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 to Supply Finnair with Ground-like Connectivity Experience in the Skies2.11.2026 08:00:00 CET | Press release
Multi-orbit inflight connectivity service will deliver faster, more reliable onboard internet experience to 18 Embraer aircraft SES today announced a new agreement with Finnair, Finland's flagship airline, to equip 18 E195-E2s with multi-orbit in-flight connectivity, enabling Finnair’s customers to enjoy fast, reliable internet access throughout their journey. Under the agreement, the Embraer E2 aircraft, which will be line-fitted at Embraer, will be equipped with SES’s electronically steered array antenna (ESA) offering reliable connectivity to the SES multi-orbit network, combining SES’s geostationary (GEO) satellite services with low-earth orbit (LEO) capacity from its partner Eutelsat. The first connected aircraft is expected to enter service in 2027. “Inflight Wi-Fi is a core part of the travel experience,” said Blane Boynton, Senior Vice President Aviation at SES. “SES’s multi-orbit network delivers the reliability, performance and flexibility airlines need today while providing
Sofinnova Partners Promotes Javier Nunez-Vicandi to Partner, Strengthening Its Digital Medicine Strategy2.11.2026 08:00:00 CET | Press release
Physician-investor and co-builder of Sofinnova's AI platform Sofia joins the partnership, underscoring the firm’s growing interest in healthtech and techbio Sofinnova Partners ("Sofinnova"), a leading European venture capital firm in life sciences, based in Paris, London, and Milan, today announced the promotion of Javier Nunez-Vicandi to Partner. He joins Edward Kliphuis and Simon Turner in the firm’s Digital Medicine strategy, which invests in startups working at the intersection of biology, data, and AI. Since joining Sofinnova in 2022, Nunez-Vicandi has played a key role in the development of the firm's Digital Medicine strategy and broader AI efforts. He helped shape key AI investment theses within the Digital Medicine Strategy and is an observer on the boards of Latent Labs, Bioptimus, Cure51, Deepc, and Kiro. Javier has also recently led an investment that remains in stealth. Within Sofinnova's broader AI efforts, Javier co-led the project that created Sofia, Sofinnova's proprie
Speech Processing Solutions Launches Philips SpeechLive Legal Direct and Philips SpeechLive Professional Direct with Real-Time Speech Recognition Directly at Cursor2.11.2026 08:00:00 CET | Press release
Built for professionals who rely on accurate dictation, both solutions combine specialist speech recognition with familiar voice commands allowing users to see recognized text appear directly at the cursor as they speak, while keeping users in control. Speech Processing Solutions (SPS), the global leader in professional dictation and transcription solutions sold under the Philips brand, today announced the launch of Philips SpeechLive Legal Direct and Philips SpeechLive Professional Direct. The two solutions allow legal and other professionals to dictate into supported desktop applications, with recognized text appearing as they speak. They are designed both for organizations adopting professional speech recognition for the first time and for customers moving from established or end-of-life speech recognition solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261029365830/en/ Philips SpeechLive Legal Direct – legal sp
Thales Selected to Deliver Next-Generation Mine-Hunting Capability for the U.S. Navy2.11.2026 07:00:00 CET | Press release
Thales’ subsidiary Advanced Acoustic Concepts (AAC) won a $53.9 million U.S. Navy contract for two Remote Mine Hunting (RMH) modules and engineering support, with options increasing the potential value to $196.2 million for additional modules. The RMH solution enhances unmanned Mine Countermeasures (MCM) by enabling remote detection and classification and supporting rapid threat engagement, while reducing risk to sailors and platforms. The contract reinforces Thales’ position in MCM and undersea warfare, leveraging international expertise and American innovation to rapidly deliver critical capabilities that enhance U.S. Navy operational readiness and sailor safety in contested maritime environments. Thales’ subsidiary Advanced Acoustic Concepts (AAC), a U.S.-based provider of undersea warfare solutions, was awarded a $53.9 million U.S. Navy contract to produce and deliver two integrated Remote Mine Hunting (RMH) modules and accompanying engineering support. The award includes options f
Uptime Institute and Indonesia Ministry of Communication and Digital Affairs (KOMDIGI) Sign Letter of Intent (LOI) to Support Data Center Policy, Governance, and Industry Development2.11.2026 06:04:00 CET | Press release
Uptime Institute, the Global Digital Infrastructure Authority, and the Ministry of Communication and Digital Affairs (Komdigi) today announced the signing of a Letter of Intent (LOI) to explore collaboration aimed at strengthening Indonesia's data center ecosystem through policy development, governance frameworks, operational excellence, security, sustainability, and workforce capability development. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261101628182/en/ Uptime Institute and KOMDIGI sign LOI. The Letter of Intent reflects a shared interest in exploring international best practices that may support the development of reliable, secure, efficient, and sustainable digital infrastructure aligned with Indonesia's national priorities and regulatory framework. The LOI was signed by Mustapha Louni, Chief Business Officer, Uptime Institute, and Wayan Toni Supriyanto, Director General of Digital Infrastructure, Indonesia's Min
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