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SEC Comment Letter 0000000000-23-001100 to TriSalus Life Sciences, Inc. (TLSI)

TriSalus Life Sciences, Inc.
Date: Feb. 2, 2023 · CIK: 0001826667 · Accession: 0000000000-23-001100

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File numbers found in text: 333-269138

Date
February 2, 2023
Author
Not clearly detected
Form
UPLOAD
Company
TriSalus Life Sciences, Inc.

Letter

United States securities and exchange commission logo February 2, 2023 Christopher Dewey Chief Executive Officer MedTech Acquisition Corp 48 Maple Avenue Greenwich, CT 06830 Re:MedTech Acquisition Corp Registration Statement on Form S-4 Filed January 6, 2023 File No. 333-269138 Dear Christopher Dewey: We have reviewed your registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Form S-4 filed on January 6, 2023 Q: What equity stake will current stockholders of MTAC and TriSalus stockholders hold in the Combined Company after the closing?, page 10 1.Please revise your disclosure here and elsewhere throughout the prospectus, such as on pages 27-28, to disclose the Sponsor and its affiliates' total potential ownership interest in the combined company, assuming exercise and conversion of all securities, including the private placement and conversion warrants. 2.Please revise your disclosure in this section to show the potential impact of redemptions on the per share value of the shares owned by non-redeeming stockholders by including a sensitivity analysis showing a range of redemption scenarios, including minimum, maximum and interim redemption levels.

FirstName LastNameChristopher Dewey Comapany NameMedTech Acquisition Corp February 2, 2023 Page 2 FirstName LastNameChristopher Dewey MedTech Acquisition Corp February 2, 2023 Page 2 3.We note your disclosure that the maximum redemption scenario reflects maximum redemptions of 1,149,694 shares of Class A Common Stock owned by MTAC public stockholders. Please clarify what percentage of total outstanding common stock held by MTAC public stockholders this maximum redemption scenario represents. 4.We note your disclosure beginning on page 29 regarding additional dilution that stockholders may experience following the closing of the business combination. Please revise your disclosure here to disclose all possible sources and extent of dilution that stockholders who elect not to redeem their shares may experience in connection with the business combination. Provide disclosure of the impact of each significant source of dilution, including the amount of equity held by founders, convertible securities, including warrants retained by redeeming stockholders, at each of the redemption levels detailed in your sensitivity analysis, which should include an interim redemptions scenario, including any needed assumptions. Questions and Answers about the Proposals Q: Are there any arrangements to enable MTAC to obtain sufficient funds, together with the proceeds in its Trust Account..., page 10 5.Please highlight material differences in the terms and price of securities issued at the time of the IPO as compared to the Magnetar Convertible Notes, which are contemplated to be issued at the time of the business combination, and the Combined Company Common Stock that the Notes convert into. 6.We note that you have arranged to sell additional securities to Magnetar Capital LLC to raise funds to help satisfy the minimum cash required to complete the business combination transaction after returning funds to redeeming stockholders. Revise the disclosure to discuss the key terms of these convertible securities, including the anti- dilution rights and exclusivity mentioned on page 10, and the potential impact of those securities on non-redeeming stockholders. Q: Do any of MTAC's directors or officers have interests that may conflict with my interests with respect to the Business Combination?, page 11 7.We note your disclosure on page 145 that "MTAC’s independent directors reviewed and considered these interests during the negotiation of the Business Combination." Please clarify how the board considered these conflicts in negotiating and recommending the business combination here as well as in your discussion of the interests of certain persons in the business combination beginning on page 30. Q: How do I exercise my redemption rights?, page 13 8.We note your disclosure on page 261 that your Sponsor, officers and directors have agreed to waive their redemption rights. Please revise your disclosure here to discuss this waiver. Additionally, please describe any consideration provided in exchange for this agreement.

