"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.

About Limaca Medical
Limaca Medical, Ltd, is a privately held company based in Israel that is dedicated to improving endoscopic biopsy results for patients facing potentially life threatening gastroenterology cancers. Limaca has an experienced team of engineers, clinicians, and business professionals with successful track records of innovating, developing, and commercializing specialized medical devices. Limaca Medical is primarily funded by the Israeli 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 that invents, discovers, invests in, and incubates innovation-based medical and agricultural technologies to fulfil its mission to improve the human condition.


SOURCE Limaca Medical

Back to HCB News

Endoscopy Homepage