Full Press Release Details
TriSalus Life Sciences Highlights Pressure-Enabled
Regional Immuno-Oncology (PERIO ) Clinical Trial Progress and Pre-clinical Research Developments
DENVER and CHICAGO, December 15, 2022 - TriSalus Life
Sciences , Inc. ("TriSalus" or the "company"), an oncology company in the process of going public
through a business combination transaction (the "Business Combination") with MedTech Acquisition Corporation (Nasdaq: MTAC)
("MedTech" or "MTAC"), today announced that it has expanded the reach of its ongoing Pressure-Enabled Regional
Immuno-Oncology ("PERIO -01" and "PERIO -02") clinical program.
In recent months TriSalus has opened five new PERIO -01 (NCT04935229)
clinical trial sites, at Stanford University Hospitals, University of California Los Angeles, University of Colorado's Anschutz
Medical Campus, University of Washington Medical Center and University of Miami's Sylvester Comprehensive Cancer Center, in addition
to five previously activated sites. The PERIO -01 trial is studying an investigational drug, SD-101, delivered intravascularly
by the TriNav Infusion System ("TriNav ") using the company's proprietary
Pressure-Enabled Drug Delivery ("PEDD ") method of administration. The study is evaluating whether this
platform approach with SD-101 and PEDD can improve the performance of systemic checkpoint inhibitors in treating patients with
uveal melanoma with liver metastases. In addition to these U.S. sites, TriSalus anticipates opening future PERIOTM-01
clinical trial sites in the United Kingdom, Europe, and Canada.
In parallel, TriSalus opened PERIOTM-02 (NCT05220722) trial
sites at Columbia University and University of Colorado Denver, along with Rhode Island Hospital - which was announced last
month as part of an expanded research collaboration with Lifespan Health System. The PERIOTM-02 trial, expected to add additional
sites in 2023, is evaluating whether this same platform approach with SD-101 and PEDD can improve the performance of systemic
checkpoint inhibitors in treating patients with hepatocellular carcinoma or intrahepatic cholangiocarcinoma.
Both the PERIO -01 and PERIOTM-02 trials, which were
initiated at The University of Texas MD Anderson Cancer Center as part of a multi-year strategic collaboration agreement, are studying
the ability of SD-101 delivered by the PEDD method of administration to overcome two major challenges in treating patients with
liver and pancreatic tumors: immunosuppression and high intratumoral pressure. These two barriers can limit the delivery and efficacy
of therapeutics, such as immunotherapy drugs, from reaching their targets and result in poor outcomes.1,2,3,4,5
TriSalus recently shared initial findings from both clinical
studies, which indicate the potential of the company's therapeutic platform to improve immunotherapy outcomes for patients with
liver and pancreatic tumors.
The company has also published promising pre-clinical data in Cancer
Gene Therapy6 highlighting the potential of SD-101, a toll-like receptor 9 class C ("TLR9C") agonist,
to deplete or favorably reprogram myeloid-derived suppressor cells ("MDSCs") that have been shown to contribute to the limited
success of immunotherapy in the liver.7 The
lead author was Chandra Gosh, PhD, a biomedical scientist and project leader for TriSalus. Pre-clinical data was also presented at the
Society for Immunotherapy of Cancer's 37th Annual Meeting, which indicated that SD-101 has a distinct biologic profile
relative to other TLR agonists. The pre-clinical findings align with recently released clinical data which supported the potential that
SD-101 may reduce MDSCs in patient liver tumors.8,9,10
DaSilva NA, et al. Cell Death Discov. 2021;7(1):232.
Stylianopoulos T, et al. Cancer Res. 2013;73(13):3833-3841.
Zhang X, et al. PLoS ONE. 2019;14(12):e0225327.
Loeuillard E, et al. J Clin Invest. 2020;130(10):5380-5396.
Thorn M, et al. Cancer Gene Ther. 2016;23(6):188-198.
6 Ghosh, et al. Cancer
Gene Therapy. 2022 June 14 (online ahead of print).
Rev Cancer. 2021 July 29 (online ahead of print).
8 Ghosh, et al. Cancer
Gene Therapy. 2022 June 14 (online ahead of print).
Katz, Steven. (2022). 1165 Impact of SD-101, a toll-like receptor 9 class C (TLR9C), agonist on myeloid derived suppressor cells. Journal
for ImmunoTherapy of Cancer. 10. A1206-A1206. 10.1136/jitc-2022-SITC2022.1165.
