Limaca's Precision-GI™ Enters US Market
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.
Limaca Medical ha lanciato il suo dispositivo per biopsie endoscopiche automatizzate e motorizzate Precision-GI™ nel mercato statunitense, supportato da studi clinici, approvazione della FDA e riconoscimento per il pagamento TPT (Transitional Pass-Through) da parte del CMS. Il dispositivo è progettato per ottenere risultati di biopsia migliorati per sospetti tumori nel tratto gastrointestinale e negli organi adiacenti.
Uno studio clinico condotto su 40 pazienti presso il IECED Medical Center ha dimostrato risultati eccezionali, mostrando la capacità del Precision-GI di fornire campioni di biopsia coerenti e di alta qualità, con un'eccellente qualità del tessuto e efficienza procedurale. Il meccanismo di taglio rotante, motorizzato e automatizzato del dispositivo consente un'acquisizione del tessuto superiore con meno contenuto ematico in un'unica passata.
L'azienda sta inizialmente concentrando le vendite nell'area metropolitana di New York/New Jersey, con casi già completati in tre centri medici della metro di New York. Lo stato di rimborso della designazione TPT sta facilitando una maggiore adozione da parte degli ospedali con supporto finanziario.
Limaca Medical ha lanzado su dispositivo de biopsia endoscópica automatizado y motorizado Precision-GI™ en el mercado de EE. UU., respaldado por ensayos clínicos, aprobación de la FDA y el reconocimiento del pago TPT (Transitional Pass-Through) por parte de CMS. El dispositivo está diseñado para obtener resultados de biopsia mejorados para cánceres sospechosos en el tracto gastrointestinal y órganos adyacentes.
Un ensayo clínico con 40 pacientes en el IECED Medical Center demostró resultados sobresalientes, mostrando la capacidad del Precision-GI para proporcionar muestras de biopsia consistentes y de alta calidad, con excelente calidad de tejido y eficiencia en el procedimiento. El mecanismo de corte rotativo, motorizado y automatizado del dispositivo permite una adquisición de tejido superior con menos contenido sanguíneo en una sola pasada.
La empresa se está enfocando inicialmente en las ventas en el área metropolitana de Nueva York/Nueva Jersey, con casos ya completados en tres centros médicos de la metro de Nueva York. El estado de reembolso de la designación TPT está facilitando una adopción más amplia por parte de los hospitales con apoyo financiero.
Limaca Medical은 미국 시장에 Precision-GI™ 자동화된 모터화 내시경 생검 장치를 출시했습니다. 이 장치는 임상 시험, FDA 승인 및 CMS 전환 통과(TPT) 지불 수상으로 뒷받침됩니다. 이 장치는 GI 관과 인접한 장기에서 의심되는 암에 대해 개선된 생검 결과를 얻도록 설계되었습니다.
IECED Medical Center에서 40명의 환자를 대상으로 한 임상 시험에서는 Precision-GI가 일관되고 고품질의 생검 샘플을 제공할 수 있는 능력을 보여주는 뛰어난 결과가 나타났습니다. 장치의 모터화된 자동 회전 절단 메커니즘은 단일 통과에서 혈액 함량이 적은 우수한 조직 획득을 가능하게 합니다.
회사는 처음에 뉴욕/뉴저지 메트로 지역에서 판매에 집중하고 있으며, 이미 세 개의 뉴욕 메트로 의료 센터에서 사례를 완료했습니다. TPT 지명 환급 상태는 재정 지원과 함께 병원 채택을 촉진하고 있습니다.
Limaca Medical a lancé son dispositif de biopsie endoscopique automatisé et motorisé Precision-GI™ sur le marché américain, soutenu par des essais cliniques, une autorisation de la FDA et une désignation de paiement TPT (Transitional Pass-Through) par le CMS. Le dispositif est conçu pour obtenir de meilleurs résultats de biopsie pour des cancers suspects dans le tractus gastro-intestinal et les organes adjacents.
Un essai clinique avec 40 patients au IECED Medical Center a démontré des résultats exceptionnels, montrant la capacité du Precision-GI à fournir des échantillons de biopsie cohérents et de haute qualité avec une excellente qualité des tissus et une efficacité procédurale. Le mécanisme de coupe rotatif, motorisé et automatisé du dispositif permet une acquisition de tissu supérieure avec moins de contenu sanguin en une seule passe.
L'entreprise concentre initialement ses ventes dans la région métropolitaine de New York/New Jersey, avec des cas déjà complétés dans trois centres médicaux de la métropole de New York. Le statut de remboursement de la désignation TPT facilite une adoption plus large par les hôpitaux avec un soutien financier.
Limaca Medical hat sein endoskopisches automatisiertes motorisiertes Biopsiegerät Precision-GI™ auf dem US-Markt eingeführt, unterstützt durch klinische Studien, FDA-Zulassung und CMS Transitional Pass-Through (TPT) Zahlungszuschuss. Das Gerät ist darauf ausgelegt, verbesserte Biopsieergebnisse bei verdächtigen Tumoren im Magen-Darm-Trakt und angrenzenden Organen zu erzielen.
Eine klinische Studie mit 40 Patienten im IECED Medical Center zeigte herausragende Ergebnisse und demonstrierte die Fähigkeit des Precision-GI, konsistente, hochwertige Biopsieproben mit ausgezeichneter Gewebequalität und Verfahrenseffizienz zu liefern. Der motorisierte, automatisierte, rotierende Schneidmechanismus des Geräts ermöglicht eine überlegene Gewebeentnahme mit weniger Blutgehalt in einem einzigen Durchgang.
Das Unternehmen konzentriert sich zunächst auf den Verkauf im Großraum New York/New Jersey, wobei bereits Fälle in drei medizinischen Zentren im New Yorker Großraum abgeschlossen wurden. Der TPT-Zuschussstatus erleichtert die breitere Akzeptanz durch Krankenhäuser mit finanzieller Unterstützung.
- 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
- 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,
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
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
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
Contact:
Assaf Klein, CEO
Assaf@limaca-medical.com
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SOURCE Limaca Medical
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