ONWARD
17.6.2021 14:32:12 CEST | Business Wire | Press release
ONWARD today announced the Company has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for their ARC-IM platform for blood pressure and trunk control in people with spinal cord injury. This is the third such Breakthrough Device Designation awarded to ONWARD, following previous awards for ARC-EX for upper extremity function and ARC-IM for mobility.
ARC-IM consists of an implantable pulse generator and lead that is placed near the spinal cord. The system is operated via a tablet programmer and smartwatch. The STIMO study demonstrated the ability of this technology to enable long-paralyzed people to stand and walk again with little or no assistance and a recently published Nature paper showed the potential for this same therapy to normalize blood pressure in people with spinal cord injury.
“Blood pressure and trunk control are two of the many challenges people with spinal cord injury must manage in order to navigate their daily lives,” said Dave Marver, Chief Executive Officer of ONWARD. “We are excited about this award and thankful to the FDA for recognizing the potential of our technology to improve the quality of life for those with spinal cord injury.”
Breakthrough Device Designation is an FDA program designed to help patients and their physicians receive timely access to technologies that have the potential to provide more effective treatment or diagnosis for debilitating conditions of great unmet need, such as spinal cord injury. As part of this designation, the FDA will provide ONWARD with priority review and the opportunity to interact with FDA's experts throughout the premarket review phase as the technology moves toward eventual commercialization.
About ONWARD
ONWARD (@onwdempowered ) is a medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury. ONWARD’s work builds on more than a decade of basic science and preclinical research conducted at the world’s leading neuroscience laboratories. ONWARD’s ARC Therapy, which can be delivered by implantable (ARC-IM) or external (ARC-EX) systems, is designed to deliver targeted, programmed stimulation of the spinal cord to restore movement and other functions in people with spinal cord injury, ultimately improving their quality of life. ONWARD has received three Breakthrough Device Designations from the FDA encompassing both ARC-IM and ARC-EX. The company’s first FDA pivotal trial, called Up-LIFT, commenced in January 2021 with plans to enroll 65 subjects at up to 15 centers worldwide.
ONWARD is headquartered at the High Tech Campus in Eindhoven, the Netherlands and the EPFL Innovation Park in Lausanne, Switzerland, with a growing U.S. presence in Boston, Massachusetts, USA. For additional information about the company, please visit ONWD.com and follow us on Twitter and LinkedIn .
View source version on businesswire.com: https://www.businesswire.com/news/home/20210617005478/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
emnify Appoints Sacha Herrmann as Chief Financial Officer and Christian Friis as Chief Revenue Officer2.10.2026 17:12:00 CEST | Press release
Appointments expand emnify executive team to accelerate global growth emnify, a global leader in IoT connectivity, today announced the appointments of Sacha Herrmann as Chief Financial Officer and Christian Friis as Chief Revenue Officer, effective immediately. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261001902751/en/ emnify Appoints Sacha Herrmann as Chief Financial Officer and Christian Friis as Chief Revenue Officer The appointments follow the recent naming of Kenneth De Spiegeleire as Chief Executive Officer and Frank Stoecker as Executive Chairman of the Board. Together, these leadership changes strengthen emnify financial, operational, and commercial capabilities as the company enters its next phase of international growth. “We have proven momentum. Our ambition is to now turn it into global category leadership,” said Kenneth De Spiegeleire, CEO of emnify. “That requires sharper focus, disciplined execution, and
Tacton Appoints Former IFS Executive Merlin Knott as Chief Commercial Officer to Accelerate Global Growth and Scale Beyond CPQ2.10.2026 15:00:00 CEST | Press release
Enterprise software veteran to lead Tacton’s united commercial organization and partner expansion worldwide. Tacton, a global leader in Configure, Price, Quote (CPQ) software and configuration solutions for manufacturers of complex products, today announced the appointment of Merlin Knott as Chief Commercial Officer (CCO). In this role, Knott will lead Tacton’s global commercial organization, including marketing, sales, and pre-sales, aligning the teams responsible for bringing Tacton’s solutions to market, and driving value to its customers and partners globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261002794882/en/ Merlin Knott, Chief Commercial Officer, Tacton Knott joins Tacton with decades of experience building and scaling commercial organizations across the enterprise software industry. Most recently, he held senior leadership roles at IFS, the world’s leading provider of Industrial AI software, where he led
EDW Presents 2026 Data Quality Award to Repeat Winner Domivest2.10.2026 15:00:00 CEST | Press release
European DataWarehouse (EDW) presented its fifth annual Data Quality Award at the 2026 TSI Congress in Berlin. This year, EDW's Best Data Quality – Deal of the Year (2026) award was presented to Domivest B.V. for its transaction Domi 2023-1 B.V., recognising the firm's outstanding commitment to accurate, complete, and consistent reporting. The award is based on EDW's proprietary data quality scoring methodology, which evaluates transactions against thousands of validation rules and checks. Data quality excellence is not a one-off achievement. The fact that the same issuers continue to rank among the top performers year after year demonstrates that superior data quality is the result of sustained commitment, robust processes, and ongoing investment. "Receiving the Data Quality Award for a second time means a great deal to us. Transparent, accurate loan-level data is key to investor trust in our transactions, and we are grateful to European DataWarehouse for recognising the work our trea
ILiAD Biotechnologies Expands BPZE1 Public Health and Commercial Potential with Publication of Pediatric Phase 2b Study in The Lancet Infectious Diseases2.10.2026 14:00:00 CEST | Press release
Intranasal pertussis vaccine candidate BPZE1 demonstrates robust nasal mucosal and systemic immune responses with a favorable safety profile in children ages 6 through 17 yearsFirst pediatric clinical trial builds on 5 prior adult BPZE1 clinical studiesDemonstrates safety and immunogenicity of BPZE1 in acellular pertussis vaccine primed individualsNo interference observed when BPZE1 co-administered with diphtheria and tetanus antigens ILiAD Biotechnologies, Inc. (ILiAD), an advanced clinical stage biotech company focused on the prevention and treatment of disease caused by Bordetella pertussis, today announced the publication of results from its Phase 2b SUPER (Stand Up to Pertussis) clinical trial in The Lancet Infectious Diseases. This randomized, double blind, placebo- and active-comparator-controlled trial demonstrated that BPZE1, a live attenuated intranasal pertussis vaccine, induced robust nasal mucosal immune responses in healthy children aged 6 through 17 years (LINK). The stu
NIQ Brings New AI and Automation Capabilities to Retail Space Planning and Merchandising2.10.2026 12:45:00 CEST | Press release
New AI and automation capabilities help retailers close execution gaps and scale merchandising decisions across every store. NielsenIQ (NYSE: NIQ), a leading consumer intelligence company, today announced new AI and automation capabilities for NIQ Spaceman®, its retail space planning and merchandising platform trusted by more than 600 retailers across 65+ countries. The enhancements help retailers create store-specific planograms up to 50 times faster, identify execution and compliance gaps, and scale merchandising decisions across their store networks through expanded cloud-based access. "Retailers are under increasing pressure to localize assortments, execute consistently across stores, and respond more quickly to changing shopper behavior," said Natalie Williams, SVP, Product at NIQ. "These enhancements help simplify that process by embedding agentic AI directly into merchandising workflows and automating traditionally manual planning tasks. That means teams can spend less time buil
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom