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Clinical Testing

MedicInvent has conducted In Vivo animal studies in conjunction with Oklahoma State University to measure the efficacy of the Technology on promoting tissue growth at the juncture of the catheter and the cutaneous incision point and on increasing the tensile strength and stiction at the adherence point of the tissue growth and the catheter.

The results of MedicInvent's studies indicate that MedicInvent's texturing design can increase and accelerate tissue growth at the juncture of the catheter and the cutaneous incision point and increase stiction as measured by the tensile strength of the adherence point of the tissue growth and the catheter. Further, MedicInvent has demonstrated that it can implement its Technology using a non-disruptive manufacturing process which does not alter the diameter (gauge) or shape of the catheter.

The perceived benefits of increased and accelerated tissue growth and increases in tensile strength and stiction are:

  • increased blockage of bacterium and other microorganisms migrating into the bloodstream which can result in CRBI;

  • increased anchoring at entry site which reduces catheter dislodgement a problem closely associated with CRBI in both short-term and long-term vascular access.

The following photographs demonstrate increases in tissue growth as a result of texturing after catheters and Vero cells were cultured under routine cell conditions for 48 hours (100x magnification):

Smooth Catheter
Textured Catheter
 

The Company’s animal studies were conducted to determine if the Company’s texturing design can increase and accelerate tissue growth at the juncture of the catheter and the cutaneous incision point and increase stiction as measured by the tensile strength of the adherence point of the tissue growth and the catheter.

The following chart demonstrates tensile strength over time during pull test from In Vivo studies:

The Company believes that observed increases in tensile strength were as a result of:

  • the stiction created by increased tissue growth at the point of incision due to the textured surface;

  • texture induced increases in the build up of tissue growth which results in a larger surface area for tissue adherence to, and a more robust biomass to bond the tissue to, the catheter.


 

 
 

 

     
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