MiMedx (NSDQ:MDXG) said today that it filed an IND application with the FDA for the company’s late-stage Achilles tendonitis trial.
The 158-patient study is designed to compare MiMedx’s AmnioFix Injectable with a saline placebo injection in the treatment of moderate to severe pain due to Achilles tendonitis.
If approved, the trial will be the second IND late-stage trial for the Marietta, Ga.-based company’s regenerative product.
“In addition to this IND study, we are planning to file for another IND study by the end of this quarter. This additional IND study 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. We will continue to keep shareholders very well informed of our new biopharmaceutical initiatives. 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.”
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.