BiBBInstruments AB announces that the first clinical tissue acquisition procedures with EndoDrill® GI at Karolinska University Hospital in Stockholm have been successfully performed.BiBB is now planning to initiate more evaluations at a series of Scandinavian hospitals. In February, BiBB announced that the entire EndoDrill® product portfolio had received CE certification in accordance with MDR, i.e. market approval for the European market. This meant that the Company could begin clinical evaluations of the first product variant, EndoDrill® GI, which is used for sampling in the GI tract, e.g. pancreatic tumors, and submucosal tumors in the stomach.

This pre-commercial evaluation has now been initiated at Karolinska University Hospital in Stockholm. In late March, doctors at Karolinska University Hospital performed tissue samplings on two patients with tumors in the pancreas and stomach, respectively. In both cases, histological core biopsies (CNB, Core Needle Biopsy) were taken, which have now been shown to provide diagnoses in both cases.

The instrument was called "FNB on steroids" in the endoscopy room as a sign that it takes larger, more informative, biopsies compared to the latest generation of existing manual EUS biopsy instruments (EUS-FNB). High-quality biopsies are essential to establish a complete diagnosis for personalized treatment. The evaluation at Karolinska University Hospital has continued and the doctors have now independently performed another successful patient case without on-site support.

The trials in Stockholm will be followed by more evaluations at a series of Scandinavian hospitals. The launch of EndoDrill® GI in Sweden is expected to take place later this year.