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
LZE GmbH Introduces Fraunhofer’s RFicient® Technology to the Market12.3.2026 14:51:00 CET | Press release
LZE GmbH is expanding its technology transfer portfolio and making the RFicient® ultra-low-power wake-up receiver technology from the Fraunhofer Institute for Integrated Circuits IIS available for the first time as a standard chip for close-to-production industrial applications. The solution enables energy-efficient IoT designs that remain continuously reachable while consuming only microamps – a key step for long-lasting, low-maintenance IoT products. LZE GmbH drives technology transfer to market: standard chip availability for close-to-production applications As a bridge between research and industry, LZE GmbH is making it easier for companies to access innovative technologies and helping them to quickly and reliably transform new developments into market-ready solutions. With RFicient®-IC (FH101RF), LZE is providing another high-tech product that comes directly from Fraunhofer research and can now be ordered in volume and integrated into close-to-production product development for t
Owkin Creates New Spin out Waiv, Formerly Owkin Dx, With $33M Financing12.3.2026 14:30:00 CET | Press release
Investment lead by OTB Ventures and Alpha Intelligence CapitalWaiv develops AI-powered precision testing to better identify and stratify patients in the clinic and in clinical trials, transforming patient careWaiv extends Owkin’s strategy of real-world validation for its AI Owkin, the AI company on a mission to solve the complexity of biology, today announced the spin out of Waiv, formerly known as Owkin Dx. The move follows significant investor interest and positions Waiv to bring AI-powered precision testing for better identification of patients in the clinic and in clinical trials, to transform patient care. This follows on from the successful launch of Bioptimus, an Owkin incubated company, in February 2024. Waiv translates AI innovation into real-world clinical impact, developing tests that predict biomarkers and patient outcomes, including RlapsRisk BC for prognostic risk profiling. With multiple tests already in use in clinical settings, its deployment platform Destra, and colla
RQM+ Launches SMART Solutions Life Cycle Partnership Model12.3.2026 14:30:00 CET | Press release
Helps MedTech Companies Navigate MDR, IVDR, and AI-Enabled Device Development RQM+, a leading MedTech CRO offering regulatory consulting, clinical trial, laboratory, and reimbursement services, today announced the launch of SMART Solutions, a life cycle partnership model designed to help medical device and diagnostics companies manage growing regulatory and development complexity. SMART Solutions introduces a strategy-led operating framework that unifies regulatory, quality, clinical, reimbursement, and laboratory expertise to support MedTech companies across the entire product life cycle to help reduce risk from early development through post-market. “MedTech companies are navigating unprecedented complexity as regulatory expectations evolve, product innovation accelerates, and post-market expectations are expanding,” said John Potthoff, Ph.D., chief executive officer of RQM+. “SMART Solutions moves beyond traditional consulting by providing an integrated life cycle partnership that h
Cryptio Raises $45m Series B as Digital Assets Move Into Regulated Financial Markets12.3.2026 14:06:00 CET | Press release
The system of record for tokenized finance – ERP infrastructure for institutions operating in digital assets Cryptio, a leader in financial data transformation and enterprise resource planning (ERP) applications for regulated digital assets, announced today a $45 million Series B funding round co-led by BlackFin Capital Partners and Sentinel Global, with participation from 1kx, Alven, BlueYard Capital and Ledger Cathay Capital. Banks, exchanges, asset managers, including Société Générale’s SG Forge, Circle, Gemini, and Securitize rely on Cryptio to ensure financial integrity across their digital assets businesses. Existing ERP systems fall short for digital assets Traditional ERP and accounting systems were not designed for blockchain-native assets, real-time reporting, or modern custody frameworks. As regulated financial institutions expand into stablecoins, tokenized securities and other on-chain instruments, these limitations create material operational and reporting challenges. Cry
HyperLight Introduces 145 GHz Reference Modulators to Enable 448Gbps per Lane Datacom and 260GBaud Telecom Development12.3.2026 14:03:00 CET | Press release
HyperLight Corporation, creator of the TFLN Chiplet™ platform, today announced the release of its 145 GHz Packaged Intensity Modulator (IM), expanding the company‘s high-speed modulator portfolio. The new device is designed for ultra-wide modulation bandwidth, high signal fidelity, and stable operation control, enabling 448 Gbps per lane intensity-modulated-direct-detection (IMDD), 260 GBaud coherent links, and broadband RF photonics systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260312319685/en/ Fig. 1: HyperLight’s 145 GHz intensity modulator for 448Gbps per lane IMDD and 260GBaud coherent applications, with operational electro-optical bandwidth >145GHz, stable bias control, 0.8 mm-connector; available in O-, C-, and L-bands. As symbol rates and analog bandwidth requirements continue to rise across data center interconnects, AI-driven photonics infrastructure, and laboratory test environments, system architects in
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