FirstName LastNameChristopher Dewey Comapany NameMedTech Acquisition Corp February 2, 2023 Page 3 FirstName LastNameChristopher Dewey MedTech Acquisition Corp February 2, 2023 Page 3 Summary of the Proxy Statement Parties to the Business Combination, page 20 9.Please disclose TriSalus’ current state of operations and history of net losses in this Summary section. The Merger Agreement Conditions to Closing, page 21 10.We note your disclosure on page 130 that “[a]ny party to the Merger Agreement may […] waive any of the terms or conditions of the Merger Agreement.” Please identify the closing conditions that are subject to waiver here and in your disclosure beginning on page 128. Please also revise your risk factor on page 93, as applicable, to address material risks that are subject to waiver. Interests of Certain Persons in the Business Combination, page 30 11.We note your disclosure that if the "founder shares were unrestricted and freely tradeable, they would be valued at approximately $62.8 million, based on the closing price of the Class A Common Stock on January 4, 3023" and that the Sponsor has invested an aggregate of $7,425,000. Please expand your disclosure regarding the Sponsor's ownership interest in the target company here and elsewhere throughout the prospectus, as appropriate, to also disclose the approximate dollar value of the interest based on the transaction value and to discuss the interest based on the transaction value and recent trading prices as compared to the price paid. Recommendations of the Board and Reasons for the Business Combination, page 33 12.We note your disclosure here as well as on page 144 that the board did not obtain a fairness opinion on which to base its assessment. Please revise your disclosure to clarify the basis for the board determining it was not necessary to obtain a fairness opinion for the business combination. Risk Factors Risks Related to TriSalus' Intellectual Property TriSalus may be subject to claims challenging the inventorship or ownership of its patents and other intellectual property, page 80 13.We note your statement on page 80 that "TriSalus has been subject to claims that former employees, collaborators or other third parties have an ownership interest in the patents and intellectual property that TriSalus is or that it may own or license in the future." You describe one litigated case here as an example, please revise to describe any other material claims.

FirstName LastNameChristopher Dewey Comapany NameMedTech Acquisition Corp February 2, 2023 Page 4 FirstName LastNameChristopher Dewey MedTech Acquisition Corp February 2, 2023 Page 4 Internal Controls, page 87 14.Please clarify your description of the 2021 material weakness. Quantify the number of "trained resources" that perform the task(s) identified as a weakness and the estimated number of additional resources needed to remedy the weakness. Identify the steps you have taken to remediate the weakness. Explain to readers how this weakness actually impacted, or could impact, your financial reporting. Proposal 1 - the Business Combination Proposal Background of the Business Combination, page 134 15.Please revise the Background section to detail the negotiations concerning key aspects of the business combination and related transactions, including, without limitation, the scope and valuation of TriSalus' business, the merger consideration and the structure of the transaction (including the negotiation and marketing processes for the PIPE transaction). Each proposal (preliminary or otherwise) and counterproposal concerning a material transaction term made between June 16 and November 11 should be described and the proposing party identified. In this regard, we note that the Background section as written discusses in general terms the topical areas discussed by the parties during the five months of negotiations and some of the final terms they mutually agreed upon but does so without any indication of how those terms evolved during the course of the discussions/negotiations. 16.Please disclose whether the Sponsor and management and affiliates have a track record with SPACs. If so, please provide balanced disclosure about this record and the outcomes of prior transactions. 17.In the event that the Sponsor has other SPACs in the process of searching for a target company, please revise to disclose whether the Sponsor considered more than one active SPAC to be the potential acquirer of TriSalus and how the final decision was reached. 18.Please clarify whether there were any discussions about continuing employment or involvement for any persons affiliated with the SPAC before the merger or any formal or informal commitment to retain the financial advisors after the merger. 19.We note your disclosure on page 136 that you and Memic mutually agreed to terminate your business combination agreement on March 10, 2022 “due to the challenging market conditions in the first quarter of 2022, along with the associated volatility related to world events.” Please clarify why you chose not to resume discussions with Memic later in 2022, but decided instead to engage with other potential target businesses. 20.Please clarify whether any discussions took place with TriSalus about the potential loss of clients in the near future or other events that may materially affect its prospects or its financial projections for future performance of the business.

