ONWARD Medical Reports Q1 2024 Update and Year-to-Date Highlights

Nature Medicine published Up-LIFT pivotal trial results

Submitted FDA De Novo application for ARC-EX System

Successfully raised EUR 20M in equity capital

EINDHOVEN, the Netherlands, May 23, 2024 (GLOBE NEWSWIRE) --  ONWARD Medical N.V. (Euronext: ONWD), a medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today provided a Q1 2024 business update.

“This week’s publication of Up-LIFT pivotal trial results in Nature Medicine underscores the tremendous potential of ARC-EX Therapy to restore independence in daily activities for people with spinal cord injury,” said Dave Marver, CEO of ONWARD Medical. “We are working closely with the FDA toward clearance for the ARC-EX System and we are preparing to introduce this technology to the SCI Community in the US later this year.”

Q1 and Year-To-Date Highlights:

Clinical and Development

• In January 2024, the Company expanded its HemON clinical feasibility study to explore use of the ARC-IM System to improve blood pressure regulation after SCI with the addition of Sint Maartenskliniek in the Netherlands. This additional research site prepares the Company for expected Q4 2024 initiation of a global pivotal trial called Empower BP to assess the safety and efficacy of ARC-IM Therapy to improve blood pressure regulation.
  
  
• In February 2023, the Company announced it has been awarded Breakthrough Device Designation (BDD) by the US Food and Drug Administration (FDA) for the ARC-BCI System, which uses brain-computer interface (BCI) technology in conjunction with its ARC-IM Therapy to restore thought-driven lower limb mobility after spinal cord injury (SCI). This is the Company’s tenth BDD.
  
  
• In March 2024, ONWARD Medical was only the second BCI company admitted into the FDA’s new Total Product Lifecycle Advisory Program (TAP).
  
  
• In April 2024, the Company announced it had submitted a De Novo application to the US FDA to obtain regulatory clearance to begin marketing its non-invasive ARC-EX System in the United States. Clearance is expected Q4 2024.
  
  
• In May 2024, the Company announced the publication of global Up-LIFT pivotal trial results in Nature Medicine. The study achieved all primary and secondary safety and effectiveness endpoints, and ARC-EX Therapy demonstrated significant improvements in upper limb strength, function, and sensation among people with chronic tetraplegia due to cervical SCI.