Limaca's Precision-GI? endoscopic ultrasound guided motorized fine needle biopsy (EUS-mFNB) device delivers substantial tissue acquisition.

YOKNEAM, Israel, May 15, 2024 /PRNewswire/ -- Limaca Medical ("Limaca") announced today the successful completion of twenty-four Precision-GI? endoscopic ultrasound guided motorized fine needle biopsy (EUS-mFNB) cases. Precision-GI's motorized rotational cutting needle demonstrated significant tissue acquisition. Cases completed by Dr. Carlos Robles-Medranda and colleagues in the ongoing study demonstrate that Precision-GI is quickly and efficiently obtaining contiguous intact core tissue samples for definitive diagnosis of target tissues. Dr. Robles-Medranda is Head of the Endoscopy Division, Ecuadorian Institute of Digestive Diseases, Guayaquil, Ecuador. Precision-GI? has received FDA Clearance and Breakthrough Device Designation.

Six cases were in pancreas, eighteen were in liver. Two-thirds of the cases were completed in a single pass in and out of the endoscope with a median average of three total motorized actuations of the coring needle to achieve overall excellent biopsy results. In 21 of 24 cases, the biopsy samples achieved the top grade of Exceeded Clinical Expectations.

Precision-GI obtains tumor tissue within or adjacent to the gastrointestinal tract, accessing targeted tumors via the working channel of ultrasound visualization endoscopes.

Unlike traditional manually operated endoscopic ultrasound fine needle biopsy (EUS-FNB) devices requiring repetitive stabbing with a manual needle, Precision-GI features a unique motorized rotational cutting needle for maximal tissue acquisition. Other endoscopic biopsy devices have limitations relative to consistently obtaining quality tissue, sample tissue fragmentation, and blood contamination.

Precision-GI is designed to obtain biopsies for definitive diagnosis of pancreatic cancer and other life-threatening GI cancers more efficiently and less traumatically than current products. The automated design is intended to yield significantly greater quality and quantity of diagnostically relevant biopsy tissue. With twenty-four cases completed by Dr. Robles-Medranda and colleagues, the ongoing study demonstrates that Precision-GI is quickly and efficiently obtaining contiguous intact core tissue samples for definitive diagnosis of target tissues.

Dr. Carlos Robles-Medranda commented, during a recent medical conference's live televised Precision-GI case, on his experience: "I believe there are several advantages. You can see the needle very well. I just pushed the button. And now we see the result of the biopsy after just one pass. This is the core you see. It is not bloody. No red stuff. It's very clear, the quality of the biopsy tissue is impressive. I've used core needles for many years, and they're still bloody, for example with the liver. When you have hard tissue, it is very difficult when you are pushing manually. The lesion moves sometimes. This is one of the things that I believe could be an advantage. This needle, in spite of being a 20 gauge needle, is really flexible. This will be very revolutionary for quality of tissue overall, and the results we need to evaluate comparing to standard core needles."