ONWARD Medical N.V. announced the successful first-in-human use of its investigational ARC-IM Lead. The ARC-IM Lead delivers targeted electrical pulses to the spinal cord and is a key component of the ONWARD ARC-IM system, an innovative platform engineered to deliver ARC Therapy to address multiple indications. The ARC-IM Lead is designed to be used with the ARC-IM neurostimulator (IPG) and is purpose-built for placement along the spinal cord to stimulate the dorsal roots, with specific parameters designed for each anatomical location.

ONWARD is developing a portfolio of ARC-IM Leads in a range of sizes, shapes, and electrode arrays for the many indications the Company is developing or exploring, such as improved blood pressure management, mobility, upper extremity function, and bladder control. The ARC-IM Lead was implanted by Jocelyne Bloch, MD, neurosurgeon at Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland, to benefit a patient with poor blood pressure regulation following SCI. During today's surgery, the ARC-IM Lead was placed in the “Hemodynamic Hotspot” along the thoracic spinal cord, an area in which targeted electrical stimulation may restore better blood pressure regulation after an SCI.

This specific location and accompanying mechanism of action were first discovered by the Company's research partners at the Swiss Federal Institute of Technology Lausanne (EPFL) and University of Calgary and published in Nature in January 2021. In December 2022, ONWARD announced positive interim results from the first ten people treated with targeted ARC-IM Therapy to improve blood pressure regulation following SCI. All participants reported improved quality of life.

ONWARD received an FDA Breakthrough Device Designation in 2021 for this indication. All ONWARD devices and therapies referenced here, including but not limited to ARC-IM, ARC-EX, and ARC Therapy, are investigational and not available for commercial use.