Table of Contents As filed with the U.S. Securities and Exchange Commission on December 15, 2023. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TRISALUS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 3841 (Primary Standard Industrial Classification Code Number) 85-3009869 (I.R.S. Employer Identific ...

FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Table of Contents As filed with the U.S. Securities and Exchange Commission on December 15, 2023. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Mary Szela Chief Executive Officer 6272 W. 91st Ave. Westminster, Colorado 80031 (888) 321-5212 (Name, address, including zip code, and telephone number, including area code, of agent for service) Copy to: TRISALUS LIFE SCIENCES, INC. (Exact name of regis ...

Table of Contents As filed with the U.S. Securities and Exchange Commission on December 14, 2023. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 3 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TRISALUS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) 3841 (Primary Standard Industrial Delaware (State or other jurisdiction of incorporation or organization) Classification Code Number) 6272 W. 91st Ave. Westminster, Colorado ...

Table of Contents As filed with the U.S. Securities and Exchange Commission on December 14, 2023. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 3 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TRISALUS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) 3841 (Primary Standard Industrial Mary Szela Chief Executive Officer 6272 W. 91st Ave. Westminster, Colorado 80031 (888) 321-5212 (Name, address, including zip code, and tele ...

Company Overview - TriSalus Life Sciences, Inc. focuses on innovative drug delivery technology and immune-oncology therapeutics, particularly for liver and pancreatic cancer [172]. - The company has developed two product lines: Pressure Enabled Drug Delivery (PEDD) infusion systems and the investigational agent SD-101, aimed at enhancing immune response in treating solid tumors [172]. Financial Performance - 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 an increase in units of TriNav sold [208]. - 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% in the same period last year [210]. - 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 [218]. - 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% [220]. Expenses - R&D expenses increased by $4.6 million or 94.8% for the three months ended September 30, 2023, driven by costs associated with clinical trials for drug candidate SD-101 [211]. - 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 [213]. - 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 [214]. - 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 [221]. - 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 [225]. Cash Flow and Financing - 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 [239]. - Net cash provided by financing activities was $54.6 million for the nine months ended September 30, 2023, primarily from the merger proceeds and issuance of preferred stock [245]. - The company anticipates requiring additional capital in the near term to fund operations, which may not be available on favorable terms or at all [252]. - The company has entered into the Yorkville Purchase Agreement, allowing it to sell up to $30.0 million of shares of Common Stock [252]. Losses and Concerns - 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 [231]. - The company may face substantial doubt regarding its ability to continue as a going concern due to insufficient cash flow and liquidity [254]. - The company may need to delay or curtail operations if it cannot secure sufficient capital to capitalize on business opportunities [253]. Business Developments - The company completed a Business Combination on August 10, 2023, with an aggregate consideration of $220 million, resulting in the exchange of approximately 890 million shares of TriSalus common stock for about 22 million shares of MTAC common stock [175][177]. - In October 2022, TriSalus raised approximately $9.8 million through the sale of 706,243 shares of Series B-2 preferred stock at $14.16 per share [179]. - In August 2023, the Board approved a warrant repurchase program with an expenditure of up to $4 million, having repurchased 28,502 Public Warrants for $9.9 thousand by October 31, 2023 [185]. - On October 2, 2023, TriSalus entered into a Standby Equity Purchase Agreement with Yorkville, allowing the sale of up to $30 million of Common Stock during the commitment period [186][187]. Regulatory and Compliance - TriSalus applied for a new technology Ambulatory Payment Classifications code with CMS on June 1, 2023, to ensure continued reimbursement for the TriNav device starting January 1, 2024 [173]. - The company recognizes revenue from TriNav shipments when control of the units has been transferred to the customer, following ASC 606 guidelines [259]. - The company has no off-balance sheet financing arrangements or relationships with unconsolidated entities [257]. Future Outlook - The company expects R&D expenses to increase significantly in future periods as it advances its manufacturing technologies and seeks regulatory approvals for drug candidates [196]. - The company expects to incur significant expenses related to the commercialization of TriNav, including manufacturing, distribution, marketing, and sales costs [249]. - Approximately 12% of the company's R&D costs are headcount-related, with the remainder being external services for pre-clinical and clinical activities [268]. - 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 [276]. - 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 [276]. - The company has elected to take advantage of the extended transition period under the JOBS Act, which may affect comparability with other public companies [275]. - Recent accounting pronouncements may impact the company's financial condition and results of operations, as detailed in the quarterly report [277].

TABLE OF CONTENTS As filed with the U.S. Securities and Exchange Commission on October 18, 2023. Registration No. 333-274292 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TRISALUS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) (Address, including zip code, and telephone number, including area code, of registrant's principal executive offices) Mary Szela Chief Executive Of ...

TABLE OF CONTENTS As filed with the U.S. Securities and Exchange Commission on October 18, 2023. Registration No. 333-274292 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TRISALUS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 3841 (Primary Standard Industrial Classification Code Number) 85-3009869 (I ...

Table of Contents As filed with the U.S. Securities and Exchange Commission on September 1, 2023. Registration No. 333-274292 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TRISALUS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) 3841 Delaware (State or other jurisdiction of incorporation or organization) Westminster, Colorado 80031 (888) 321-5212 (Address, including zip co ...

Table of Contents As filed with the U.S. Securities and Exchange Commission on September 1, 2023. Registration No. 333-274292 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TRISALUS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) 3841 Delaware (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) 6272 W. 91st ...

TRISALUS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) TABLE OF CONTENTS As filed with the U.S. Securities and Exchange Commission on August 31, 2023. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 8071 (Primary Standard Industrial 85-3009869 (I.R.S. Employer Identification No.) Delaware (State or other jurisdiction of incorporation or organization) 6272 W. 91st Ave. W ...