Updates from TLA

CE marking of TLA Gut
TLA has successfully completed regulatory audit according to the medical device directive MDD 93/42/EEC (Annex II). The certification allows TLA to market its TLA Gut device for treatment of ulcerative colitis within the European Economic Area (EEA).
April 30, 2021
TLA launches the TLA-002 dosing trial
TLA has received regulatory approval to launch an open-label, randomized, dose evaluation study of TLA Gut™. The aim of the trial is to evaluate the efficacy and safety of two different TLA Gut™ dose regimens in patients with acute exacerbation of ulcerative colitis.
September 20, 2020
TLA receives ISO 13485 certification
TLA har received certification of its quality management system according to ISO 13485:2016.
December 9, 2020