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ONWARD Medical Receives FDA IDE Approval to Initiate the Empower BP Pivotal Study with the ARC-IM System
Globenewswire· 2025-08-18 16:30
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].
Bocana Resources Corp. Schedules Due Diligence and Site Visit to Arizona Mining Claims
Globenewswire· 2025-08-18 16:16
Core Viewpoint - Bocana Resources Corp. is advancing its due diligence efforts by scheduling a site visit to the U.S. Bureau of Land Management placer mining claims in Arizona, owned by LP Associates, LLC, to gather essential information for operational development [1][4]. Group 1: Due Diligence Efforts - The company management and geologist will meet with key parties, including the seller, lead on-site geologist, mining consulting firms, legal representatives, and BLM officials, to ensure a thorough due diligence process [2]. - The objective includes verifying previously acquired assayed reports, understanding the permitting process, and strategizing with local engineering firms for optimal processing methods to maximize recovery of precious metals [2][3]. Group 2: Legal and Strategic Review - Bocana will review title documents related to property ownership and BLM Claims, as well as evaluate nearby Claims for potential strategic opportunities [3]. - The company will assess access to the Claims area via public roadways and examine existing conditions that may impact future development, such as restrictive covenants and environmental concerns [3]. Group 3: Company Background - Bocana Resources Corp. is focused on the acquisition, exploration, and development of mineral properties in North and South America, holding a 100% working interest in the Escala area concessions in Bolivia [5].
Rexel: Disclosure of trading in own shares from August 11 to August 15, 2025
Globenewswire· 2025-08-18 16:00
RELEASE DISCLOSURE OF TRADING IN OWN SHARES FROM AUGUST 11 TO AUGUST 15, 2025 In accordance with the authorization granted by the Shareholders’ Meeting in order to trade in own shares and pursuant to applicable law on share repurchases, Rexel declares the following purchases of its own shares from August 11 to August 15, 2025: Name of the issuerIdentity code of the issuer (Legal Entity Identifier)Day of transactionIdentity code of the financial instrumentTotal daily volume (in number of shares)Daily we ...
Marie Brizard Wine & Spirits Monthly declaration of the total number of voting rights and shares
Globenewswire· 2025-08-18 15:49
MONTHLY DECLARATION OF THE TOTAL NUMBER OF VOTING RIGHTS AND SHARES (ARTICLE L233-8II THE COMMERCIAL CODE and 223-16 OF THE GENERAL REGULATIONS OF THE FINANCIAL MARKETS AUTHORITY (AMF)) Charenton-le-Pont, 18th August 2025 MARIE BRIZARD WINE & SPIRITS ISIN Code: 0000060873 Situation at:Total number of shares comprising share capitalTotal number of voting rights31 July 2025111 989 823Number of voting rights (1): 194 047 142Number of exercisable voting rights (2): 193 916 356 Do the Marie Brizard Wine & Spirit ...
VINCI awarded design and build contract in Australia
Globenewswire· 2025-08-18 15:45
Core Points - VINCI Construction subsidiary Seymour Whyte, in collaboration with John Holland, Jacobs, Mott MacDonald, and Major Road Projects Victoria, has secured a contract for a significant upgrade of the Eastern Freeway in Australia [2][5] - The total value of the construction contract is approximately 450 million euros (AUD 800 million), with an expected completion date by mid-2028 [2][5] Project Details - The upgrade will include the addition of one lane in each direction, a new dedicated busway, shared-use paths, various civil structures, and noise barriers to improve the living conditions for nearby residents [3]
Vaisala Corporation: Share Repurchase 18.8.2025
Globenewswire· 2025-08-18 15:30
Group 1 - Vaisala Corporation executed a share repurchase on August 18, 2025, buying 2,700 shares at an average price of €46.8344 per share, totaling €126,452.88 [1] - Following this transaction, Vaisala Corporation now holds a total of 140,084 shares [1] - The share buybacks are conducted in compliance with European regulations, specifically Regulation No. 596/2014 and Commission Delegated Regulation (EU) 2016/1052 [1] Group 2 - Vaisala is recognized as a global leader in measurement instruments and intelligence for climate action, focusing on improving resource efficiency and driving energy transition [2] - The company has nearly 90 years of innovation and expertise, employing around 2,500 experts dedicated to environmental measures [2] - Vaisala's series A shares are listed on the Nasdaq Helsinki stock exchange [2]
Roadzen Addresses Inaccurate Reporting of Analyst Expectations in Q1 FY2026 Results
Globenewswire· 2025-08-18 15:28
Recent media reports, originating from an AI-generated article on The Motley Fool and widely syndicated, misstated Roadzen’s analyst expectations as over $21 million in Q1 revenue, implying a revenue miss of more than 50%. Roadzen clarifies that these figures were never issued by its covering analysts, and that its record first quarter — the strongest Q1 in Company history — was in line with its operating plan and market estimates.NEW YORK, Aug. 18, 2025 (GLOBE NEWSWIRE) -- Roadzen Inc. (Nasdaq: RDZN) ("Roa ...
