ONWARD® Medical Accepted to New US FDA TAP Program for Development of its ARC-BCI™ System

Advertisement

The Company is one of the first brain-computer interface entrants accepted into this program, intended to optimize the commercialization pathway for breakthrough medical technology

EINDHOVEN, the Netherlands, March 11, 2024 (GLOBE NEWSWIRE) — ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces that it has been accepted into the US FDA’s new Total Product Lifecycle Advisory Program (TAP) for its brain-computer interface (BCI) technology.  

This acceptance follows ONWARD Medical’s announcement last week that its investigational ARC-BCI System was awarded FDA Breakthrough Device Designation (BDD), a requirement for TAP consideration. ONWARD Medical is only the second BCI company to be accepted into the program.  

Advertisement

TAP provides ONWARD Medical with early and frequent strategic engagement from the FDA, patients, providers, and payers to facilitate more rapid development and widespread patient access to safe, effective, high-quality medical devices of public health importance. As part of TAP, the Company benefits from more timely premarket interactions, earlier identification and mitigation of device development risk, and a more efficient premarket review process. 

“We are honored to be one of the first BCI companies included in this important program, which allows for the fastest FDA review times of new medical technology,” said ONWARD Medical CEO Dave Marver. “TAP enables us to reduce the time and cost to deliver the benefits of ARC-BCI to people living with paralysis.” 

The ONWARD ARC-BCI System pairs BCI technology with ARC-IM® Therapy to restore mobility after spinal cord injury (SCI). To date, two clinical feasibility studies support the potential of ARC-BCI, including one in 2021 and one in 2023 that restored lower and upper limb movement after SCI respectively. These were the first studies in history in which a human regained thought-driven movement of their limbs after paralysis. 

*All ONWARD Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use. 

About ONWARD Medical  

ONWARD® Medical is a medical technology company creating therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disabilities. Building on more than a decade of science and preclinical research conducted at leading neuroscience laboratories, the Company has received ten Breakthrough Device Designations from the US Food and Drug Administration for its ARC Therapy™ platform.   

ONWARD® ARC Therapy, which can be delivered by external ARC-EX® or implantable ARC-IM® systems, is designed to deliver targeted, programmed spinal cord stimulation. Positive results were presented in 2023 from the Company’s pivotal study, called Up-LIFT, evaluating the ability for transcutaneous ARC Therapy to improve upper extremity strength and function. The Company is now preparing regulatory approval submissions for ARC-EX for the US and Europe. In parallel, the Company is conducting studies with its implantable ARC-IM platform, which demonstrated positive interim clinical outcomes for improved blood pressure regulation, a component of hemodynamic instability, following SCI. Other ongoing studies include combination use of ARC-IM with a brain-computer interface (BCI) to address multiple symptoms of SCI.   

Headquartered in Eindhoven, the Netherlands, ONWARD Medical has a Science and Engineering Center in Lausanne, Switzerland and a US office in Boston, Massachusetts. The Company also has an academic partnership with .NeuroRestore, a collaboration between the Swiss Federal Institute of Technology (EPFL), and Lausanne University Hospital (CHUV).  

ONWARD Medical is listed on Euronext Brussels and Amsterdam (ticker: ONWD). 

For more information, visit ONWD.com and connect with us on LinkedIn and YouTube.  

For Media Enquiries:   

Aditi Roy, VP Communications  

[email protected]  

  

For Investor Enquiries:  

Khaled Bahi, Interim CFO   

[email protected]   
  

Disclaimer  

Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve several 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. All ONWARD Medical devices and therapies referenced here, including but not limited to ARC-IM®, ARC-EX®, ARC Therapy™, and ARC-BCI™ are investigational and not available for commercial use. 

   

Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. AfternoonHeadlines.com takes no editorial responsibility for the same.