FirstName LastNameChristopher Dewey Comapany NameMedTech Acquisition Corp February 2, 2023 Page 5 FirstName LastNameChristopher Dewey MedTech Acquisition Corp February 2, 2023 Page 5 21.Please revise to clarify when in discussions with TriSalus you were first provided its financial projections and the date the projections were prepared. Please also disclose any discussions that took place relating to the assumptions underlying the projections. 22.We note your disclosure on page 138 that you also engaged “third-party consultants” to review certain aspects of TriSalus’ business, including TriSalus’ current reimbursement model. Please identify the consultants who were engaged to conduct this review and disclose when they were retained. Please also revise to describe any materials or information that these consultants shared with your board in connection with this transaction, to the extent material. 23.We note your disclosure on page 139 that from September through November 2022 potential investors met with MTAC, TriSalus and Raymond James to discuss the possibility of making an investment in MTAC in connection with the potential business combination. Please revise your disclosure to clarify whether there were any valuation or other material information about the SPAC, TriSalus, or the de-SPAC transaction provided to these potential investors that have not been disclosed publicly. Please also state whether Magnetar has a preexisting relationship with the Sponsor. MTAC's Board's Reasons for the Approval of the Business Combination, page 141 24.You state the companies shown on pages 146-147 are a “select group of high growth publicly traded companies in the healthcare and medical device sector that were identified by Raymond James.” Please revise to state whether any companies meeting the selection criteria were excluded from the analyses and, if so, explain why. Please also provide additional detail concerning the qualitative aspect of your analysis, such as whether operating history or, with respect to therapeutics companies, clinical stage, was considered, as well as how long these entities have had commercial operations. Projected Financial Information, page 147 25.We note your assumption that 40% of an estimated total market size of 30,000 patients would be eligible TriNav candidates. Please revise your disclosure to provide your basis for the estimates of patients that would be unachievable due to anatomy and tortuosity with the current TriNav design, that would make use of office-based labs and that would use the “super selective” approach combined with radio segmentectomy. 26.We note your assumed TriNav market shares of 12%, 22% and 37% in FY2022, FY2023 and FY2024, respectively. Please revise your disclosure to clearly describe the basis for projecting this revenue growth, specifically, the basis for the projected unit sales for each year in the forecast period and assumed TriNav total market opportunity for each such year, and the factors or contingencies that would affect such growth ultimately materializing. For example, please clarify whether these projections assume any new market entrants during this period or take into account macroeconomic factors.

FirstName LastNameChristopher Dewey Comapany NameMedTech Acquisition Corp February 2, 2023 Page 6 FirstName LastNameChristopher Dewey MedTech Acquisition Corp February 2, 2023 Page 6 Certain Engagements in Connection with the Business Combination and Related Transactions, page 152 27.We note your disclosure here as well as elsewhere, such as on page 32, that Raymond James will receive compensation for its investment banking advisory services as well as its role as sole placement agent with respect to the institutional debt financing arrangement and that payment of these fees is contingent on the closing of the business combination. Please quantify the aggregate fees payable to Raymond James that are contingent on completion of the business combination. Management's Discussion and Analysis of Financial Condition and Results of Operations of MTAC Results of Operations, page 189 28.Please disclose your results of operations for fiscal year ended December 31, 2021 and 2020. See the Instructions to Item 303(b) of Regulation S-K. Our Platform Solution: Addressing the Limitations of Current Approaches in Cancer Immunotherapy, page 196 29.Please revise your description of TriSalus' PEDD devices to state that its TPT payments approval from CMS for its TriNav device expires at the end of this year. Please also state here expressly whether its PRVI device is a commercial-stage device that is actively sold. 30.We note your statements that TriSalus' PEDD with standard of care therapies achieved improved results as compared to standard endhole microcatheter approaches as well as the statement in your graphic at the top of page 201, where you appear to be comparing TriSalus' Synergy -001/KEYNOTE-184 Phase 1b/2 study to a single agent pembro study in an academic journal. Please clarify whether TriSalus conducted head-to-head trials for each of these comparisons. 31.We note your disclosure regarding results from three clinical trials of PEDD with SD-101. You state that initial data indicate that SD-101 “efficiently reduced MDSC” and has a "favorable emerging safety profile" when delivered by PEDD. We note similar statements on page 200 where you refer to SD-101’s “tolerable safety profile” and therapeutic activity that was “substantiated,” and your statement on page 201, where you state that TriSalus' strategy is to "replicate the strong response that SD-101 demonstrated in Stage IV melanoma across a wide array of liver and pancreatic indications." Conclusions regarding efficacy and safety are det

