Onward Medical, a Dutch medical technology company that focuses on creating therapies for people with spinal cord injury (SCI), has enrolled the first patient in its HemON Study.
The move also marks the first-in-human use of its ARCIM implantable pulse generator (IPG). The device is programmed to stimulate the spinal cord and help restore movement for patients with spinal cord injuries and other mobility issues.
ARCIM IPG focuses on delivering targeted electrical stimulation to the specific areas of the spinal cord that control movement and autonomic functions.
It can operate in closed-loop and deliver therapy through an associated ARCIM lead.
Onward plans to enrol up to 16 participants at CHUV university hospital in Lausanne, Switzerland, for the HemON Study.
It will assess the safety and preliminary efficacy of ARCIM Therapy to enhance blood pressure management and trunk control in participants.
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The study will enrol people with SCI suffering from orthostatic hypotension.
Orthostatic hypotension is a form of low blood pressure that occurs when people change body position. It is observed in nearly 75% of people with SCI.
ONWARD CEO Dave Marver said: “The first implant of our ARCIM IPG is a huge milestone for ONWARD and the SCI community.
“This important achievement validates our vision for a future in which clinicians will no longer need to struggle with modified pain stimulators to explore new treatments and instead will be able to use devices and therapies designed specifically to treat people with SCI and their unique needs.”