10 TriSalus Life Sciences,
Inc. (2022 November 21). Form 8-K.
"The expansion of the PERIOTM-01 and PERIOTM-02
trials represents meaningful progress for our research program-extending trial access to patients across a broader geographic area
and increasing the number of partnerships with leading cancer centers," said Steven C. Katz, MD, FACS, Chief Medical Officer at
TriSalus. "Further, our pre-clinical work indicates a solid scientific foundation to inform our approach as we seek to advance
immunotherapy treatment options for patients with liver and pancreatic tumors. We look forward to building on this momentum for the PERIOTM
About TriSalus and Its Proposed Business Combination with MedTech
TriSalus is an oncology company integrating immunotherapy with disruptive
delivery technology to transform the treatment paradigm for patients with liver and pancreatic tumors.
TriSalus' proprietary platform approach addresses immune dysfunction
in liver and pancreatic tumors by combining its highly effective drug delivery technology with immunotherapeutics. The TriSalus platform
comprises the TriNav Infusion System and SD-101, a class C toll-like receptor 9 ("TLR9") agonist. TriNav is an
FDA-cleared device that is designed to administer established and emerging therapeutics. SD-101, the company's investigational
TLR9 agonist, is being delivered via TriNav to selected sites, including tumors in the liver. TriNav is the latest TriSalus
asset for the proprietary PEDD method of administration which has been shown to overcome intratumoral pressure through modulation
of pressure and flow to increase delivery of therapeutic agents.
As announced on November 14, 2022, TriSalus has entered into a definitive
merger agreement with MedTech (the "Merger Agreement"), a publicly traded special purpose acquisition company in connection
with the proposed business combination and related transactions between the parties. Upon the closing of the transaction (expected to
occur in the first quarter of 2023), the combined company will be a publicly traded company and its common stock is expected to be listed
on the NASDAQ Stock Exchange under the ticker "TLSI". The transaction is subject to the satisfaction of the necessary regulatory
approvals and customary closing conditions, including the approval of MedTech's shareholders.
To learn more about clinical trial treatment protocol and enrollment,
visit http://www.periotrial.com or http://www.clinicaltrials.gov and search NCT04935229 or NCT05220722.
About MedTech Acquisition Corporation
MedTech is a blank check company formed for the purpose of effecting
a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses
or entities. MedTech has stated a focus on the medical technology industry in the United States and other developed countries.
Forward-Looking Statements
This communication contains certain "forward-looking statements"
within the meaning of the United States federal securities laws regarding MTAC's or TriSalus' expectations, hopes, beliefs,
assumptions, intentions or strategies regarding the future including, without limitation, statements regarding: (i) the tolerability
of SD-101 infusion with TriNav , (ii) the potential of TriSalus' proprietary PEDD method to enable SD-101 to have broad
immune effects in liver tumors and eliminate MDSC, (iii) expectations for continuing program development and potential outcomes, (iv)
TriSalus' ability to compete with other companies, and (v) expectations for topline data and regulatory approval. These forward-looking
statements generally are identified by words such as "anticipate," "believe," "continue," "could,"
"estimate," "expect," "intend," "may," "might," "plan," "possible,"
"potential," "predict," "project," "should," "strive," "would,"
"will" and similar expressions or the negative or other variations of such statements. These statements are predictions,
projections and other statements about future events that are based on various assumptions, whether or not identified in this communication
and on the current expectations of MTAC's and TriSalus' respective managements and are not predictions of actual performance
and, as a result, are subject to risks and uncertainties.
Many factors could cause actual results or developments to differ
materially from those expressed or implied by such forward-looking statements, including but not limited to: (i) the risk that the Business
Combination may not be completed in a timely manner or at all, which may adversely affect the price of MTAC's securities; (ii)
the risk that the Business Combination may not be completed by MTAC's business combination deadline and the potential failure to
obtain an extension of the business combination deadline; (iii) the failure to satisfy the conditions to the consummation of the Business
Combination, including the approval of the Merger Agreement by the stockholders of MTAC, the satisfaction of the minimum cash amount
following any redemptions by MTAC's public stockholders, and the receipt of certain governmental and regulatory approvals, including
reimbursement approval; (iv) the lack of a third-party valuation in determining whether or not to pursue the Business Combination; (v)