MISGAV, Israel, May 16, 2019 - Limaca Medical Ltd. ("Limaca"), a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T) (OTCQX: TRNLY), announced the start of its first-in-human ("FIH") clinical study for its electromechanically driven Endoscopic Ultrasound-guided ("EUS") biopsy device. The study is being conducted in two leading Israeli medical centers. The study's objectives are to assess safety and performance.
Current biopsy products -- manually operated EUS, Fine Needle Aspiration (FNA), and FNB -- face numerous limitations: multiple, imprecise stabbings; tissue acquisition rate of only 70% to 80%; and repeat procedures due to failed biopsies. Of even great significance, is small sample yields unsuitable for cytological (cell) analysis, prohibiting advanced analysis of tumors, such that therapy cannot be tailored to match precise tumor types, resulting in suboptimal treatment.
Limaca's KORA GI, an electromechanically driven, EUS-guided biopsy device for improved diagnosis of gastrointestinal system and adjacent organ tumors, is less operator dependent than manually-driven devices, yielding better results. It is used with an ultrasound endoscope for Fine Needle Biopsy of masses within or adjacent to the GI tract.
Limaca CEO Assaf Klein: "We are extremely pleased to report the start of our first-in-human study and look forward to gaining traction from the study results to provide the market with a much-needed, superior biopsy product. KORA GI will advance precision medicine by enabling improved diagnosis."
Limaca Founder and Medical Director, Prof Iyad Khamaysi: "After using the KORA-GI in clinical procedures, I have stronger confidence that the new, well-designed device has superior usability and can provide physicians with safe and better tissue acquisition for the needs of personalized medicine."
Limaca Board Chairman Carl Rickenbaugh: "The story in percutaneous biopsy over the years has been an evolution to better automated products capable of obtaining better quality and quantity of captured biopsy tissue. The future of endoscopic biopsy evolution is in fact developing in the same direction to improve sample capture, and Limaca is developing leadership in this exciting future."
Limaca has launched a $2 million financing round to support its FDA 510(k) submission and CE mark clearance, production scale-up, and U.S. Registry Study.
Limaca will attend DDW in San-Diego starting this week, May 17-22, 2019. To set a meeting, contact Assaf Klein.