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
Phase of Trial: Phase III
Latest Information Update: 07 Sep 2017
At a glance
- Drugs DHACM (Primary)
- Indications Pain
- Focus Adverse reactions; Therapeutic Use
- 07 Sep 2017 According to a MiMedx media release, the Company has been notified by the Food and Drug Administration (FDA) that the Investigational New Drug (IND) Phase 3 Achilles Tendonitis clinical study may proceed. The Company expects patient enrollment to commence in the next quarter.
- 08 Aug 2017 New trial record
- 05 Aug 2017 The Company expects patient enrollment to commence in the next few months, according to a MiMedx media release. According to a company media release, MiMedx plans to submit a Biologic License Application (BLA) to the FDA for tendonitis after completion of the Plantar Fasciitis phase 3 trial.