Limaca Medical & Precision-GI™

Company: Limaca Medical’s major innovation is the Precision-GI™ product, the first and only motorized, battery operated, automated, rotational cutting and coring endoscopic ultrasound (EUS) biopsy product, which received the FDA’s special designation as a Breakthrough Product in March 2022, and received the FDA’s 510(k) clearance in August 2023.

Value Proposition: Precision-GI™ provides superior volume and quality tissue acquisition needed for histopathologic and molecular analysis, and high quality outcome standardization across physician skill levels

Precision-GI™ Technology / Product: Automated, Motorized EUS Biopsy Device with high speed rotational coring mechanism so that more tissue can be taken, with less blood content, in a single pass, saving critical procedure time and effort.

Precision-GI enables the gastroenterologist to take higher quality and quantity intact tumor tissue in a single pass through the endoscope, saving critical procedure time and effort.  

Precision-GI consists of a battery operated control handle, connected to a rotating shaft enabling access through the endoscope. The shaft’s distal end connects to the biopsy coring needle specially designed with the flexibility to access challenging to reach tumors in the GI track, such as in the head of the pancreas. The motorized single use product rotates the coring needle at high speed while programmatically advancing axially into the tumor at a controlled pace.

Precision-GI produces a faster, more efficient, superior, and highly consistent endoscopic biopsy yield regardless of physician skill level. Precision enables the cancer care team to always achieve a definitive diagnosis superior to the standard of care.