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TriSalus Life Sciences Launches TriNav® LV Infusion System and TriGuide™ Guiding Catheters, Expanding Portfolio of PEDD™ Devices for Improved Tumor Treatment

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TriSalus Life Sciences (Nasdaq: TLSI) has launched the TriNav® LV Infusion System and TriGuide™ Guiding Catheter, expanding its portfolio of Pressure-Enabled Drug Delivery (PEDD™) devices for liver and pancreatic tumor treatment. The TriNav LV Infusion System, designed for vessels 3.5-5.0 mm in diameter, broadens patient eligibility for PEDD technology. The TriGuide Guiding Catheters feature a larger inner diameter and reverse curve design, facilitating femoral access and improving procedural efficiency. Early users reported a 97% satisfaction rate. The devices are eligible for existing HCPCS codes, ensuring seamless reimbursement. CEO Mary Szela emphasized the company's commitment to advancing their pipeline and improving patient outcomes.

TriSalus Life Sciences (Nasdaq: TLSI) ha lanciato il TriNav® LV Infusion System e il TriGuide™ Guiding Catheter, ampliando il proprio portafoglio di dispositivi per la somministrazione di farmaci abilitati alla pressione (PEDD™) per il trattamento di tumori epatici e pancreatici. Il TriNav LV Infusion System, progettato per vasi con diametro da 3.5 a 5.0 mm, amplia l'idoneità dei pazienti per la tecnologia PEDD. I cateteri guida TriGuide presentano un diametro interno maggiore e un design a curva inversa, in grado di facilitare l'accesso femorale e migliorare l'efficienza della procedura. I primi utilizzatori hanno riportato un tasso di soddisfazione del 97%. I dispositivi sono idonei per i codici HCPCS esistenti, garantendo un rimborso agevole. L'amministratore delegato Mary Szela ha sottolineato l'impegno della società nel promuovere il proprio pipeline e nel migliorare i risultati per i pazienti.

TriSalus Life Sciences (Nasdaq: TLSI) ha lanzado el TriNav® LV Infusion System y el TriGuide™ Guiding Catheter, ampliando su cartera de dispositivos de entrega de medicamentos habilitados por presión (PEDD™) para el tratamiento de tumores hepáticos y pancreáticos. El TriNav LV Infusion System, diseñado para vasos de 3.5 a 5.0 mm de diámetro, amplía la elegibilidad de los pacientes para la tecnología PEDD. Los catéteres guía TriGuide cuentan con un diámetro interno más grande y un diseño de curva inversa, lo que facilita el acceso femoral y mejora la eficiencia del procedimiento. Los primeros usuarios informaron una tasa de satisfacción del 97%. Los dispositivos son elegibles para los códigos HCPCS existentes, asegurando un reembolso sin problemas. La CEO Mary Szela enfatizó el compromiso de la empresa con el avance de su pipeline y la mejora de los resultados para los pacientes.

TriSalus Life Sciences (Nasdaq: TLSI)는 간 및 췌장 종양 치료를 위한 압력 기반 약물 전달 장치(PEDD™) 포트폴리오를 확장하며 TriNav® LV Infusion SystemTriGuide™ Guiding Catheter 를 출시했습니다. TriNav LV Infusion System은 직경이 3.5-5.0 mm인 혈관을 위해 설계되어 PEDD 기술을 위한 환자 적격성을 넓힙니다. TriGuide 유도 카테터는 더 큰 내부 직경과 역커브 디자인을 특징으로 하여 대퇴부 접근을 용이하게 하고 절차의 효율성을 개선합니다. 초기 사용자들은 97%의 만족도를 보고했습니다. 이 장치들은 기존 HCPCS 코드에 적합하여 원활한 상환이 보장됩니다. CEO Mary Szela는 회사가 파이프라인을 발전시키고 환자 결과를 개선하는 데 전념하고 있음을 강조했습니다.

