the availability of medical technologies for Veteran populations [6][8] - ONWARD Medical is headquartered in the Netherlands and operates a US office in Boston, with its stock listed on Euronext [9]
ARC Resources: Attachie Startup Is Now
Seeking Alpha· 2025-01-17 21:07
Group 1 - The article discusses the analysis of oil and gas companies, specifically focusing on ARC Resources and its projects, highlighting the search for undervalued companies in the sector [1] - The Attachie project startup by ARC Resources is mentioned as a significant factor contributing to an expected increase in free cash flow due to the completion of necessary projects [2] - The cyclical nature of the oil and gas industry is emphasized, indicating that it requires patience and experience to navigate effectively [2] Group 2 - The analyst has a beneficial long position in the shares of ARC Resources, indicating a personal investment interest in the company [3] - The article is presented as an independent analysis, with no compensation received from the companies mentioned, ensuring objectivity in the insights provided [3]
ONWARD Medical Announces First Commercial Sales of ARC-EX System
GlobeNewswire News Room· 2025-01-09 06:30
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]
ARCPOINT CLOSES SALE OF OWNERSHIP STAKE IN NON-CORE ASSET
Globenewswire· 2025-01-03 23:00
Group 1 - ARCpoint Inc. has completed the sale of its 68% ownership interest in Achieve Behavioral Health Greenville LLC for a total consideration of US$480,000, which includes US$360,000 in cash and US$120,000 in settled amounts owed [1] - The transaction is classified as a Non-Arm's Length Transaction and a related party transaction under Multilateral Instrument 61-101, but it was exempt from formal valuation and minority shareholder approval requirements [2] - ARCpoint is a US-based healthcare company that utilizes technology and physical locations to provide accessible and cost-effective healthcare solutions with transparent pricing [3]
ARCPOINT REACHES AGREEMENT TO SELL 68% OWNERSHIP STAKE IN NON-CORE ASSET
Globenewswire· 2024-12-30 22:00
Group 1 - ARCpoint Inc. has entered into an agreement to sell its 68% ownership interest in Achieve Behavioral Health Greenville LLC for a total consideration of US$480,000, resulting in a net cash payment of US$360,000 after deducting US$120,000 for amounts owed between the parties [1] - The sale is part of a strategy to streamline operations and provide working capital for advancing technology platform integration for CRESSO Brands franchisee locations [7] - The joint venture CRESSO Brands LLC, formed with Any Lab Test Now, combines over 235 franchise locations from ALTN and more than 135 from ARCpoint, making it the largest franchise network of its kind in the United States [2] Group 2 - Achieve Behavioral Health operates under the brand name Vertical Treatment Centers, providing drug and alcohol addiction treatment services in South Carolina [1] - ARCpoint leverages technology and physical locations to offer convenient and cost-effective healthcare solutions with transparent pricing [3]
ONWARD Medical Receives FDA De Novo Classification and US Market Authorization for World's First Non-Invasive Spinal Cord Stimulation System for People with Chronic Spinal Cord Injury
GlobeNewswire News Room· 2024-12-19 16:58
Core Insights - ONWARD Medical N.V. has received FDA de novo classification and authorization to market its ARC-EX System, the first FDA-approved technology to improve hand strength and sensation after chronic spinal cord injury (SCI) [1][2] - The ARC-EX System is recognized as a Breakthrough Device and was named one of TIME Magazine's Best Inventions of 2024 [1][7] - The device utilizes non-invasive electrical stimulation to enhance spinal cord function, marking a significant advancement in therapies for individuals with chronic SCI [2][7] Company Overview - ONWARD Medical is focused on developing innovative therapies aimed at restoring movement and independence for individuals with spinal cord injuries and other movement disabilities [8] - The company has a pipeline of technologies, including the investigational ARC-IM System and ARC-BCI System, which incorporates brain-computer interface technology [3][8] - The company is headquartered in the Netherlands and has additional facilities in Switzerland and the United States [9] Clinical Impact - The Up-LIFT clinical study demonstrated that 90% of participants improved in strength or function, and 87% reported enhanced quality of life, with benefits observed up to 34 years post-injury [3][6] - Regaining hand function is prioritized significantly higher than other abilities lost due to paralysis, indicating a strong demand for effective therapies in this area [3] Market Authorization and Future Plans - The current FDA authorization is for clinical use, with home use expected to be authorized by mid-2025 [3] - The company plans to seek CE Mark certification for the ARC-EX System in Europe, with expectations for authorization in the second half of 2025 [3]
Nanox.ARC Imaging System Receives FDA Clearance for General Use, Including Pulmonary Indication
GlobeNewswire News Room· 2024-12-05 10:55
Core Viewpoint - Nanox Imaging Ltd has received FDA clearance for its Nanox.ARC system, expanding its imaging capabilities to include pulmonary, intra-abdominal, and paranasal indications, in addition to its previous clearance for musculoskeletal imaging [2][4]. Group 1: FDA Clearance and Technology - The Nanox.ARC is a stationary X-ray system designed for general use, now cleared for multiple imaging indications [2]. - It features a proprietary digital X-ray source and advanced tomosynthesis technology, providing a three-dimensional view of the body and reducing the limitations of traditional 2D X-rays [3][4]. - The system is currently deployed in healthcare facilities across seven states in the U.S., with additional units being shipped worldwide [4]. Group 2: Impact on Healthcare Providers - The FDA clearance allows U.S. healthcare providers to access broader imaging capabilities similar to traditional X-ray devices, enhancing patient care [4]. - The technology aims to reduce patient wait times and improve overall diagnostic efficiency, potentially allowing for faster care without the need for separate imaging facilities [5][6]. - The system is designed for integration into existing clinical workflows, operated by trained professionals in various healthcare settings [5]. Group 3: Company Vision and Future Plans - Nanox aims to drive the transition to preventive healthcare through affordable medical imaging technologies, leveraging AI for smarter diagnostics [7][8]. - The company envisions expanding its technology beyond hospital settings, providing a comprehensive solution from scan to diagnosis [8]. - The Nanox ecosystem includes various components such as Nanox.AI for enhanced imaging analysis and Nanox.CLOUD for data management [9].
ONWARD Medical Awarded Grant to Study Potential for ARC-BCI Therapy to Restore Movement after Stroke
GlobeNewswire News Room· 2024-11-19 06:30
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 ...
Major Trump Media shareholder ARC Global unloads nearly all DJT stock
CNBC· 2024-11-15 17:39
Core Viewpoint - A significant shareholder of Trump Media, ARC Global Investments II, has sold nearly its entire stake, reducing its ownership from over 11 million shares (5.4%) to just 30,147 shares (0.01%) as per SEC filings [1][2]. Group 1: Shareholder Actions - ARC Global Investments II and its manager, Patrick Orlando, no longer own more than 5% of Trump Media stock following a substantial sell-off [1]. - The SEC filing indicates that the actions leading to this change occurred on September 30, although the specific timing of the stock sale remains unclear [4]. - The diminished stake of ARC is now valued at approximately $850,000 [3]. Group 2: Legal and Market Context - A Delaware judge ruled in mid-September that Trump Media breached an agreement with ARC, necessitating the granting of additional shares to ARC [3]. - Trump Media experienced a significant sell-off in late summer, with stock prices nearing post-merger lows by the end of September, but saw a recovery in October [5]. - The stock rally in October is attributed to the upcoming presidential election, with many retail investors reportedly buying shares to support Trump [6].
Aqua Metals reports Q3 progress, prepares for commercial deployment of Sierra ARC
Proactiveinvestors NA· 2024-11-14 21:42
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 ...