Limaca Medical Receives Breakthrough Device Designation from the FDA

ByLance T. Lee

May 2, 2022

Limaca’s Precision-GI Endoscopic Biopsy Device Advances Precision Medicine

YOKNEAM, Israel, May 2, 2022 /PRNewswire/ — Limaca Medical (“Limaca”) today announced that its Precision-GI™ ultrasound endoscopic biopsy product has received Breakthrough Device Designation from the U.S. Food and Drug Administration (“FDA”).

The Precision-GI™ device is designed to harvest tumor tissue from within or near the gastrointestinal tract. Endoscopic biopsy is performed by a gastroenterologist who accesses the targeted gastrointestinal tumor using an ultrasound viewing endoscope. Precision-GI™ is deployed and actuated through an instrument channel in the endoscope to biopsy the tumor. Suspicious locations of gastrointestinal tumors include submucosal lesions, mediastinal masses, lymph nodes, intraperitoneal masses, and in organs related to the gastrointestinal tract such as the pancreas and liver.

While all existing endoscopic ultrasonic fine-needle biopsy (EUS-FNB) devices require manual operation, Precision GI™ features a unique motorized and automated rotary cutting needle for successful tissue acquisition. Today’s endoscopic biopsy devices have limitations in consistently obtaining sufficient quality tissue, which can lead to tissue sample fragmentation, inadequate tissue quantity, and blood contamination.

Precision GI™ is designed to obtain biopsies for definitive diagnosis of pancreatic cancer and other life-threatening gastrointestinal cancers faster and less traumatically than current products. The automated design will provide more effective and efficient diagnosis of gastrointestinal cancers since it is designed to produce significantly higher quality and quantity of diagnostically relevant biopsy tissue.

Initial cases from Limaca’s ongoing Comparative Clinical Feasibility Study demonstrate that Precision GI™ has obtained contiguous intact core tissue samples that are well suited for the definitive diagnosis of pancreatic lesions. Clean, uncontaminated tissue samples provided a high percentage of tumor content, with less blood and extraneous fluids.

“Precision-GI™ is an automated, motorized endoscopic biopsy product that has the potential to improve our biopsy outcomes for the evaluation of gastrointestinal malignancies. Endoscopic biopsy is a highly specialized and highly skilled procedure. We salute innovation from Precision-GI™ that can provide automation and standardization of results with less variation from operator to operator,” said Seth A. Gross, MD, Clinical Chief, Division of Gastroenterology and Hepatology, NYU Langone Health. “Our field is moving towards individualized, patient-centered cancer therapy, known as precision medicine, which requires consistent quality and quantity of endoscopic biopsy tissue, allowing for an optimal match of tumor genetic profile for personalize a patient’s treatment plan.”

“We are delighted with the FDA’s decision to grant Breakthrough Device Designation to Precision-GI™,” said Carl Rickenbaugh, CEO of Limaca. “At Limaca, our vision is to ensure that endoscopic biopsies always result in a definitive diagnosis to enable optimal and timely treatment of gastrointestinal cancer. We are dedicated to the mission of providing a much better endoscopic biopsy experience for the endoscopist and patient, with the goal of achieving faster, more efficient biopsy throughput with highly consistent results. With the breakthrough device designation, we look forward to accelerating our progress toward our goal of obtaining 510 clearance. (k) the FDA to bring Precision-GI™ to patients in the United States in the near future.”

FDA Breakthrough Device designation accelerates the development and evaluation of new devices that offer the potential to improve patient outcomes through more effective treatment or improved diagnosis of life-threatening conditions. As part of the program, the FDA will provide Limaca with the opportunity to provide feedback during the pre-marketing phase and priority review of the device submission.

About Limaca Medical

Limaca Medical, Ltd, is a private company based in Israel dedicated to improving endoscopic biopsy outcomes for patients facing life-threatening gastroenterological cancers. Limaca has an experienced team of engineers, clinicians and business professionals with proven track records in the innovation, development and commercialization of specialty medical devices. Limaca Medical is primarily funded by the Israel Innovation Authority, Agriline (a trust of which Vincent Tchenguiz is a discretionary beneficiary) and The Trendlines Group, Ltd (SGX:42T;OTCQX:TRNLY), an innovation commercialization company which invents, discovers, invests and incubates innovation-based medical and agricultural technologies to fulfill its mission of improving the human condition.

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Carl RickenbaughCEO
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