Acusphere, Inc. (ACUS.PK) today announced that it had completed the Marketing Authorisation Application (MAA) dossier for its lead product candidate, Imagify™ (Perflubutane Polymer Microspheres) for Injectable Suspension, and is now starting the process of filing the MAA dossier with the European Medicines Agency (EMA) to support the regulatory review of Imagify in the European Union (EU). The company has also secured an additional $8 million of debt financing this year, following stockholder approval of a reverse stock split in early 2012.
“We are very pleased that we have completed the MAA dossier within the timing we predicted, since starting the submission in Europe marks a major milestone for Acusphere and Imagify”
"We are very pleased that we have completed the MAA dossier within the timing we predicted, since starting the submission in Europe marks a major milestone for Acusphere and Imagify," said Sherri C. Oberg, President and CEO of the company. "With the benefit of our new financing as well as this critical step, we look forward to working with the European Rapporteurs through their schedule of reviews in our efforts to bring what we believe is a very promising drug forward into the European marketplace. At the same time, we are ramping up our potential partnership efforts, focused both on the European opportunity as well as global and U.S. markets, so that the timing of those discussions is synchronized with the MAA review process. "