Tuesday, September 12, 2023
Limaca Medical, operating under the name Limaca, has achieved a significant milestone by obtaining FDA 510(k) clearance for its Precision GI™ Endoscopic Ultrasound (EUS) Biopsy Device. This accomplishment follows the device's prior recognition with FDA Breakthrough Device Designation. The Precision GI™ device represents a substantial advancement in the field, offering a faster and less invasive approach to obtaining biopsies for the diagnosis of pancreatic cancer and other critical gastrointestinal (GI) cancers when compared to current methods. This automated device has been meticulously designed to bolster the efficiency and effectiveness of GI cancer diagnosis by delivering a significantly improved quality and quantity of diagnostically relevant biopsy tissue. Limaca's pioneering work was spotlighted in a publication by iGIE on April 26, 2023, elucidating their successful First-In-Human EUS-Biopsy cases involving patients with suspected pancreatic cancer.
Diverging from existing endoscopic ultrasound fine needle biopsy (EUS-FNB) devices that rely on manual operation, Precision GI™ showcases a distinctive motorized, automated rotational cutting needle, ensuring both safety and the acquisition of high-quality tissue. Current endoscopic biopsy devices frequently grapple with the challenge of consistently obtaining adequate, uncontaminated tissue, resulting in issues such as tissue fragmentation, insufficient sample size, and blood contamination. Prof. Iyad Khamaysi, MD, Director of the Invasive Endoscopy Unit at the Rambam Health Care Campus, underscored the profound significance of this technological leap.
Limaca's CEO, Assaf Klein, highlighted the successful outcomes of their initial patient series, demonstrating Precision GI™'s capability to procure intact core tissue samples ideally suited for definitive diagnoses of pancreatic lesions. These pristine, uncontaminated samples yield a high percentage of tumor content while minimizing blood and extraneous fluids. The FDA clearance represents a pivotal moment for Limaca, empowering them to introduce Precision GI™ to the market, in alignment with their mission to consistently deliver precise, efficient, and definitive biopsy samples.
Carl Rickenbaugh, Vice Chair of Limaca, expressed their gratification regarding the FDA's clearance of Precision GI™ subsequent to its Breakthrough Device Designation. The company remains steadfast in its commitment to enhancing the endoscopic biopsy experience for both endoscopists and patients, with the aim of achieving faster, more efficient biopsy results characterized by high consistency. They eagerly anticipate making Precision GI™ available to patients in the United States in the near future.