ONWARD Medical Reports Full Year 2024 Financial and Operating Results and Shares 2025 Year-to-Date Highlights

Received FDA authorization and recorded first commercial sales of ARC-EX System

Secured strategic investment from Ottobock and extended cash runway for two years

Gained exclusive rights to premier brain-computer interface technology

EINDHOVEN, The Netherlands, April 01, 2025 (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) and other movement disabilities, today announces its Full Year 2024 Financial and Operating Results.

"2024 was a transformative year for ONWARD®, highlighted by our FDA De Novo authorization and first commercial sales of the ARC-EX® System," said Dave Marver, CEO of ONWARD Medical. "We strengthened our balance sheet, welcomed Ottobock as a strategic investor and partner, and advanced our technology portfolio by gaining exclusive rights to a premier brain-computer interface (BCI) technology. Our US commercial launch is underway, marking the next chapter in our mission to deliver life-changing therapies to people with spinal cord injuries."

Full Year 2024 and Year-to-Date 2025 Highlights

Clinical and Development

In January 2024, the Company announced the expansion of its HemON clinical feasibility study with the addition of Sint Maartenskliniek in the Netherlands. This additional site prepares the Company for the expected 1H 2025 initiation of a global pivotal trial called Empower BP to assess the safety and efficacy of ARC-IM® Therapy to improve blood pressure stability.

In February 2024, the Company announced it has been awarded Breakthrough Device Designation (BDD) by the US Food and Drug Administration (FDA) for the investigational ARC-BCI® System, which uses brain-computer interface (BCI) technology in conjunction with its investigational ARC-IM Therapy to restore thought-driven lower limb mobility after SCI, creating the ONWARD DigitalBridge™. This is the Company's tenth BDD.

In March 2024, ONWARD was accepted into the US FDA's new Total Product Lifecycle Advisory Program (TAP) for the development of its ARC-BCI System, becoming only the second BCI company to join the program.

In April 2024, the Company announced it had submitted a De Novo application to the US FDA to obtain regulatory authorization to begin marketing its non-invasive ARC-EX System in the United States. Authorization was awarded in Q4 2024.

In May 2024, the Company announced the 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*.

In July 2024, the Company announced a publication in Neuromodulation: Technology at the Neural Interface, summarizing effective stimulation parameters informed by the Up-LIFT and LIFT Home studies, and a decision-making framework for clinical implementation of ARC-EX Therapy, summarizing effective stimulation parameters informed by the Up-LIFT and LIFT Home studies, and a decision-making framework for clinical implementation of ARC-EX Therapy.

In September 2024, renowned neurosurgeon Dr. Jocelyne Bloch performed another successful implant of the ARC-BCI System at Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland.

Also in September 2024, the Company announced a USD 1.1M grant from the Christopher & Dana Reeve Foundation to expand an ongoing clinical feasibility study exploring the use of ARC-BCI Therapy to restore thought-driven use of the hands and arms after SCI. The grant will support four additional study participants to be implanted with the ARC-BCI System.

In October 2024, ONWARD signed an exclusive license with the French Alternative Energies and Atomic Energy Commission (CEA) to develop and commercialize the investigational WIMAGINE® BCI as part of the Company's ARC-BCI System. This exclusive license positions the Company to be first to market with a BCI-enabled system to restore thought-driven movement after paralysis.

In November 2024, the Company announced a grant from the European Innovation Council (EIC) to study the use of ARC-BCI Therapy to restore upper limb movement after stroke.

In December 2024, the Company's De Novo application was granted by the US Food and Drug Administration (FDA) and the Company received market authorization for its ARC-EX System.

In February 2025, results from the investigator-sponsored Pathfinder2 Study were published in Neuromodulation: Technology at Neural Interface, highlighting the benefits of sustained access (at least one year) to ARC-EX Therapy.

In March 2025, the Company announced two new grants to support studies using its ONWARD ARC-IM System to help people with Parkinson's disease: A USD 1M grant from The Michael J. Fox Foundation for Parkinson's Research to address mobility challenges and a US Department of Defense grant of ~USD 1.5M to address blood pressure instability.

Also in March 2025, the Company announced the first-in-human use of its investigational ARC-IM Lumbar Lead, designed to be used as part of the ARC-IM System to restore standing, stepping, and lower limb mobility.

Intellectual Property

In 2024, ONWARD added 20 patents to its IP portfolio. It now has more than 150 issued patents, excluding EP country validations. Including EP country validations, the Company exited 2024 with more than 290 issued patents, strengthening the Company's first-mover advantage.

Commercial Developments and Industry Recognition

In October, the Company's ARC-EX System was named one of TIME Magazine's Best Inventions of 2024.

In December 2024, the Company earned the first commercial sales of its ARC-EX System to UW Medicine (University of Washington) and Next Steps Chicago, a community-based rehabilitation clinic.

In January 2025, the Company's ARC-EX System was added to US Veterans Affairs (VA) online procurement platforms, allowing the VA and other government agencies to purchase the breakthrough technology. This is the first major benefit resulting from the Company's partnership with Lovell Government Services, a Service-Disabled Veteran-Owned Small Business (SDVOSB).

Corporate

In February 2024, the Company announced that KBC Securities initiated research coverage with a Buy rating.

In March 2024, the Company completed a EUR 20M equity financing that strengthened its balance sheet to support investments in product development, clinical studies, and operational and commercial capabilities.

In April 2024, the Company announced that Stifel, a US-based full-service investment bank, had initiated research coverage with a Buy rating. The Company now has five banks providing equity research coverage, each with Buy ratings.

In June 2024, the Company signed a debt financing agreement for up to EUR 52.5M with US-based lender Runway Growth Capital.

In July 2024, the Company published its 2023 Annual Sustainability Summary, underscoring its commitment to integrating responsible and sustainable practices into all aspects of its business.

In September 2024, the Company added a Euronext Paris listing, highlighting the Company's strong French roots and significant ties to France, including its close partnership with CEA (see Clinical and Development section above).

In October 2024, the Company announced medtech leader Rob ten Hoedt, former Medtronic President and Executive Committee member and longtime Chairman of MedTech Europe, joined its Board of Directors as incoming Chairman (he was elevated to Chairman in December 2024).

Also ...

https://www.benzinga.com/pressreleases/25/04/g44578055/onward-medical-reports-full-year-2024-financial-and-operating-results-and-shares-2025-year-to-date