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A Phase 3, Prospective, Double Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis

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Trial Profile

A Phase 3, Prospective, Double Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 May 2022

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At a glance

  • Drugs DHACM (Primary)
  • Indications Musculoskeletal pain; Pain
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors MiMedx

    • Most Recent Events

    • 18 May 2022 Status changed from active, no longer recruiting to completed.
    • 28 Apr 2021 According to a MiMedx media release, top-line results expected later this summer.
    • 19 Apr 2021 According to a MiMedx media release, The Company does not anticipate pursuing a BLA for Achilles Tendonitis at this time, and plans to review options for this program after assessing the results of the Phase 3 study, including potentially exploring the efficacy of AmnioFix Injectable in a more well-defined subset of patients.

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