MiMedx To File First IND, Signs Up New Execs
MiMedx Group announced its plans to file its first Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in July 2014.
The company will file the IND application for certain indications regarding use of its micronized allografts. This is in line with MiMedx’s target of submitting a future a Biologics License Application (BLA) for its investigational products. Parker H. "Pete" Petit, Chairman and CEO, said that the company has advanced in regulatory filing schedule with its meetings and discussions with the FDA. “The filing of this IND is the first step in the process that we expect will culminate in at least two separate BLAs for certain indications for use of our micronized allografts. Other BLA applications will follow.”
Bill Taylor, President and COO, also announced that the company has signed on two key executives in support of its planned IND and BLA filings. “Additionally, we have previously communicated that we were expanding our Research and Development ('R&D') function and increasing related R&D and clinical investments in support of our BLA applications. These include the addition of two executives with a wealth of experience in managing pre-clinical and clinical studies in support of this complex regulatory process: David H. Mason, M.D., and Conan S. Young, Ph.D.”
Dr. Mason will serve as Vice President of Medical Affairs for Clinical Programs while Dr. Young will head the MiMedx team as Director of Research. Taylor said that Dr. Mason presents extensive clinical and regulatory experience in all phases of applications for both drugs and devices. Dr. Young presents research expertise in regenerative medicine.
“We believe the rapid submission of our first IND application with the addition of new staff demonstrates MiMedx's level of commitment to this process and our ability to successfully transition certain indications for use of our micronized products from Section 361 HCT/Ps to licensed biologics,” said Chairman Petit.