Financial Performance - TriNav achieved $18.5 million in revenue in 2023, with fourth quarter growth of 77% compared to the previous year[29]. - TriNav is expected to increase the addressable market by approximately 25%, translating to an opportunity of 47,500 units or about $368 million based on current pricing[52]. - TriNav received a unique and permanent HCPCS code (C9797) with a payment rate of $16,724.70 for calendar year 2024, enhancing reimbursement options[55]. Product Development and Clinical Trials - The PRVI device for pancreatic tumors is currently in clinical trials, with commercialization not anticipated before 2025[29]. - The company is advancing its Pancreatic Retrograde Venous Infusion Device (PRVI), currently in Phase 1 clinical trials for locally advanced pancreatic cancer[77]. - The Phase 1 PERIO studies are testing the nelitolimod/PEDD therapeutic platform in indications such as locally advanced pancreatic carcinoma and uveal melanoma with liver metastases[90]. - The company has initiated three Phase 1/1b studies focused on enhancing immunotherapy responses in liver and pancreatic tumors using nelitolimod[90]. - The company anticipates reporting full Phase 1 experience in the second half of 2024, with Phase 1b enrollment beginning if data remains supportive[120]. - The company is studying the PRVI device in combination with nelitolimod in the PERIO-03 trial, which has received 510(k) clearance[186]. Market Opportunity and Patient Demographics - The incidence of primary liver tumors is over 41,000 cases annually in the U.S., with an additional 96,000 individuals diagnosed with liver metastases[48]. - Approximately 40% of liver cancer patients are eligible for TACE or TARE procedures, representing a potential market opportunity of approximately 37,000 units, or $286 million[49]. - Approximately 137,000 new cases of liver cancers and over 60,000 cases of pancreatic cancer are diagnosed annually in the U.S., with more than 80,000 potentially addressable through the nelitolimod/PEDD platform[106]. - The five-year survival rate for pancreatic ductal adenocarcinoma (PDAC) is only 13%, highlighting the high unmet medical need in this area[108]. Technology and Innovation - The unique SmartValve on the PEDD device preserves more than 70% of forward blood flow, enhancing therapeutic delivery[37]. - PEDD has demonstrated a median increase of 24% in the tumor-to-normal liver ratio (T/N ratio) and a median increase of 23% in tumor dose delivery compared to standard catheters[45]. - The proprietary PEDD technology addresses the limitations of current cancer immunotherapy approaches by overcoming intra-tumoral pressure barriers, enabling effective therapeutic delivery[102]. - The SmartValve technology in TriNav allows for greater therapeutic delivery to tumors while minimizing exposure to healthy tissue[53]. - TriNav's competitive advantage lies in its ability to modulate pressure and flow, unlike standard microcatheters, which lack clinical evidence for improved therapeutic delivery[70]. Regulatory and Compliance - The company plans to seek FDA approval for nelitolimod through a 505(b)(1) regulatory pathway, which requires data demonstrating its contribution to the efficacy of the therapeutic regimen[185]. - The FDA's goal for a non-priority review of an NDA is ten months, but this can be extended by requests for additional information[190]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a new product outweigh its risks prior to approval[189]. - The company is subject to various healthcare laws and regulations, which may impose significant penalties if non-compliance is determined[221]. - The company is required to report annually to CMS information related to payments and transfers of value to healthcare professionals under the Physician Payments Sunshine Act[223]. Collaborations and Partnerships - The collaboration with MD Anderson Cancer Center includes a $10 million funding agreement for preclinical and clinical studies, with $6 million already paid[129]. - The company is exploring collaborations with therapeutic partners to enhance the uptake of various therapeutics using the PEDD approach[86]. - Collaboration with Hangzhou for PEDD combination therapies includes a milestone payment of $2.5 million for each therapy receiving regulatory approval[146]. Manufacturing and Operations - Manufacturing of TriNav is conducted in Westminster, Colorado, with adequate capacity for future demands[141]. - The principal office is located in Westminster, Colorado, leasing approximately 21,000 square feet of office, manufacturing, and warehouse space, with the lease expiring on December 31, 2026[223]. - The company has approximately 112 full-time employees, including 10 with Ph.D. or M.D. degrees, as of March 5, 2024[225]. Employee Relations and Corporate Governance - The company has not experienced any material work stoppages and maintains a good relationship with its employees[225]. - The company actively engages with managers to collect feedback on improving the working environment[225]. - The company may need to negotiate new leases or evaluate additional space for operations in the future[224].