Show Raw Text
United States securities and exchange commission logo
February 2, 2023
Christopher Dewey
Chief Executive Officer
MedTech Acquisition Corp
48 Maple Avenue
Greenwich, CT 06830
Re:MedTech Acquisition Corp
Registration Statement on Form S-4
Filed January 6, 2023
File No. 333-269138
Dear Christopher Dewey:
            We have reviewed your registration statement and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
            Please respond to this letter by amending your registration statement and providing the
requested information.  If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Form S-4 filed on January 6, 2023
Q: What equity stake will current stockholders of MTAC and TriSalus stockholders hold in the
Combined Company after the closing?, page 10
1.Please revise your disclosure here and elsewhere throughout the prospectus, such as on
pages 27-28, to disclose the Sponsor and its affiliates' total potential ownership interest in
the combined company, assuming exercise and conversion of all securities, including the
private placement and conversion warrants.
2.Please revise your disclosure in this section to show the potential impact of redemptions
on the per share value of the shares owned by non-redeeming stockholders by including a
sensitivity analysis showing a range of redemption scenarios, including minimum,
maximum and interim redemption levels.

 FirstName LastNameChristopher Dewey
 Comapany NameMedTech Acquisition Corp
 February 2, 2023 Page 2
 FirstName LastNameChristopher Dewey
MedTech Acquisition Corp
February 2, 2023
Page 2
3.We note your disclosure that the maximum redemption scenario reflects maximum
redemptions of 1,149,694 shares of Class A Common Stock owned by MTAC public
stockholders. Please clarify what percentage of total outstanding common stock held by
MTAC public stockholders this maximum redemption scenario represents.
4.We note your disclosure beginning on page 29 regarding additional dilution that
stockholders may experience following the closing of the business combination. Please
revise your disclosure here to disclose all possible sources and extent of dilution that
stockholders who elect not to redeem their shares may experience in connection with the
business combination. Provide disclosure of the impact of each significant source of
dilution, including the amount of equity held by founders, convertible securities, including
warrants retained by redeeming stockholders, at each of the redemption levels detailed in
your sensitivity analysis, which should include an interim redemptions scenario, including
any needed assumptions.
Questions and Answers about the Proposals
Q: Are there any arrangements to enable MTAC to obtain sufficient funds, together with the
proceeds in its Trust Account..., page 10
5.Please highlight material differences in the terms and price of securities issued at the time
of the IPO as compared to the Magnetar Convertible Notes, which are contemplated to be
issued at the time of the business combination, and the Combined Company Common
Stock that the Notes convert into.
6.We note that you have arranged to sell additional securities to Magnetar Capital LLC to
raise funds to help satisfy the minimum cash required to complete the business
combination transaction after returning funds to redeeming stockholders. Revise the
disclosure to discuss the key terms of these convertible securities, including the anti-
dilution rights and exclusivity mentioned on page 10, and the potential impact of those
securities on non-redeeming stockholders.
Q: Do any of MTAC's directors or officers have interests that may conflict with my interests
with respect to the Business Combination?, page 11
7.We note your disclosure on page 145 that "MTAC’s independent directors reviewed and
considered these interests during the negotiation of the Business Combination." Please
clarify how the board considered these conflicts in negotiating and recommending the
business combination here as well as in your discussion of the interests of certain persons
in the business combination beginning on page 30.
Q: How do I exercise my redemption rights?, page 13
8.We note your disclosure on page 261 that your Sponsor, officers and directors have agreed
to waive their redemption rights. Please revise your disclosure here to discuss this waiver.
Additionally, please describe any consideration provided in exchange for this agreement.

