Inotec AMD Limited announces enrolment completed for NATROX® trial

Cambridge, UK – 18th February 2020

Cambridge based Inotec AMD Limited 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” comments 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.”
About Inotec
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.