TriSalus Announces Journal of Vascular and Interventional Radiology Publication of Data that Demonstrate Improved Therapeutic Delivery of Glass Microspheres to Solid Tumors With PEDD™ Method via the TriNav® Infusion System
23 Setembro 2024 - 8:00AM
Business Wire
Pressure enabled drug deliver (PEDD) method
significantly increased penetration of glass microspheres into
porcine liver tumors (117%; p=0.004 and 39%; p=0.032) with lobar
infusions and selective infusions, respectively
TriSalus Life Sciences®, Inc. (“TriSalus” or the “Company”)
(Nasdaq: TLSI), an oncology company integrating its novel delivery
technology with standard of care therapies and immunotherapy to
transform treatment for patients with liver and pancreatic tumors,
announced today the publication of research titled, “Intra-arterial
Pressure-Enabled Drug Delivery Significantly Increases Penetration
of Glass Microspheres in a Porcine Liver Tumor Model,” in the
peer-reviewed Journal of Vascular and Interventional Radiology. The
article illustrates that the PEDD method via the TriNav Infusion
System significantly improved delivery of glass microspheres (GM)
with deeper penetration into liver tumors and the peritumoral
tissue, when compared to delivery of GM with a conventional
microcatheter in a transgenic (oncopig) model.
“This is another example of how our PEDD approach effectively
tackles a significant challenge in cancer care by ensuring the
selective and increased delivery of therapeutics to the tumor. This
research advances and validates our understanding of the PEDD
method, providing high-resolution evidence of enhanced delivery,”
said Bryan F. Cox, Ph.D., Chief of Research for TriSalus. “With
both proximal and distal placements of the PEDD device, we observed
significantly improved delivery of glass microspheres to the tumor,
quantified on a millimeter scale. The strength of the proximal
infusion data suggests an opportunity to selectively target
multiple tumors simultaneously in patients with heavy disease
burdens.”
“These results contribute to the substantial and expanding body
of pre-clinical and clinical evidence supporting the wide-ranging
potential applicability of the PEDD approach,” said Mary Szela,
Chief Executive Officer and President of TriSalus. “Efficient
delivery of therapeutics into tumor cells without causing harm to
off-target normal tissue remains a real-world challenge in cancer
care, and the PEDD approach aims to overcome this obstacle. This
publication strengthens our current understanding that, regardless
of placement of the technology, either lobar or selective
infusions, the PEDD method increased glass microspheres delivery
uptake compared to conventional microcatheters. The TriNav device
signifies a potential breakthrough in delivering glass microspheres
and other drugs into tumors in a highly controlled and targeted
manner.”
“This study shows the potential of PEDD method to address an
unmet need in liver cancer therapy – achieving the same safety
profile of selective Y90 treatment to those performed for more
advanced diffuse disease using lobar injections. This study
suggests that the use of PEDD method alters hemodynamics and the
microenvironment in a manner resulting in higher concentrations of
microspheres in the tumor compared to the adjacent liver
parenchyma, thereby offering the ability to increase efficacy and
improve safety. If further validated in human models, this may
represent a significant advancement in the management of liver
cancer,” said Dr. Riad Salem, Chief of Interventional Radiology,
and Professor of Radiology, Surgery, and Medicine in Chicago.
The research involved transgenic pigs (oncopigs) with induced
liver tumors. These tumors were intra-arterially infused with
fluorescently labeled GM. The PEDD method with the TriNav device
was compared to the use of conventional microcatheter delivery in
both lobar and selective infusions. Near-infrared (near IR) imaging
was utilized to detect the GM fluorescent signal in tumors. The
results showed significant increases in GM signal intensity in and
around tumors after delivery with the PEDD method, with a 117%
increase in tumor penetration with lobar infusions and a 39%
increase with selective infusions compared to conventional
delivery. Lobar PEDD delivery of GM to the tumor was statistically
equivalent to conventional selective delivery (p=0.497).
A copy of the full abstract can be accessed here.
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 PEDD are commonly present as
well. Nelitolimod delivered by PEDD 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.
Forward-Looking Statements
Certain statements made in this press release are
“forward-looking statements” within the meaning of Section 27A of
the Securities Act and Section 21E of the Securities Exchange Act
of 1934, as amended, and are subject to the safe harbor created
thereby under the Private Securities Litigation Reform Act of 1995.
Forward-looking statements may be identified by the use of words
such as “become,” “may,” “intend,” “will,” “expect,” “anticipate,”
“believe” or other similar expressions that predict or indicate
future events or trends or that are not statements of historical
matters. These forward-looking statements may include, but are not
limited to, statements regarding the consummation of the Offer and
Consent Solicitation, the timing of the Expiration Date, the future
effectiveness of the registration statement on Form S-4, the
approval by the holders of Warrants of the Warrant Amendment and
subsequent entry into the Warrant Amendment, the effects of the
Offer on our capital structure and expected changes to the dilutive
impact of the Warrants. These statements are based on various
assumptions, whether or not identified in this press release, and
on the current expectations of the Company’s management and are not
predictions of actual performance. These forward-looking statements
are provided for illustrative purposes only and are not intended to
serve as, and must not be relied on by any investor as, a
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fact or probability. Actual events and circumstances are difficult
or impossible to predict and may differ from assumptions. Many
actual events and circumstances are beyond the control of the
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Company’s ability to successfully complete the Offer and Consent
Solicitation; the number of holders of Warrants that approve the
Warrant Amendment in the Consent Solicitation; the timing and
results of the SEC review of the registration statement on Form S-4
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conditions; risks relating to the uncertainty of the projected
financial and operating information with respect to the Company;
risks related to future market adoption of the Company’s offerings;
risks related to the Company’s marketing and growth strategies;
risks related to the Company’s ability to acquire or invest in
businesses, products or technologies that may complement or expand
its products, enhance its technical capabilities or otherwise offer
growth opportunities; the effects of competition on the Company’s
future business; the risks discussed in the Company’s quarterly
report on Form 10-Q for the period ended March 31, 2024 under the
heading “Risk Factors”; and the risks discussed in the Company’s
Registration Statement on Form S-4 filed on May 24, 2024, under the
heading “Risk Factors” and other documents of the Company filed, or
to be filed, with the SEC. If any of these risks materialize or any
of the Company’s assumptions prove incorrect, actual results could
differ materially from the results implied by these forward-looking
statements. There may be additional risks that the Company
presently does not know of or that the Company currently believes
are immaterial that could also cause actual results to differ from
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forward-looking statements reflect the Company’s expectations,
plans or forecasts of future events and views as of the date of
this press release. The Company anticipates that subsequent events
and developments will cause the Company’s assessments to change.
However, while the Company may elect to update these
forward-looking statements at some point in the future, the Company
specifically disclaims any obligation to do so except as required
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relied upon as representing the Company’s assessments as of any
date subsequent to the date of this press release. Accordingly,
undue reliance should not be placed upon the forward-looking
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20240919558761/en/
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
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