ONWARD Announces First Patient Enrollment in HemON Study and First-in-Human Use of its ARCIM Implantable Neurostimulator
ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury (SCI), today announces the first patient enrollment in the HemON Study and first-in-human use of the Company’s ARCIM implantable pulse generator (IPG), designed to stimulate the spinal cord to restore movement and autonomic function for people with spinal cord injury and other conditions that affect mobility.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220509005325/en/
Neurosurgeon Dr. Jocelyne Bloch holding ARC-IM IPG. Credit: ONWARD Medical
“ONWARD’s ARCIM IPG offers surgeons precision and flexibility never before available in an implantable neurostimulator,” said Dr. Jocelyne Bloch, Chief of Functional Neurosurgery at Switzerland’s Lausanne University Hospital (CHUV). “Clinicians will be able to leverage these advanced capabilities to refine and deliver epidural stimulation therapies for people with spinal cord injury.”
The ONWARD ARCIM IPG was purpose-designed to deliver targeted electrical stimulation to the spinal cord in the precise areas responsible for triggering or controlling movement and autonomic functions that may be affected by a spinal cord injury or neurodegenerative disorder. The IPG is designed to operate in closed-loop, incorporating data from sensors or other devices that may be deployed inside or outside the body. It is also designed to deliver therapy through an associated ARCIM lead with precision and flexibility, allowing clinicians to apply biomimetic stimulation that can closely replicate normal spinal cord activity patterns during mobility or autonomic function.
The HemON Study (NCT05111093) aims to evaluate the safety and preliminary efficacy of ARCIM Therapy to improve blood pressure management and trunk control in people with spinal cord injury who suffer from orthostatic hypotension, which is characterized by debilitatingly low blood pressure that may occur when people sit upright, stand, or change body position. Orthostatic hypotension has been observed in approximately 75% of people with spinal cord injury. HemON will enroll up to 16 participants at CHUV in Lausanne, Switzerland.
“The first implant of our ARCIM IPG is a huge milestone for ONWARD and the SCI community,” said Dave Marver, CEO of ONWARD. “This important achievement validates our vision for a future in which clinicians will no longer need to struggle with modified pain stimulators to explore new treatments and instead will be able to use devices and therapies designed specifically to treat people with spinal cord injury and their unique needs.”
To learn more about ONWARD’s ARC Therapy and the company’s vision to restore movement, independence and health in people with spinal cord injury, please visit ONWD.com.
THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014).
ONWARD 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 (ARCIM) or external (ARCEX) 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 ARCIM and ARCEX. The company’s first FDA pivotal trial, called Up-LIFT, completed enrollment in December 2021 with 65 subjects worldwide.
ONWARD is headquartered at the High Tech Campus in Eindhoven, the Netherlands. It maintains an office in Lausanne, Switzerland and has a growing U.S. presence in Boston, Massachusetts, USA. For additional information about the company, please visit ONWD.com. To access our 2022 Financial Calendar, please visit IR.ONWD.com.
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
For Media Enquiries:
Simon Gentry +44 (0)20 3757 6772
For Investor Enquiries:
For Company Enquiries:
ONWARD – email@example.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
xFusion Held the European Partner Summit Under the Theme of "Together for a Better Future"19.5.2022 20:00:00 EEST | Press release
On May 19, xFusion held its first 2022 European Partner Summit in Paris, under the theme of "Together for a Better Future." xFusion Digital Technologies Co., Ltd. invited dozens of core partners from more than 10 countries, including France, Germany, Switzerland, Sweden, Poland, Hungary, and countries in the Nordic region to discuss the future and new value exploitation of the industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220519005813/en/ (Photo: Business Wire) Terry Fang, President of xFusion Global Marketing and Sales Department, gave a welcome speech on behalf of xFusion. Intel and other partners then shared the latest concepts and practices within the European digital economy, focusing on topics such as industrial digitization and intelligentization, while offering suggestions for the development of industrial digital intelligence. Cooperation with Partners for a New European Digital Ecosystem Europe is transi
RMS Expands Global Risk Views Coverage19.5.2022 17:30:00 EEST | Press release
RMS ®, a Moody’s Analytics company and world-leading risk modeling and solutions company, announces it will be launching new global views for acute and chronic perils and their climate change impact. RMS already offers a range of regional peril and climate change models, which support detailed acute physical loss modeling products, as well as data products covering hazard and risk scores, and loss costs for individual locations, across multiple time horizons. RMS climate change models and data products have been welcomed by the market, and allow users to stress test portfolio management, risk mitigation, and adaption strategies. The newly announced global views significantly extend RMS’s peril and climate change impact coverage to provide fully correlated global views of risk, and include event frequency and severity, and analysis for current baseline and future climate views. With these new global views, RMS not only delivers a view of risk for acute peril-specific risks, but also chr
Envision the Future and Take on the Power of Computing with GIGABYTE at COMPUTEX 202219.5.2022 17:29:00 EEST | Press release
GIGABYTE, a world leader in computer technology, will be presenting “Power of Computing” as its theme of the year, and exhibiting its leading products and solutions designed for various industries and fields in the upcoming COMPUTEX Taipei. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220519005640/en/ Envision the Future and Take on the Power of Computing with GIGABYTE at COMPUTEX 2022 GIGABYTE has curated its presentation around the theme “Power of Computing” to demonstrate that, everything from the cloud to the edge, from team collaboration to individual creation, from business applications to personal use, computing done by servers in data centers to process massive data and embedded systems in IoT and personal computers to render real-time information is the key behind groundbreaking innovations that appear in the fields of AI, cloud deployment, smart technologies, and digital content creation, etc. Data Center is an i
Immervision Brings Human-Like Vision Capabilities to Halodi Robotics19.5.2022 16:17:00 EEST | Press release
Immervision, the world’s leading developer of advanced vision systems combining optics, image processing, and sensor fusion technology, is proud to announce it was chosen by Halodi Robotics to provide their next generation vision system for their humanoid service robot platform, capable of handling both human and computer vision. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220519005594/en/ (Graphic: Business Wire) Robots are capable of performing a wide variety of tasks that are difficult or dangerous for humans to perform. To intelligently and accurately perform these tasks, they require mobility and the aptitude to explore, understand and function within various environments. For a robot to work autonomously, or problem-solve with human assistance, it requires sensor data to understand the human world and the ability to process the data and respond in a timely manner. The difficulty is that for certain applications, a r
Mary Kay Inc. Collaborates With European Partners to Support Native Oyster Restoration Projects19.5.2022 16:03:00 EEST | Press release
Oyster reefs benefit humans and the environment through a suite of ecosystem services. A single oyster can filter up to 240 liters of water a day, resulting in increased water quality and clarity and support a unique and highly diverse community of fish and invertebrate marine species. At the same time, oyster reefs are the world’s most threatened marine habitat, with an estimated 85 percent loss globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220519005168/en/ Mary Kay logo In celebration of World Endangered Species Day and International Day for Biological Diversity, Mary Kay Inc., a global leader in corporate sustainability, announced its collaboration with The Nature Conservancy (TNC) and European partners to support native oyster restoration projects in the UK and continental Europe. TNC helped to launch the Native Oyster Restoration Alliance (NORA), a European network made up of governmental agencies, scientists
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