"The role of the FDA is to ensure the highest standards of safety for new products. We view the requested clarifications from the FDA in regards to safety studies as part of the normal process of FDA submission. Given that the HemaXellerate I™ possesses the potential to treat multiple conditions, we view the demonstration of safety as a fundamental step, which will position the Company to expand use of this 'stem cell drug' for multiple other indications," noted David Koos, the Company's Chairman & CEO. "Having passed the clinical trial protocol approval and the manufacturing approval, are major milestones for Regen."

On May 9, 2014 the Company updated its IND with changes requested by the FDA and submitted them for review.