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:
- Faster, more efficient biopsy yields
- Highly consistent results, regardless of physician skill level
- Easily replicable method to achieve a definitive diagnosis for histological and genetic testing
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.
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:
- Non-diagnostic biopsy rates
- High skill dependency
- Low standardization
- Repeated passes, and many throws
- Less optimal tissue at times for histology, or biologic structure
- Higher rates of inadequate biopsy tissue during molecular analysis testing
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 ENDOSCOPICBIOPSY 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
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
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
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.
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, 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 and HekaBio Announce Japan Partnership
YOKNEAM, Israel, May 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, 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...
References and Disclaimers
- GLOBOCAN 2020 https://gco.iarc.fr/
Precision-GI™ has received FDA clearance in the United States as of August, 2023.
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info@limaca-medical.com