UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure.
On November 11, 2022, MedTech Acquisition Corporation, a Delaware corporation (“MTAC”), entered into an Agreement and Plan of Merger (the “Merger Agreement”) with MTAC Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of MTAC (“Merger Sub”), and TriSalus Life Sciences, Inc., a Delaware corporation (“TriSalus”), pursuant to which, subject to the satisfaction or waiver of certain conditions set forth therein, Merger Sub will merge with and into TriSalus (the “Merger”), with TriSalus surviving the Merger as a wholly owned subsidiary of MTAC, and with TriSalus’ equity holders receiving shares of MTAC common stock (the transactions contemplated by the Merger Agreement and the related ancillary agreements, the “Business Combination”). Upon consummation of the Business Combination, MTAC will be renamed “TriSalus Life Sciences, Inc.”
On December 21, 2022, MTAC and TriSalus circulated a video statement from Dr. Carvajal, Director of Experimental Therapeutics and Director of the Melanoma Service at Columbia University Medical Center, and made social media posts providing a further update on its ongoing Pressure-Enabled Regional Immuno-Oncology 01 and 02 clinical studies for primary and metastatic liver tumors. The video transcript and social media posts are furnished hereto as Exhibit 99.1 and Exhibit 99.2, respectively.
The information in this Item 7.01, including Exhibit 99.1 and Exhibit 99.2, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liabilities under that section, and shall not be deemed to be incorporated by reference into the filings of MTAC under the Securities Act of 1933, as amended (the “Securities Act”) or the Exchange Act, regardless of any general incorporation language in such filings. This Current Report on Form 8-K will not be deemed an admission as to the materiality of any information in this Item 7.01, including Exhibit 99.1 and Exhibit 99.2.
Changes and Additional Information in Connection with SEC Filing
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 U.S. Securities and Exchange Commission (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 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”). 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 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.
Forward-Looking Statements
This Current Report on Form 8-K 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 TriSalus’ TriNav Infusion System, (ii) the potential of TriSalus’ proprietary Pressure-Enabled Drug Delivery™ method to enable SD-101 to have broad immune effects in liver tumors and eliminate myeloid-delivered suppressor cells, (iii) expectations for continuing program development and potential outcomes, (iv) TriSalus’ 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 Current Report on Form 8-K 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, 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’ 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’ 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 TriSalus’ product candidates, if successfully developed and approved by the applicable regulatory authorities, being less than TriSalus 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 its product candidates; (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; and (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. 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 2021 Form 10-K, the preliminary proxy statement/prospectus included in the Registration Statement 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.
No Offer or Solicitation
This Current Report on Form 8-K 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 Securities Act.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Transcript of Video Statement of Dr. Carvajal, dated December 21, 2022. | |
| 99.2 | Social Media Posts. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MedTech Acquisition Corporation | |||
| Dated: December 21, 2022 | By: | /s/ Christopher C. Dewey | |
| Name: | Christopher C. Dewey | ||
| Title: | Chief Executive Officer | ||
Exhibit 99.1
TriSalus Video Transcript
Text on screen: Dr. Carvajal is a Member of the TriSalus Scientific Advisory Board and Investigator for the PERIO-01 Study.
My name is Rich Carvajal. I’m a medical Oncologist at Columbia University Irving Medical Center where I oversee the melanoma program as well as the experimental therapeutics program.
Text on screen: What Are the Challenges in Trying to Find a Cure for Liver Cancer?
Well cancers that go to the liver are extremely challenging to treat. You know, if we look at any cancer – whether it’s pancreatic cancer, colon cancer, uveal melanoma, skin melanoma – if it goes to the liver, it is invariably harder to treat. Overall survival that we see in these patients is inferior to patients who don’t have liver disease.
Text on screen: How Does TriSalus Try to Address These Challenges?
So TriSalus tries to address these challenges in two very unique ways.
One: It has a technology called a pressure enabled drug delivery system through this TriNav catheter when it can use pressure to infuse any sort of drug or therapy into the liver – into the tumor. And, that allows for greater saturation of the organ as well as a cancer with whatever drug needs to be infused.
The second piece is that they specifically address the immunosuppressive microenvironment to the liver by using a drug called SD 101. So, SD 101 is an investigational drug. It’s a class C Toll Like Receptor 9 agonist that really functions to do a few things: One, it activates the good cells of the immune system – those cells that are trying to kill off the cancer. And, it suppresses some of the bad cells such as these immune cells like myeloid derived suppressor cells. These are cells that actually impair the ability of the immune system to kill cancer.
Text on screen: Where do the PERIOTM Trials Currently Stand?
TriSalus has a series of clinical trials now looking at their pressure enabled drug delivery system – a drug called SD 101 which is a Toll Like Receptor 9 agonist in combination with check point blockade in patients with various cancers, including uveal melanoma, hepatocellular carcinoma, liver cancer, and intrahepatic cholangiocarcinoma.
Text on screen: Why are you Optimistic Towards These Trials?
So, the data that we’ve seen thus far from these trials are extremely exciting, albeit early.
So, what we’re saying is that treatment with SD 101 is able to do the things in the liver that we expect to see. That is, we’re seeing activation of the immune system. We’re seeing suppression of the bad immune cells these myeloid derived suppressor cells. In the periphery, we’re seeing activation of the immune system.
And, all of this is dose dependent. The more SD 101 is delivered, the greater the effect that we’re seeing.
Along this clinical trial program, we’re collecting something called circulating tumor DNA, which is a marker of tumor burden.
And very intriguingly, we’re seeing suppression of circulating tumor DNA in some of the patients that were treating with this combination therapy. And, so I think, you know, if this continues, the safety, the biologic activity consistent with immune activation, antitumor effects, we’re very hopeful that we’ll see meaningful clinical benefit in the patients treated on this program.
Exhibit 99.2
TriSalus Corporate Twitter Post
Listen to Dr. Richard Carvajal, member of our scientific advisory board and investigator on the PERIO™-01 #clinicaltrial, discuss challenges of treating #livercancer, our investigational platform, and early findings from the PERIO™ trials below👇 https://youtu.be/zvgCMqUcZ-M
TriSalus Corporate LinkedIn Post
Listen to Dr. @Richard Carvajal, member of our scientific advisory board and investigator on the PERIO™-01 #clinicaltrial, discuss the challenges of treating #livercancer, what makes our investigational platform unique, and early findings from the ongoing PERIOTM clinical trials below 👇 https://youtu.be/zvgCMqUcZ-M