US-based medical technology firm Origin has started treating patients in the Phase IIb-equivalent GENESIS trial of its nitric oxide (NO) technology for the treatment of chronic diabetic foot ulcers (DFUs).
The technology is the firm's proprietary method being developed to produce and deliver plasma-generated NO in therapeutic quantities.
It involves a patented, portable device consisting of handheld, computer-guided system that produces nitrogen from ambient room air within a defined plasma stream. The generated NO is then delivered to the target treatment area.
The single-blinded 27-week GENESIS trial will demonstrate the healing and optimise the treatment regimen in approximately 100 patients across 15 clinical sites in the country.
Origin chairman and chief executive officer Michael Preston said: “Diabetes and consequential diabetic foot ulcers are a growing healthcare burden impacting millions of people.
“Plasma-generated nitric oxide has the potential to offer a new safe and effective therapy to close wounds actively, serving a large unmet need.
“This marks another step forward in our mission to become the advanced therapy of choice for the treatment of DFUs.”
Following a two-week run-in period, patients will be randomised into one of four different dosing regimens or a standard of care (SOC) treatment arm to evalute efficacy and safety.
Patients will be treated over a period of 12 weeks and monitored for another 12 weeks after the treatment.
The firm intends to provide an update and initial readout of the interim results in the fourth quarter of this year.