ONWARD Medical Reports Half Year 2024 Results and Provides a Business Update

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

Up-LIFT Study results published in Nature Medicine

De Novo application submitted to FDA to obtain clearance to market the investigational ARC-EX System in the United States

Up to EUR 52.5M in growth financing obtained from US-based Runway Growth Capital

Several additional milestones achieved with the investigational ARC-BCI System, leveraging brain-computer interface (BCI) technology to restore thought-driven movement

EINDHOVEN, the Netherlands, Sept. 10, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces its Half Year 2024 Financial Results and provides a Business Update.

“We had an excellent first half of 2024, submitting a De Novo application for our ARC-EX System to the FDA, publishing the results of our Up-LIFT pivotal study in Nature Medicine, and obtaining up to EUR 52.5M in growth financing from Runway Growth Capital,” said Dave Marver, CEO of ONWARD Medical. “We also extended our leadership in the brain-computer interface realm, adding an FDA Breakthrough Device Designation (our 10^th) and gaining admittance into the FDA’s new TAP program to streamline commercialization. We are leading the way in developing a BCI-enabled therapy to restore movement after SCI.”

Half Year Operating and Financial Results

Clinical and Development

• In January, the Company expanded its HemON clinical feasibility study to explore use of its investigational ARC-IM System to improve blood pressure regulation after SCI. The addition of Sint Maartenskliniek in the Netherlands prepares the Company for expected initiation in the coming months of its global pivotal trial, Empower BP, to assess the safety and efficacy of ARC-IM Therapy to improve blood pressure regulation after SCI.
• In February, the Company announced it was awarded Breakthrough Device Designation (BDD) by the US Food and Drug Administration (FDA) for the ARC-BCI System, which uses BCI technology combined with its ARC-IM Therapy to restore thought-driven lower limb mobility after SCI. This is the Company’s 10th BDD.
• In March, ONWARD Medical was only the second BCI company admitted into the FDA’s new Total Product Lifecycle Advisory Program (TAP), which is intended to streamline the commercialization of innovative new technologies.
• In April, the Company announced it submitted a De Novo application to the FDA to obtain regulatory clearance to market its non-invasive ARC-EX System in the US. Clearance is expected Q4 2024.
• In May, the Company announced publication of its 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.

Science and Intellectual Property