This month of May we have finished the preclinical studies that we started in January at MiWEndo. The studies have consisted of analyzing how our device behaves in real colons extracted from patients.
The first thing, therefore, to remember and to be grateful for, is the generosity of our patients, as they have all accepted their tissues to be used for scientific purposes. Without this enormous generosity, our project would certainly not have been able to move forward.
Specifically, we have analyzed 21 colons, of which 6, unfortunately, have not served us for different reasons, such as the coexistence of other diseases, the samples being too small, having previously been irradiated with radiotherapy or having other previous surgical interventions that prevented the use of our device. Of the remaining 15 samples, 1 was not well prepared and contained many debris, but despite this, we included it in the study.
So with this set of samples we have carried out the study that has validated our prototyping device works on human tissue, reinforcing the proof of concept that was done a few years ago. In fact, the result has been a sensitivity of 100% and a specificity of 98%, that is, we have not had false negatives and there was only one false positive due to poor preparation of the colon in question.
With this stage now closed, we take a great step forward in progress towards the great litmus test: clinical trials with in vivo patients.
