Founded March 2017
Stage Technology development
Investors The Trendlines Group
CEO Assaf Klein
Limaca Medical is developing an Endoscopic Ultrasound Fine Needle Biopsy (EUS-FNB) system to obtain a core tissue sample for increased biopsy yield with fewer needle entries.
The market seeks a EUS-FNB that can retrieve core tissue with fewer stabs and increased acquisition rate for improved diagnostic accuracy and clinical outcomes.
15 years’ experience in medical device companies, including managerial and R&D positions; former CEO, MediValve; MBA, Bar-Ilan University; BSc, mechanical engineering, Technion-Israel Institute of Technology
Director, Invasive Endoscopy Unit, Department of Gastroenterology and Hepatology, Rambam Health Care Campus, Israel
Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) is a standard, minimally invasive procedure that utilizes ultrasound imaging to guide a thin, hollow needle for tissue sampling to diagnose and evaluate benign and malignant lesions of the gastrointestinal (GI) tract and adjacent organs.
Unfortunately, this procedure requires “stabbing” the lesion tens of times to acquire an adequate diagnostic sample. Current aspiration systems obtain only a 60% to 70% tissue sample acquisition rate. Even when the procedure is successful, the acquired small tissue sample is suitable for a cytological (cell) analysis only and not a complete histological (tissue) analysis.
To solve this problem, FNB was developed to remove pieces of core tissue and to enable histological analysis. While these needles are designed to reduce the number of needle stabs and to improve acquisition, current FNBs have yet to demonstrate improved superior performance when compared to FNA.
According to Limaca’s research and estimates, the EUS-FNA market in 2016 was $200 million, with 750,000 procedures worldwide that is expected to reach 1 million in 2019. Interviews with key opinion leaders suggests that 80% of EUS-FNA is used for solid lesions. Limaca estimates its market potential in 2019 at $240 million.