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 naïve, 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
shareholders.
For Patients
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, financial, political and
legal conditions; (xii) unfavorable changes in the reimbursement
environment for TriSalus’ products; (xiii) TriSalus’ product
candidates not achieving success in preclinical or clinical trials
or not being able to obtain regulatory approval, either on a timely
basis or at all or subject to any conditions that negatively impact
TriSalus’ ability to commercialize the applicable product
candidates; (xiv) TriSalus being unable to continue to grow TriNav
sales; (xv) the size of the addressable markets for TriNav and
SD-101, if successfully developed and approved by the applicable
regulatory authorities, being less than TriSalus currently
estimates; (xvi) TriSalus’ ability to successfully commercialize
any product candidates that it successfully develops and that are
approved by applicable regulatory authorities; (xvii) TriSalus’
ability to continue to fund preclinical and clinical trials for
SD-101; (xviii) TriSalus’ ability to partner with other companies;
(xix) future economic and market conditions; (xx) the development,
effects and enforcement of laws and regulations affecting TriSalus’
business or industry; (xxi) TriSalus’ ability to manage future
growth; (xxii) TriSalus’ ability to maintain and grow its market
share; (xxiii) the effects of competition on TriSalus’ business;
(xxiv) the ability of MTAC or the combined company to raise
additional financing in connection with the Business Combination or
to finance its operations in the future; (xxv) the ability to
implement business plans, forecasts and other expectations after
the completion of the Business Combination, and identify and
realize additional opportunities; (xxvi) costs related to the
Business Combination; (xxvii) the failure to realize the
anticipated benefits of the Business Combination or to realize
estimated pro forma results and the underlying assumptions,
including with respect to estimated stockholder redemptions; and
(xxviii) other risks and uncertainties indicated from time to time
in the Registration Statement, including those under the “Risk
Factors” section therein and in MTAC’s other filings with the SEC.
The foregoing list of factors is not exclusive.
MTAC’s other SEC filings identify and address other important
risks and uncertainties that could cause actual events and results
to differ materially from those expressed or implied in the
forward-looking statements. Forward-looking statements speak only
as of the date they are made. Readers are cautioned not to put
undue reliance on forward-looking statements, and none of MTAC,
TriSalus, or any of their respective representatives assume any
obligation and do not intend to update or revise these
forward-looking statements, whether as a result of new information,
future events, or otherwise. None of MTAC, TriSalus, or any of
their respective representatives gives any assurance that either
MTAC or TriSalus will achieve its expectations.
Participation in Solicitation
MTAC and TriSalus and their respective directors and executive
officers, under SEC rules, may be deemed to be participants in the
solicitation of proxies of MTAC’s stockholders in connection with
the Business Combination. Investors and security holders may obtain
more detailed information regarding the names and interests in the
Business Combination of MTAC’s directors and officers in MTAC’s
filings with the SEC, including MTAC’s registration statement on
Form S-1, which was originally filed with the SEC on November 30,
2020, as amended, MTAC’s 2022 Form 10-K, and the Registration
Statement. To the extent that holdings of MTAC’s securities have
changed from the amounts reported in the Registration Statement,
such changes have been or will be reflected on Statements of Change
in Ownership on Form 4 filed with the SEC. Information regarding
the persons who may, under SEC rules, be deemed participants in the
solicitation of proxies from MTAC’s stockholders in connection with
the Business Combination are included in the Registration Statement
and will be set forth in the definitive proxy statement/prospectus
forming a part of the Registration Statement. Investors and
security holders of MTAC and TriSalus are urged to carefully read
in their entirety the proxy statement/prospectus and other relevant
documents that will be filed with the SEC, when they become
available, because they will contain important information about
the Business Combination.
Investors and security holders will be able to obtain free
copies of the proxy statement/prospectus and other documents
containing important information about MTAC and TriSalus through
the website maintained by the SEC at www.sec.gov. Copies of the
documents filed with the SEC by MTAC can be obtained free of charge
by directing a written request to MedTech Acquisition Corporation
at 48 Maple Avenue, Greenwich, CT 06830.
INVESTMENT IN ANY SECURITIES DESCRIBED HEREIN HAS NOT BEEN
APPROVED OR DISAPPROVED BY THE SEC OR ANY OTHER REGULATORY
AUTHORITY NOR HAS ANY AUTHORITY PASSED UPON OR ENDORSED THE MERITS
OF THE OFFERING THEREOF OR THE ACCURACY OR ADEQUACY OF THE
INFORMATION CONTAINED HEREIN. ANY REPRESENTATION TO THE CONTRARY IS
A CRIMINAL OFFENSE.
Use of Data
The data contained herein is derived from various internal and
external sources. Neither MTAC nor TriSalus has independently
verified the accuracy or completeness of the information derived
from external sources. Any market data in the communication
involves a number of assumptions and limitations, and there can be
no guarantee as to the accuracy or reliability of such assumptions.
Further, no representation is made as to the reasonableness of the
assumptions made within or the accuracy or completeness of any
projections or modeling or any other information contained herein.
Any data on past performance or modeling contained herein is
preliminary, subject to change and may not be indicative of actual
future performance. MTAC and TriSalus assume no obligation to
update the information in this communication.
No Offer or Solicitation
This communication shall not constitute an offer to sell, a
solicitation of an offer to buy or a recommendation to purchase any
securities, or the solicitation of any proxy, vote, consent or
approval in any jurisdiction in connection with the Business
Combination, nor shall there be any offer, solicitation or sale of
securities in any jurisdiction in which the offer, solicitation or
sale would be unlawful prior to the registration or qualification
under the securities laws of such jurisdictions. This communication
is restricted by law; it is not intended for distribution to, or
use by any person in, any jurisdiction where such distribution or
use would be contrary to local law or regulation. No offering of
securities shall be made except by means of a prospectus meeting
the requirements of Section 10 of the U.S. Securities Act of 1933,
as amended.
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version on businesswire.com: https://www.businesswire.com/news/home/20230419006005/en/
Media: press@trisaluslifesci.com
Investors: Aaron Palash / Gregory Klassen / Allison Sobel Joele
Frank, Wilkinson Brimmer Katcher +1 212 355 4449
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