TriSalus Life Sciences Provides Updates on Pressure-Enabled Regional Immuno-Oncology™ (PERIO™) 01 and 02 Clinical Studies
Data further substantiates potential to significantly improve immunotherapy outcomes for patients with liver and pancreatic tumors
DENVER and CHICAGO, November 21, 2022 – TriSalus Life Sciences®, Inc. (“TriSalus”) (the “Company”), an oncology therapeutics 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 filed a presentation for investors with additional information regarding its ongoing Pressure-Enabled Regional Immuno-Oncology™ (“PERIO™ 01”) and (“PERIO™ 02”) clinical studies for primary and metastatic liver tumors.
“We are commercializing our TriNav® Infusion System (TriNav®) and developing SD-101 to potentially enable more patients with liver and pancreatic tumors to benefit from immunotherapeutics and the current standard of care,” said Mary Szela, President and Chief Executive Officer of TriSalus. “Today we are providing recent clinical data from our SD-101 studies so investors can better understand the progress to date and the potential upside that our company can generate.”
“The initial findings from these studies offer encouraging data supporting TriSalus’ proprietary Pressure-Enabled Drug Delivery™ (“PEDD™”) method,” said Steven C. Katz, MD, FACS, Chief Medical Officer at TriSalus. “This promising clinical data demonstrate that SD-101 delivered via TriNav® may support broad immune effects in liver tumors and eliminate myeloid-derived suppressor cells (“MDSC”). Importantly, the data further substantiates the potential of our therapeutic platform to significantly improve immunotherapy outcomes for patients with liver and pancreatic tumors.”
Highlights of the presentation include:
- Data is consistent with the hypothesis that TriNav® can achieve high SD-101 levels in the liver with limited systemic exposure using the PEDD™ method.
- SD-101 delivered via TriNav® is associated with evidence of induction of immunostimulatory cytokines in the blood and has demonstrated reductions in liver tumor monocytic MDSC levels.
- To date, 27 patients have been treated with 123 infusions of SD-101 in the PERIO™ trials, with no serious cytokine adverse events related to SD-101 or serious adverse events related to TriNav® or PEDD™.
- The Company expects PERIO™ 01 and PERIO™ 02 Phase 1 response data in December 2022. The studies continue to enroll at higher SD-101 dose levels in combination with checkpoint inhibitors.
The full presentation has been filed with the Securities and Exchange Commission (“SEC”) and is accessible on TriSalus’ investor relations page at https://trisaluslifesci.com/investors/.
About TriSalus and Its Proposed Business Combination with MedTech
TriSalus is an oncology therapeutics 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 intra-tumoral pressure through modulation of pressure and flow to increase delivery of therapeutic agents.
As previously 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, which is 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.
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.
This communication contains certain “forward-looking statements” within the meaning of the United States federal securities laws regarding MTAC’s or TriSalus’s 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’s 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’s 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’s 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) 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’s 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 instituted against TriSalus or MTAC related to the Merger Agreement 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’s products; (xiii) TriSalus’s 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’s 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 TriSalus’s product candidates, if successfully developed and approved by the applicable regulatory authorities, being less than TriSalus estimates; (xvi) TriSalus’s ability to successfully commercialize any product candidates that it successfully develops and that are approved by applicable regulatory authorities; (xvii) TriSalus’s ability to continue to fund preclinical and clinical trials for its product candidates; (xviii) TriSalus’s ability to partner with other companies; (xix) future economic and market conditions; the development, effects and enforcement of laws and regulations affecting TriSalus’s business or industry; (xx) TriSalus’s ability to manage future growth; (xxi) TriSalus’s ability to maintain and grow its market share; (xxii) the effects of competition on TriSalus’s business; (xxiii) 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; (xxiv) the ability to implement business plans, forecasts and other expectations after the completion of the Business Combination, and identify and realize additional opportunities; (xxv) costs related to the Business Combination; and (xxvi) 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. The foregoing list of factors is not exclusive.
You should carefully consider the foregoing factors and other risks and uncertainties described in the “Risk Factors” section of MTAC’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the SEC on March 2, 2022 (the “2021 Form 10-K”), the preliminary proxy statement/prospectus on Form S-4 relating to the Business Combination, which is expected to be filed by MTAC with the SEC and other documents filed by MTAC from time to time with the SEC. These 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.
Changes and Additional Information in Connection with SEC Filing
The information in this communication has not been reviewed by the SEC and certain information may not comply in certain respects with SEC rules. MTAC intends to file a registration statement on Form S-4 (the “Registration Statement”) that will include 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.
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, and MTAC’s 2021 Form 10-K. To the extent that holdings of MTAC’s securities have changed from the amounts reported in MTAC’s 2021 Form 10-K, 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 will be set forth in the 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 MedTech 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. MedTech 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.
Aaron Palash / Gregory Klassen / Allison Sobel
Joele Frank, Wilkinson Brimmer Katcher
+1 212 355 4449