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PROTEON THERAPEUTICS INC filed this Form S-1/A on 10/07/2014
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Unassisted Maturation—Radiocephalic AVFs

CHART


              (1)
              p-value=0.08 vs. placebo

              (2)
              p-value<0.01 vs. placebo

    The average rate of procedures to restore or maintain patency per patient year at risk.  Patients undergoing a procedure often require repeated procedures over time because procedures such as balloon angioplasty can restore blood flow acutely but also damage the blood vessel. These data can be expressed as a procedure rate calculated as the number of days in which procedure to restore or maintain patency was performed per patient divided by the patient's time on the trial. Procedures included thrombectomy, angioplasty, stent deployment and surgical revision. There was a 56% reduction in the rate of procedures in the 30 microgram group versus the placebo group. In the radiocephalic subset there was a 69% reduction in the average rate of procedures in the 30 microgram group versus the placebo group. In the brachiocephalic subset there was a 43% reduction in the average rate of procedure in the 30 microgram group versus the placebo group. Excluding procedures to treat central stenosis, in the brachiocephalic subset there was an 86% reduction in the average rate of procedures in the 30 microgram group versus the placebo group.

Average Procedure Rate to Restore/Maintain Patency (p-Value vs. Placebo)

 
  Placebo   PRT-201
10 micrograms
  PRT-201
30 micrograms

All AVFs (Prespecified)

           

Number of Patients

  N=51   N=50   N=48

Procedures per Year

  0.9   0.8 (p=0.53)   0.4 (p=0.07)

All AVFs Excluding Central Stenoses (Non-prespecified)

           

Number of Patients

  N=51   N=50   N=48

Procedures per Year

  0.8   0.7 (p=0.44)   0.2 (p<0.01)

Radiocephalic AVFs (Non-prespecified)

           

Number of Patients

  N=24   N=23   N=20

Procedures per Year

  1.0   0.8 (p=0.63)   0.3 (p=0.06)

Brachiocephalic AVFs (Non-prespecified)

           

Number of Patients

  N=27   N=27   N=28

Procedures per Year

  0.7   0.7 (p=0.72)   0.4 (p=0.50)

Brachiocephalic AVFs Excluding Central Stenoses (Non-prespecified)

           

Number of Patients

  N=27   N=27   N=28

Procedures per Year

  0.7   0.7 (p=0.54)   0.1 (p=0.07)

93