This is what I copied from press release dated december 14, 2012.....
the Company has filed a request with the U.S. Food and Drug Administration (FDA) for Humanitarian Use Device (HUD) designation for its biopolymer scaffolding product. InVivo is currently working with the FDA on the final steps to seek approval to begin a clinical trial of the scaffolding in acute SCI in early 2013.
looks like just a request so far...approval probably not far away...jmo
Have you seen MIT News this week? Robert Langer is co-chair of the Japanese Symposium on drug delivery systems taking place the first week in January. He also recently received an award from the Pres. Software wouldn't allow me to post the link.
Science is getting some well deserved recognition and support worldwide.