Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Micronized DHACM · 2 trials · 2 indications
Visual Analog Scale, Left end point is "No Pain". Right end point is "worst pain imaginable"
The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection
Visual Analog Scale (VAS): 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain
Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 questions divided into 3 subscales: * Pain (5 questions) * Stiffness (2 questions) * Physical Function (17 questions) The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score, with a possible total score range of 0-96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Number of Participants with At Least 1 Treatment Emergent Adverse Event (TEAE) Reported
Number of Participants with At Least 1 Serious Treatment Emergent Adverse Event (TEAE) Reported
Number of Participants with At Least 1 Unanticipated Treatment Emergent Adverse Event (TEAE) Reported
| Arm | Type | Description |
|---|---|---|
| Micronized DHACM | EXPERIMENTAL | 1mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM) |
| Saline Injection | PLACEBO_COMPARATOR | Injection of 1mL 0.9% Sodium Chloride Injection, USP |
| Saline | PLACEBO_COMPARATOR | Injection of 0.9% Sodium Chloride Injection, USP |
| Name | Type | Description |
|---|---|---|
| Micronized DHACM | BIOLOGICAL | 1 mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM). |
| Saline Injection | DRUG | Injection of 1mL 0.9% Sodium Chloride Injection, USP |
| Saline | DRUG | Injection of 1 mL 0.9% Sodium Chloride, USP |
Inclusion Criteria All subjects enrolled must meet all the following criteria: 1. Confirmed diagnosis of Achilles tendonitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator 2. VAS Pain scale of ≥ 45 at randomization 3. Achilles Tendonitis with conservative treatment for ≥1 month (30 da...
Micronized DHACM is an investigational injectable being studied for the treatment of Achilles tendonitis and knee osteoarthritis. It is a micronized form of dehydrated human amnion/chorion membrane, developed by MiMedx Group, Inc. (MDXG). The drug is currently in clinical development and is not FDA approved.
Micronized DHACM is a micronized form of dehydrated human amnion/chorion membrane, which contains extracellular matrix components and growth factors. It is being studied for its potential to reduce inflammation and promote tissue repair in musculoskeletal conditions such as Achilles tendonitis and knee osteoarthritis.
Micronized DHACM is developed by MiMedx Group, Inc., a biopharmaceutical company traded on the stock exchange under the ticker MDXG. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational injectable for musculoskeletal indications.
Micronized DHACM is in Phase 3 clinical development for Achilles tendonitis, based on a completed Phase 3 trial (NCT03414255). A separate Phase 2 trial (NCT03485157) for knee osteoarthritis has also been completed. The drug remains investigational and has not received FDA approval.
Micronized DHACM has been studied in two completed clinical trials in the United States. NCT03414255 was a Phase 3 trial for Achilles tendonitis with 146 participants. NCT03485157 was a Phase 2 trial for knee osteoarthritis with 447 participants. Both trials were randomized, double-blind, and placebo-controlled.
Micronized DHACM is a micronized formulation of dehydrated human amnion/chorion membrane (dHACM). The clinical trials refer to it as Micronized dHACM, indicating it is the micronized version of the dHACM product. It is being investigated as an injectable for tendon and joint conditions.