Limaca's Precision-GI™ Enters US Market

Rhea-AI Summary

Limaca Medical has launched its Precision-GI™ endoscopic automated motorized EUS biopsy device in the US market, supported by clinical trials, FDA clearance, and CMS Transitional Pass-Through (TPT) Payment award. The device is designed to obtain improved biopsy results for suspected cancers in the GI tract and adjacent organs.

A clinical trial with 40 patients at IECED Medical Center demonstrated outstanding results, showing Precision-GI's ability to provide consistent, high-quality biopsy samples with excellent tissue quality and procedural efficiency. The device's motorized, automated, rotating cutting mechanism enables superior tissue acquisition with less blood content in a single pass.

The company is initially focusing sales in the New York/New Jersey Metro area, with cases already completed at three NY metro medical centers. The TPT designation reimbursement status is facilitating broader hospital adoption with financial support.

Positive

• Successful completion of 40-patient clinical trial demonstrating superior biopsy sample quality
• FDA clearance and CMS Transitional Pass-Through Payment approval secured
• Initial market penetration with three NY metro medical centers already using the device
• TPT reimbursement status enabling broader hospital adoption

Negative

• initial market presence (only NY/NJ Metro area)
• Early stage of commercialization with uncertain market acceptance

CMS Transitional Pass-Through (TPT) Payment and completion of successful clinical studies position Limaca for US market entry.

YOKNEAM, Israel, Feb. 18, 2025 /PRNewswire/ -- Limaca Medical Ltd. ("Limaca") has launched its Precision-GI™ endoscopic automated motorized EUS biopsy device in the US market. Commercialization is supported by Limaca's clinical trials, operational capabilities, FDA clearance, and CMS Transitional Pass-Through (TPT) Payment award.

Limaca's Precision-GI™ endoscopic device is designed to obtain improved biopsy results for patients with suspected cancers in the GI tract and adjacent organs, including the pancreas, liver, and other adjacent organs. Due to Precision-GI's motorized, automated, rotating cutting mechanism, superior volume and quality tissue acquisition can be acquired for histopathologic and molecular analysis with less blood content, far more efficiently in a single pass.

Carlos Robles-Medranda, M.D., FASGE, AGAF and his team at the IECED Medical Center successfully completed a clinical trial with 40 patients, primarily focused on endoscopic ultrasound-guided biopsies of solid pancreatic masses, as well as liver and other masses within or adjacent to the gastrointestinal tract. The trial delivered outstanding results, with Precision-GI™ demonstrating its ability to provide consistent, high-quality biopsy samples – achieving excellent tissue quality and procedural efficiency. 

Dr. Carlos Robles-Medranda further stated: "The procedure with Precision GI is super easy for the physician and the results after just one pass are phenomenal – the core sample is not fragmented or bloody. It's very clear, it's impressive. The quality of the biopsy tissue is amazing. Having used core needles for many years, I haven't had samples that are not bloody, especially for example, with the liver. This will be very revolutionary for quality of tissue overall." 

Limaca has put in place robust manufacturing capabilities and is focused on selling in the New York/New Jersey Metro area; the Company recruited Michael Davis, a seasoned medical device sales director with multinational medical companies, as Sales Director and is in the process of reinforcing US sales resources. Cases have been completed at three NY metro medical centers and additional major hospitals are in the process of adding Precision GI to their systems. Precision-GI's TPT designation reimbursement status is enabling broader hospital adoption with financial support for hospitals purchasing Precision-GI. 

Dr. Rosario Ligresti MD FASGE, Chief of Gastroenterology, Hackensack Medical Center has conducted more than twenty cases using Precision GI. He commented on his experience: "I am excited to partner with Limaca to help bring an amazing automated, 20 gauge EUS biopsy needle to the USA. We biopsied everything from lymph nodes to bile duct and pancreas masses successfully. Hackensack Meridian Health and Hackensack University Medical Center are leading the way to precise biopsy results with cutting-edge endoscopic capabilities."

Limaca's CEO Assaf Klein added, "Our progress over the past year has positioned Limaca as a leader in innovative endoscopic biopsy solutions, with the potential to redefine GI cancer diagnostics. Limaca Medical is well-positioned for growth through providing superior diagnostics, better results for the patient, and improved physician experience."

About Limaca Medical

Limaca Medical Ltd. is a privately held Israel-based company dedicated to improving endoscopic biopsy results for patients facing potentially life-threatening cancers. The company is funded by the Israeli Innovation Authority, Agriline, The Trendlines Group, Ltd. (SGX: 42T) (OTCQX: TRNLY) and additional medical device veterans in the U.S. Israel, and Japan. Partnerships include HekaBio, a Japan-based healthcare innovation commercialization company.

Contact:

Assaf Klein, CEO
Assaf@limaca-medical.com

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SOURCE Limaca Medical

FAQ

What are the key features of Limaca's Precision-GI biopsy device?

Precision-GI is an automated motorized EUS biopsy device featuring a rotating cutting mechanism that obtains high-quality tissue samples with less blood content in a single pass, designed for GI tract and adjacent organ biopsies.

What were the results of Precision-GI's clinical trial?

The 40-patient clinical trial at IECED Medical Center demonstrated outstanding results, showing consistent, high-quality biopsy samples with excellent tissue quality and procedural efficiency.

Where is Limaca currently selling the Precision-GI device?

Limaca is initially focusing sales in the New York/New Jersey Metro area, with cases completed at three NY metro medical centers.

What regulatory approvals has Precision-GI received?

Precision-GI has received FDA clearance and CMS Transitional Pass-Through (TPT) Payment approval for the US market.