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.
Christopher Dewey
FirstName LastNameChristopher Dewey
MedTech Acquisition Corp
Comapany2,NameMedTech
February 2023 Acquisition Corp
February
Page 2 2, 2023 Page 2
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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.
Christopher Dewey
FirstName LastNameChristopher Dewey
MedTech Acquisition Corp
Comapany2,NameMedTech
February 2023 Acquisition Corp
February
Page 3 2, 2023 Page 3
FirstName LastName
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.
Christopher Dewey
FirstName LastNameChristopher Dewey
MedTech Acquisition Corp
Comapany2,NameMedTech
February 2023 Acquisition Corp
February
Page 4 2, 2023 Page 4
FirstName LastName
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.
Christopher Dewey
FirstName LastNameChristopher Dewey
MedTech Acquisition Corp
Comapany2,NameMedTech
February 2023 Acquisition Corp
February
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FirstName LastName
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.
Christopher Dewey
FirstName LastNameChristopher Dewey
MedTech Acquisition Corp
Comapany2,NameMedTech
February 2023 Acquisition Corp
February
Page 6 2, 2023 Page 6
FirstName LastName
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 determinations that only the FDA or
a foreign
government equivalent has the authority to make. Please revise your
disclosure throughout
your document, including but not limited to the statements noted here,
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
FirstName LastNameChristopher Dewey
MedTech Acquisition Corp
Comapany2,NameMedTech
February 2023 Acquisition Corp
February
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participants who met the identified trial endpoints.
Market Opportunity for TriNav Delivery Technology and Investigational
Therapeutic SD-101,
page 197
32. We note that footnote three to the table on page 198 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 and when and by whom Lumanity was retained.
Additionally, please tell
us whether you commissioned this data and, if so, file a consent for
the use of such data or
advise. Refer to Securities Act Rule 436.
Competitive Strengths, page 200
33. We note that TriSalus' TriNav device has support from key opinion
leaders. Please
revise your disclosure to clarify who these key opinion leaders are
and to discuss their
relation and significance to TriSalus' business.
34. We note your statement that TriNav has near-term expansion
opportunities by partnering
or collaborating with companies advancing CPIs, CAR-T therapies and
other cell
immunotherapies. Please expand your disclosure here or elsewhere in
the business
section to discuss any material near-term partnerships or
collaborations that TriSalus
is pursuing.
35. We note your statement on page 201: Our targeting of orphan
indications and rare
disease creates an opportunity for expedited development and the
potential for an
accelerated path to approval and commercialization. Please revise
to state here, and
elsewhere as applicable, if true, that TriSalus currently does not
have orphan drug
designation, fast track designation or priority review from the FDA or
other comparable
regulators and may never obtain it. Additionally, we note your
statement on page 204 that
in orphan and ultra-orphan indications, including many cancer
indications, there is a
regulatory pathway for approval based on a single pivotal clinical
trial. Thus, diseases
with unmet medical need may only require a single pivotal study as
compared to the
regulatory approval pathway for new medicines generally. Please revise
to clarify that the
FDA can require more trials or reject trial data in both the orphan
drug and non-orphan
drug context.
Clinical Development Plan, page 204
36. Please revise page 206 to provide further information about TriSalus
PERIO-03 trial such
as, but not limited to, the number of participants anticipated to be
enrolled, the primary
and secondary endpoints and any statistical analysis to be performed.
37. We note your statement on page 205 that there were no serious cytokine
adverse events
related to SD-101 and there were no severe immune-related events in
the procedure rooms
or during follow-up. Please revise to state whether there were any
serious adverse events
Christopher Dewey
FirstName LastNameChristopher Dewey
MedTech Acquisition Corp
Comapany2,NameMedTech
February 2023 Acquisition Corp
February
Page 8 2, 2023 Page 8
FirstName LastName
related to SD-101 aside from the two types of events mentioned, and if
so, describe them.
38. For each of TriSalus' material partnerships, such as the 5-year
Alliance Program with MD
Anderson Cancer Center, the partnership with the University of
Colorado Anschutz
Medical School and the agreement with Lifespan, please expand your
disclosure to
discuss all material terms of these arrangements. Please also file
these agreements
as exhibits to your registration statement. Alternatively, advise us
why such agreements
are not material and required to be described and filed. See Item
601(b)(10) of Regulation
S-K.
