Transcript RenehaVis

RenehaVis Original Study
Design:
A randomized, prospective, double-blind cohort
followed for 16 weeks
50
50
50
50 Placebo
RenehaVis Original Study
RenehaVis Original Study
RenehaVis Original Study
Summary:
Therapeutic effects of RenehaVis can be seen
after second injection
These effects are maintained following the
third injection up to the follow up at 16 weeks
RenehaVis is able to work quickly and
efficiently in relieving the OA patients of their
symptoms
RenehaVis Long Term Follow Up
Design:
The primary objective was efficacy as evaluated through the selfpaced 40m walking pain visual analog scale (VAS) at week 16, 52
and 104.
The secondary endpoints were as follows:
 Efficacy through assessment of the following:
• Pain at rest. A 10cm visual analog scale (VAS) was used prior to
first treatment and again at weeks 16, 52, 104
• Patient global satisfaction using a 5-point numerical scale
• Consumption of concomitant medications
• Patients with <45mm pain at follow-up 52 and 104 weeks
 Safety through the number of recorded adverse events
RenehaVis Long Term Follow Up
Results:
Performance: At 16, 52 and 104 weeks respectively, walking VAS
pain was significantly improved in all treatment groups vs. placebo:
DMW (89.3%, p<0.001; 87.4%, p<0.001; 88.1%, p<0.001); LMW
(81.3%, p<0.001; 78.2%, p<0.001; 77.0%, p<0.001) and HMW
(78.1%, p<0.001; 81.1%, p<0.001; 79.4%, p<0.001)
At 52 weeks, 8 patients in DMW group had resting VAS <45mm.
No patient in the LMW or HMW groups had VAS<45mm.
DMW had lower (62mm, p<0.001) compared to LMW (76mm) and
HMW (88mm) VAS at rest.
Similar differences were observed for walking VAS (77mm vs
89mm vs 91mm respectively). 39, 41 and 43 (DMW, LMW, HMW)
received repeat injections.
At 104 weeks, these differences were similar. DMW and LMW had
no reported adverse events; HMW had 2 local reactions at 52
weeks and 1 at 104 weeks.
Safety: There were no serious adverse events. Non- serious adverse events included pain and local
swelling at the injection site (21%), erythema at the injection site (12%) and stiffness in the
index knee (7%).
Long Term Results
Walking VAS
100
80
Walking VAS
score
60
DMW
*
LMW
HMW
Placebo
40
20
0
012
16
52 104
Week
Injection
Long Term Results
Resting VAS
100
Rest VAS score
80
60
DMW
*
LMW
HMW
Placebo
40
20
0
012
16
52 104
Week
Injection
Long Term Results
Global patient satisfaction
87.7%
83.5%
Percentage
71.6%
DMW
LMW
86.5%
HMW
73.0%
67.1%
P<0.005
P<0.005
P<0.005
16 weeks
52 weeks
104 weeks
Long Term Results
Long Term Results
RenehaVis Long Term Follow Up
Summary:
Intra-articular Hyaluronic Acid injections using any of
low, high or combined MW were highly effective in
improving resting and more so, walking pain in patients
with osteoarthritis of the knee.
Greater improvement in both rest and activity
outcomes in patients who received the DMW
product
DMW group had concomitantly greater patient
satisfaction and fewer use of concomitant
therapeutic modalities at 16, 52 and 104 weeks
Greater patient satisfaction in DMW groups
Summary
RenehaVis provides better and faster
therapeutic effects because of the 2 HAs
comprising of different characteristics
RenehaVis provides shortened treatment
regimen (2 injection per treatment)
1 treatment course of RenehaVis lasts up to 1
year
RenehaVis has international patent coverage