TriSalus Life Sciences (Nasdaq: TLSI) a lancé le TriNav® LV Infusion System et le TriGuide™ Guiding Catheter, élargissant ainsi son portefeuille de dispositifs de délivrance de médicaments activés par pression (PEDD™) pour le traitement des tumeurs hépatiques et pancréatiques. Le TriNav LV Infusion System, conçu pour des vaisseaux de 3,5 à 5,0 mm de diamètre, élargit l'éligibilité des patients pour la technologie PEDD. Les cathéters de guidage TriGuide présentent un diamètre interne plus grand et un design à courbe inversée, facilitant l'accès fémoral et améliorant l'efficacité des procédures. Les premiers utilisateurs ont rapporté un taux de satisfaction de 97 %. Les dispositifs sont éligibles pour les codes HCPCS existants, garantissant un remboursement fluide. La PDG Mary Szela a souligné l'engagement de l'entreprise à faire progresser son pipeline et à améliorer les résultats pour les patients.

TriSalus Life Sciences (Nasdaq: TLSI) hat das TriNav® LV Infusion System und den TriGuide™ Guiding Catheter eingeführt und damit sein Portfolio von druckunterstützten Arzneimittelabgabe-Geräten (PEDD™) zur Behandlung von Leber- und Bauchspeicheldrüsenkrebs erweitert. Das TriNav LV Infusion System, das für Gefäße mit einem Durchmesser von 3,5-5,0 mm konzipiert ist, erweitert die Patienteneignung für die PEDD-Technologie. Die TriGuide-Führungs-Katheter verfügen über einen größeren Innendurchmesser und ein umgekehrtes Kurven-Design, das den Zugang zum Oberschenkel erleichtert und die Effizienz des Verfahrens verbessert. Erste Anwender berichteten von einer Zufriedenheitsquote von 97%. Die Geräte sind für bestehende HCPCS-Codes geeignet, was eine reibungslose Rückerstattung gewährleistet. CEO Mary Szela betonte das Engagement des Unternehmens zur Weiterentwicklung ihres Portfolios und zur Verbesserung der Patientenergebnisse.

Positive
  • Launch of TriNav LV Infusion System and TriGuide Guiding Catheters expands TriSalus' PEDD device offerings.
  • TriNav LV Infusion System increases the number of patients eligible for PEDD technology.
  • High satisfaction rate (97%) among early users of the TriNav LV Infusion System.
  • Reimbursement compatibility with existing HCPCS codes ensures seamless integration into billing structures.
Negative
  • None.

Insights

The launch of TriNav LV Infusion System and TriGuide Guiding Catheters represents a significant expansion of TriSalus's medical device portfolio. The 97% satisfaction rate from early users and compatibility with larger vessels (3.5-5.0 mm) indicates strong market potential. The expanded vessel size range (1.5-5.0 mm) effectively doubles the addressable patient population for PEDD technology.

The innovative design features, including the lubricious inner lining and reverse curve design, address key procedural challenges in interventional oncology. Maintaining existing reimbursement codes (C9797 and C1982) ensures smooth market adoption and revenue potential. This product launch strengthens TriSalus's competitive position in the interventional oncology space and sets the stage for their planned product pipeline expansion over the next 12-18 months.

This product launch is strategically significant as it expands TriSalus's Total Addressable Market (TAM). The larger vessel compatibility opens up new patient segments, potentially driving revenue growth. The maintenance of existing reimbursement codes reduces barriers to adoption and ensures predictable revenue streams.

The high physician satisfaction rate suggests strong potential for market penetration and recurring sales. The announcement of additional product launches in the pipeline indicates a robust growth strategy that could positively impact investor sentiment. For a company with a market cap of $124.13M, this expansion represents a meaningful catalyst for potential value creation.

DENVER--(BUSINESS WIRE)-- TriSalus Life Sciences® Inc. ("TriSalus" or the "Company") (Nasdaq: TLSI), a leader in oncology innovations integrating advanced delivery technology to transform treatment for liver and pancreatic tumors, today announced the launch of the TriNav® LV Infusion System and TriGuide™ Guiding Catheter. These new devices are designed to optimize therapeutic delivery, enhancing treatment options and potentially improving outcomes for patients.