 FirstName LastNameChristopher Dewey
 Comapany NameMedTech Acquisition Corp
 February 2, 2023 Page 3
 FirstName LastNameChristopher Dewey
MedTech Acquisition Corp
February 2, 2023
Page 3
Summary of the Proxy Statement
Parties to the Business Combination, page 20
9.Please disclose TriSalus’ current state of operations and history of net losses in this
Summary section.
The Merger Agreement
Conditions to Closing, page 21
10.We note your disclosure on page 130 that “[a]ny party to the Merger Agreement may […]
waive any of the terms or conditions of the Merger Agreement.” Please identify the
closing conditions that are subject to waiver here and in your disclosure beginning on
page 128. Please also revise your risk factor on page 93, as applicable, to address material
risks that are subject to waiver.
Interests of Certain Persons in the Business Combination, page 30
11.We note your disclosure that if the "founder shares were unrestricted and freely tradeable,
they would be valued at approximately $62.8 million, based on the closing price of the
Class A Common Stock on January 4, 3023" and that the Sponsor has invested an
aggregate of $7,425,000. Please expand your disclosure regarding the Sponsor's
ownership interest in the target company here and elsewhere throughout the prospectus, as
appropriate, to also disclose the approximate dollar value of the interest based on the
transaction value and to discuss the interest based on the transaction value and recent
trading prices as compared to the price paid.
Recommendations of the Board and Reasons for the Business Combination, page 33
12.We note your disclosure here as well as on page 144 that the board did not obtain a
fairness opinion on which to base its assessment. Please revise your disclosure to clarify
the basis for the board determining it was not necessary to obtain a fairness opinion for the
business combination.
Risk Factors
Risks Related to TriSalus' Intellectual Property
TriSalus may be subject to claims challenging the inventorship or ownership of its patents and
other intellectual property, page 80
13.We note your statement on page 80 that "TriSalus has been subject to claims that former
employees, collaborators or other third parties have an ownership interest in the patents
and intellectual property that TriSalus is or that it may own or license in the future." You
describe one litigated case here as an example, please revise to describe any other material
claims.

 FirstName LastNameChristopher Dewey
 Comapany NameMedTech Acquisition Corp
 February 2, 2023 Page 4
 FirstName LastNameChristopher Dewey
MedTech Acquisition Corp
February 2, 2023
Page 4
Internal Controls, page 87
14.Please clarify your description of the 2021 material weakness. Quantify the number of
"trained resources" that perform the task(s) identified as a weakness and the
estimated number of additional resources needed to remedy the weakness. Identify the
steps you have taken to remediate the weakness. Explain to readers how this weakness
actually impacted, or could impact, your financial reporting.
Proposal 1 - the Business Combination Proposal
Background of the Business Combination, page 134
15.Please revise the Background section to detail the negotiations concerning key aspects of
the business combination and related transactions, including, without limitation, the scope
and valuation of TriSalus' business, the merger consideration and the structure of the
transaction (including the negotiation and marketing processes for the PIPE transaction).
Each proposal (preliminary or otherwise) and counterproposal concerning a material
transaction term made between June 16 and November 11 should be described and the
proposing party identified. In this regard, we note that the Background section as written
discusses in general terms the topical areas discussed by the parties during the five months
of negotiations and some of the final terms they mutually agreed upon but does so without
any indication of how those terms evolved during the course of the
discussions/negotiations.
16.Please disclose whether the Sponsor and management and affiliates have a track record
with SPACs. If so, please provide balanced disclosure about this record and the outcomes
of prior transactions.
17.In the event that the Sponsor has other SPACs in the process of searching for a target
company, please revise to disclose whether the Sponsor considered more than one active
SPAC to be the potential acquirer of TriSalus and how the final decision was reached.
18.Please clarify whether there were any discussions about continuing employment or
involvement for any persons affiliated with the SPAC before the merger or any formal or
informal commitment to retain the financial advisors after the merger.
19.We note your disclosure on page 136 that you and Memic mutually agreed to terminate
your business combination agreement on March 10, 2022 “due to the challenging market
conditions in the first quarter of 2022, along with the associated volatility related to world
events.” Please clarify why you chose not to resume discussions with Memic later in
2022, but decided instead to engage with other potential target businesses.
20.Please clarify whether any discussions took place with TriSalus about the potential loss of
clients in the near future or other events that may materially affect its prospects or its
financial projections for future performance of the business.

