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
One Biosciences Receives BOOST Funding From Paris-Saclay Cancer Cluster to Advance the First Single-Cell Assay Approach for ADC Therapies22.6.2026 22:15:00 CEST | Press release
One Biosciences, a techbio company pioneering clinical-grade single-cell tumor profiling, today announced financial support via a Paris-Saclay Cancer Cluster (PSCC) BOOST grant to develop the first single-cell assay for antibody-drug conjugates (ADC) therapies in oncology. The rapid growth of ADCs is driving demand for more sophisticated biomarker strategies. By capturing tumor complexity at cellular resolution, single-cell profiling has the potential to enhance patient selection and support the development of next-generation ADCs. Ultimately, it will help match the right patients to the right therapies, maximizing therapeutic benefit. The PSCC BOOST-funded project seeks to bring a new level of precision to ADC development. It will be conducted in collaboration with Adcytherix, a clinical-stage biotech company developing differentiated ADCs for cancers with high unmet medical need. The collaboration will combine Adcytherix’s expertise in ADC development with One Biosciences’ AI-powered
Interactive Brokers Expands AI Integration Capabilities – Adding ChatGPT and Grok to Its Growing Suite of Agentic Trading Tools22.6.2026 16:00:00 CEST | Press release
Additional Asset Classes Available Including Options and Futures Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced the expansion of its agentic trading capabilities with the addition of ChatGPT and Grok, further broadening a growing ecosystem of AI platform integrations that began with Claude. Available through certified AI connector marketplaces across multiple leading platforms, these integrations allow clients to research, analyze, and generate instructions with speed and efficiency to uncover new trading and investing opportunities instantly. With this release, Interactive Brokers also extends the selection of products available for order instructions to include support for options, futures and futures options in addition to equities and ETFs. “We continue to see growing interest from investors in using artificial intelligence as a more natural way to interact with financial markets,” said Milan Galik, Chief Executive Officer of Interactive Brokers. “A
IQM Named Among Quantum Collaborators in HPE's New Hybrid Quantum-HPC Platform22.6.2026 15:22:00 CEST | Press release
The collaboration will advance practical and scalable hybrid classical-quantum applications. This follows IQM's first on-premises quantum computer installation in the United States, at Oak Ridge National Laboratory. IQM has sold 23 quantum systems globally to date and intends to list on Nasdaq in the United States by mid 2026. Hewlett Packard Enterprise has named IQM Quantum Computers among the companies collaborating on its hybrid classical-quantum computing platform, announced at HPE Discover Las Vegas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260622035759/en/ IQM Radiance quantum computer at HPE Discover Las Vegas 2026 IQM, a global leader in full-stack superconducting quantum computers, is contributing superconducting quantum processor technology to the effort, in which HPE is integrating multiple quantum modalities with its Cray supercomputing infrastructure. This collaboration strengthens IQM's global expansion p
Return Abuse Goes Mainstream as Nearly Half of Consumers Use AI in Return Claims, New Riskified Research Finds22.6.2026 14:30:00 CEST | Press release
New global study shows normalization of strategic returns, widening regional differences, and rapid AI adoption reshaping ecommerce post-purchase risk Riskified (NYSE: RSKD), a global leader in ecommerce fraud detection and risk intelligence, today released a new global report, “Rewriting the Rules on Returns”, exploring how consumer attitudes and behaviors around ecommerce returns are evolving in the age of artificial intelligence (AI). The Riskified-commissioned study, conducted by eTail Insights, is based on a survey of 2,091 consumers across seven countries, alongside in-depth interviews with senior leaders from many of the largest retail companies in the world. The research finds that return abuse behaviors are increasingly normalized, while nearly half of consumers already use generative AI tools to assist with return or refund claims. At the same time, merchants are responding by tightening return policies, shortening return windows, and deploying advanced AI detection to better
Forrester Unveils Agendas For 2026 Technology & Innovation Forums In North America And EMEA22.6.2026 14:00:00 CEST | Press release
The Forums will equip technology leaders with the capabilities needed to operationalize AI and build high-performing IT organizations that deliver measurable business outcomes Forrester (Nasdaq: FORR) today announced the full conference agendas for its Technology & Innovation Forum Central (Austin, September 14–15, 2026), Technology & Innovation Forum EMEA (London, September 30–October 1, 2026), and Technology & Innovation Forum East (New York City, November 4–5, 2026). This year’s theme, “The IT Singularity,” dives into the new AI era in which AI has become ubiquitous and no longer a competitive advantage on its own. To succeed, technology leaders including chief information officers, chief data officers, and chief AI officers need to integrate AI into their operating models, modernize software development and IT operations, strengthen data and governance practices, and align technology investments with business strategy. Across the Forums, tech leaders and their teams will learn how
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