ONWARD® Medical Reaffirms Guidance, Shares 2024 Strategic Priorities, and Releases Unaudited Q4 Financial Highlights

THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014)

Company expects to commercialize its ARC-EX^® System and commence the Empower BP Pivotal Study for the ARC-IM^® System in 2024

Company ended2023 with EUR 29.8M in cash; Q4 cash burn was EUR 7M; cash runway guidance reaffirmed through year-end 2024

Company reaffirms guidance and is highly confident the FDA submission for itsARC-EX System will occur in 1H 2024

Company expects to advance clinical and development activities for its unique ARC-BCITM brain-computer interface therapy

EINDHOVEN, the Netherlands, March 15, 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 reaffirms previous cash guidance, shares its strategic priorities for 2024, and releases its unaudited Q4 financial highlights.  

2024 Strategic Priorities

• ARC-EX commercial launch. The Company expects to launch its investigational ARC-EX Therapy to improve the strength and function of the upper extremities after SCI in the US in Q4 2024. Major associated milestones this year include FDA De Novo submission, FDA clearance, and first commercial sale. 

• ARC-IM pivotal study commencement. The Company intends to launch its global pivotal study, called Empower BP, for investigational ARC-IM Therapy to address blood pressure instability after spinal cord injury. Major associated milestones this year include FDA IDE submission, FDA IDE approval and first participant enrollment. 

• ARC-BCI therapy advancement. The Company plans to advance clinical and development activities for its investigational ARC-BCI System, leveraging grant funding and the recently announced FDA Breakthrough Device Designation and acceptance into the FDA’s new TAP program. 

Q4 Unaudited Financial Highlights

• The Company plans to publish its Full Year 2023 financial statements on April 25, 2024. 
• The preliminary unaudited cash and cash equivalent balance on December 31, 2023 was EUR 29.8 million. 
• Net cash outflow in Q4, 2023 was EUR 7.0 million, consistent with the EUR 7.0M cash burn in Q3, 2023. 
• The Company confirms its previous guidance of expected cash runway through the end of 2024 and will look for efficient ways to strengthen its balance sheet in the coming months. 

“We made robust progress in 2023, achieving important clinical milestones, spending capital wisely, and preparing for regulatory submission of our first therapy,” said Dave Marver, CEO of ONWARD Medical. “In 2024, our focus is commercialization -- we look forward to bringing the SCI Community the first-ever therapy that can improve strength and function even years after a spinal cord injury.”  

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 ONWD.com. 

*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   

media@onwd.com

For Investor Enquiries:   

Khaled Bahi, Interim CFO    

investors@onwd.com

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-BCI™ and ARC Therapy™, are investigational and not available for commercial use.  

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