Limaca Medical today announced that its Precision GI endoscopic ultrasound biopsy device has received FDA breakthrough device designation.
Israel-based Limaca Medical designed the endoscopic device to obtain tumor tissue within or adjacent to the gastrointestinal tract. Precision GI is deployed and operated through an instrument channel in the endoscope to biopsy a tumor.
Precision GI uses a unique motorized, automated rotational cutting needle for successful tissue acquisition. It obtains biopsies for definitive diagnosis of pancreatic cancer and other life-threatening GI cancers more quickly and less traumatically than gold-standard procedures, according to the company.
In a comparative feasibility clinical study, Precision GI demonstrated contiguous intact core tissue samples that were fully adequate for definitive diagnosis of pancreatic lesions, Limaca said. The clean, non-contaminated tissue samples had a high percentage of tumor content with less blood and extraneous fluids.
“We are pleased with the FDA’s decision to grant the breakthrough device designation to Precision GI,” CEO Carl Rickenbaugh said in a news release. “At Limaca, our vision is to ensure that endoscopic biopsies always achieve a definitive diagnosis to enable optimal and timely GI cancer treatment. We are dedicated to the mission to provide a far better endoscopic biopsy experience for the endoscopist and patient, with the goal to achieve a faster, more efficient biopsy yield with highly consistent results. With the breakthrough device designation, we look forward to accelerating our progress toward our goal of obtaining the FDA’s 510(k) clearance to bring Precision GI to patients in the US in the near future.”