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
Cooler Master Earns Four iF Design Awards 2026 for PC Design Innovation10.3.2026 08:07:00 CET | Press release
COSMOS Alpha, MasterFrame 360 Panorama, Custom GPU Fan Cooling Kit, and MasterFan A120 Recognized for Outstanding Product Design Cooler Master, a global leader in PC components and tech lifestyle solutions, today announced that four of its products have received the iF DESIGN AWARD 2026, one of the world’s most respected design honors presented annually by iF Design in Hamburg, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310659475/en/ Cooler Master's winning iF designs: MasterFan A120, MasterFrame 360 Panorama, COSMOS Alpha and Custom GPU Fan Cooling Kit. The award recognizes outstanding achievement in product design, innovation, and user experience. For Cooler Master, the recognition highlights a design philosophy that combines engineering performance with builder-focused creativity. The award-winning products include the COSMOS Alpha, MasterFrame 360 Panorama, Custom GPU Fan Cooling Kit, and MasterFan A120,
GigaDevice Expands GD25UF Series Density Empowering AI Computing with 1.2V Ultra-Low Power Storage10.3.2026 08:00:00 CET | Press release
GigaDevice (HKEX: 3986), a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, today announced the expanded density range of its GD25UF series 1.2V ultra-low power SPI NOR Flash, now spanning from 8Mb to 256Mb. This expansion precisely addresses diverse storage needs across wide range of applications from the advanced high performance AI computing space to the low power battery operated devices. From its intrinsic low-voltage and ultra-low power performance, portable devices like wearables, hearables, AI ASIC platforms, medical devices, and other fast-growing emerging markets can have longer battery life while driving device miniaturization from edge AI to ultra-compact form factors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310862079/en/ GD25UF SPI NOR Flash Expanded Density Powering the Low-Voltage SoC Era with a Smarter System Architecture As se
GigaDevice Introduces GD32M531 MCU, Empowering Technological Innovation in Motor Control10.3.2026 08:00:00 CET | Press release
GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products today officially announced the launch of the GD32M531 series 32-bit microcontrollers (MCUs) specifically tailored for motor control applications. Powered by the Arm® Cortex®-M33 core, the series integrates dedicated hardware accelerators for motor control and highly integrated peripheral resources. With exceptional computing performance, precise control capability, and industrial-grade high reliability, it achieves accurate control of dual motors + PFC, providing a high-efficiency and cost-effective solution for various home appliance application scenarios such as air conditioner outdoor units, air source heat pumps, washing machines/dryers, dishwashers, and multi-burner induction cookers. Samples and development boards of the GD32M531 series MCU are now available, and mass production and supply will officially start in April. This press release feature
TTNE Announces the World Sauna Award “SAUNA37 2026”10.3.2026 04:00:00 CET | Press release
TTNE Inc. today announced “SAUNA37 2026”, the world sauna award recognizing 37 sauna destinations worldwide This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260308149186/en/ SAUNA37 Through this initiative, we aim to contribute to the global growth of sauna culture and create a future where people around the world can lead happier and healthier lives through saunas. TTNE was founded by Totonoe Oyakata (Dai Matsuo) and Sauna Master (Daisuke Akiyama), who have personally experienced some of the world's finest saunas. Their desire to establish a similar deep-rooted sauna culture in Japan led to the creation of TTNE. As people once again have the opportunity to explore sauna experiences around the world, SAUNA37 aims to introduce the diverse and unique sauna facilities and cultures across the globe. Through this initiative, we seek to further evolve Japan’s sauna culture while also sharing it with the world. TTNE remains committed
Hexagon Semi’s HX77 AR Display Processor Achieves Ultra-Low Power Consumption with VeriSilicon’s Nano IP Portfolio10.3.2026 01:00:00 CET | Press release
VeriSilicon’s Mature GPU, Display Processing, and DeWarp IPs Collaboratively EnableHighlyIntegrated, Low-Latency AR Display Processing VeriSilicon (688521.SH) today announced that Hefei Hexagon Semiconductor (Hexagon Semi), an image processing SoC provider, has adopted VeriSilicon’s proven IP portfolio in its high-performance HX77 series image processing SoC. The adopted IPs include the GCNanoUltraV 2.5D Graphics Processing Unit (GPU) IP, DW100 DeWarp Processing IP, and DC9200Nano Display Processing IP. The SoC has successfully taped out, achieving a first-pass silicon success. The HX77 series is a highly integrated, low-power image processing SoC based on RISC-V architecture, integrating comprehensive video input/output interfaces, image processing, and system control capabilities. By leveraging an innovative heterogeneous computing architecture and sophisticated power management technology, HX77 has successfully achieved a technological breakthrough that enables 2K@60fps output with
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