Butterfly Medical received verification from the FDA approving IDE submission for the Butterfly study. This approval allows Butterfly to begin preparing for our Pivotal trial and plan for initial US procedures in early 2022!
The FDA concluded that sufficient data was provided to support activation of a human clinical study in the US. The decision was based on the total evidence provided, including clinical data from the ongoing “first in man” study in Israel, which verified our early safety and performance outcomes.
On behalf of Butterfly Medical, we are extremely excited to start preparing for our US Pivotal trial and the ability to help many men who suffer from BPH symptoms.