MiMedx Group, Inc. (NASDAQ:MDXG) Q3 2015 Earnings Conference Call Transcript
Oct 29, 2015 • 10:30 am ET
Good day, ladies and gentlemen. And welcome to the MiMedx Group Third Quarter 2015 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will be given at that time. (Operator Instructions)
As a reminder, today's conference is being recorded. I'd now like to turn the call over to your host for today, Mr. Thornton Kuntz, SVP of Administration. Sir, you may begin.
(Forward-Looking Cautionary Statements)
With that, I will turn the call over to Pete Petit, MiMedx's Chairman and CEO.
Good morning. Thank you for joining us for our third quarter shareholder call and update. I have with me Bill Taylor, our President and COO; Mike Senken, our CFO; and Thornton Kuntz, our SVP, Administration and certain other officers.
I'm not going to review our strategic initiatives today in any detail. There were numerous discussions covering those subjects on our Analyst Meeting and those excerpts are available through our website.
However, I am going to start my comments with something that just come up this morning that relates to the Food and Drug Administration. So it's a newsworthy today relative to an announcement, it should be appearing on the FDA's or in the public register shortly. There should be a notice in the Federal register shortly about the FDA issuing a guidance document on homologous use of human tissue, which is skin, dermis, bone, tendon, ligament and amniotic tissue, it's all of those. Also today the FDA senior staff is meeting with representatives of the American Association of Tissue Banks in Washington to discuss this document and its previous document they issued in December on manipulation of human tissue.
We have one of our executives at this meeting and the information we have received is positive. It's positive from the standpoint that it seems as if the FDA has heard from the American Association of Tissue Banks, AlaMed, and the Alliance for Regenerative Medicine and their industry constituents that any attempt to change these regulations utilizing only guidance documents will be met with industry, as well as congressional disdain.
At this point, it seems that the agency is agreeing to follow its own regulations to go through the normal "Notice-and-comment rulemaking process" which involves industry and congress and any endeavor to change or modify regulations. As I think you know, MiMedx has spent the last two years working with the FDA staff and congressional leadership on attempting to resolve issues associated with untitled letters and the agencies attempts to change regulations without going through this normal process of Notice-and-comment rulemaking.
There are a number of committee heads and committee members that have involvement with the FDA that are very knowledgeable about these issues and have concerns as great as industry does relative to the implications. Therefore, we feel that industry and the trade associations and Congress can all work with the FDA to resolve issues that maybe related to their desire to further regulate human tissue products. This