Highlights of the Launch:

  • Expanded Patient Access: The TriNav LV Infusion System is tailored for larger vessels (3.5-5.0 mm), increasing the number of patients eligible for TriSalus' proprietary Pressure-Enabled Drug Delivery (PEDD™) technology.
  • Comprehensive Device Portfolio: This launch marks an expansion of TriSalus’ PEDD device offerings, now covering vessel sizes from 1.5 mm to 5.0 mm, giving interventional radiologists a broader range of treatment options and increasing the Total Addressable Market (TAM).
  • Innovative Design for Ease of Access: The new TriGuide Guiding Catheters, uniquely equipped with a larger inner diameter, lubricious inner lining, and reverse curve design, are the first of their kind to support femoral access for the TriNav LV Infusion System, enhancing procedural efficiency.
  • High Satisfaction Among Early Users: In a limited market release, physicians reported a 97% satisfaction rate with the TriNav LV Infusion System, underscoring its clinical effectiveness and ease of use.
  • Reimbursement Compatibility: The TriNav LV Infusion System is eligible for the same HCPCS codes—C9797 for procedures and C1982 for devices—as the existing TriNav products, supporting seamless integration into current billing structures.

"We are thrilled to introduce TriNav LV, an infusion system developed in direct response to customer feedback for a larger-diameter PEDD device suited for lobar therapeutic delivery in patients with larger vessels," said Mary Szela, Chief Executive Officer and President of TriSalus. "This launch is a testament to our commitment to meeting clinician needs and marks the first of several innovative products we plan to introduce over the next 12 to 18 months. Our focus remains on advancing our pipeline to make a significant difference in patient outcomes and to drive progress in cancer treatment."

About TriSalus Life Sciences

TriSalus Life Sciences® is an oncology focused medical technology business providing disruptive drug delivery technology with the goal of improving therapeutics delivery to liver and pancreatic tumors.

The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s two FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD™) approach to deliver a range of therapeutics: the TriNav® Infusion System for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. PEDD is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. Nelitolimod, the Company’s investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. Patient data generated during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that nelitolimod delivered via PEDD may have favorable immune effects within the liver and systemically. The target for nelitolimod, TLR9, is expressed across cancer types and the mechanical barriers addressed by the PEDD method are commonly present as well. Nelitolimod delivered by the PEDD method will be studied across several indications in an effort to address immune dysfunction and overcome drug delivery barriers in the liver and pancreas.

In partnership with leading cancer centers across the country – and by leveraging deep immuno-oncology expertise and inventive technology development – TriSalus is committed to advancing innovation that improves outcomes for patients. Learn more at trisaluslifesci.com and follow us on X (formerly Twitter) and LinkedIn.

For Media Inquiries:

Stephanie Jacobson

Argot Partners

610.420.3049

TriSalus@argotpartners.com

For Investor Inquiries:

James Young

SVP-Investor Relations/Treasurer

847.337.0655

james.young@trisaluslifesci.com

Source: TriSalus Life Sciences

FAQ

What new devices did TriSalus Life Sciences launch?

TriSalus Life Sciences launched the TriNav® LV Infusion System and TriGuide™ Guiding Catheters.

What is the purpose of the TriNav LV Infusion System?

The TriNav LV Infusion System is designed to optimize therapeutic delivery for larger vessels (3.5-5.0 mm), enhancing treatment options for liver and pancreatic tumors.

What is the satisfaction rate among early users of the TriNav LV Infusion System?

Early users reported a 97% satisfaction rate with the TriNav LV Infusion System.

Are the new TriSalus devices eligible for existing reimbursement codes?

Yes, the TriNav LV Infusion System is eligible for the same HCPCS codes—C9797 for procedures and C1982 for devices—as existing TriNav products.

How do the TriGuide Guiding Catheters improve procedural efficiency?

The TriGuide Guiding Catheters have a larger inner diameter, lubricious inner lining, and reverse curve design, supporting femoral access and enhancing procedural efficiency.

TriSalus Life Sciences, Inc.

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