Limaca's Precision-GI™ Granted CMS Transitional Pass-Through (TPT) Payment

Rhea-AI Summary

Limaca Medical's Precision-GI™ endoscopic biopsy device has been granted transitional pass-through (TPT) payment by CMS, effective January 1, 2025, for up to three years. The device, which received FDA Breakthrough Device Designation in 2022 and FDA clearance in August 2023, is designed to improve biopsy results for gastrointestinal cancers. The motorized, automated rotating cutting mechanism enables superior tissue acquisition with less blood content in a single pass, enhancing diagnostic efficiency. The TPT program will support broader patient access by providing additional payments to hospitals to cover adoption costs. The device began its U.S. market entry in September 2024.

Positive

• Received CMS transitional pass-through payment approval, enabling broader market access
• Previously obtained FDA Breakthrough Device Designation and FDA clearance
• Technology demonstrates superior tissue acquisition capabilities
• Large market potential with 510,992 new pancreatic cancer cases globally in 2022
• Additional payments to hospitals will support adoption

Negative

• None.

Precision-GI™ FDA Designated Breakthrough product and FDA cleared semi-automated motorized endoscopic biopsy device entering U.S. market

YOKNEAM, Israel, Nov. 7, 2024 /PRNewswire/ -- The Centers for Medicare & Medicaid Services (CMS) has granted transitional pass-through (TPT) payment for Limaca Medical Ltd. ("Limaca")'s Precision-GI™ motorized endoscopic biopsy device. Limaca's endoscopic device is designed to obtain improved biopsy results for patients with suspected gastrointestinal cancers such as pancreatic, liver, and other GI-related and adjacent organs cancers and illnesses. The Precision-GI™ TPT grant is for up to three years beginning January 1, 2025, thus supporting patient access to Limaca's new and innovative technology; previously, Precision-GI™ was granted the FDA's Breakthrough Device Designation in 2022 and received clearance by the U.S. Food and Drug Administration (FDA) in August 2023.

"Receiving TPT approval for our Precision-GI™ product is a major accomplishment for Limaca, enabling greater patient access to the breakthrough device, standardizing higher quality outcomes for these critical endoscopic biopsy procedures, and reducing repeat procedures for patients anxiously awaiting diagnostic results for suspected pancreatic and other GI cancers," said Limaca's CEO Assaf Klein. "Very few products are granted TPT, and even fewer achieve both TPT and the FDA's Breakthrough designation. We are proud of these achievements and deeply pleased that the CMS TPT grant will enable broad patient access to Precision-GI."

The purpose of the TPT program is to support access to newly approved innovative technologies where the costs to adopt them may otherwise inhibit patient access. The TPT program reduces barriers for Medicare beneficiaries to access critical healthcare innovations shortly after products receive FDA approval by providing hospitals with additional payments to cover their costs, while allowing CMS to collect necessary cost data to determine future outpatient payments.

Endoscopic biopsy is a mainstay diagnostic procedure performed with standard manually operated needles threaded through the working channel of the endoscopic ultrasound (EUS) device to visualize and access the target suspect lesion. Due to Precision-GI's motorized, automated, rotating cutting mechanism, much better quality tissue can be taken, with less blood content, in a single pass, saving critical procedure time and effort. A major benefit for patients over current endoscopic biopsy devices is the ability to consistently obtain superior volume and quality tissue acquisition needed for histopathologic and molecular analysis along with a high quality outcome, and standardization across a broad variation of physician skill levels.

Limaca's Precision-GI performed its first U.S.-based cases in September 2024 and is now commencing U.S. market entry. A total of 510,992 new cases of pancreatic cancer were recorded around the world in 2022, with some of the highest rates occurring in Japan, USA, Germany, UK, and France - all between 8.0 - 9.8 per ASR (age standardized rates)^[1]. Precision-GI is additionally working toward Japan's PMDA clearance and market entry along with its partner HekaBio. 

^[1] World Cancer Research Fund International
https://www.wcrf.org/cancer-trends/pancreatic-cancer-statistics/

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

 

View original content:https://www.prnewswire.com/news-releases/limacas-precision-gi-granted-cms-transitional-pass-through-tpt-payment-302298613.html

SOURCE Limaca Medical

FAQ

When will Limaca's Precision-GI TPT payment status begin?

The TPT payment status for Precision-GI will begin on January 1, 2025, and can last up to three years.

What are the key advantages of Precision-GI over traditional biopsy devices?

Precision-GI features a motorized, automated rotating cutting mechanism that obtains superior tissue quality with less blood content in a single pass, saving procedure time and standardizing outcomes across physician skill levels.

When did Precision-GI receive FDA clearance?

Precision-GI received FDA clearance in August 2023, following its FDA Breakthrough Device Designation in 2022.

When did Precision-GI begin its U.S. market entry?

Precision-GI performed its first U.S.-based cases in September 2024 and is now commencing its U.S. market entry.