
ONWARD
Building on more than a decade of science and preclinical research conducted at leading neuroscience laboratories, the Company has received nine Breakthrough Device Designations from the US Food and Drug Administration for its ARC Therapy™ platform. ONWARD® ARC Therapy, which can be delivered by external ARC-EX® or implantable ARC-IM® systems, is designed to deliver targeted, programmed spinal cord stimulation. Positive results were presented in 2023 from the Company’s pivotal study, called Up-LIFT, evaluating the ability for transcutaneous ARC Therapy to improve upper extremity strength and function. The Company is now preparing regulatory approval submissions for ARC-EX for the US and Europe. In parallel, the Company is conducting studies with its implantable ARC-IM platform, which demonstrated positive interim clinical outcomes for improved blood pressure regulation, a component of hemodynamic stability following SCI. Other ongoing studies include combination use of ARC-IM with a brain-computer interface (BCI). Headquartered in Eindhoven, the Netherlands, ONWARD has a Science and Engineering Center in Lausanne, Switzerland and a US office in Boston, Massachusetts. The Company also has an academic partnership with .NeuroRestore, a collaboration between the Swiss Federal Institute of Technology (EPFL), and Lausanne University Hospital (CHUV). For more information, visit ONWD.com, and connect with us on LinkedIn and YouTube.
Recent milestones · External platform (ARC-EX): o Pivotal study met all primary endpoints with high responder rate (upper limb) – Q2 2023 · Implantable platform (ARC-IM): o ARC-IM Lead - First-in-human use (blood pressure) – Q2 2023 o Early feasibility clinical study first participant enrollment (mobility) – Q3 2023 · Implantable platform with brain computer interface (ARC-IM BCI): o Nature Medicine publication (mobility) – Q2 2023 o First-in-human use (upper limb) – Q3 2023 Upcoming milestones · ARC-EX: o FDA De Novo request submission (upper limb – US) – 2024 o First commercial sale (upper limb – US) – 2024 · ARC-IM: o Interim data, peer reviewed publication (blood pressure) – 2024 o Pivotal study first participant enrollment (blood pressure) – 2024 o Early feasibility study first participant enrollment (Parkinson’s mobility) – 2024 Products · ARC-EX: External system for non-invasive, programmed stimulation of the spinal cord · ARC-IM: Implantable IPG and leads for direct, programmed stimulation of the spinal cord · ARC-IM BCI: Enhanced implantable platform with brain computer interface for movement-related therapies
Investors: EQT Life Sciences, Inkef Capital, Wellington Partners, Gimv, Christopher & Dana Reeve Foundation, Invest-NL, Onassis Foundation, AXA, Öhman, Belfius Insurance
Full Company address & contact details: ONWARD Medical NV, South Building, Schimmelt 2-16, 5611 ZX Eindhoven, The Netherlands