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
SES Launches Multi-Orbit Satellite Connectivity on Mexico’s Viva1.6.2026 20:00:00 CEST | Press release
SES, a leading space solutions company, and Viva, Mexico’s ultra low-cost airline, launched fast and reliable multi-orbit satellite inflight connectivity service on Viva’s Airbus aircraft, strengthening SES’s position as a leading provider of satellite-powered broadband inflight service in the Americas and around the world. “Viva’s passengers will soon benefit from reliable, multi-orbit satellite connectivity that will provide the same fast and dependable internet access they enjoy at home no matter where or when they fly. SES’ partnerships with growing airlines like Viva highlight how carriers throughout the Americas are leading the way when it comes to the most advanced connectivity. SES is the engine that powers inflight connectivity, a trusted partner that makes airline operations easier,” said Mike DeMarco, SES President of Mobility. A total of 60 A320s and 40 A321s are set to offer the SES solution in the coming years. With the youngest Latin American fleet of Airbus A320s and A3
Motive Powers Latin America’s Next Wave of Mobile Innovation1.6.2026 17:00:00 CEST | Press release
Motive Entitlement Server enabling satellite connectivity in the Andes to fraud-free authentication in Brazil Motive, a global leader in entitlement and connected device & service management, joined operators and industry leaders at M360 LATAM in Mexico City, showcasing live deployments across the region's most consequential use cases: Satellite Direct-to-Device connectivity for unreachable geographies, end-to-end eSIM provisioning and visibility at scale, and SIM-based silent authentication replacing fraud-exposed SMS OTP. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260531906729/en/ Across landmark deployments with multiple Claro, Vivo, and Entel operations, Motive’s Entitlement Server (Motive ES) has moved from infrastructure component to regional growth engine. These deployments are citing measurable commercial growth, enabling streamlined eSIM provisioning, improved device onboarding experiences, and new revenue oppor
Interactive Brokers Integrates AI into Client Portfolios – Informed by Agentic Technology, Controlled by the Client1.6.2026 16:00:00 CEST | Press release
Clients Can Research Stocks, Analyze Performance, and Generate Trade Instructions in Claude. The Client Approves Every Trade. Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced agentic trading through direct integration with Claude, one of the world's leading AI platforms. Available through the AI platform’s certified connector marketplace, the integration lets clients manage their accounts and access more than 170 global markets. "Interactive Brokers has used technology for over four decades to help investors make more informed decisions and interact more efficiently with markets," said Milan Galik, Chief Executive Officer of Interactive Brokers. "Investors are increasingly using artificial intelligence to research markets, analyze information and generate ideas. We believe the next logical step is to allow clients to securely connect AI tools directly to their brokerage accounts — whether they want a simple conversational interface, deeper portfolio analy
AIM Expands Life Sciences Supply Chain Capabilities and Hires New Partner, Thomas Ebel1.6.2026 15:01:00 CEST | Press release
AIM today announced the appointment of veteran pharma supply chain expert Thomas Ebel as Partner, effective June 15. Mr. Ebel brings more than 25 years of supply chain consulting experience at leading firms including CAMELOT, McKinsey, and Accenture, and will anchor a broader initiative to expand AIM’s end-to-end supply chain capabilities. According to Richard de Bakker, Statutory Director and Founder at AIM, the firm is significantly expanding its capabilities around “end-to-end” supply chain needs. “AIM is well known as a leader in supply chain development for launch, as well as optimization of existing supply chains — supporting clients in getting their finished products to patients,” said Mr. de Bakker. “We are now adding new capabilities in supply chain diagnostics and strategy, end-to-end planning optimization, supply reliability, and working capital optimization, among others. Combined with AIM’s established supply chain expertise, this expanded offering gives clients true ‘end-
Seoul Semiconductor's World-First 'HV Opto-Semiconductor' Powers Up Global Top 4 Automakers1.6.2026 15:00:00 CEST | Press release
Seoul Semiconductor Co., Ltd. (KOSDAQ: 046890), a global opto-semiconductor technology company, announced that its world's first High Voltage (HV) opto-semiconductor technology has entered mass production with four of the world's top automotive brands across the Americas, Europe, and Asia, with plans to expand supply to 10 models by the end of the year. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260601232986/en/ Comparison: Conventional 3V LED vs. Seoul Semiconductor 12V 'HV Opto-Semiconductor' (Figure: Seoul Semiconductor) The technology combines micro-scaled opto-semiconductor chips capable of 12V single-chip operation — as opposed to conventional 3V LEDs — with a high-voltage (HV) driver technology. This enables a reduction of more than 10% in the number of driver-related components used in hybrid and electric vehicles, while lowering power consumption by approximately 10%, contributing to cost reduction and simplific
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