MiMedx Announces Publication Of Phase 2B Clinical Trial Efficacy Data For Micronized dHACM In The Treatment Of Plantar Fasciitis In Foot & Ankle International
The paper entitled "Randomized Controlled Trial of Micronized Dehydrated Human Amnion/Chorion Membrane (dHACM) Injection Compared to Placebo for the Treatment of Plantar Fasciitis," was authored by:
The Phase 2B prospective, single-blinded, randomized, controlled trial (RCT) studied a single injection of 40 mg of micronized dHACM injection as compared to a single injection of saline (placebo control) in the treatment of Plantar Fasciitis. The trial enrolled and treated 145 patients at 14 study sites.
The primary efficacy endpoint was the mean change in VAS score for pain between baseline and the 3-month follow-up visit. The secondary efficacy endpoint was the mean change in Foot Function Index - Revised (FFI-R) score between baseline and 3 months. The baseline VAS and FFI-R scores were similar between groups. At the 3-month follow-up, the mean VAS score was reduced by 76% for patients in the
Overall, at the three-month study follow-up visit, 60 (82.2%) patients in the treatment group, and 34 (47.2%) patients in the control group reported at least a 50% reduction in VAS score from baseline (p<0.0001).
Biologics License Application (BLA)
Based on its Phase 2B interim study results, in
"This is a positive step towards a BLA filing and helping patients with painful plantar fasciitis conditions," noted
MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind the Company's mission to give physicians products and tissues to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization.
Safe Harbor Statement
This press release includes forward-looking statements. Statements regarding expectations of further favorable study results, the timing of study results, and the expected timing of a BLA filing are forward-looking. Additional forward-looking statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," "preliminary," and similar expressions, and are based on management's current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.
Actual results may differ materially from those set forth in the forward-looking statements. The Company describes additional risks and uncertainties in the Risk Factors section of its most recent annual report and quarterly reports filed with the
Footnotes for Study Authors' Institutions:
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