ONWARD Medical has announced the first patient enrolment in the HemON study and first-in-human use of the company’s ARC implantable pulse generator (IPG), which is designed to stimulate the spinal cord to restore movement and autonomic function for people with spinal cord injury (SCI) and other conditions that affect mobility.
Jocelyne Bloch, chief of functional neurosurgery at Lausanne University Hospital (CHUV; Lausanne, Switzerland), said: “ONWARD’s ARC IPG offers surgeons precision and flexibility never before available in an implantable neurostimulator. Clinicians will be able to leverage these advanced capabilities to refine and deliver epidural stimulation therapies for people with SCI.”
The ONWARD ARC IPG aims to deliver targeted electrical stimulation to the spinal cord in the precise areas responsible for triggering or controlling movement and autonomic functions that may be affected by a SCI or neurodegenerative disorder.
The IPG is designed to operate in a closed-loop, incorporating data from sensors or other devices that may be deployed inside or outside the body. It is also designed to deliver therapy through an associated ARC lead with precision and flexibility, allowing clinicians to apply biomimetic stimulation that can closely replicate normal spinal cord activity patterns during mobility or autonomic function, say the company.
The HemON study aims to evaluate the safety and preliminary efficacy of ARC therapy to improve blood pressure management and trunk control in people with SCI who suffer from orthostatic hypotension. The study will enrol up to 16 participants at CHUV.
“The first implant of our ARC IPG is a huge milestone for ONWARD and the SCI community,” said Dave Marver, CEO of ONWARD. “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.”