HemON NL is evaluating the use of ARC-IM Therapy to address hemodynamic instability after spinal cord injury
Dr. Erkan Kurt, MD implants his first ARC-IM Neurostimulator. (Credit: GlobeNewswire/ ONWARD Medical)
ONWARD Medical, the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces the start of the HemON NL clinical feasibility study at Sint Maartenskliniek in Nijmegen, the Netherlands.
In late 2023, a study participant was implanted with an investigational ARC-IM Neurostimulator and Lead to assess the safety and effectiveness of ARC-IM Therapy to address hemodynamic instability after SCI. The surgery was performed by neurosurgeon Erkan Kurt, MD at Radboud University Medical Center, which has a neurosurgery department affiliated with Sint Maartenskliniek.
Building on the Swiss HemON clinical feasibility study, HemON NL prepares the Company for expected initiation of a global pivotal trial, called Empower BP, which is designed to provide the evidence necessary to submit a pre-market approval (PMA) to the US Food and Drug Administration (FDA) and other global regulatory authorities. In December 2022, the Company announced positive interim clinical results from its early feasibility studies showing improved regulation of blood pressure, thereby improving hemodynamic stability, after SCI.
The Company plans to enroll participants in both HemON and HemON NL as it finalizes the design of the Empower BP pivotal study.
“Sint Maartenskliniek has long been an outstanding research partner, and we are delighted to work with them on this new and exciting study to evaluate the use of ARC-IM Therapy to stabilize disruptive and potentially life-threatening fluctuations in blood pressure after SCI,” said Dave Marver, CEO of ONWARD. “This is an important but underappreciated recovery target after SCI. We hope this research and the expected upcoming pivotal study will shine a light on the importance of hemodynamic stability in this population.”
The Principal Investigator of the HemON NL study is Dr. Ilse van Nes, a leading rehabilitation physician in the spinal cord injury department of Sint Maartenskliniek.
“The procedure went smoothly and the participant is responding well,” said Dr. van Nes. We are excited to monitor this and additional patients’ ongoing response to this groundbreaking therapy, which is designed to deliver programmed electrical stimulation to the area of the spine responsible for regulating blood pressure after SCI.”
ONWARD has received nine FDA Breakthrough Device Designations for its ARC-IM System, one of them for hemodynamic instability after SCI, inclusive of blood pressure regulation.
*All ONWARD devices and therapies, including but not limited to ARC-IM, ARC-EX, and ARC Therapy, alone or in combination with a BCI, are investigational and not available for commercial use.
Source: Company Press Release