Positive outcome data of large Randomized Controlled Trial presented at American Diabetes Association Scientific Sessions & Reapplix business update
Birkerød, Denmark, 26 June, 2018 – Reapplix ApS, the regenerative medicine company, initially focussed on chronic wounds, announces that positive outcome data of an independent Randomized Controlled Trial (RCT) of its LeucoPatch® wound healing platform was presented at the American Diabetes Association 78th Scientific Sessions meeting in Orlando, Florida. The Company has also provided an update on the Company’s progress.
Positive outcome data:
LeucoPatch®, marketed in the US as 3CPatch®, is a novel platform technology which provides cells and growth factors concentrated from a small sample of the patients’ own blood to produce a small ‘patch’ at the point of care, with no reagents or additives. This is applied topically for the management of exuding cutaneous wounds.
The multicentre, multinational, observer-blinded RCT, (ClinicalTrials.gov NCT02224742) was undertaken at 32 specialist diabetic foot clinics in the UK, Denmark and Sweden. The aim of the trial was to determine whether the application of LeucoPatch® when used in addition to usual care in a multidisciplinary diabetes foot clinic setting, is superior to usual care alone with regard to complete healing of hard-to-heal diabetic foot ulcers.
269 people were randomized to either usual care or care supplemented by weekly application of LeucoPatch®. The primary outcome measure for the trial was healing within 20 weeks of randomization and the trial found a significantly higher incidence (p=0.0235) of healing (Odds Ratio 1:58, a 58% increased chance of healing) in those receiving LeucoPatch®.
This investigator driven trial was run independently by the sponsors, Nottingham University Hospitals NHS Trust. Reapplix involvement was limited to funding the study.
Based on this strong clinical evidence, Reapplix has moved forward with key corporate activities and formed Reapplix Inc, based in Texas to bring the 3CPatch® System to the market in the US.
James G Wetrich has been appointed as President of Reapplix Inc, responsible for building sales in the US market. He brings a wealth of experience in wound care and corporate strategy, having been President and GM USA & LATAM for Mölnlycke Health Care from 2006 to 2014, where he oversaw the creation of its large and successful wound care business. He also ran his own consulting business having had previous roles in corporate and strategic planning at Abbott and VP roles in various US hospital groups.
Additionally, Morten Have-Rasmussen has been appointed as Chief Financial Officer. Morten previously held Finance Director roles at Qiagen and at Exiqon in Denmark.