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
Andersen Consulting udvider platformen med Reach Consulting5.3.2026 22:05:00 CET | Pressemeddelelse
Andersen Consulting udvider sin platform i Mellemøsten gennem en samarbejdsaftale med Reach Consulting, et digitalt transformations- og rådgivningsfirma med hovedsæde i De Forenede Arabiske Emirater. Reach Consulting hjælper organisationer med at skabe vækst, håndtere risici og navigere i komplekse forandringer gennem en omfattende portefølje af ydelser, herunder digital transformation, strategi, intern revision og M&A-rådgivning. Med en tilstedeværelse i De Forenede Arabiske Emirater, Saudi-Arabien, Oman, Qatar og Jordan betjener firmaet kunder i både den offentlige og private sektor med skræddersyede løsninger, tværfaglig ekspertise og indgående lokalkendskab. Reach Consulting kombinerer skala med agilitet for at fremme driftsresultater og innovation i arbejdsstyrken. "Transformation fungerer bedst, når lokal indsigt, tværfaglig ekspertise og praktisk udførelse spiller sammen," udtalte Suhail Shaker, administrerende direktør for Reach Consulting. "Ved at samarbejde med Andersen Consu
2PointZero Group Completes Majority Acquisition in Italy-Based ISEM Packaging Group for AED 704 Million5.3.2026 22:02:00 CET | Press release
Transaction results in 60.8% ownership by 2PointZero Packaging becomes the sixth consumer-focused vertical with ISEM as an anchor 2PointZero Group PJSC (ADX: 2PointZero), a next-generation investment powerhouse focused on energy and consumer sectors, announced today that it has formally completed the transaction to acquire a majority position in ISEM, a leading European packaging group serving beauty, fashion, luxury, nutraceuticals and more, for AED 704 million through a combination of secondary and primary capital earmarked to accelerate organic and inorganic growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305800523/en/ 2PointZero Group completes majority acquisition in Italy-based ISEM Packaging Group for AED 704 million (Photo: AETOSWire) 2PointZero Group now holds 60.8% of ISEM, while Peninsula Capital and minority investors own the remaining 39.2%. This marks the start of a strategic partnership between 2Poin
Xsolla Announces Reseller Program to Help Game Developers Unlock New Revenue Streams in Local Markets5.3.2026 18:00:00 CET | Press release
Game Developers And Publishers Can Now Reach More Players By Partnering with Official Distributors And Resellers Globally Without Building Local Infrastructure Xsolla, a leading global video game commerce company, today announced the Xsolla Reseller Program, a new product designed to help game developers scale and capture untapped revenue in local markets with no development needed. The program launches with a curated cohort of resellers and distributors in Southeast Asia and Latin America, with expansion into additional regions throughout 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305047070/en/ Graphic: Xsolla As game developers pursue global growth, they face a fundamental infrastructure challenge: billions of dollars in revenue remain untapped in emerging, cash-dependent economies, such as Southeast Asia, Latin America, the Middle East, and North Africa, where players purchase digital content through local di
Andersen Consulting styrker sine kompetencer inden for cybersikkerhed gennem samarbejde med A3Sec5.3.2026 17:16:00 CET | Pressemeddelelse
Andersen Consulting styrker sine tilbud inden for cybersikkerhed og teknologisk transformation gennem en samarbejdsaftale med A3Sec, et firma, der specialiserer sig i datadrevet trusselsdetektion, hændelsesrespons og exposure management. Med hovedsæde i Spanien og kontorer i Mexico og Colombia har A3Sec mere end 14 års erfaring med at hjælpe offentlige og private organisationer inden for finans, telekommunikation, energi, den offentlige sektor og erhvervslivet med at sikre deres digitale aktiver. Virksomheden driver sit Security and Digital Surveillance Center® (CSVD®) døgnet rundt med et team på over 180 cybersikkerhedseksperter og betjener mere end 280 kunder verden over. Firmaet leverer integrerede cybersikkerhedstjenester, herunder managed detection and response, cybertelemetri, trusselsanalyse og krisestyring, og hjælper kunder med at styrke deres robusthed og omdanne risiko til en strategisk fordel, samtidig med at de effektivt håndterer eksponering og minimerer risiko. "Vores fo
Xsolla Agency Launches to Empower Creators Across Entertainment-Based Intellectual Property5.3.2026 16:23:00 CET | Press release
New Service Simplifies Access to Premium IP Licensing, Driving Discoverability, Player Engagement, and Revenue for Game Developers Xsolla, a global video game commerce company, today launched Xsolla Agency, a comprehensive service connecting game developers with premium entertainment-based intellectual property (IP). The integrated offering addresses critical challenges for game creators: access to world-class IP, global monetization capabilities, and the operational infrastructure needed to build sustainable businesses. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305044119/en/ Graphic: Xsolla Xsolla Agency simplifies access to entertainment-based licenses through expert-led negotiations and industry relationships, offering affordable, monetization-focused deals structured for maximum ROI. Strategic IP partnerships increase discoverability, reduce user acquisition costs, and drive higher player spend through impactful
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