Full Press Release Details
Life Sciences Presents New Data at AACR for SD-101 Delivered by the Proprietary PEDD
Method in Stage IV Uveal Melanoma Patients With Liver Metastases
and FORT LAUDERDALE, Fla., April 20, 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 announced new Phase 1 clinical data presented at the American Association
for Cancer Research ("AACR") 2023 Annual Meeting taking place in Orlando, Florida, from April 14-19, 2023.
The clinical data presented at
the AACR 2023 Annual Meeting relates to the Company's ongoing Pressure-Enabled Regional Immuno-Oncology ("PERIO-01")
clinical study for uveal melanoma with liver metastases ("UMLM"). The PERIO-01 trial is studying an investigational class
C toll-like receptor-9 agonist, SD-101, delivered intravascularly with the TriNav Infusion System ("TriNav") using the
Pressure-Enabled Drug Delivery ("PEDD ") method of administration. PERIO-01 is evaluating whether this platform
approach can improve the performance of systemic checkpoint inhibitors in patients with UMLM.
PERIO-01 is an open-label, first-in-human
Phase 1 trial of SD-101, given by hepatic arterial infusion with TriNav using PEDD in UMLM (NCT04935229). The study consists of
dose-escalation cohorts of SD-101 (2, 4, or 8 mg) alone or with immune checkpoint inhibition ("ICI"). At data cutoff as of
January 14, 2023, based on pooled data from 27 patients enrolled in the PERIO-01 trial, only 3 patients were treatment na ve, and
others received 1-7 lines of prior therapy. Within these 27 patients, there has been one treatment-related serious adverse event. The most common treatment related adverse events overall were fatigue (9 events), abdominal
discomfort (6 events), and dizziness (3 events) which were all graded as non-serious. Grade 3 liver function test elevations were noted
in one subject, which was not clinically serious.
Circulating tumor cell and circulating
tumor DNA ("ctDNA") levels were noted to decrease in 6 out of 13 patients and 6 out of 9 patients, respectively, based on
available data. Decreases of ctDNA have been associated with longer overall survival in the stage IV uveal melanoma population. 5 out
of 5 patients with available data demonstrated reductions in intratumoral myeloid derived suppressor cells ("MDSCs"), which
the Company has previously demonstrated in pre-clinical liver metastasis models to be associated with immunosuppression. This data supports
the hypothesis that checkpoint inhibitors in combination with SD-101 delivered via the PEDD method can enable broad immune effects,
including the depletion of liver MDSCs.
"We believe our approach
has the potential to improve outcomes and enhance the quality of life for patients with liver and pancreatic tumors receiving checkpoint
inhibitor therapy," said Steven C. Katz, MD, FACS, Chief Medical Officer at TriSalus. "The data presented at the AACR 2023
Annual Meeting shows that SD-101 has been well tolerated to date when administered via PEDD , at multiple dose levels alone and
in combination with checkpoint inhibition. SD-101 infusions have also been associated with encouraging immunologic activity and ctDNA
decreases, even at the lower doses, in heavily pre-treated patients. The serious adverse event rate related to treatment to date suggests
that our delivery approach may enhance the therapeutic index for SD-101. We look forward to continuing our trials and adding to the growing
body of evidence that our proprietary PEDD method is a potentially powerful approach for enabling SD-101 to improve efficacy of
systemic immunotherapies like checkpoint inhibitors."
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 Business Combination. Upon the closing of the transaction, 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
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 (the "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 and (iii) expectations for continuing program development. 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, as amended, 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,
as amended; (v) the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement,
as amended; (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) the risk that the Business Combination disrupts current plans and operations of TriSalus; (ix)
the outcome of any legal proceedings that may be instituted against TriSalus or MTAC related to the Merger Agreement, as amended, or the
Business Combination; (x) the ability to maintain the listing of MTAC's securities on the Nasdaq; (xi) changes in business, market,