Limaca's Precision-GI™ Granted CMS Transitional Pass-Through (TPT) Payment
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.
Il dispositivo di biopsia endoscopica Precision-GI™ di Limaca Medical ha ricevuto il pagamento transitorio (TPT) da parte del CMS, efficace dal 1° gennaio 2025, per un periodo di fino a tre anni. Il dispositivo, che ha ottenuto la Designazione di Dispositivo Innovativo dalla FDA nel 2022 e l'autorizzazione FDA nell'agosto 2023, è progettato per migliorare i risultati delle biopsie per i tumori gastrointestinali. Il meccanismo di taglio rotante automatico e motorizzato consente un'acquisizione superiore dei tessuti con un contenuto di sangue ridotto in un'unica passata, migliorando l'efficienza diagnostica. Il programma TPT supporterà un accesso più ampio per i pazienti, fornendo pagamenti aggiuntivi agli ospedali per coprire i costi di adozione. Il dispositivo ha iniziato il suo ingresso nel mercato statunitense a settembre 2024.
El dispositivo de biopsia endoscópica Precision-GI™ de Limaca Medical ha recibido el pago transitorio (TPT) por parte de CMS, efectivo desde el 1 de enero de 2025, durante un periodo de hasta tres años. El dispositivo, que recibió la Designación de Dispositivo Innovador de la FDA en 2022 y la autorización de la FDA en agosto de 2023, está diseñado para mejorar los resultados de biopsias para cánceres gastrointestinales. El
리마카 메디컬의 정밀-GI™ 내시경 생검 장치가 2025년 1월 1일부터 강제 적용(하한) 지불을 승인받았습니다. 이 장치는 최대 3년 동안 유효합니다. 이 장치는 2022년 FDA 혁신 기기 지정과 2023년 8월 FDA 승인을 받았으며, 위장관 암의 생검 결과를 개선하기 위해 설계되었습니다. 모터화된 자동 회전 절단 기구는 단일 통과에서 더 적은 혈액 함량으로 우수한 조직 획득을 가능하게 하여 진단 효율성을 높입니다. TPT 프로그램은 채택 비용을 감당하기 위해 병원에 추가 지급을 함으로써 환자의 접근성을 넓히는 데 기여할 것입니다. 이 장치는 2024년 9월에 미국 시장에 진입했습니다.
Le dispositif de biopsie endoscopique Precision-GI™ de Limaca Medical a obtenu un paiement transitoire (TPT) de la part de CMS, à compter du 1er janvier 2025, pour une durée pouvant aller jusqu'à trois ans. Ce dispositif, qui a reçu la désignation de dispositif révolutionnaire de la FDA en 2022 et l'autorisation de la FDA en août 2023, est conçu pour améliorer les résultats de biopsies pour les cancers gastro-intestinaux. Le Mécanisme de coupe rotatif motorisé et automatisé permet une acquisition de tissus supérieure avec moins de contenu sanguin en un seul passage, améliorant ainsi l'efficacité diagnostique. Le programme TPT soutiendra un accès élargi pour les patients en fournissant des paiements supplémentaires aux hôpitaux pour couvrir les coûts d'adoption. Le dispositif a commencé son entrée sur le marché américain en septembre 2024.
Das endoskopische Biopsiegerät Precision-GI™ von Limaca Medical hat von CMS eine transitorische Durchlasszahlung (TPT) erhalten, die ab dem 1. Januar 2025 für bis zu drei Jahre gültig ist. Das Gerät erhielt 2022 die FDA-Designierung als Durchbruchgerät und erhielt im August 2023 die FDA-Zulassung. Es wurde entwickelt, um die Biopsieergebnisse bei gastrointestinalen Krebserkrankungen zu verbessern. Der motorisierte, automatisierte Rotationsschneidemechanismus ermöglicht eine überlegene Gewebeentnahme mit geringeren Blutanteilen in einem einzigen Durchgang, wodurch die diagnostische Effizienz gesteigert wird. Das TPT-Programm unterstützt einen breiteren Patientenzugang, indem es den Krankenhäusern zusätzliche Zahlungen zur Deckung der Anlaufkosten zur Verfügung stellt. Das Gerät trat im September 2024 in den US-Markt ein.
- 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
- None.
Precision-GI™ FDA Designated Breakthrough product and FDA cleared semi-automated motorized endoscopic biopsy device entering U.S. market
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"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
[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
Contact:
Assaf Klein, CEO
Assaf@limaca-medical.com
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SOURCE Limaca Medical
FAQ
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