Onward Medical has successfully raised $54 million (€50 million) through a bookbuild offering to further the clinical development and potential U.S. commercialization of its neuromodulation systems, ARC-EX and ARC-IM, for spinal cord injury patients. The funding, secured via a private placement of ten million new ordinary shares priced at €5 each, extends the company's financial runway for the next two years.
The proceeds will support ongoing research and development activities, including clinical studies and regulatory submissions for ARC-EX and ARC-IM. These systems aim to restore limb movement and improve blood pressure regulation, respectively, in individuals with spinal cord injuries.
ARC-EX and ARC-IM: Non-Invasive and Implantable Neuromodulation
ARC-EX is designed as a non-implantable counterpart to ARC-IM, both utilizing spinal cord stimulation to achieve therapeutic effects. In May 2024, ARC-EX demonstrated success in the Up-LIFT trial (NCT04697472), meeting both primary and secondary endpoints. Meanwhile, a feasibility study for ARC-IM commenced in January.
Brain-Computer Interface System: ARC-BCI
In addition to ARC-EX and ARC-IM, Onward is also developing ARC-BCI, a system that uses commands from an implanted brain-computer interface (BCI). This system is currently under evaluation in an early feasibility study.
Regulatory and Commercialization Milestones
Onward submitted a de novo application to the U.S. Food and Drug Administration (FDA) for ARC-EX in April and anticipates a commercial launch later this year, pending approval. The company is preparing to scale up its sales and customer-facing operations to support the launch.
Market Growth and Competitive Landscape
According to a GlobalData market model, the global neuromodulation device market is projected to reach $11.4 billion by 2033, a significant increase from $6 billion in 2022. Other players in this space include Neuralink, which raised $43 million in November 2023.
Strategic Collaboration with Ottobock
Following the capital increase, Ottobock SE & Co. KGaA, a German prosthetics company, will hold approximately 10% of Onward's share capital. Onward CEO Dave Marver expressed enthusiasm about the collaboration, stating, "We look forward to exploring opportunities to collaborate closely with Ottobock to enhance and accelerate our ability to develop and commercialise our breakthrough therapies worldwide."
