MiMedx Group, Inc., a leading regenerative medicine company, announced that the company has received a subpoena from the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) in connection with a civil investigation into matters primarily related to the company's sales and marketing activities.

MiMedx intends to cooperate fully with the government in its investigation, and the company will attempt to expedite the process. MiMedx has already begun the process of producing the responsive documents. To the company's knowledge, no proceedings have been initiated at this time.  The company cannot predict whether any proceeding might be initiated.  

Parker H. Petit, chairman and CEO, said, "I can assure you that the corporate officers at MiMedx are not aware of anything that would stimulate this investigation. We have continually maintained and improved a robust compliance programme. We have been very focused on the thoroughness of our compliance policies and our staff adhering to those policies. For instance, MiMedx employees participate in a thorough training programme regarding our policies and the standards that have been established and enforced to assure their understanding and adherence to our compliance programmes. Employees may convey anonymously and directly to senior management and our Board of Directors any form of concern, complaint or inquiry related to our compliance programmes or other issues. With the significant growth we are experiencing, this has been and continues to be an initiative in which we devote considerable time, attention and resources."

Petit continued,  "We are aware of investigations in the wound care market over the past several years, in particular, the ongoing investigation into the sales and marketing practices of Advanced BioHealing (ABH), the original manufacturer of Dermagraft. We anticipated that the ABH investigation could lead to a review of other industry participants, particularly in view of the fact that several industry participants, including MiMedx and some of our competitors, have hired former ABH employees. We screen all of our applicants very carefully. With respect to former ABH applicants, we sought additional input from some former ABH corporate management who joined MiMedx and who were familiar with the suspected violations and the individuals involved.  Approximately 18 months ago, we had confirmation of a violation of our compliance policies, and within 24 hours, that individual was terminated."

Petit concluded, "We expect this investigation will confirm that our policies and procedures are working as intended. If any issues are uncovered, we will certainly address them promptly and take steps to ensure future compliance."

MiMedx is an integrated developer, processor and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane.