ONWARD Medical reports half-year results 2024 and provides business update Page 1

De Novo application submitted to FDA seeking marketing authorization for Investigational Drug ARC-EX System in the United States

Up to 52.5 million euros in growth financing from the US company Runway Growth Capital

Several more milestones achieved with the experimental ARC-BCI System that uses brain-computer interface (BCI) technology to restore thought-controlled movements

EINDHOVEN, Netherlands, September 10, 2024 (GLOBE NEWSWIRE) — ONWARD Medical NV (Euronext: ONWD), the medical device company developing innovative therapies to restore movement, function and independence in people with spinal cord injury (SCI), today announces its financial results for the first half of 2024 and provides a business update.

“We had an excellent first half of 2024, submitted a De Novo application for our ARC-EX system to the FDA, published the results of our Up-LIFT registration study in Natural medicineand up to €52.5 million in growth financing from Runway Growth Capital,” said Dave Marver, CEO of ONWARD Medical. “We also extended our leadership position in the field of brain-computer interfaces and received an FDA Breakthrough Device Designation (our 10^th) and inclusion in the FDA's new TAP program to facilitate commercialization. We are leading the development of a BCI-assisted therapy to restore mobility after spinal cord injury.”

Operating and financial results for the first half of the year

Clinic and development

• In January, the Company expanded its HemON proof-of-concept clinical trial to investigate the use of its experimental ARC-IM system to improve blood pressure regulation following spinal cord injury. With the addition of the Sint Maartenskliniek in the Netherlands, the Company is now ready for the anticipated start of its global registration study, Empower BP, in the coming months to evaluate the safety and efficacy of ARC-IM therapy to improve blood pressure regulation following spinal cord injury.
• In February, the company announced that it had received Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) for the ARC-BCI system. The system uses BCI technology in combination with ARC-IM therapy to restore mind-controlled lower limb mobility following spinal cord injury. This is the company's 10th BDD.
• In March, ONWARD Medical became only the second BCI company to be included in the FDA's new Total Product Lifecycle Advisory Program (TAP), which is designed to streamline the commercialization of innovative new technologies.
• In April, the company announced that it had submitted a de novo application to the FDA seeking regulatory approval to market its non-invasive ARC-EX system in the United States. Approval is expected in the fourth quarter of 2024.
• In May, the company announced the publication of the results of its Up-LIFT registration study. Natural medicine. The study met all primary and secondary safety and efficacy endpoints, and ARC-EX therapy demonstrated significant improvements in upper extremity strength, function, and sensation in people with chronic tetraplegia due to cervical SCI.

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