ONWARD Medical secures €40.6M for spinal cord implant
▼ Summary
– ONWARD Medical raised €40.6 million in a private placement, anchored by a €25 million investment from EQT Life Sciences.
– The funds will primarily support the development of the ARC-IM® implantable system and the commercial expansion of the ARC-EX® external system.
– The ARC-IM® system is being tested in the Empower BP pivotal trial to treat dangerous blood pressure instability after spinal cord injury.
– The company’s ARC-EX® system is already commercially cleared and uses non-invasive spinal cord stimulation to improve motor function.
– This financing extends the company’s cash runway into the first quarter of 2028.
ONWARD Medical has secured a significant €40.6 million in funding through a private placement with institutional investors, extending its financial runway into early 2028. This capital injection will accelerate the company’s dual-track strategy, fueling the pivotal clinical trial for its next-generation implantable system while expanding the commercial footprint of its already-approved external therapy.
The private placement, anchored by a €25 million investment from EQT Life Sciences, involved the issuance of over 13.5 million new ordinary shares. ONWARD has outlined a clear allocation for the proceeds, directing 40% toward the development of its investigational ARC-IM® implantable system. Another 30% is earmarked for expanding commercial operations for its ARC-EX® external therapy system in the US, Europe, and other key markets. The remaining funds will support quality systems, administrative functions, and general corporate purposes.
These two systems represent the core of the company’s neurotechnology platform. The ARC-EX® System is a non-invasive therapy that uses surface electrodes to deliver electrical stimulation to the spinal cord, improving voluntary motor function. It is already commercially available. The ARC-IM® System is an implantable version designed to provide more precise and direct stimulation. Its initial target is treating severe blood pressure instability after spinal cord injury, including conditions known as orthostatic hypotension and autonomic dysreflexia.
A major focus of the new funding is the Empower BP pivotal trial, which is testing the ARC-IM® system’s efficacy for these life-altering complications. This randomised, double-blinded, and sham-controlled study received FDA approval last year and is now actively enrolling participants across approximately 20 leading research centres in North America and Europe. The first participant was implanted at Craig Hospital in Colorado earlier this year.
The company’s progress is further underscored by its regulatory standing. ONWARD holds 10 FDA Breakthrough Device Designations, a status that facilitates a more efficient development and review pathway for promising technologies addressing unmet medical needs.
CEO Dave Marver stated that the strong investor support validates the commercial adoption of the ARC-EX® system and the clinical potential of the ARC-IM® platform. The new shares from this placement are expected to begin trading shortly, with EQT and certain board members subject to a standard 90-day lockup period. ONWARD’s shares trade on multiple Euronext exchanges under the ticker ONWD.
(Source: The Next Web)
