superior endoscopic biopsy

Our VISION

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:

Introducing Precision-GI™

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.

DESIGNED FOR THE PHYSICIAN

Physicians will prefer Precision-GI™ over existing endoscopic biopsy devices because it provides:

  • superior volume and quality tissue acquisition needed for histopathologic and molecular analysis
  • high quality outcome standardization across a broad variation of physician skill levels

AUTOMATED MECHANISM

Due to Precision-GI’s motorized, automated, rotating cutting mechanism:

  • more tissue can be taken
  • with less blood content,
  • in a single pass,
  • saving critical procedure time and effort
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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:

PRECISION-GI

DESIGNED TO MEET OR EXCEED ALL CUSTOMER NEEDS
  • Automated, no user-dependency
  • 1 Pass, 2-3 controlled cores obtained
  • Far shorter procedure
  • Precise control
  • Excellent tissue quality

vs.

STANDARD OF CARE

CURRENT ENDOSCOPIC
BIOPSY DEVICES
  • Manual tool, user-dependent
  • 2-5 Passes, 30-50 stabs
  • Time consuming
  • Imprecise
  • Fragmented, inconsistent sample quality

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)
5.64
3.87 (p=0.001)
Total Procedure Average Throws/Activations
55
5 (p=0.00002)
Histology Scores Average (Scale of 1-5, 5 being the best)
3.2
4.6 (p=0.002)

CORE SAMPLES

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.

PRECISION-GI™

Contiguous 110mm core biopsy sample

STANDARD OF CARE

Fragmented, no segment greater than 10mm

HISTOLOGY

AUTOMATED precision-GI™ vs. MANUAL FNB

AUTOMATED PRECISION-GI™

Intact, voluminous, preserved tissue samples

Adequate for cyto- and histopathologic diagnoses, and molecular tumor profiling

Manual FNB Histology Sample

MANUAL FNB

Fragmented tissue, detached epithelial strips, with admixed blood

Adequate for categorical cytologic diagnosis, sometimes agnosis

EUS SKyline

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

USA POPULATION
0
PANCREATIC CANCER - 56,654 NEW CASES
0%
LIVER CANCER - 42,283 NEW CASES
0%
LUNG CANCER - 227,875 NEW CASES
0%

FDA BREAKTHROUGH

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

"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.

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.”
Seth A. Gross, MD
Clinical Chief, Division of Gastroenterology and Hepatology, NYU Langone Health. April 2022

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.

AGA Shark Tank Finalist

LIMACA MEDICAL COMPLETES 24 FIRST-IN-HUMAN CASES

Precision-GI™ continues to be tested to gauge its effectiveness in a clinical setting. 

LIMACA TEAM

TODD DOLLINGER

CHAIR

CARL RICKENBAUGH

VICE CHAIR

ASSAF KLEIN

ceo

iyad khamaysi

FOUNDER

SETH GROSS

CHIEF MEDICAL ADVISOR

VIVEK KAUL

SR. MEDICAL ADVISOR

OUR PARTNERS

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, IsraelSept. 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 and HekaBio Announce Japan Partnership

YOKNEAM, IsraelMay 16, 2022 -- Limaca Medical and HekaBio K.K. announced today that they have inked a strategic partnership agreement, whereby HekaBio is to distribute Limaca's Precision-GI™ Endoscopic Biopsy Device in Japan...

Limaca Medical Receives FDA Breakthrough Device Designation

YOKNEAM, IsraelMay 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, IsraelNov. 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...

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