Limaca Medical initiates FIH study of biopsy device for improved tumor diagnosis

Editor’s note: This news appeared in Yahoo! Finance.

Current biopsy products — manually operated endoscopic ultrasound (EUS), fine needle aspiration (FNA), and fine needle biopsy (FNB) — face numerous limitations: multiple, imprecise stabbings; tissue acquisition rate of only 70% to 80%; and repeat procedures due to failed biopsies. Of even greater 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 Medical‘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 FNB of masses within or adjacent to the gastrointestinal tract.

Prof Iyad Khamaysi using Limaca’s KORA-GI in first-in-human trial at the advanced endoscopy unit of the gastroenterological department of Rambam Health Care Campus, Haifa, Israel.

Prof Iyad Khamaysi using Limaca’s KORA-GI in the FIH trial, Advanced Endoscopy Unit, Gastroenterology Department, Rambam Health Care Campus, Haifa, Israel.

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.”

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 Founder and Medical Director, Prof Iyad Khamaysi

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 Board Chairman Carl Rickenbaugh

 

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.