Clinical Trials Strategy

Following MHRA approval in June 2014, Smart Matrix Limited commenced a clinical trial in two UK hospitals with the first patient being recruited in August 2014. The study was designed to assess the safety, tolerability and performance of Smart Matrix® as a dermal replacement scaffold in the treatment of full thickness wounds following surgical excision.

The trial had been designed to demonstrate the ability of Smart Matrix® to act as a scaffold to help the body rapidly close a wound and regenerate its own inner skin (dermis), protected by a skin graft forming the outer skin (epidermis).

Following analysis of the clinical data from five patients, including the review by a Data Monitoring Committee comprising a number of external consultants, it was concluded that there were no safety issues associated with use of Smart Matrix®. The broad consensus of the medical experts who separately reviewed the clinical data was that the experience from the first five patients suggested that the expected USP of Smart Matrix® was not being adequately demonstrated. However, there were unexpected findings from the primary clinical data, namely that Smart Matrix® may have a more valuable and hitherto unexpected USP, namely the ability to close wounds without the need for a skin graft. This would have the following advantages over current best therapy:

  • Less trauma for the patient, specifically the avoidance of the pain and suffering caused by the excision of skin from a donor site;
  • Reduced costs, primarily from the reduction in time spent in theatre;
  • Improved quality of healing in terms of colour match and reduction in contour defect; and
  • Easier and more cost effective maintenance during the healing process. Both clinical groups described wounds treated with Smart Matrix® as being easy to maintain during the healing process. Problems that may occur during wound healing include the formation of slough, exudate, crusting or inflammation and bleeding; none of these problems were observed in wounds treated with Smart Matrix®.

A second clinical trial is currently being designed to assess the safety, tolerability and performance of Smart Matrix® when used without a skin graft.

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Smartmatrix award

Smart Matrix Limited - Winners of the 2016 International Life Sciences Award for Best Medical Implant & Technology Research Group

SmartMatrix Limited – Winner of the 2016 ACQ5 Global Award for UK Gamechanger of the Year – Ms Leonor Stjepic

Smart Matrix Limited – Winner of the 2016 ACQ5 Global Award for UK Gamechanger of the Year – Ms Leonor Stjepic

SmartMatrix Limited – Winner of the 2016 ACQ5 Global Award for UK - Company of the Year

Smart Matrix Limited – Winner of the 2016 ACQ5 Global Award for UK - Company of the Year

Corporate LiveWire Healtcare and Life Sciences Awards 2016 Winner

Smart Matrix Limited – Winner of the 2016 Healthcare and Life Sciences Award