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Design: A randomized, prospective, double-blind cohort followed for 16 weeks RenehaVis Original Study 50 DMW 50 HMW 50 LMW 50 Placebo.

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Presentation on theme: "Design: A randomized, prospective, double-blind cohort followed for 16 weeks RenehaVis Original Study 50 DMW 50 HMW 50 LMW 50 Placebo."— Presentation transcript:

1 Design: A randomized, prospective, double-blind cohort followed for 16 weeks RenehaVis Original Study 50 DMW 50 HMW 50 LMW 50 Placebo

2 Results: At 4, 12 and 16 weeks, significant improvement in walking VAS pain in all three active treatment groups: LMW (73.6%, p<0.001; 81.3%, p<0.001); HMW (69.1%, p<0.001; 78.1%, p<0.001) and DMW (79.6%, p<0.001; 89.3%, p<0.001) Patients in the DMW group had significantly greater improvement at 4, 12 and 16 weeks (p<0.007) compared to the other active treatment groups which did not differ from each other The improvement in walking VAS pain was significantly greater from baseline and compared to other treatments at V3 (after the second injection) for DMW with no further changes following the third injection or at 12 or 16 weeks follow up Global satisfaction was significantly higher for the DMW group compared to the other groups at 16 weeks (p<0.005) RenehaVis Original Study

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5 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 Original Study

6 Design: The primary objective was efficacy as evaluated through the self- paced 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

7 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%). RenehaVis Long Term Follow Up

8 Long Term Results

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13 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 RenehaVis Long Term Follow Up

14 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 Summary


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