MiMedx (NSDQ:MDXG) said today that it filed an IND with the FDA for a Phase II trial of its AmnioFix product in patients with osteoarthritis of the knee.
The 318-patient study is designed to compare the safety and efficacy of MiMedx’s micronized dehydrated human amnion/chorion membrane (dHACM) injection with a 0.9% sodium chloride USP placebo injection.
“With the variability of efficacy, cost, and side effects of current treatments for osteoarthritis, other treatment options are needed. This is particularly true when chronicity begins to develop and surgery is becoming the only remaining option,” president & COO Bill Taylor said in prepared remarks. “We believe our Purion Processed AmnioFix Injectable would be an ideal treatment alternative for osteoarthritis of the knee. Studies have confirmed that the natural characteristics of amniotic membrane may provide clinical benefits in the areas of enhanced soft tissue healing and inflammation modulation.”
The osteoarthritis study, if approved by the FDA, will be the fourth IND trial for MiMedx’s AmnioFix product.
“There should not be any further concerns about MiMedx becoming a biopharma focused organization in an expedited fashion,” CEO Parker Petit added. “We have accomplished rapid asset development in these areas over the years, and in March we disclosed to shareholders that our new strategic focus would be new therapeutic areas as a biopharma company. At that point, I did not think our level of expertise and accomplishments to date were fully appreciated. However, having two ongoing Phase III trials and one Phase II trial at a large number of centers will be quite an accomplishment. We have been able to very efficiently and effectively conduct our trials to this point without the assistance of a Clinical Research Organization. We expect to continue to build our staff as our demands increase. Along those lines, we will shortly announce additional very experienced biopharma executives to our staff. They will help continue our rapid development of the opportunities we have with our placenta based technology.”
“We are anxious to commence the Phase II clinical trial and we expect the study results to be compelling. We look forward to reporting the results to the medical and investment communities,” Taylor said.
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why u are using amnion without decellularization? whether there is no any effect of amnioin cells?