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
WHOOP Expands Commitment to Women's Health by Including One-Year Subscription of Natural Cycles° App in Membership4.8.2026 11:00:00 CEST | Press release
The integration gives eligible WHOOP members seamless access to the only FDA-cleared hormone-free birth control app, with the first year of Natural Cycles° included for those new to the app as part of their WHOOP membership. WHOOP, the human performance company, today announced an expansion of its women’s health offering through an integration with Natural Cycles° (NC°), the only FDA-cleared, hormone-free birth control app. WHOOP is offering a 12-month subscription to the NC° app to eligible new Natural Cycles users. Members with compatible WHOOP devices can now automatically share overnight skin temperature with the NC° app to enable personalized fertility insights and hormone-free birth control. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260804399367/en/ WHOOP Expands Commitment to Women's Health by Including One-Year Subscription of Natural Cycles° App in Membership The Natural Cycles app, a Class II medical device, u
Alphatax Makes Two Acquisitions to Strengthen Transfer Pricing Capabilities4.8.2026 10:00:00 CEST | Press release
Acquisitions Expand Transfer Pricing Offering and Support Long-Term Platform Strategy Alphatax, the global tax compliance software provider, has today announced the acquisitions of TP Accurate and Intra Pricing Solutions, expanding its transfer pricing capabilities and reinforcing its ambition to build the world's first tax operating system. The acquisitions strengthen Alphatax's transfer pricing portfolio with complementary capabilities across financial transactions and documentation. TP Accurate provides specialist software for intra-group financing arrangements, while Intra Pricing Solutions' flagship product, TPGenie, enables multinational organisations and advisors to produce transfer pricing documentation using intelligent automation and AI. Together, they expand Alphatax's ability to support the full transfer pricing lifecycle, helping customers manage compliance more efficiently while improving governance and reducing audit risk. They also represent another step towards Alphata
LabPMM® Launches Global KMT2A MRD Testing Service to Support Menin Inhibitor Development and Acute Leukemia Care4.8.2026 09:10:00 CEST | Press release
LabPMM®, an Invivoscribe® subsidiary, today announced the global availability of its new KMT2A measurable residual disease (MRD) testing service. The highly sensitive digital PCR service is available to healthcare providers, clinical researchers, and biopharmaceutical partners through LabPMM’s global laboratory network, with CAP/CLIA-accredited testing available in the U.S. The service addresses a growing need for accurate molecular monitoring in acute leukemias.1,2,3 KMT2A rearrangements (KMT2Ar) are oncogenic drivers in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).4 These rearrangements are present in about 80% of infant cases and 5-15% of childhood and adult leukemia cases.5 KMT2Ar leukemias are associated with chemotherapy resistance, high relapse rates, and poor clinical outcomes.5 The emergence of menin inhibitors is transforming the therapeutic landscape for patients with AML and ALL, particularly those with KMT2A-rearranged and NPM1-mutated disease.6 The
“HATSUNE MIKU LIGHTS TOKYO” Debuts on July 254.8.2026 09:00:00 CEST | Press release
Giant Hatsune Miku Returns to Light Up Tokyo’s Night! The Tokyo Metropolitan Government has been presenting year-round projection mapping displays on the Tokyo Metropolitan Government Building, using light and sound to showcase a wide range of artistic expressions as part of its efforts to create new nighttime tourism attractions in Tokyo. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260802298570/en/ © Crypton Future Media, INC. On Saturday, July 25, "HATSUNE MIKU LIGHTS TOKYO", featuring the globally beloved virtual singer Hatsune Miku, held its first screening. The work brings the world of the popular song “M@GICAL☆CURE! LOVE ♥ SHOT!” to life across the entire façade of the Tokyo Metropolitan Government Building. Since its launch in February 2024, “TOKYO Night & Light” has welcomed visitors from Japan and around the world, with total attendance surpassing 1.55 million. As one of Tokyo’s emerging landmark attractions, the
Mosaic Therapeutics appoints Dr Allison Jeynes as Chair of the Board4.8.2026 09:00:00 CEST | Press release
Accomplished life sciences leader with a proven track record of driving successful development of novel therapeutics, joins Mosaic to guide its next phase of growthAllison brings three decades of drug development, board and executive leadership experience to support Mosaic’s transition towards a clinical-stage company Mosaic Therapeutics, Ltd, (‘Mosaic’, or ‘the Company’) an oncology therapeutics company developing novel, targeted drug combinations across a range of haematological and solid cancers, today announced the appointment of Dr Allison Jeynes as Chair of the Board to support its next phase of growth and advancement towards clinical development. Allison succeeds Dr Edward Hodgkin, who remains a Non-Executive Director of the Board. Allison is a UK-trained oncologist and highly-experienced life sciences leader, and brings over three decades of drug development and executive experience to Mosaic Therapeutics. As CEO of Avillion, a clinical development company, for the last 13 year
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