PolyNovo announced it has received final Independent Review Board (IRB) ethics approval for the first phase of a clinical study evaluating NovoSorb® SynPath for the treatment of non-healing diabetic foot ulcers. This study will generate data to support PolyNovo gaining reimbursement from US health insurers for the use of NovoSorb SynPath in wound care centres. US wound care centres are non-inpatient settings covered by health insurers. It is a $400 million (USD) market segment treating diabetic and venous leg ulcers. NovoSorb® SynPath is a tailored format of NovoSorb BTM specific for the Chronic wound care segment. The study is in two parts. The first is a single arm pilot study evaluating wound closure with the application of SynPath in ten patients. The first patients has been enrolled at LewisGale Medical Center in Roanoke Virginia. Full patient enrolment in the first phase is expected to be completed May 2021 with interim results due in July. The second part of the trial will be a 100 patient randomised trial of SynPath versus the standard of care. The company expects this stage to begin in September/October 2021. Study Chairs are David Armstrong DPM, MD PhD from University of Southern California and Robert Galiano MD from North-western University in Chicago. This study will be done in conjunction with the CRO, Professional Education and Research Institute (PERI).