Results from a Phase 2B Study comparing Mimedx Group, Inc.’s AmnioFix injection to a placebo suggest that the injection offers significant reduction of pain and inflammation for patients with plantar fasciitis when compared with placebo.
Mimedx’s AmnioFix Injection Reduces Plantar Fasciitis Pain
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Secondary
Plantar fasciitis is the most common cause of heel pain. Traditional treatment typically involves six weeks of consistent and daily icing, rest, stretching, activity and shoe modifications, night splints, and nonsteroidal antiinflammatory drugs (NSAIDS) use. Platelet-rich plasma injection (PRP), steroid injections and extracorporeal shock wave therapy are also used. Unfortunately these approaches have limited efficacy.
AmnioFix through the proprietary PURION process is composed of micronized amniotic tissue that contains the growth factors and cytokines inherent in placental tissue. It reduces scar tissue formation, modulates inflammation in the surgical site, enhances healing, and acts as a barrier.
The Phase 2B study was a prospective, single-blinded randomized controlled study of 147 patients comparing AmnioFix to a placebo. The Mean Visual Analog Scale (VAS) reduction at three months was 77.5% for AmnioFix compared with 45.7% for the placebo group (p = 0.0001).
The Mean VAS Reduction at six months was 89.5% for the AmnioFix injectable Group compared with 57.1% for the placebo group.
Donald E. Fetterolf, M.D., F.A.C.P., chief medical officer of MiMedx, told OTW, “We were not surprised to learn that the difference between study cohorts was statistically significant because of our prior clinical studies in this indication. However, we were pleased to see this robust clinical study continued to demonstrate a statistically significant difference when the product was used in a broader, multisite trial.”
“AmnioFix will stand out, when it is approved, as the first biologically active product, really a product specifically cleared by the United States Federal Drug Administration [FDA] for this indication. It is truly an innovator in this clinical setting. Current treatments have been symptomatic or involve physical measures and have not addressed the basic disease process.”
MiMedx is a biopharmaceutical company that focuses on regenerative biologics utilizing human placental tissue allografts. The Phase III study, which will be very similar in design to the Phase 2b trial, is expected to start in the next couple of months.
The FDA has accepted a reduction in the follow-up duration for the Phase 3 trial from 12 months to 6 months.
In addition MiMedx has filed with the FDA to initiate an investigational New Drug Phase 3 Achilles Tendonitis Clinical Study comparing AmnioFix Injectable to saline.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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