On November 14, 2022 TriSalus Life Sciences (the "Company" or "TriSalus"), a privately held oncology therapeutics company integrating immunotherapy with disruptive delivery technology to transform the treatment paradigm for patients with liver and pancreatic tumors, reported it has entered into a definitive merger agreement with MedTech Acquisition Corporation (Nasdaq: MTAC) ("MedTech"), a publicly traded special purpose acquisition company (Press release, TriSalus Life Sciences, NOV 14, 2022, View Source [SID1234624048]). 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 represents a post-transaction market capitalization of approximately $244.4 million for TriSalus upon closing.

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TriSalus Combines Proprietary Drug Delivery Technology and Therapeutics Platform to Drive Better Patient Outcomes

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:

TriNav Infusion System: Launched in 2020, TriNav is an FDA-cleared device that is designed to administer established and emerging therapeutics, including SD-101, the Company’s investigational TLR9 agonist, to selected sites, including tumors in the liver with the ability to treat disease throughout the entire organ. TriNav is the latest TriSalus asset for the proprietary Pressure-Enabled Drug Delivery (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 and improve patient outcomes.
SD-101: TriSalus is developing SD-101, a class C toll-like receptor 9 (TLR9) agonist, that promotes T Cell infiltration, reduction of myeloid derived suppressor cells (MDSC) and broad immune activation to reverse immunosuppression in the liver and pancreas. TriSalus is investigating SD-101 as a therapeutic candidate delivered by PEDD to enable deeper and more durable responses to other immunotherapeutics (e.g., checkpoint inhibitors) in a range of liver and pancreatic cancers for which limited therapeutic options currently exist. Thus far, across two clinical trials, over 100 infusions of SD-101 have been delivered at several dose levels as monotherapy and in combination with checkpoint inhibitors in more than 20 patients with safety data indicating treatments were well-tolerated.
Management Comments

"TriSalus is scaling a differentiated, integrated and disruptive approach to the treatment of tumors in the liver and pancreas, and this transaction is an important step forward in enabling better patient outcomes," said Mary Szela, president and CEO of TriSalus. "Our commercial-stage drug delivery technology, together with the continued development of our promising immunotherapeutic, positions TriSalus to capitalize on a significant opportunity in an area with high unmet need. Partnering with MedTech accelerates our access to financial resources and brings us an experienced partner as we continue to commercialize our TriNav device and advance our SD-101 clinical programs. We look forward to working together to achieve accelerated growth and to bring hope to patients with liver and pancreatic tumors."

"This is an exciting day for our shareholders, and we could not be more pleased to announce the signing of our merger agreement with TriSalus," said Chris Dewey, CEO of MedTech. "With multiple value inflection points anticipated over the next 18 months, we believe that TriSalus’ first-of-its-kind technology and deep expertise in immuno-oncology, coupled with our team’s success in commercializing medical device companies, will create significant value in the years ahead."

Transformational Upside Potential

Fast-Growing Device Business: While TriSalus is pursuing commercialization of additional technologies leveraging the PEDD approach, such as the Pancreatic Retrograde Venous Infusion (PRVI) System, the TriNav Infusion System is already a commercial-stage, high margin, and FDA cleared drug delivery device. The TriNav Infusion System using the PEDD approach has been validated in peer-reviewed studies at multiple clinical sites and performed in more than 17,000 cases to date. TriNav already has a strong customer base and support from key opinion leaders. With its ability to optimize Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Radioembolization (TARE) procedures that to date have underperformed in patients with liver and pancreatic cancers, the platform has near-term expansion opportunities by partnering with companies advancing checkpoint inhibitors, CAR-T therapies and other cell immunotherapies. Longer term, TriNav is expected to support the growth and effectiveness of SD-101. In 2021, TriNav achieved $8.4 million in net sales and it is on track to achieve $12.6 million in 2022.
Significant Potential Upside From SD-101 Program in Development: SD-101’s tolerable safety profile and therapeutic activity was substantiated in over 300 patients enrolled in various Phase 1 and Phase 2 studies of melanoma, lymphoma, and head and neck squamous cell carcinoma. TriSalus’ targeting of orphan indications and rare disease creates an opportunity for expedited development and the potential for an accelerated path to approval and commercialization. Phase 1/1b early response data for the uveal melanoma and intrahepatic cholangiocarcinoma indications are expected in the fourth quarter of 2022, with a potential New Drug Application (NDA) submission as early as 2025.
Targeting a $15 Billion Addressable Market Opportunity: There are significant limitations in existing immunotherapy treatment success for liver and pancreatic cancers. More than 41,000 people are expected to be diagnosed with primary liver cancers this year, and more than 96,000 people are expected to have liver metastases in the United States this year.1 Additionally, there is a high global incidence in key targeted indications, providing an attractive non-U.S. opportunity.
Successful Track Record of Value Creation: The MedTech team’s strong track record of value creation across an array of medical device companies, together with the TriSalus team’s deep clinical expertise and strategic partnerships with leading cancer centers, positions the Company to successfully develop and bring to market life-saving cancer treatments.
Transaction Overview

The pending merger has been unanimously approved by the Boards of Directors of both TriSalus and MedTech and is expected to close in the first quarter of 2023, subject to the satisfaction of the necessary regulatory approvals and customary closing conditions, including the approval of MedTech’s shareholders.

The board of the combined company post-close would be comprised of nine members, of which seven are selected by TriSalus and two from MedTech. The leadership team will be the existing TriSalus team led by Mary Szela.

At the completion of the transaction, the company expects to have at least $60 million in cash, assuming significant redemptions. The expected cash at closing includes up to $50 million from a convertible note for which MedTech and the Company have entered into a non-binding term sheet with a leading institutional investor.

Additional information about the proposed merger, including a copy of the merger agreement and investor presentation, will be provided in a Current Report on Form 8-K to be filed by MedTech with the Securities and Exchange Commission ("SEC") and available at www.sec.gov.

Advisors

Cooley LLP is acting as legal counsel to TriSalus. Raymond James is acting as exclusive financial advisor to MedTech and as the sole placement agent on the convertible offering, and Paul Hastings LLP is serving as legal counsel to the placement agent. Foley & Lardner LLP is acting as legal counsel to MedTech.

Conference Call Information

TriSalus and MedTech will host a joint conference call to discuss the proposed merger today, November 14, 2022, at 8:30 am Eastern Time. A live webcast of the conference call and associated presentation materials will be accessible on TriSalus’ investor relations page at View Source A replay of the conference call will be available after completion of the conference call and can be accessed on the investor relations page.