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Design: A randomized, prospective, double-blind cohort followed for 16 weeks

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

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Design: A randomized, prospective, double-blind cohort followed for 16 weeks

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

  2. RenehaVis Original Study

  3. RenehaVis Original Study

  4. 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

  5. RenehaVis Long Term Follow Up 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

  6. 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%).

  7. Long Term Results

  8. Long Term Results

  9. Long Term Results

  10. Long Term Results

  11. Long Term Results

  12. 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

  13. Summary • RenehaVis provides better and fastertherapeutic 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

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