Sam Brusco, Associate Editor01.18.24
ONWARD Medical has begun its 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 evaluate safety and effectiveness of ARC-IM therapy for hemodynamic instability after spinal cord injury (SCI). HemON NL will prepare the company for expected start of the Empower BP global pivotal trial, which aims to offer evidence for submission to the U.S. Food and Drug Administration (FDA) for a pre-market approval.
“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.”
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. The company also completed its first-in-human for ARC-IM to restore upper extremity function in September 2023.
In late 2023, a study participant was implanted with an investigational ARC-IM neurostimulator and lead to evaluate safety and effectiveness of ARC-IM therapy for hemodynamic instability after spinal cord injury (SCI). HemON NL will prepare the company for expected start of the Empower BP global pivotal trial, which aims to offer evidence for submission to the U.S. Food and Drug Administration (FDA) for a pre-market approval.
“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.”
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. The company also completed its first-in-human for ARC-IM to restore upper extremity function in September 2023.