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

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The Centers for Medicare & Medicaid Services (CMS) has granted transitional pass-through (TPT) payment for Limaca Medical'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.

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. Precision-GI is additionally working toward Japan's PMDA clearance and market entry along with its partner HekaBio.