This week, we reaffirmed our 2024 strategic priorities, and we have an exciting 2H ahead! Our top priority remains preparing for commercialization, and we look forward to bringing the investigational ARC-EX® System to the Spinal Cord Injury (SCI) Community in the US later this year. *
Here’s more detail:
➡️ ARC-EX® commercial launch. We intend to launch our ARC-EX Therapy for people with SCI in the US in Q4 2024, pending Food and Drug Administration (FDA) clearance.
➡️ ARC-IM ® interim data publication. We expect a peer-reviewed publication in a top-tier medical journal detailing the results of the first 10+ patients implanted with investigational ARC-IM Therapy to address blood pressure instability after SCI.
➡️ ARC-IM pivotal study commencement. We are preparing to launch our global pivotal study, called Empower BP, for investigational ARC-IM Therapy to address blood pressure instability after SCI, pending FDA Investigational Device Exemption approval.
➡️ ARC-BCI™ Therapy advancement. Clinical and development activities for our investigational ARC-BCI System continue and several additional ARC-BCI System implants are expected in 2H 2024 and 1H 2025 as part of the ongoing clinical feasibility study with partners at .NeuroRestore and @CEA-Clinatec.
Here are our unaudited Q2 2024 financial highlights:
✅ We plan to publish our Half Year 2024 financial statements on September 10, 2024.
✅ The net cash balance on June 30, 2024, was EUR 32.1 million.
To learn more about ONWARD Medical’s commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit www.ONWD.com
*All ONWARD Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARC-BCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.
#EmpoweringMovement #SCI #StrategicPriorities
d4871b2d-3d8c-4e4b-99fd-2774a1714fb6 (onwd.com)
Senior Director | Strategic Account Partner
7moCongrats, graet news Nate