Inotec AMD Announces Enrolment Complete for NATROX® O₂ Trial
[Cambridge, UK – 18th February 2020] – Cambridge based Inotec AMD Ltd is pleased to announce the conclusion of the enrolment phase of their USA Randomised Control Trial (RCT).
The launch strategy of NATROX® Oxygen Wound Therapy into the USA included securing reimbursement for topical oxygen therapy. The first step towards this goal was completing a 120 patient RCT based solely in the USA. In alignment with Inotec’s dynamic and determined approach to all projects, a record-breaking completion date was projected for this study.
Finding a partner who shared the same drive and determination was difficult. However, the SerenaGroup® Research Foundation proved to be the perfect match.
“Enrolling over 120 patients in just 7 months is unheard of in the wound care sector” commented Craig Kennedy, CEO of Inotec. “This type of study normally takes years to complete, and with the NATROX® study set to finish less than 8 months after starting, we couldn’t be happier with our partnership.”
The enrolment phase is now complete with the end of the study predicted for March 2020. This compressed timeline will facilitate CMS (Center for Medical Services) reimbursement application in 2020, 12 months ahead of plan.
SerenaGroup® Research Foundation CEO Thomas Serena MD FACS stated that “the NATROX® DFU clinical trial exemplifies the power of our cooperative group of researchers: The rate of enrolment and quality of the data far exceeded previous clinical trials. The NATROX® trial represents the new benchmark with which all future DFU trials will be measured.”
Inotec AMD is a maker of mobile medical devices designed to heal chronic, hypoxic wounds that afflict millions of sufferers around the world every year. The global wound care market is projected to grow to over $18.3 billion globally in 2020, driven in part by changing lifestyles and ageing populations in many countries. There are some 400 million diabetes sufferers around the world, some 60 million of whom are likely to develop a lower limb ulcer. As more than 90% of wounds suffer from a lack of oxygen, the launch of NATROX® Oxygen Wound Therapy addresses this serious concern with a simple, cost-effective application that treats a broad spectrum of chronic health problems.