TriSalus Life Sciences Announces Real-World Data Demonstrating the Ability of TriNav® to Successfully Treat Patients with Higher Disease Burden and to Improve Delivery of Therapeutics to Liver Tumors
29 Februar 2024 - 1:00PM
Business Wire
– Data published in Current Medical Research
and Opinion provide a comparison of the TriNav Infusion System vs.
standard drug delivery and show the ability of TriNav to
successfully treat sicker, treatment refractory, and higher disease
burden patients, further validating previous data in the real-world
setting –
TriSalus Life Sciences® Inc. (Nasdaq: TLSI), an oncology company
integrating its novel delivery technology with immunotherapy to
transform treatment for patients with liver and pancreatic tumors,
today announced the publication in Current Medical Research and
Opinion a manuscript detailing a real-world study of the use of the
pressure-enabled drug delivery (PEDD™) method with the
TriNav® device for trans-arterial chemoembolization
(TACE) and trans-arterial radioembolization (TARE) in patients with
hepatocellular carcinoma (HCC) and liver metastases.
The data presented in this study captured real-world safety and
clinical outcomes data for TriNav in its launch phase (2020-2022)
utilizing a large, 300 million patient dataset covering 98% of US
payers. These data provide valuable insights into the important
benefits of this technology that would otherwise take many years to
accumulate through alternative approaches using clinical trials.
Key findings include that TriNav patients, despite a higher
baseline disease burden and clinical complexity, showed overall
clinical results comparable to patients with lower disease burden.
The study also revealed that:
- In TACE procedures, interventional radiologists could deliver
significantly more chemotherapeutic to the tumor when using TriNav
vs. the amount delivered using standard catheters, a critical
treatment goal.
- In a matched cohort comparison, TriNav patients had fewer
30-day inpatient visits post-procedure than non-TriNav
patients.
- TriNav HCC patients were more likely to have a post-procedure
liver transplant in a matched cohort comparison.
- TriNav TARE patients with liver metastases had fewer clinical
complications post-procedure vs. non-TriNav patients in a matched
cohort comparison.
- TriNav TARE patients with liver metastases had lower rates of
post-procedure fatigue vs. non-TriNav patients.
These study data clearly demonstrate that TriNav is
preferentially selected to treat patients with a higher burden of
disease than patients treated with standard catheters, yet these
patients show similar results post-treatment compared to patients
with a lower disease burden. TriNav patients showed impressive
trends toward better outcomes in matched cohort comparisons,
including an increased rate of liver transplants. The results also
demonstrate how real-world data complement traditional clinical
trials to provide a more robust and timely understanding of the
benefits realized by patients. TriSalus is committed to updating
this data set continuously and affirming the benefit TriNav and the
PEDD approach bring to patients, providers, and payers.
“Analyses of real-world data are critical to obtaining a
holistic understanding of the benefits of treatment with TriNav.
The ability of the PEDD method to impact more complex patients when
compared to standard-of-care drug delivery systems is potentially
game-changing and brings us closer to addressing the limitations of
current treatment options for HCC and other liver cancer patients,”
said Mary Szela, Chief Executive Officer of TriSalus. “This
important, peer-reviewed, real-world study speaks to our commitment
to improve patient care and outcomes. These data, together with the
recent, new Centers for Medicare and Medicaid (CMS) Healthcare
Common Procedure Coding System (HCPCS) code effective as of this
year, are a testament to TriNav’s continued emergence as a
potentially best-in-class and cost-effective drug delivery method
for patients with liver and pancreatic tumors.”
“These new population-based findings resonate well with
previously published clinical studies that indicate PEDD improves
therapeutic uptake, accuracy of therapeutic delivery, and clinical
outcomes in liver cancer patients. The ability of the TriNav’s
SmartValve™ to favorably modulate drug delivery pressure and flow
within target blood vessels gives liver cancer patients, even those
with major medical co-morbidities and large tumor burdens, the
opportunity to achieve better outcomes,” said Steven C. Katz, M.D.,
FACS, Chief Medical Officer at TriSalus. “This large sample size
study underscores the particular benefits of the TriNav device
compared to standard drug delivery systems.”
About the TriNav Infusion System
TriNav is a flexible, ultra-thin therapy delivery system with
SmartValve technology, a self-expanding, nonocclusive one-way
dynamic microvalve that opens and closes in synchrony with the
patient’s heart to modulate pressure and flow. This system uses the
Pressure-Enabled Drug Delivery approach and has demonstrated the
ability to overcome intratumoral pressure in solid tumors and
potentially improve distribution and penetration of therapy during
Transcatheter Arterial Chemoembolization (TACE) and Transcatheter
Arterial Radioembolization (TARE) procedures. For more information,
please visit www.trinavinfusion.com.
About TriSalus Life Sciences
TriSalus Life Sciences is an oncology company integrating novel
delivery technology with immunotherapy to transform treatment for
patients with 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 to 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. SD-101, the Company’s
investigational immunotherapeutic candidate, is designed to improve
patient outcomes by treating the immunosuppressive environment
created by many tumors, 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 SD-101 delivered via PEDD may
have favorable immune effects within the liver and systemically.
The target for SD-101, TLR9, is expressed across cancer types, and
the mechanical barriers addressed by PEDD are commonly present as
well. SD-101 delivered by PEDD will be studied across several
indications 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 LinkedIn and X, formerly
Twitter.
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212.600.1902 TriSalus@argotpartners.com
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