Apnicure Winx, User Manual, Page: 52 / 60

46
Results
Clinical Success was observed in 41.3% (4/15 mild, 10/18 moderate, 12/30 severe) of the Primary Endpoint Cohort comparing First Treatment Night
with Control. Clinical Success was observed in 38.5% (5/16 mild, 10/23 moderate, 15/39 severe) of the Intent-to-Treat Cohort comparing Day 28
Treatment Night with Control. AHI and ODI were significantly reduced by treatment with the Winx System (see Tables 1-4).
TABLE 1: FIRST TREATMENT NIGHT AND DAY 28 TREATMENT NIGHT AHI RESULTS
(PRIMARY ENDPOINT COHORT)
Control Night
Median
(Q1 – Q3)
Treatment Night
Median
(Q1 – Q3)
Median Change
(Q1 – Q3)
Median of % Change
(Q1 – Q3)
Control Night vs First Treatment Night
(N= 63)
AHI
27.5
(16.7, 50.9)
13.4
(6.2, 28.9)
-10.4
(-21.8, 1.0)
-46.2
(-74.7, 3.3)
p-value <0.0001 <0.0001
Control Night vs Day 28 Treatment Night
(N= 52)
AHI
24.6
(11.8, 48.4)
14.8
(6.6, 29.4)
-7.9
(-26.0, 4.2)
-43.2
(-71.7, 15.9)
p-value 0.0002 0.0050
p-value = signed rank test
PN 12149-B.indd 46 4/23/13 11:53 AM