The Food and Drug Administration published draft guidance for the minimal manipulation of human cells tissues and cellular and tissue-based products, and now device companies are making comments.
MiMedx executives added their comments to the mix. The company uses human amniotic tissue and a patent-protected process to develop market-advanced products and therapies for the wound care, surgical orthopedic, spinal, sports medicine, ophthalmic and dental sectors.
"It is evident to us that FDA's view on minimal manipulation has evolved since its prior public statements on the subject," said President and COO Bill Taylor. "It's also obvious that the agency began selective enforcement of this evolved view some 16 months ago when it issued MiMedx an Untitled Letter without first having vetted its new position through any public process."
Chairman and CEO Parker H. Petit urged the FDA to consider a "more robust" process and formal transition period for the industry to come into compliance with any new requirements. The company was prepared to submit a plan to discontinue sales of their micronized product — the target of an August 2013 letter from the FDA. But with the new draft guidance updates, the company requested to continue selling their current products until the draft guidance is finalized.
The company's $175 million to $190 million reported 2015 revenue forecast won't be impacted by the ability to continue marketing a micronized product, according to Mr. Petit.
"In addition, I am pleased to advise shareholders that we will exceed the upper end of our revenue guidance for both the fourth quarter and full year 2014," he said.