Limaca Medical ("Limaca") that its Precision-GI™ Endoscopic Ultrasound Biopsy Product has received a Breakthrough Device Designation from the U.S. Food and Drug Administration ("FDA").
The Precision-GI™ device is designed to obtain tumor tissue within or adjacent to the gastrointestinal tract. Endoscopic biopsy is performed by a gastroenterologist who accesses the targeted GI tumor utilizing an ultrasound visualization endoscope.
Precision-GI™ is deployed and operated through an instrument channel in the endoscope to biopsy the tumor. Suspect GI tumor locations include submucosal lesions, mediastinal masses, lymph nodes, intraperitoneal masses, and within GI related organs such as the pancreas and liver.
While all existing endoscopic ultrasound fine needle biopsy (EUS-FNB) devices require manual hand operation, Precision GI™ features a unique motorized, automated rotational cutting needle for successful tissue acquisition.
Today's endoscopic biopsy devices have limitations in consistently obtaining quality tissue with sufficient quantity, which can result in sample tissue fragmentation, inadequate tissue amount, and blood contamination.
Precision GI™ is designed to obtain biopsies for definitive diagnosis of pancreatic cancer and other life-threatening GI cancers more quickly and less traumatically than current products.
The automated design will provide for more efficient and effective diagnosis of GI cancers since it is designed to yield significantly superior quality and quantity of diagnostically relevant biopsy tissue.
Initial cases from Limaca's comparative feasibility clinical study, which is ongoing, demonstrates that Precision GI™ obtained contiguous intact core tissue samples fully adequate for definitive diagnosis of pancreatic lesions.
The clean, non-contaminated 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 results for the evaluation of gastrointestinal malignancies. Endoscopic biopsy is a highly specialized, high skill procedure.
We welcome the innovation of Precision-GI™ which can provide automation and standardization of outcomes with less variation from operator to operator," stated Seth A. Gross, MD, Clinical Chief, Division of Gastroenterology and Hepatology, NYU Langone Health.
"Our field is driving toward patient centric individualized cancer therapy, known as Precision Medicine, which requires consistently high quality and quantity of endoscopic biopsy tissue, enabling optimal matching of the tumor's genetic profile to personalize a patient's treatment plan."
"We are pleased with the FDA's decision to grant the Breakthrough Device Designation to Precision-GI™," stated Carl Rickenbaugh, Limaca's CEO. "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."
The FDA Breakthrough Device Designation expedites the development and evaluation of novel devices that offer the potential to enhance patient outcomes through more effective treatment or improved diagnosis of life-threatening conditions.
Under the program, the FDA will provide Limaca with the opportunity to provide its feedback during the pre-market phase and prioritized review of the device submission.
