MiMedx wins FDA nod for AmnioFix pivotal trial

MiMedx (NSDQ:MDXG) said today that the FDA has approved its Phase III Achilles tendonitis trial.

The 158-patient study is designed to compare the company’s AmnioFix Injectable with a saline placebo injection in the treatment of moderate to severe pain due to Achilles tendonitis.

The trial, which is the company’s second late-stage study of AmnioFix, will start enrolling patients next quarter, MiMedx reported. Its primary efficacy endpoint will be the change in visual analog scale score for patients between baseline and 90 days.

The study’s primary safety endpoint will be the proportion of product-related adverse, serious adverse and unanticipated adverse events during the first 180 days following injection between the two trial groups.

The company’s AmnioFix Injectable is a dehydrated human amnion chorion membrane injection. MiMedx said it hopes to submit a biologic license application to the FDA for tendonitis as soon as it closes out its plantar fasciitis Phase III trial.

“We are pleased to receive the FDA’s notification that we can proceed with another Phase III IND study in the orthopedic/sports medicine area. In addition to this IND study, we are planning to file for another IND by the end of this quarter. This additional IND will be for the use of our micronized dHACM in the treatment of osteoarthritis knee pain.  With the commencement of the osteoarthritis study, we will have three IND studies ongoing,” CEO Parker Petit said in prepared remarks.

“We are excited about our progress in moving our focus into the biopharmaceutical market, and we look forward to keeping our shareholders appraised on our future study results. Later this year, we will hold a meeting in New York that will include presentations by MiMedx executives and the physicians involved with our various IND studies to better inform analysts and our shareholders of these important activities.”

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