Business Combination and Financing - TriSalus Life Sciences, Inc. reported a Business Combination with MedTech Acquisition Corporation, resulting in an aggregate consideration of $220.0 million, payable in 22,000,000 shares of common stock [171]. - In October 2022, TriSalus raised approximately $9.8 million through the sale of 706,243 shares of Series B-2 preferred stock at a price of $14.16 per share [174]. - The company completed a portion of the second tranche of the B-2 Preferred Stock Financing in March 2023, raising approximately $2.9 million [177]. - In June 2023, TriSalus raised approximately $3.7 million through the sale of 257,779 shares of Series B-2 preferred stock [179]. - A warrant repurchase program was approved in August 2023, authorizing up to $4.0 million for repurchases of Public Warrants [181]. - On October 2, 2023, TriSalus entered into a Standby Equity Purchase Agreement with Yorkville, allowing the company to sell up to $30.0 million of common stock during the commitment period [183]. - The company entered into the Yorkville Purchase Agreement in October 2023, allowing it to sell up to $30.0 million of shares of Common Stock [246]. Revenue and Profitability - Revenue for the three months ended September 30, 2023, increased by $1.3 million or 32.4% compared to the same period in 2022, primarily due to a $1.1 million increase in units of TriNav sold [203]. - Gross profit for the three months ended September 30, 2023, increased by $1.4 million or 42.9%, with gross margin rising to 88.7% from 82.1% [205]. - Revenue increased by $3.6 million, or 39.4%, for the nine months ended September 30, 2023, compared to the same period in 2022, primarily due to higher sales volume of TriNav [213]. - Gross profit increased by $3.0 million, or 39.3%, for the nine months ended September 30, 2023, while gross margin slightly decreased from 84.3% to 84.2% [215]. Expenses and Losses - R&D expenses increased by $4.6 million or 94.8% for the three months ended September 30, 2023, driven by costs associated with three clinical trials of drug candidate SD-101 [206]. - Sales and marketing expenses rose by $1.7 million or 54.8% for the three months ended September 30, 2023, primarily due to increased payroll and travel expenses [208]. - General and administrative expenses increased by $5.5 million or 158.2% for the three months ended September 30, 2023, mainly due to higher professional services costs related to the Business Combination [209]. - R&D expenses rose by $6.8 million, or 44.9%, for the nine months ended September 30, 2023, mainly due to increased spending on clinical trials and manufacturing development [216]. - General and administrative expenses surged by $9.1 million, or 107.7%, for the nine months ended September 30, 2023, largely due to higher professional service fees and increased payroll expenses [220]. - The company incurred net losses of $23.5 million for the nine months ended September 30, 2023, and has substantial doubt about its ability to continue as a going concern [226][227]. Cash Flow and Liquidity - Net cash used in operating activities was $41.2 million for the nine months ended September 30, 2023, compared to $24.0 million for the same period in 2022 [232]. - Net cash provided by financing activities was $54.6 million for the nine months ended September 30, 2023, primarily from merger proceeds and preferred stock issuance [239]. - The company had cash and cash equivalents of approximately $21.4 million as of September 30, 2023, which may not be sufficient to fund projected liquidity requirements for the next 12 months [228]. - As of September 30, 2023, the company had approximately $21.4 million in cash and cash equivalents, which is insufficient to fund projected liquidity requirements for the next 12 months [246]. - The company anticipates requiring additional capital in the near term to continue operations, which may not be available on favorable terms [246]. - The company may need to delay or curtail operations if it cannot raise sufficient capital [247]. Research and Development - The company has initiated Phase 1 human trials for SD-101, which aims to treat liver and pancreatic cancers, with no guarantee of favorable data or FDA approval [175]. - Approximately 12% of the company's R&D costs are headcount-related, with the remainder being external services [262]. - The company expects to incur significant expenses related to the commercialization of TriNav, including manufacturing, distribution, marketing, and sales costs [243]. - The company has paid Dynavax $12 million as of September 30, 2023, and may owe up to an additional $158 million upon achieving certain development and regulatory milestones for SD-101 [250]. Accounting and Compliance - The company recognizes revenue from TriNav shipments when control of the units has been transferred to the customer, following ASC 606 guidelines [253]. - The company faces substantial doubt regarding its ability to continue as a going concern as of September 30, 2023 [248]. - The company will remain an emerging growth company until the earlier of December 31, 2025, or achieving total annual gross revenue of at least $1.235 billion [270]. - The market value of the company's common equity held by non-affiliates must exceed $700 million to be deemed a "large accelerated filer" under SEC rules [270]. - The company has elected to take advantage of the extended transition period under the JOBS Act, which may affect comparability with other public companies [269]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [272]. - Recent accounting pronouncements and their potential impact on financial condition and results of operations are detailed in the quarterly report [271].

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (MARK ONE) (State or other jurisdiction of incorporation or organization) Delaware 85-3009869 (I.R.S. Employer Identification No.) 48 Maple Avenue For the transition period from to Co ...

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (MARK ONE) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39813 MEDTECH ACQUISITION CORPORATION (Exact Name of Registrant as Specified in Its Charter) (State or other ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39813 MedTech Acquisition Corporation (Exact name of registrant as specified in its charter) | Delaware | 85-3009869 ...