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United States securities and exchange commission logo
February 28, 2023
Christopher Dewey
Chief Executive Officer
MedTech Acquisition Corp
48 Maple Avenue
Greenwich, CT 06830
Re: MedTech Acquisition
Corp
Amendment No. 1 to
Registration Statement on Form S-4
Filed February 14,
2023
File No. 333-269138
Dear Christopher Dewey:
We have reviewed your amended 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.
Unless we note
otherwise, our references to prior comments are to comments in our
February 2, 2023 letter.
Amendment No. 1 to the Registration Statement on Form S-4
Summary of the Proxy Statement
Certain Related Agreements, page 25
1. On page 26 and
elsewhere you state that you are obligated to file, no later than 45 days
after the Closing Date,
a registration statement covering the re-sale of the Registrable
Securities, which term
you state is defined in the Agreement and Plan of Merger. Please
revise to define this
term in this proxy statement/prospectus.
Christopher Dewey
FirstName LastNameChristopher Dewey
MedTech Acquisition Corp
Comapany28,
February NameMedTech
2023 Acquisition Corp
February
Page 2 28, 2023 Page 2
FirstName LastName
Proposal 1 - The Business Combination Proposal
Background of the Business Combination, page 141
2. We note your response to comment 20 and reissue the comment in part.
We also note that
the contract with ACD, which previously accounted for 20% of TriSalus'
revenues, was
terminated in December 2022. Please clarify whether any discussions
took place with
TriSalus during the negotiation period about the potential loss of
clients, such as ACD, in
the near future.
Projected Financial Information, page 157
3. We note your response to comment 26. Please revise to provide
additional detail
concerning the assumptions underlying your projected unit sales and
market share. For
example, on page 159 you state that one assumption is that TriSalus
will increase "the
number of TriSalus sales representatives in FY2023 to provide full
nationwide coverage
allowing TriNav sales to continue to accelerate in both FY2023 and
FY2024." Please
revise to state at what percent sales are assumed to be accelerated in
FY2023 and FY2024
and how this compares to historical figures.
Material U.S. Federal Income Tax Consequences, page 191
4. We note your disclosure here regarding the material U.S. federal
income tax consequences
of the exercise of redemption rights by stockholders. We also note
that the Agreement and
Plan of Merger, included as Annex A, states that the business
combination is intended to
qualify as a reorganization within the meaning of Code Section
368(a). Please amend
the disclosure here, and where appropriate, to describe the federal
income tax
consequences of the entire transaction and not just the federal income
tax consequences of
redemptions, as the public stockholders will be making an investment
decision whether or
not to redeem their shares. See Item 4(a)(6) of Form S-4.
TriSalus' Business
Our Customers, page 212
5. We note your revised disclosure on page 258 in Management's Discussion
and Analysis of
Financial Condition and Results of Operations of TriSalus and in your
Risk Factors on
pages 48-49 and 56 discussing the December 2022 termination of your
contract with
ACD, who previously accounted for 20% of TriSalus' revenues. We also
note that you
discuss on page 49 that "TriSalus intends to further develop an
in-house marketing
organization and sales force with technical expertise and supporting
distribution
capabilities to commercialize TriNav." Please revise your disclosure
here or elsewhere in
TriSalus' Business section as appropriate, such as in your discussion
of TriSalus'
distribution on page 231, to discuss any past dependence TriSalus had
on ACD as a
significant customer, to disclose the termination of the contract with
ACD and to discuss
the implications this has for TriSalus' sales, marketing and
distribution strategy. Refer to
Item 101(h)(4)(vi) of Regulation S-K.
Christopher Dewey
FirstName LastNameChristopher Dewey
MedTech Acquisition Corp
Comapany28,
February NameMedTech
2023 Acquisition Corp
February
Page 3 28, 2023 Page 3
FirstName LastName
Our Platform Solution: Addressing the Limitations of Current Approaches in
Cancer
Immunotherapy, page 214
6. We note your response to comment 30 and reissue the comment in part.
On page 222 you
state PEDD improved tumor targeting in liver radioembolization with
resin microspheres
and significantly increased both T/N ratio and dose delivery compared
to a standard
endhole microcatheter and PEDD achieved greater on-target
distribution of
chemotherapy eluting beads, delivering a significantly higher
concentration of therapy in
the tumor as compared to standard endhole microcatheters in
association with higher
radiographic and pathologic response rates. Please revise to
clarify whether TriSalus
conducted head-to-head trials for these comparisons.
Market Opportunity for TriNav Delivery Technology and Investigational
Therapeutic SD-101,
page 215
7. We note your response to comment 32, where you state that you revised
footnote three to
the table on page 216. However, footnote three to the table on page
216
appears unchanged and still indicates that the SD101/PEDD US patient
population
estimates were management estimates based on TriSalus data and models
and prepared by
Lumanity. Please clarify what role Lumanity played in preparing these
estimates.
Clinical Sites and Partnerships
MD Anderson Cancer Center, page 222
8. We note your response to comment 38 and your revised disclosure on
page 222 with
respect to TriSalus' partnership with the MD Anderson Cancer Center.
Please revise your
disclosure here to discuss all material terms of the agreement with
the MD Anderson
Cancer Center, including, to the extent applicable:
the nature and scope of any intellectual property transferred;
quantification of all up-front or execution payments received or
paid to date;
the aggregate amounts paid or received to date under the
agreement; and
disclosure of the termination provisions.
Industry and Competition
Hepatocellular Carcinoma (HCC), page 230
9. We note your response to comment 31 and your revisions throughout the
prospectus and
we reissue the comment in part. We note that you continue to reference
here "the
favorable emerging safety profile of SD-101 delivered by PEDD."
Conclusions regarding
efficacy and safety are determinations that only the FDA or a foreign
government
equivalent has the authority to make. Please revise your disclosure to
eliminate the
implication that any TriSalus' product candidate has been or will
ultimately be determined
safe and/or effective. Alternatively, we advise you that you may
present the objective data
from pre-clinical and clinical trials without drawing a conclusion
from the results. For
example, you may note that a candidate was well tolerated or the
number of trial
Christopher Dewey
MedTech Acquisition Corp
February 28, 2023
Page 4
participants who met the identified trial endpoints.
Intellectual Property, page 231
10. We note your response to comment 41 and your revised disclosure here and
on pages 80-
81 of your Risk Factors. Please revise your disclosure to clearly
describe the type of
patent protection granted and the jurisdiction of each patent that will
or is expected to
expire in 2023.
11. We note your response to comment 42. Please revise page 230 to state the
term of the
Dynavax Asset Purchase Agreement and its termination provisions.
You may contact Christie Wong at 202-551-3684 or Al Pavot at
202-551-3738 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jessica Ansart at 202-551-4511 or Margaret Schwartz at 202-551-7153
with any other
questions.
Sincerely,
FirstName LastNameChristopher Dewey Division of
Corporation Finance
Office of
Industrial Applications and
Comapany NameMedTech Acquisition Corp
Services
February 28, 2023 Page 4
cc: Kevin Shuler
FirstName LastName