Tissue Regenix sees positive trial results ahead of key US product launch
TISSUE Regenix today announced that trials of its key DermaPure product have produced further positive results ahead of its planned launch in the US next year.
The York-based regenerative medical products company said that a UK trial of the product published in a leading industry journal found that 60% of patients with chronic wounds were completely healed and patients treated saw an average 87% reduction in the size of their wounds.
The trial, published in the journal Wound Repair and Regeneration, also said that DermaPure can be easily applied in hospital or community settings, which, with an aging population and increasing prevalence of diabetes and obesity, current strategies such as compression bandaging, are expensive, labour-intensive, and slow to show results.
The report added: “With no requirement for hospital admission or anesthetic, DermaPure could be administered in hospital and community settings, such GP clinics and can be stored at room temperature, meaning expensive refrigeration equipment is not needed.”
The clinical paper states that 1-in-100 people in the UK will suffer from a leg ulcer during their lifetime, with treatment of these chronic wounds taking 1% of the country’s annual healthcare budget.
DermaPure uses Tissue Regenix’s dCELL patented process which removes cells and other components from donor human skin tissue, allowing it to be used as a patch to place over open wounds, in a single application. The treatment maintains the essential structure of normal skin and serves as a scaffold to kick start the healing process and regenerate living, functional skin tissue.
The clinical trial into the effectiveness of DermaPure in Wound Repair and Regeneration, was undertaken by the University Hospital of South Manchester with NHS Blood and Transplant on patients with chronic wounds, with 70% of the test group suffering from venous leg ulcers.
The results show that patients who had chronic wounds for an average of 4.5 years and who were treated with a single application of Tissue Regenix’s dCELL Dermis, saw an average 87% reduction in the size of all wounds, while 60% of patients were completely healed, with virtually no recurrences.
DermaPure is planned for launch in the US during the first half of 2014 and Tissue Regenix said it is well advanced in its plans to appoint distributors and the US clinical trial using DermaPure to treat diabetic foot ulcers. Tissue Regenix’s UK partners NHSBT (NHS Blood & Transplant) are working towards launching the product in the UK.
