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
AI Meets Traditional Culture: Huangshan Captures Widespread Attention at ITB Berlin7.3.2026 10:22:00 CET | Press release
Huangshan, one of China’s most iconic scenic destinations, drew significant attention at this year’s ITB by presenting a compelling fusion of traditional Chinese culture and cutting-edge artificial intelligence under the slogan “The world of Huangshan is for the world.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260307909978/en/ International visitor admires Huangshan cultural and creative exhibits at the Huangshan stand during ITB Berlin. Located in eastern China’s Anhui Province, Huangshan is famed for its “Five Natural Wonders” — fantastic pines, grotesque rocks, sea of clouds, hot spring and winter snow. The mountain is widely regarded as one of China’s greatest mountain landscapes. It is also a rare natural heritage site that simultaneously holds multiple international designations, including UNESCO World Cultural and Natural Heritage status, a UNESCO Global Geopark and a World Biosphere Reserve. At ITB, the Huangsh
Incyte Announces the European Commission Approval of Zynyz® (retifanlimab) for the First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC)6.3.2026 22:42:00 CET | Press release
- Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) is the first systemic treatment for adult patients with advanced SCAC in Europe- The EC approval is based on results of the POD1UM-303 study which showed that adult patients with advanced SCAC achieved significantly improved progression-free survival with Zynyz in combination with carboplatin and paclitaxel as a first-line treatment compared to chemotherapy alone.1 Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). “The EC approval of Zynyz marks an important step forward for patients with advanced SCAC, a rare cancer for which meaningful treatment advances have not occurred in several decades,” said Bill Meur
Dfns Launches Payouts6.3.2026 21:27:00 CET | Press release
Dfns today announced the launch of Payouts, a new API enabling institutions to convert stablecoins to fiat and route payouts across multiple bank accounts while keeping wallet-level governance and controls in place. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305327930/en/ Convert stablecoins to fiat and settle payouts to bank accounts in 94 countries, today. Solving the problem of single-rail off-ramps Today, most fintechs and institutions still hard-wire a single payout provider into their stack, or rely on vertically integrated models that bundle routing, pricing, custody, and settlement together. That approach may be convenient early on, but it creates structural problems at scale: weak price discovery because there is no competitive pressure on margins, limited auditability because routing decisions are opaque, and operational fragility because a single provider degradation in any corridor requires architectural i
Klarna Group Plc Clarifies Mechanics of March 9 Lock-Up Expiration6.3.2026 20:23:00 CET | Press release
Klarna Group plc (NYSE: KLAR) today issues the following clarification to ensure investors and market participants have accurate information regarding the mechanics of its lock-up expiration on March 9, 2026, the processes required before pre-IPO shares can be traded on the NYSE, and the prior liquidity opportunities already available to shareholders. This release contains only factual descriptions of the Company's share structure and applicable processes. It does not constitute guidance or a projection of any kind regarding future trading volumes, share price, or the intentions of any shareholder and speaks only as of the date of this press release. 1. 335 million locked-up shares — but two different categories Of the 378 million total ordinary shares outstanding, approximately 335 million are subject to lock-up restrictions expiring March 9, 2026. However, these shares fall into two distinct categories governed by separate sets of regulations. A. 159 million shares (48% of locked-up
Lone Star Funds Announces Agreement to Acquire the Capsules & Health Ingredients Division of Lonza Group AG6.3.2026 18:30:00 CET | Press release
Lone Star Funds (“Lone Star”) today announced that an affiliate of Lone Star Fund XII, L.P. has entered into a definitive agreement to acquire the Capsules & Health Ingredients (“CHI”) division of Lonza Group AG. As part of the transaction, Lonza will retain a 40% equity position in the business. Headquartered in Basel, Switzerland, CHI operates globally across the Americas, Europe and Asia Pacific. The business comprises three segments: Hard Empty Capsules: leading global manufacturer of gelatin and plant-based capsules offering a broad range of innovative solutions for pharmaceutical and nutraceutical customers. Dosage Form Solutions: end-to-end development and manufacturing platform serving nutraceutical and pharmaceutical customers. Health Ingredients: provider of branded, science-backed nutrition ingredients serving joint health, energy and active lifestyle markets. Lone Star believes CHI is a high-quality, globally recognized platform with strong technical capabilities, different
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