 FirstName LastNameChristopher Dewey
 Comapany NameMedTech Acquisition Corp
 February 2, 2023 Page 5
 FirstName LastNameChristopher Dewey
MedTech Acquisition Corp
February 2, 2023
Page 5
21.Please revise to clarify when in discussions with TriSalus you were first provided its
financial projections and the date the projections were prepared. Please also disclose any
discussions that took place relating to the assumptions underlying the projections.
22.We note your disclosure on page 138 that you also engaged “third-party consultants” to
review certain aspects of TriSalus’ business, including TriSalus’ current reimbursement
model. Please identify the consultants who were engaged to conduct this review and
disclose when they were retained. Please also revise to describe any materials or
information that these consultants shared with your board in connection with this
transaction, to the extent material.
23.We note your disclosure on page 139 that from September through November
2022 potential investors met with MTAC, TriSalus and Raymond James to discuss the
possibility of making an investment in MTAC in connection with the potential business
combination. Please revise your disclosure to clarify whether there were any valuation or
other material information about the SPAC, TriSalus, or the de-SPAC transaction
provided to these potential investors that have not been disclosed publicly. Please also
state whether Magnetar has a preexisting relationship with the Sponsor.
MTAC's Board's Reasons for the Approval of the Business Combination, page 141
24.You state the companies shown on pages 146-147 are a “select group of high growth
publicly traded companies in the healthcare and medical device sector that were identified
by Raymond James.” Please revise to state whether any companies meeting the selection
criteria were excluded from the analyses and, if so, explain why. Please also provide
additional detail concerning the qualitative aspect of your analysis, such as whether
operating history or, with respect to therapeutics companies, clinical stage, was
considered, as well as how long these entities have had commercial operations.
Projected Financial Information, page 147
25.We note your assumption that 40% of an estimated total market size of 30,000 patients
would be eligible TriNav candidates. Please revise your disclosure to provide your basis
for the estimates of patients that would be unachievable due to anatomy and tortuosity
with the current TriNav design, that would make use of office-based labs and that would
use the “super selective” approach combined with radio segmentectomy.
26.We note your assumed TriNav market shares of 12%, 22% and 37% in FY2022, FY2023
and FY2024, respectively. Please revise your disclosure to clearly describe the basis for
projecting this revenue growth, specifically, the basis for the projected unit sales for
each year in the forecast period and assumed TriNav total market opportunity for each
such year, and the factors or contingencies that would affect such growth ultimately
materializing. For example, please clarify whether these projections assume any new
market entrants during this period or take into account macroeconomic factors.

 FirstName LastNameChristopher Dewey
 Comapany NameMedTech Acquisition Corp
 February 2, 2023 Page 6
 FirstName LastNameChristopher Dewey
MedTech Acquisition Corp
February 2, 2023
Page 6
Certain Engagements in Connection with the Business Combination and Related Transactions,
page 152
27.We note your disclosure here as well as elsewhere, such as on page 32, that Raymond
James will receive compensation for its investment banking advisory services as well as
its role as sole placement agent with respect to the institutional debt financing
arrangement and that payment of these fees is contingent on the closing of the business
combination. Please quantify the aggregate fees payable to Raymond James that are
contingent on completion of the business combination.
Management's Discussion and Analysis of Financial Condition and Results of Operations of
MTAC
Results of Operations, page 189
28.Please disclose your results of operations for fiscal year ended December 31, 2021 and
2020. See the Instructions to Item 303(b) of Regulation S-K.
Our Platform Solution: Addressing the Limitations of Current Approaches in Cancer
Immunotherapy, page 196
29.Please revise your description of TriSalus' PEDD devices to state that its TPT payments
approval from CMS for its TriNav device expires at the end of this year. Please also state
here expressly whether its PRVI device is a commercial-stage device that is actively sold.
30.We note your statements that TriSalus' PEDD with standard of care therapies achieved
improved results as compared to standard endhole microcatheter approaches as well as the
statement in your graphic at the top of page 201, where you appear to be comparing
TriSalus' Synergy -001/KEYNOTE-184 Phase 1b/2 study to a single agent pembro study
in an academic journal. Please clarify whether TriSalus conducted head-to-head trials for
each of these comparisons.
31.We note your disclosure regarding results from three clinical trials of PEDD with SD-101.
You state that initial data indicate that SD-101 “efficiently reduced MDSC” and has a
"favorable emerging safety profile" when delivered by PEDD. We note similar statements
on page 200 where you refer to SD-101’s “tolerable safety profile” and therapeutic
activity that was “substantiated,” and your statement on page 201, where you state that
TriSalus' strategy is to "replicate the strong response that SD-101 demonstrated in Stage
IV melanoma across a wide array of liver and pancreatic indications." Conclusions
regarding efficacy and safety are det