Metalenz 扩展其在超表面市场的技术,涵盖系统级传感应用
Globenewswire· 2025-08-18 15:25
该公司的专利组合正在不断扩大,目前已拥有超过 150 项专利申请和已授权专利,其中包括超表面的设计与制造以及芯片、模块、产品和图像处理等领域。Metalenz 推进其全面的知识产权组合,以实现能够简化并提升 3D 深度传感技术的产品创新,例如单元件点阵投影仪。随着超表面市场及消费级传感应用场景的快速扩展,Metalenz 继续基于核心创新进行拓展,将基于偏振的超表面技术整合到最新的图像传感解决方案中。 波士顿, Aug. 18, 2025 (GLOBE NEWSWIRE) -- 专注于超表面技术创新与商业化的 Metalenz 公司今日宣布,其产品及专利组合已进一步扩展,现涵盖用于安全生物识别领域的超表面技术及系统级应用。 该公告发布之际,单元件点阵投影仪及基于偏振技术的面部识别技术已获得专利授权。 这些创新技术使更小巧的 3D 传感和生物识别解决方案成为可能,从而简化了操作并提升了在各类大规模消费和工业市场中的性能表现。 Yole 集团进行的第三方拆解分析显示,顶级消费电子原始设备制造商(OEM)生产的智能手机和平板电脑中已采用超表面技术,证实了该新型光学技术在大众市场中的广泛应用。据预测,该技术到 202 ...
Tims China to Announce Second Quarter 2025 Financial Results on August 26, 2025
Globenewswire· 2025-08-18 14:59
Core Viewpoint - TH International Limited, operating as Tims China, is set to release its second quarter 2025 financial results on August 26, 2025, before the U.S. market opens, followed by a conference call [1] Group 1: Company Overview - TH International Limited (Nasdaq: THCH) is the exclusive master franchisee of Tim Hortons coffee shops in mainland China, Hong Kong, and Macau [2] - The company was founded by Cartesian Capital Group and Tim Hortons Restaurants International, a subsidiary of Restaurant Brands International (TSX: QSR) (NYSE: QSR) [2] Group 2: Company Philosophy - The company's philosophy emphasizes world-class execution, data-driven decision making, local relevance, continuous innovation, community engagement, and convenience [3]
Valeo - Voting rights - July 2025
Globenewswire· 2025-08-18 14:59
Company Overview - Valeo is a technology company that partners with automakers and new mobility players, focusing on making mobility cleaner, safer, and smarter [2] - The company has a strong technological and industrial leadership in four key areas: electrification, driving assistance systems, interior experience reinvention, and lighting [2] Financial Performance - Valeo reported sales of €21.5 billion in 2024 [3] - As of December 31, 2024, the company employed 106,100 people across 28 countries, operating 155 plants and 46 research and development centers [3] Share Capital and Voting Rights - As of July 31, 2025, Valeo's issued capital was €244,633,504, with a total of 244,633,504 shares [1] - The total number of theoretical voting rights was 275,030,593, while the total number of exercisable voting rights was 274,920,605 [1][2]