Orphan drug designation schedule for VascoStem, a stem cell treatment agent for Buerger’s disease, changed by MFDS

Notification of a change in the orphan drug designation schedule for VascoStem, a stem cell treatment agent for Buerger’s disease, from MFDS

The Biostar Stem Cell Research Institute, jointly operated by Nature Cell and R Bio, announced on August 21 that it has been notified by the Ministry of Food and Drug Safety (MFDS) that the date of decision-making regarding the orphan drug designation of VascoStem, a stem cell treatment agent for Buerger’s disease, has been postponed to September 14.

In accordance with MFDS’ request, Biostar submitted the supplementary documents on August 17 and met with the representatives of MFDS on August 20.

Dr. Ra Jeong-chan, the President of the Biostar Stem Cell Research Institute, stated, “Just as we have faithfully made the necessary preparations in the past, we will make an effort to obtain good results and do our utmost until the end so that VascoStem can be designated as an orphan drug and contribute to the treatment of Buerger’s disease.”