The Icellator® has been approved for commercial use in Korea as a Class III medical device by the Korean FDA (KMFDS) and has been used in more than 1,200 commercial applications. The Ukraine and the Bahamas have also given regulatory approval for Tissue Genesis’ patented, clinical grade cell therapy processing solutions. In 2017, Human Life CORD, Japan struck a 10-year exclusive agreement with TG to distribute its products in commercial clinics, research institutions, and hospitals in Japan and China.

Asia

Japan Japan: In clinical use.
South Korea South Korea: In clinical and commercial use.

Europe

Ukraine Ukraine: In clinical and commercial use.

North America & the Caribbean

USA: In clinical use under FDA-cleared IDE(s).
Bahamas: In clinical and commercial use.