Full Press Release Details
TriSalus Life Sciences Presents Additional Data
for SD-101 Delivered by the Proprietary PEDD Method with the TriNav Device for Uveal Melanoma Liver Metastases at the ASCO
from PERIO-01 clinical trial indicates PEDD method resulted in modulation of the tumor microenvironment and decreased circulating
tumor DNA (ctDNA) levels
DENVER and CHICAGO, June 12, 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 additional Phase 1 clinical data presented at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting taking place
in Chicago, Illinois, from June 2-6, 2023.
TriSalus' ongoing Phase
1 Pressure-Enabled Regional Immuno-Oncology (PERIO-01) (NCT04935229) clinical study for uveal melanoma with liver metastases (UMLM) is
studying an investigational class C toll-like receptor-9 agonist, SD-101, delivered intravascularly by TriSalus' TriNav
Infusion System (TriNav) using the Company's proprietary 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
"The data presented by
Dr. Kamaneh Montazeri from Mass General Brigham at ASCO reflect important clinical progress of our Phase 1 PERIO-01 trial and builds on
the promising data released in April," said Steven C. Katz, MD, FACS, Chief Medical Officer at TriSalus. "We are pleased that
SD-101 in combination with systemic checkpoint inhibition and delivered with TriNav was well tolerated based on a low treatment related
serious adverse event rate of 5% and resulted in immune cell activation and natural killer cell expansion. We look forward to moving into
Phase 2 later this year and are optimistic about the potential of SD-101 playing an important role in the management of patients with
Pharmacokinetic data indicate
that the strategy of delivering a toll-like receptor-9 agonist with the PEDD method results in high drug levels in the liver, while the
drug is undetectable after four hours in the serum in 97% of patients with available data. The immune effects in liver metastases and
the blood are consistent with broad tumor microenvironment modulation and the ability of SD-101 to deplete myeloid derived suppressor
cells (MDSCs) in the liver.
PERIO-01 is an open-label, first-in-human
Phase 1 trial of SD-101, administered by hepatic arterial infusion with TriNav using PEDD in UMLM. The study consists of dose-escalation
cohorts of SD-101 (2, 4, or 8 mg) alone or with immune checkpoint inhibition. At the data cutoff as of May 12, 2023, 39 patients were
enrolled in the PERIO-01 trial, with each having received at least one dose of SD-101. Of the patients with available data, five patients
were treatment-na ve and 81% had failed at least one prior line of therapy, including three patients on their sixth-line of treatment.
Following receipt of SD-101,
patients demonstrated a statistically significant expansion of peripheral natural killer cells, along with evidence of decreased expression
of exhaustion markers on these cells. Increases in serum cytokines, including IFNg and IL-18, also supported systemic immune activation.
Additionally, decreased levels of ctDNA levels were observed within eight out of 13 evaluable patients. Stable disease was noted as the
best on-treatment response for target lesions in 15 out of 25 patients, with one partial response.
These findings, along with reductions
of intratumoral MDSCs and decreases in ARG-1 (arginase 1) and IDO-1 (indoleamine 2,3-dioxygenase-1) gene levels, support the hypothesis
that SD-101 delivered via PEDD may have favorable immune effects within the liver and systemically.
Overall, the data emerging from
the PERIO-01 trial continues to indicate immunologic changes are occurring within the liver, with decreases in ctDNA and disease control
observed across a group of heavily pre-treated patients with UMLM, as well as a low treatment-related serious adverse event rate.
The data were also selected for
presentation at the Developmental Therapeutics - Immunotherapy Poster Discussion Session on June 3, 2023 at 3:00pm CT.
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 (as amended on April 4, 2023 and May 13, 2023) with MedTech, a publicly traded special
purpose acquisition company (as amended, 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.
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
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, within the liver and systemically, (iii) immunological changes within the liver
as evidence of disease control and (iv) 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