Clinical Development Approach, page 206
39. Please revise your table to include columns for Phase 2 and Phase 3 in
addition to the two
columns already shown. Additionally, please clarify in the table that
"IND-enabling" is a
preclinical trial stage. Given the PERIO-01, PERIO-02 and PERIO-03
trials are not
completed, please shorten the arrow for those studies in the pipeline
table.
Industry and Competition, page 214
40. Please revise your table showing the comparison of TriNav to TriSalus'
direct competitors
so that all the fonts are legible.
Intellectual Property, page 216
41. Please revise to disclose for each material patent and patent
application the specific
products to which such patents or patent applications relate, whether
the patents are
owned or licensed, the type of patent protection, the expiration dates
and applicable
material jurisdictions, including any foreign jurisdiction. Consider
disclosure
in tabular format by patent family or otherwise in addition to the
narrative provided. We
also note your disclosure in a risk factor on page 76 that certain of
TriSalus patents
relating to SD-101 will expire in 2023. Please revise here to disclose
what effect you
expect the expiration of these patents to have on TriSalus' patent
portfolio and business
and if there is an intent to mitigate such effect.
42. We note your disclosure on page 240 regarding the Dynavax Asset
Purchase Agreement,
please revise to describe the Agreement here and expand your
disclosure to ensure that
you are disclosing all material terms, including the following:
the nature and scope of any intellectual property transferred;
each parties' rights and obligations;
quantification of all up-front or execution payments received
or paid to date;
aggregate amounts paid or received to date under the agreement;
aggregate amounts of all potential development, regulatory and
commercial milestone payments;
quantification of the royalty rate, or a range no greater than
10 percentage points per
tier;
Christopher Dewey
FirstName LastNameChristopher Dewey
MedTech Acquisition Corp
Comapany2,NameMedTech
February 2023 Acquisition Corp
February
Page 9 2, 2023 Page 9
FirstName LastName
disclosure of the duration of the agreement and when royalty
provisions expire; and
disclosure of termination provisions.
Additionally, please provide the same disclosure for and file any
other material license
agreements as exhibits pursuant to Item 601(b)(10) of Regulation S-K,
or advise.
Facilities, page 227
43. Please file TriSalus' leases as material contracts under Item
601(b)(10) of Regulation S-K,
or, in the alternative, please tell us why you do not believe you are
required to do so.
Revenue Recognition, page 241
44. Please disclose herein whether your variable consideration sales
reserve balance is
material to either sales or to the asset from which it is deducted. If
material, then please
disclose the activity in the reserve for each periods so that readers
can assess the accuracy
of management's accounting estimates and assumptions. Also, please
tell us whether
TriSalus has any customer that exceeded 10% of its total sales in any
period presented.
Description of MTAC's Securities, page 259
45. Please revise to update your disclosures throughout this section. As
examples only:
"Because our Existing Charter authorizes the issuance of up to
100,000,000 shares of
Class A Common Stock, if we were to enter into an initial
business combination, we
may (depending on the terms of such an initial business
combination) be required to
increase the number of shares of Class A Common Stock ."
"If we seek stockholder approval of our initial business
combination and we do not
conduct redemptions in connection with our initial business
combination pursuant to
the tender offer rules, our Existing Charter provides ."
"If we submit our initial business combination to our public
stockholders for a vote,
our Sponsor, officers and directors have agreed (and its
permitted transferees will
agree) pursuant to the Letter Agreement to vote any founder
shares held by them and
any public shares held by them in favor of our initial business
combination ."
Experts, page 309
46. We understand that during 2022 TriSalus hired Plante & Moran to audit
their 2020
financial statements and also hired KPMG to audit their 2021 financial
statements. Please
tell us whether Plante & Moran resigned or was dismissed and the date
thereof. Tell us
also whether there were any disagreements or reportable events (as
defined in Item 304 of
Regulation S-K) between TriSalus and Plante & Moran. In this regard,
please also explain
to us how you considered the disclosure requirement outlined in Item
17(b)(6) of the Form
Instructions.
Christopher Dewey
MedTech Acquisition Corp
February 2, 2023
Page 10
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
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 2, 2023 Page 10
cc: Kevin Shuler
FirstName LastName