Commercial traction: The Company met its objective of 40 ARC-EX® Systems sold in Q3.
Regulatory milestones: The US Food and Drug Administration (FDA) approved an investigational device exemption (IDE) for the ARC-IM® System, allowing the initiation of the Empower BP global pivotal study. The Company received CE Mark certification for the ARC-EX System. In November, the FDA also cleared the ARC-EX System for home use in the US.
Science & technology leadership: Key publications in Nature, Nature Medicine, and Neurology: Clinical Practice added to the strong body of clinical evidence supporting the Company's innovative therapies.
Financial highlights: The Company reported EUR 1.7 million in revenue in Q3 and successfully raised over EUR 50 million in equity capital in October, extending runway into Q1 2027.
Dave Marver, CEO of ONWARD Medical, said: "We continued to deliver strong commercial execution in Q3, and we achieved several meaningful scientific and regulatory milestones across our technology platforms. Home-based ARC-EX Therapy greatly enlarges the US market opportunity and helps fulfill our mission to provide the SCI community with broad and convenient access to innovative therapies. We are also well positioned to initiate Empower BP, our second global pivotal study and the first to evaluate the ARC-IM implanted neuromodulation platform to address blood pressure instability after SCI. The recent well-supported financing allows us to further advance our strategic priorities with focus, discipline and determination."
Commercial traction
The Company met its objective of 40 ARC-EX Systems sold in Q3, demonstrating continued strong commercial traction for its groundbreaking external spinal cord stimulation technology.
ARC-EX Therapy is now available in over 60 clinics across the US.
Regulatory milestones
The Company received CE Mark certification for the ARC-EX System, allowing commercialization for both clinic and home use in the European Union. The CE Mark facilitates a streamlined regulatory pathway in other countries, including the UK and Switzerland. First commercial sales of the ARC-EX System in Europe are expected in Q4.
In November, the Company received 510(k) clearance to expand the ARC-EX System indication for home use in the US. ARC-EX is the first and only FDA-cleared technology demonstrated to improve hand strength and sensation in people with SCI.
The US FDA also approved an IDE for the ARC-IM System, allowing the initiation of the Empower BP global pivotal study designed ...
