ONWARD Medical Reaffirms 2024 Strategic Priorities and Releases Unaudited Q2 Financial Highlights

Company expects to commercialize the investigational ARC-EX System in Q4 2024 and has commenced launch preparations

Company preparing to initiate global pivotal trial for investigational ARC-IM Therapy to address blood pressure instability after spinal cord injury

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

EINDHOVEN, the Netherlands, Aug. 05, 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 its 2024 strategic priorities and releases its unaudited Q2 financial highlights.

2024 Strategic Priorities

ARC-EX commercial launch. The Company expects to launch its ARC-EX Therapy for people with SCI in the US in Q4 2024, pending FDA clearance. Accordingly, the Company has accelerated launch preparations and continues to hire and develop its field sales and service organization. More detail about its launch plans will be provided during the 1H 2024 Investor Webinar on 10 September 2024.

ARC-EX System pricing. Based on the strength of the Up-LIFT pivotal study data published in Nature Medicine in June 2024, the Company plans to price the ARC-EX System at $40,000.

ARC-IM interim data publication. The Company expects a peer-reviewed publication in a top-tier medical journal detailing the results of the first 10+ patients implanted with investigational ARC-IM Therapy to address blood pressure instability after SCI.

ARC-IM pivotal study commencement. The Company prepares to launch its global pivotal study, called Empower BP, for ARC-IM Therapy to address blood pressure instability after SCI. Major associated milestones expected to occur in Q4 2024 and Q1 2025 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, previously announced FDA Breakthrough Device Designation, and acceptance into the new FDA new Total Product Life Cycle Advisory Program (TAP). Several additional ARC-BCI System implants are expected in 2H 2024 and 1H 2025 as part of the ongoing clinical feasibility study with partners at .NeuroRestore and CEA-Clinatec.