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
SOLUM and Simbe Expand European Collaboration to Advance Intelligent Store Operations5.3.2026 08:00:00 CET | Press release
SOLUM (KOSPI: 248070) and Simbe announced the expansion of their strategic collaboration to further integrate autonomous store intelligence with SOLUM’s Newton Electronic Shelf Label (ESL) infrastructure across Europe. The collaboration was highlighted at EuroShop, where Simbe’s Store Intelligence™ platform was demonstrated live at the SOLUM booth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260304620371/en/ SOLUM and Simbe announced the expansion of their strategic collaboration to further integrate autonomous store intelligence with SOLUM’s Newton Electronic Shelf Label (ESL) infrastructure across Europe. (Image: SOLUM) Simbe recently introduced Tally 4.0, the next generation of their autonomous shelf-scanning robot, reflecting the company’s continued evolution in retail shelf digitization, incorporating extended runtime, enhanced edge computing, and advanced vision capabilities. Designed to deliver deeper shelf coverag
Mosaic Clinical Technologies Announces FDA Breakthrough Device Designation for Cognita’s Generative AI Model for Radiology5.3.2026 08:00:00 CET | Press release
Breakthrough designation means Cognita™ will engage in prioritized interaction with FDA regarding clearance of device designed to help solve the radiology capacity bottleneck Mosaic Clinical Technologies™, a wholly-owned subsidiary of Radiology Partners, is pleased to announce that Cognita™, its AI business unit developing generative vision-language models (VLMs) for radiology, has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for Cognita Chest X-Ray (CXR)™1 across multiple critical indications. Cognita CXR is an industry-first generative vision-language model designed to assist radiologists in the interpretation of chest X-rays and is the first radiology generative AI model, and one of very few radiology AI solutions, to be granted this designation2. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260304633206/en/ Cognita™ operates as the AI business unit of Mosaic Clinical Technologies™, a
Cielo Advances Resilient Remote Connectivity for Its Nationwide Payment Terminal Fleet With Thales5.3.2026 08:00:00 CET | Press release
Cielo, one of Brazil’s leading payment service providers, is piloting remote connectivity management for its point-of-sale (POS) terminals across the country, in partnership with Thales. By deploying Thales’s eSIM connectivity management platform based on the latest GSMA SGP.32 IoT standard, Cielo is accelerating its transition from manual, on-site SIM management to fully remote, secure and resilient connectivity. For Cielo, connectivity is mission critical. When payment terminals lose network access, transactions stop. To strengthen operational resilience and enhance merchant experience, Cielo is modernizing its connectivity architecture across its terminal fleet. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260304089321/en/ Cielo advances resilient remote connectivity for its nationwide payment terminal fleet with Thales. Using Thales’s eSIM technology as part of this strategy, Cielo can remotely switch mobile network op
GAIA and Daiichi Sankyo Europe Enter Exclusive Partnership to Launch Next-Generation Digital Therapeutic for Cardiovascular Care in Europe.5.3.2026 08:00:00 CET | Press release
GAIA, the pioneer in evidence-based digital therapeutics and Daiichi Sankyo Europe, today announced an exclusive strategic partnership to commercialize lipodia upon regulatory approval1. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260224658973/en/ Dr. Mario Weiss, Founder & CEO of GAIA AG This digital therapeutic is designed to support adults living with hypercholesterolemia. The comprehensive collaboration brings together GAIA’s long-standing expertise in developing clinically validated non-pharmacological interventions with Daiichi Sankyo’s highly scientific experience in cardiovascular risk management and health. Together, the partners - both members of the German Association of Research-Based Pharmaceutical Companies (vfa) - aim to address a persistent gap in chronic care: leveraging digital technologies to make a difference in patients’ lives by supporting sustainable, long-term behaviour change. Expanding Cardiovasc
Galderma Delivers Record 2025 Results With Net Sales of 5.207 Billion USD, up 17.7% at Constant Currency1, and Core EBITDA2 of 1.211 billion USD, Growing 18.9% at Constant Currency5.3.2026 07:00:00 CET | Press release
Ad hoc announcement pursuant to Art. 53 LR Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced its financial results for the full year 2025. Record net sales of 5,207 million USD, surpassing 5 billion USD in a year for the first time and representing 17.7% year-on-year growth on a constant currency1 basis, primarily driven by volume. Broad-based net sales growth, growing double-digits in both International markets and the U.S. Outperforming the market in each product category, with strong net sales growth in Injectable Aesthetics (11.5%), Dermatological Skincare (9.3%) and Therapeutic Dermatology (50.2%), all year-on-year at constant currency. Strong launch momentum across future growth drivers, including Nemluvio® (nemolizumab) delivering 452 million USD in net sales; Relfydess™ (RelabotulinumtoxinA) outperforming expectations in 17 International markets; Sculptra® gaining significant market share in its first year in China; and continued new produ
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