AOTI INC (AIM: AOTI), a medical technology group focused on durable wound healing and amputation prevention, announced on Monday that it has initiated patient enrolment in the USA for a multi-national clinical trial assessing its Topical Wound Oxygen (TWO2) therapy for chronic Venous Leg Ulcers (VLUs).

The trial, known as VaLUe, will enrol 212 patients and aims to demonstrate the efficacy of TWO2 in achieving complete, durable healing of VLUs. The study follows a design similar to the award-winning Frykberg et al. trial, which evaluated TWO2 in diabetic foot ulcers.

VLUs, caused by venous hypertension and tissue damage, affect around 2% of the global population, with 60% progressing to chronic, non-healing wounds. Recurrence rates for these ulcers can reach 75%, leading to ongoing suffering and significant healthcare costs.

AOTI's TWO2 therapy combines non-contact cyclical compression with higher partial pressure oxygen to promote healing. The therapy can be applied by patients at home over existing compression dressings, improving treatment access and patient compliance. Earlier studies have shown promising results, with TWO2 therapy demonstrating a 76% complete healing rate in a controlled study of refractory VLUs, compared to 46% with conventional compression treatment. A recent real-world study presented at the VEITH Symposium also reported high healing rates and low recurrence in patients treated with TWO2.

Founded in 2006 and based in Oceanside, California and Galway, Ireland, AOTI offers innovative solutions to treat chronic wounds globally. Its patented TWO2 therapy has been shown to significantly reduce the recurrence of Diabetic Foot Ulcers and improve patient outcomes, receiving regulatory clearance in the US, Europe, UK, Canada, China, Australia and Saudi Arabia.