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TriSalus Life Sciences Posts Updated Investor Presentation Highlighting Additional Phase 1 and 1b Clinical Data for Pressure-Enabled Regional Immuno-Oncology -01 and -02 Studies Data Further Support

Key Takeaway: TriSalus Life Sciences has released updated data from its Phase 1 and 1b clinical trials for SD-101, which is administered via the Pressure-Enabled Drug Delivery (PEDD) system. The data indicates that this investigational drug may improve treatment outcomes for patients with liver and pancreatic tumors, particularly uveal melanoma. As of February 2023, 42 patients are enrolled in the trials, with positive early findings suggesting the potential of SD-101 in conjunction with checkpoint inhibitors. TriSalus plans to provide additional data and expand clinical trials in the latter half of 2023.

Market Sentiment Analysis

POSITIVE FACTORS

  • New clinical data supports the potential of SD-101 to improve immunotherapy outcomes.
  • Initial results show decreased circulating tumor DNA in patients, indicating longer survival.
  • TriSalus anticipates further data from higher doses which could enhance treatment efficacy.

CONCERNS & RISKS

  • The transaction with MedTech Acquisition Corporation is still subject to regulatory approvals.
  • Clinical trials are ongoing, meaning that definitive results are not yet available.

Full Press Release Details

TriSalus Life Sciences Posts Updated Investor
Presentation Highlighting Additional Phase 1 and 1b
Clinical Data for Pressure-Enabled Regional Immuno-Oncology -01 and -02 Studies
Data Further Supports the Potential of the Company's
Therapeutic Platform to Improve Immunotherapy
Outcomes for Patients with Liver and Pancreatic Tumors
DENVER and CHICAGO, February 16, 2023 - 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 posted an updated investor presentation with new data regarding its ongoing Pressure-Enabled Regional Immuno-Oncology
("PERIO -01" and "PERIO -02") clinical studies for primary and metastatic liver tumors. The presentation
is available on the investor relations section of the Company's website.
The PERIO -01 and -02 trials are 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 studies are evaluating whether this platform
approach can improve the performance of systemic checkpoint inhibitors in treating patients with uveal melanoma with liver metastases,
intrahepatic cholangiocarcinoma, and hepatocellular carcinoma.
The latest data from the PERIO -01 and PERIO -02 trials,
as well as multiple nonclinical studies, are supportive of the PEDD method for delivering therapeutics, including SD-101, into
high-pressure liver tumors. Specifically, in uveal melanoma patients with liver metastases, when delivered via the PEDD method
at a 2 or 4 mg dose, SD-101 in combination with nivolumab demonstrated decreases of circulating tumor DNA in the majority of patients,
which has been associated with longer overall survival in this population. Emerging data, outlined in the Company's investor presentation,
also supports the hypothesis that SD-101 delivered via the PEDD method, can enable broad immune effects including depletion of liver myeloid
derived suppressor cells ("MDSCs"). TriSalus expects data in connection with higher doses by Q2 2023, in addition to data
from a separate cohort that combines SD-101 with the combination of nivolumab and ipilimumab.
As of February 2023, 42 patients have enrolled in PERIO -01 and
PERIO -02 and have been treated with more than 138 infusions of SD-101. TriSalus is continuing to enroll patients in both PERIO -01
and PERIO -02 and is adding additional clinical sites in anticipation of Phase 2 programs in the second half of 2023.
"The early findings from the Phase 1 PERIO -01 and Phase
1b PERIO -02 trials build on our previous findings and reinforce our confidence in the potential of SD-101 combined with TriSalus'
proprietary PEDD approach," said Steven C. Katz, MD, FACS, Chief Medical Officer at TriSalus. "Given the aggressive
nature of stage IV uveal melanoma, intrahepatic cholangiocarcinoma, and hepatocellular carcinoma, we believe that the patient enrollment
in these studies highlights the potential of SD-101 and PEDD to enable better outcomes when combined with checkpoint inhibitors.
These results, which are summarized in our new investor presentation, further support our hypothesis that SD-101, delivered by PEDD ,
may favorably reprogram the liver tumor microenvironment and reduce or eliminate MDSCs to promote better responsiveness to checkpoint
inhibition. Based on the initial data at the lower end of our SD-101 dose range in combination with checkpoint inhibition, we are eager
for clinical results at higher dose levels."
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 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 previously announced on November 14, 2022, TriSalus entered into
a definitive merger agreement with MedTech, a publicly traded special purpose acquisition company (the "Merger Agreement")
in connection with the proposed business combination and related transactions between the parties. Upon the closing of the transaction,
which is expected to occur in the second 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 the clinical trial treatment protocol and enrollment,
visit http://www.periotrial.com or http://www.clinicaltrials.gov and search NCT04935229, NCT05220722, and NCT05607953.
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.
Changes and Additional Information in Connection with SEC Filing
The information in this communication has not been reviewed by
the U.S. Securities and Exchange Commission ("SEC") and certain information may not comply in certain respects with SEC
rules. MTAC filed with the SEC a registration statement on Form S-4 (File No. 333-269138) (as amended, the "Registration
Statement"), which includes a proxy statement/prospectus of MTAC that will be both the proxy statement to be distributed to
holders of MTAC's common stock in connection with its solicitation of proxies for the vote by MTAC's stockholders with
respect to the Business Combination and other matters as may be described in the Registration Statement, as well as the prospectus
relating to the offer and sale of the securities to be issued in the Business Combination. The Registration Statement is not yet
effective. The Registration Statement, including the proxy statement/prospectus contained therein, when it is declared effective by
the SEC, will contain important information about the Business Combination and the other matters to be voted upon at a meeting of
MTAC's stockholders to be held to approve the Business Combination and other matters (the "Special Meeting"). MTAC
may also file other documents with the SEC regarding the Business Combination. MTAC stockholders and other interested persons are
advised to read, when available, the Registration Statement, including the proxy statement/prospectus contained therein, as well as
any amendments or supplements thereto, because they will contain important information about the Business Combination. When
available, the definitive proxy statement/prospectus will be mailed to MTAC stockholders as of a record date to be established for
voting on the Business Combination and the other matters to be voted upon at the Special Meeting.
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 including depletion of MDSCs, (iii) expectations for continuing program development, and (iv) expectations and timing
for topline data. 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; (iv) the lack of a third-party
valuation in determining whether or not to pursue the Business Combination on the terms set forth in the Merger Agreement; (v) the occurrence
of any event, change or other circumstance that could give rise to the termination of the Merger Agreement; (vi) the receipt of an unsolicited
offer from another party for an alternative transaction that could interfere with the Business Combination; (vii) the effect of the announcement
or pendency of the Business Combination on TriSalus' business relationships, operating results and business generally; (viii) risks
that the Business Combination disrupts current plans and operations of TriSalus; (ix) the outcome of any legal proceedings that may be

Frequently Asked Questions

What is the focus of TriSalus Life Sciences?

TriSalus focuses on integrating immunotherapy with innovative delivery technology for liver and pancreatic tumors.

What are the PERIO-01 and PERIO-02 studies about?

The studies evaluate the investigational drug SD-101 combined with systemic checkpoint inhibitors for liver tumors.

How does TriSalus deliver SD-101?

SD-101 is delivered intravascularly using the TriNav Infusion System and the PEDD method.

What is expected from PERIO trials by Q2 2023?

TriSalus anticipates data on higher doses of SD-101 and results from a new treatment cohort.

When is TriSalus going public?

TriSalus expects to complete its business combination with MedTech by the second quarter of 2023.

Last updated: Feb 16, 2023