superior endoscopic biopsy
We seek to ensure that endoscopic biopsies can always achieve a definitive diagnosis to enable optimal and timely cancer treatment.
In order to improve the endoscopic experience for both the endoscopist and the patient, we aim to provide:
Designed to always achieve a definitive diagnosis for histologic and genetic testing of endoscopic biopsy tissues.
Precision-GI™ has received FDA clearance in the United States as of August, 2023.
IMPROVING THE STANDARD OF CARE
Manual EUS needles represent the traditional standard of current endoscopic biopsy devices. The limitations of these manual tools force physicians to experience:
First-in-human clinical study
pRELIMINARY OUTCOMES OF AN ONGOING STUDY, ASSESSING INITIAL 9 COMPARATIVE CASES
|Initial 9 Cases
|EUS Fine Needle Biopsy (Manual)
|Precision-GI™ EUS Biopsy (Automated)
Sampling Time (Minutes)
Total Procedure Average Throws/Activations
Histology Scores Average (Scale of 1-5, 5 being the best)
precision-GI™ vs. standard of care
Core biopsy samples were taken in a pre-clinical study on June 26th, 2022, comparing Precision-GI’s automated mechanism to a fine needle biopsy representing today’s highest standard of care.
Contiguous 110mm core biopsy sample
STANDARD OF CARE
Fragmented, no segment greater than 10mm
AUTOMATED precision-GI™ vs. MANUAL FNB
Intact, voluminous, preserved tissue samples
Adequate for cyto- and histopathologic diagnoses, and molecular tumor profiling
Fragmented tissue, detached epithelial strips, with admixed blood
Adequate for categorical cytologic diagnosis, sometimes agnosis
carlos robles, md CONDUCTS LIVER BIOPSY
ADDRESSING THE NEED
We are dedicated to applying our technology to make a significant improvement in the delivery of endoscopic biopsy diagnosis in pancreatic, liver, and lung cancers.
The following data represents the deaths and new annual incidence cases related to these deadly cancers that occur in the United States alone. Cancer incidence is the number of new cancer cases arising in a specified population over a given period of time.¹
precision-GI™ determined to qualify for designation as a breakthrough device
Precision-GI™ is considered to offer the potential to enhance patient outcomes through more effective treatment or improved diagnosis of life-threatening conditions. This designation will expedite the development and evaluation of our novel device.
HEAR FROM KEY OPINION LEADERS
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.”
RECENT developments AT LIMACA MEDICAL
LIMACA MEDICAL ACCEPTED AS A FINALIST IN THE 2023 AGA SHARK TANK
Five companies, including Limaca Medical, were selected for the 2023 AGA Shark Tank to show a glimpse of the future of GI patient care. The AGA Shark Tank took place on March 10th during the annual AGA Tech Summit.
LIMACA MEDICAL COMPLETES 24 FIRST-IN-HUMAN CASES
Precision-GI™ continues to be tested to gauge its effectiveness in a clinical setting.
CHIEF MEDICAL ADVISOR
SR. MEDICAL ADVISOR
The Company was established in Trendlines Labs, and in partnership with Rambam Health Care with the support of the Israel Innovation Authority.
In April of 2022, Limaca Medical partnered with HekaBio, an exclusive Japan commercialization partner that provides operational capability for market entry.
Find the latest news
Limaca Medical Receives FDA 510(k) Clearance for Breakthrough Precision GI™ Endoscopic Biopsy Device
YOKNEAM, Israel, Sept. 11, 2023 -- Limaca Medical announced today that its Precision GI™ Endoscopic Ultrasound (EUS) Biopsy Device received 510(k) clearance from the U.S. Food and Drug Administration ("FDA")....
Limaca Medical Receives FDA Breakthrough Device Designation
YOKNEAM, Israel, May 2, 2022 -- Limaca Medical announced today that its Precision-GI™ Endoscopic Ultrasound Biopsy Product has received a Breakthrough Device Designation from the U.S. Food and Drug Administration ("FDA").
Limaca Medical Raises $1.25 Million to Enhance Precision Medicine Through Improved Biopsies
MISGAV, Israel, Nov. 10, 2020 -- Limaca Medical, a portfolio company of The Trendlines Group Ltd. (SGX: 42T) (OTCQX: TRNLY), a leading Israel- and Singapore-based investment group focused on high-growth medical and agrifood technologies, announced it has closed $1.25 million of a $1.5 million round to complete first-in-human ("FIH") procedures, post-market clinical studies, and obtain regulatory approvals...