ONWARD Receives FDA Breakthrough Device Designation for ARC-IM for Blood Pressure and Trunk Control in Spinal Cord Injury
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 Naturepaper 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.
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
For general inquiries:
For media inquiries:
Bryan Gibbs, Finn Partners
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
Prosus FAQ's Regarding the Voluntary Share Exchange Offer to the Holders of Naspers N Ordinary Shares30.7.2021 19:00:00 CEST | Press release
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO ANY JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. PLEASE SEE THE IMPORTANT DISCLAIMERS AT THE END OF THIS ANNOUNCEMENT. Shareholders are referred to the prospectus (Prospectus) published by Prosus N.V. (Prosus) on 12 July 2021 in respect of the voluntary share exchange offer by Prosus to Naspers (JSE:NPN) (LSE:NPSN) N Shareholders (Exchange Offer). Further to the announcement issued by Prosus today, shareholders are advised that since the publication of the Prospectus Prosus has received certain frequently asked questions regarding the Exchange Offer and has therefore made certain materials available today at www.share-exchange-offer.com, where these frequently asked questions have been addressed by Prosus. Cape Town South Africa 30 July 2021 About Naspers Established in 1915, Naspers has transformed itself to become a global consumer internet compan
Prosus FAQ's Regarding the Voluntary Share Exchange Offer to the Holders of Naspers N Ordinary Shares30.7.2021 18:59:00 CEST | Press release
Shareholders are referred to the prospectus (Prospectus) published by Prosus on 12 July 2021 in respect of the voluntary share exchange offer by Prosus to Naspers N Shareholders (Exchange Offer). Since the publication of the Prospectus Prosus has received certain frequently asked questions regarding the Exchange Offer and has therefore made certain materials available today at www.share-exchange-offer.com, where these frequently asked questions have been addressed. About Prosus Prosus is a global consumer internet group and one of the largest technology investors in the world. Operating and investing globally in markets with long-term growth potential, Prosus builds leading consumer internet companies that empower people and enrich communities. The group is focused on building meaningful businesses in the online classifieds, food delivery, payments and fintech, and education technology sectors in markets including India, Russia, and Brazil. Through its ventures team, Prosus invests in
I’mbesideyou Inc. Launched “UNION OF EMOTIONS” Service Using AI to Visualize Cheering Each Other Across National Borders30.7.2021 16:25:00 CEST | Press release
I’mbesideyou Inc. (Setagaya-ku, Tokyo CEO: Shozo Kamiya, hereinafter referred to as I'mbesideyou) launched the "UNION OF EMOTIONS" service on July 23, 2021, the opening day of an international sporting event. This is the first time we have been able to visualize people cheering each other with emotion analysis AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210730005404/en/ A visualization of the emotions of cheers flying around the world: Click on each cheer to learn more about that country. (Photo: Business Wire) More than 20,000 cheers have already been sent from more than 79 cities across more than 14 countries around the world, and the sight of the cheers flying across the globe has moved many people on social media. UNION OF EMOTIONS, is the world's first example of people's emotions connecting in real time across countries with the help of AI. It is scheduled to be available until August 8, when the closing ceremon
Palace Bidco Oy (“WSIP Bidco”) Has Received Necessary Regulatory Approval Concerning the Recommended Cash Offer to the Shareholders of Adapteo Plc (“Adapteo”)30.7.2021 14:23:00 CEST | Press release
This announcement is not an offer, whether directly or indirectly, in Australia, Canada, Hong Kong, Japan, New Zealand or South Africa or in any other jurisdiction where such offer pursuant to legislation and regulations in such relevant jurisdiction would be prohibited by applicable law. Shareholders not resident in Sweden or Finland who wish to accept the Offer (as defined below) must make inquiries concerning applicable legislation and possible tax consequences. Shareholders should refer to the offer restrictions included in the section titled “Important information” at the end of this announcement and in the offer document which was published on 23 June 2021. Shareholders in the United States should also refer to the section titled “Special notice to shareholders in the United States” at the end of this announcement and in the offer document. On 17 May 2021, WSIP Bidco, a private limited liability company formed on behalf of, and indirectly wholly owned by, West Street Global Infra
Taipei Exchange Launches Pioneer Stock Board to Support Innovative Enterprises30.7.2021 10:00:00 CEST | Press release
The Taipei Exchange, TPEx, launched Pioneer Stock Board (PSB) on July 20, 2021, which welcomed its first company on July 26. Pioneer Stock Board marks the evolution of the stock market into an innovation-friendly ecosystem. It aims to facilitate entry to capital markets for more innovative enterprises. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210730005008/en/ Taipei Exchange launches Pioneer Stock Board to support innovative enterprises (Photo: Business Wire) At the PSB Launch Ceremony, Premier Su Tseng-chang delivered the opening speech, emphasizing the government’s support. Su said, “Taiwan’s capital market breaks new ground today, by establishing this board. PSB will support innovative enterprises, a key driver of economic transformation, by providing companies with quick access to capital needed for continued growth.” Dr. Tien-mu Huang, Chairperson of Financial Supervisory Commission, remarked, “Innovation underpin
ITRS Group Continues Expansion With the Acquisition Of Opsview30.7.2021 10:00:00 CEST | Press release
ITRS Group, a leading provider of real-time monitoring and analytics software, has acquired 100% of Opsview Limited, a modern, scalable monitoring platform, which provides unified insight into dynamic IT operations on-premises, in the Cloud or hybrid. Opsview will remain and operate as a separate brand and entity. The purchase of Opsview aligns well with ITRS’ strategy to build, buy and partner to deliver smart, automated and predictive end-to-end monitoring solutions for increasingly complex IT estates across industries. This development follows the successful strategic acquisitions of Sumerian, OP5 and Uptrends. Guy Warren, CEO of ITRS commented: “Opsview is trusted by hundreds of businesses, government organisations and service providers globally. This acquisition will enhance our technological innovation, increase our portfolio capability, and provide continued expansion across our global support services.” Mike Walton, CEO and founder of Opsview said: “Partnering with ITRS represe
Schneider Electric Moves Forward With Its Sustainability Impact Targets, Mobilizing Support From Employees, Partners and Customers30.7.2021 08:32:00 CEST | Press release
Schneider Electric, the leader in the digital transformation of energy management and automation, published today its half-year progress overview on setting up and advancing on its 2021-2025 sustainability impact targets. Schneider Electric, named as the world’s most sustainable corporation 2021 by the Corporate Knights Global 100 Index, announced the acceleration of its sustainability strategy in January, aligned to its commitments regarding climate, resources, trust, equal opportunities, generations, and local communities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729006295/en/ Schneider Sustainability Impact - H1 Results (Graphic: Business Wire) Since then, the Group has successfully launched The Zero Carbon Project, its initiative to halve carbon emissions of its top supply chain partners by 2025, a call to action already joined by 91% of them. By engaging, training, and supporting the sustainable transformation
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