Onward Medical has started a Netherlands-based clinical feasibility study to assess its ARC-IM neurostimulator’s ability to improve haemodynamic instability in spinal cord injury (SCI) patients.
The HemON NL study will be conducted at the Sint Maartenskliniek hospital in Nijmegen, the Netherlands, according to an 18 January press release.
The latest clinical feasibility study follows the HemON study (NCT05111093) – which enrolled its first patient in May 2022. In May 2023, the first-in-human procedure was conducted for the ARM-IM lead for the improvement of blood pressure control after SCI.
Onward Medical has received nine FDA Breakthrough Device Designations for its ARC-IM System. One of them is for haemodynamic instability – which includes blood pressure regulation – after SCI.
Onward Medical, which is based in the Netherlands and the US, said it plans to enrol participants across both HemON and HemON NL studies. The feasibility studies will be followed by company’s Empower BP pivotal study, which is in the final design stages. The pivotal study will be used to support a pre-market approval (PMA) to the US Food and Drug Administration (FDA) and other global regulatory authorities.
In December 2022, Onward Medical reported positive interim results from the first 10 patients in its feasibility study. Patients experienced sustained increase in blood pressure and those on anti-hypotension drugs were able to reduce or discontinue their medication.
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Low blood pressure is an issue that affects patients with a spinal cord injury. Its underlying mechanisms are unclear, but research has suggested a multitude of factors including a lack of tonic sympathetic control, impaired baroreceptor regulation, skeletal muscle pumping activity changes, and cardiovascular deconditioning could play a part. It is currently managed by dietary adjustments and pharmacological therapy.
Onward’s CEO: Dave Marver “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 ARC-IM Lead is placed in the “haemodynamic Hotspot” on the thoracic spinal cord. Onward Medical believes that this targeted electrical stimulation may restore better blood pressure regulation after an SCI.
The global neuromodulation device market is expected to reach $11.4bn by 2033, according to a report by GlobalData.
In September 2023, the first-in-human implant of the neurostimulator with a brain-computer interface was carried out to restore limb movement.