Eden Prairie–based Celleration markets the MIST Therapy System, designed to treat wounds via ultrasound technology. The device has received two FDA approvals, in July 2004 (for wound cleansing) and May 2005 (for wound healing).
“We thought we could get through the FDA and into the market fairly quickly in 2002 and submitted what I thought was going to be a fairly simple indication. The FDA does not approve products; it approves indications, which are marketing lines you can use to market a product. For example, if you say X technology cures cancer, they want to see data to prove it can cure cancer.
This is a complex, lengthy, and expensive game of chess. I learned to prepare to do a lot of educating, because the FDA doesn’t have the ability to bring in the youngest and brightest from MIT or Harvard or the University of Minnesota. Things are changing so fast that these people are at a disadvantage to stay current. You need to be willing to spend a lot of time meeting with and educating them. As we keep pushing the technology envelope, this issue will continue to arise. It is not for the faint of heart.”
