ONWD ONWARD MEDICAL NV

ONWARD Medical's ARC-EX System Now Available on US Veterans Affairs Online Procurement Platforms

ONWARD Medical's ARC-EX System Now Available on US Veterans Affairs Online Procurement Platforms

ONWARD ARC-EX System for spinal cord injury is now available for purchase through VA Federal Supply Schedule and GSA Advantage platforms

Partnership with Lovell Government Services is providing commercial benefit, facilitating purchase through validated US government online purchasing platforms

EINDHOVEN, the Netherlands, Jan. 29, 2025 (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) and other movement disabilities today announces it has secured the required approvals to enable Veterans Affairs (VA) and other government agencies to immediately purchase the ARC-EX System through federal procurement systems. This milestone is the first major benefit resulting from the Company's partnership with Lovell Government Services, a Service-Disabled Veteran-Owned Small Business (SDVOSB).

"Adding the ARC-EX System to two major US federal government purchasing platforms is an important step toward making our therapy broadly available to US military Veterans living with spinal cord injury," said Dave Marver, CEO, ONWARD Medical. "The VA serves a significant percentage of Americans with spinal cord injury, and establishing these procurement channels soon after FDA authorization demonstrates our commitment to ensuring federal healthcare providers have rapid access to the latest technology."

The ARC-EX System is now available to US government clinics and other healthcare facilities through the Department of Veterans Affairs' Federal Supply Schedule National Acquisition Center (VA FSS NAC) and General Services Administration (GSA) Advantage Catalog. These web-based procurement platforms are used to manage contracts and purchases for medical equipment, supplies, pharmaceuticals and other healthcare-related products and services by VA medical centers and other authorized government providers. This comprehensive access ensures VA, Military Health System (MHS), Indian Health Service (IHS) facilities, and other US government agencies have rapid access to ONWARD's breakthrough technology for their clinics and healthcare facilities treating people with spinal cord injuries.

"We are proud to partner with ONWARD Medical to bring their breakthrough ARC-EX System to Veterans and others served by federal healthcare systems," said Chris Lovell, Major, USMC (Ret.), CEO of Lovell Government Services. "This collaboration combines our federal distribution expertise with ONWARD's innovative technology to improve access to care for those who have served our country. Together, we're dedicated to helping people with spinal cord injury regain function and independence."

As ONWARD Medical’s US government contracting and logistics partner, Lovell will also collaborate with the Company to make the ARC-EX System available through the Defense Logistics Agency's Electronic Catalog (ECAT) later this year, further broadening and facilitating purchase of the system by government healthcare providers.

The ARC-EX System delivers targeted, programmed stimulation of the spinal cord to restore upper extremity strength and function in people with SCI. This first-of-its-kind therapy represents a significant advancement in the treatment options available to Veterans and others living with SCI. It was authorized for commercial sale in the US by the FDA in December 2024.

For questions about the ARC-EX System and its availability in the US, complete this .

To learn more about ONWARD Medical’s commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit .

About Lovell Government Services

Lovell Government Services has been a trusted Service-Disabled Veteran-Owned Small Business (SDVOSB) vendor since 2013 with a proven track record of successfully introducing suppliers to the government market. Lovell is a three-time Inc. 5000 honoree and leader in the federal space. They partner with medical and pharmaceutical companies looking to better serve Veteran and military patient populations, increase their federal revenue stream, and win government contracts.

For more information, visit

About ONWARD Medical

ONWARD Medical is a medical technology company creating therapies to restore movement, function, and independence in people with SCI and other movement disabilities. Building on more than a decade of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company has developed ARC Therapy, which has been awarded ten Breakthrough Device Designations from the US Food and Drug Administration (FDA). The Company’s ARC-EX System is now cleared for commercial sale in the US. In addition, the Company is developing an investigational implantable system called ARC-IM with and without an implanted brain-computer interface (BCI).

Headquartered in the Netherlands, the Company has a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD).

For more information, visit and connect with us on and .

For Media Inquiries:

  

For Investor Inquiries:

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, delays in regulatory approvals, 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.

ARC-EX Indication for Use (US): The ARC-EX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).

Other Investigational Products: All other ONWARD Medical devices and therapies including ARC-IM and ARC-BCI are investigational and not available for commercial use.

Trademarks: ONWARD, ARC-EX, ARC-IM, ARC-BCI, and the stylized O-Logo are proprietary and registered trademarks of ONWARD Medical. Unauthorized use is strictly prohibited.



EN
29/01/2025

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on ONWARD MEDICAL NV

Guy Sips ... (+5)
  • Guy Sips
  • Jacob Mekhael
  • Mathijs Geerts Danau
  • Wim Hoste
  • Wim Lewi
Mathijs Geerts Danau
  • Mathijs Geerts Danau

Onward Medical Announces enrolment of first participant in Empower BP ...

Onward announces enrolment of the first participant in the Empower BP trial. The trial evaluates the ARC-IM system to address blood pressure instability in SCI patients. We note that Onward plans an interim analysis of the efficacy results in 2H26, which could accelerate timelines if fewer total patients are required. Short-term, we look forward to the FY25 results to gain a view on the ARC-EX commercial launch (9M25: 70 devices sold). We reiterate our € 8.9 TP and BUY rating.

 PRESS RELEASE

ONWARD Medical Announces First Participant Enrolled in Global Pivotal ...

ONWARD Medical Announces First Participant Enrolled in Global Pivotal Study Evaluating ARC-IM System to Address Blood Pressure Instability After Spinal Cord Injury Empower BP is a landmark global pivotal study evaluating the safety and effectiveness of the implantable ARC-IM® System to address blood pressure instability after spinal cord injury (SCI)Blood pressure instability is a key unmet need after SCI, with a significant impact on cardiovascular health and quality of lifeThe first participant was enrolled at Craig Hospital in Denver, Colorado, USA EINDHOVEN, the Netherlands, Feb. 04, ...

Guy Sips ... (+5)
  • Guy Sips
  • Hilde Van Boxstael
  • Mathijs Geerts Danau
  • Thomas Couvreur
  • Wim Lewi
Mathijs Geerts Danau
  • Mathijs Geerts Danau

Onward Medical Appoints Ali Kiboro as new CFO

Onward announced the appointment of a new CFO, Ali Kiboro. Mr. Kiboro brings more than 25 years of financial experience to Onward. He joins Onward from AliveDx where he served as Chief Financial Officer, leading the company's financial strategy, capital markets activities, and operational transformation. Prior to AliveDx, Ali held a variety of senior financial leadership roles at Quest Diagnostics and General Motors. Ali holds an MBA in Finance from The Wharton School and a Bachelor of Science i...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch