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January 13, 2020
William Hoffman
Chief Executive Officer
Inari Medical, Inc.
9 Parker, Suite 100
Irvine, CA 92618
Re: Inari Medical, Inc.
Draft Registration Statement on Form S-1
Filed December 19, 2019
CIK No. 0001531048
Dear Mr. Hoffman:
We have reviewed your draft 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 providing the requested information and
either submitting
an amended draft registration statement or publicly filing your registration
statement on
EDGAR. 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 the information you provide in response to these comments
and your
amended draft registration statement or filed registration statement, we may
have additional
comments.
Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1. We note that you will disclose revenues for the fourth quarter of 2019
in the first
paragraph. Please expand this disclosure to also include the net income
or loss for the
fourth quarter of 2019. Please also disclose the number of FlowTriever
and ClotTriever
systems you have sold.
2. We note that you are currently enrolling patients in two registries.
Please expand your
description of the registries to disclose the number of patients
enrolled to date and the
duration of the observational period.
William Hoffman
Inari Medical, Inc.
January 13, 2020
Page 2
3. Please clarify that you have obtained FDA clearance for your
ClotTriever and
FlowTriever products through the 510(k) pathway. Please also disclose
the completion
date for the FLARE study and when FDA clearance was obtained.
4. With reference to page 15, please revise the first sentence of the
fourth paragraph to
clarify that currently your primary clinical data regarding safety and
effectiveness of your
products is limited to your FLARE study. Please also balance your
disclosure in this
paragraph by briefly discussing any procedure or device-related major
adverse events.
Our Market, page 2
5. Please balance your estimate of the potential annual addressable
market for your products
with your estimate of the current market for your products. We note
the disclosure in the
risk factor on page 17 that you estimate only 77,000 DVT patients and
20,000 PE patients
are expected to receive interventional treatment in 2019.
Risk Factors
We have a significant amount of debt, which may affect our ability to operate
our business and
secure additional financing in the future, page 34
6. Please quantify your debt service costs for the Signature Bank Credit
Facility.
Our products must be manufactured in accordance with federal and state
regulations..., page 50
7. We note your disclosure that your former facility in Irvine,
California was audited by the
FDA in August 2016 which resulted in the issuance of two Form-483
observations.
Please briefly describe the Form-483 observations, any responses by
the company and
results. Please also disclose whether these observations could impact
your current facility.
Our amended and restated certificate of incorporation will provide that the
Court of Chancery of
the State of Delaware..., page 71
8. We note that your forum selection provision identifies the federal
district courts of the
United States of America as the exclusive forum for certain litigation
arising under the
Securities Act. Please disclose that investors cannot waive compliance
with the federal
securities laws and the rules and regulations thereunder. In that
regard, we note that
FirstName LastNameWilliam Hoffman
Section 22 of the Securities Act creates concurrent jurisdiction for
federal and state courts
Comapany NameInari Medical,enforce any duty or liability created by the
Securities Act or the
over all suits brought to Inc.
January 13, 2020regulations thereunder.
rules and Page 2
FirstName LastName
William Hoffman
FirstName LastNameWilliam Hoffman
Inari Medical, Inc.
Comapany NameInari Medical, Inc.
January 13, 2020
Page 3
January 13, 2020 Page 3
FirstName LastName
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Liquidity and Capital Resources, page 89
9. Please revise this discussion to properly round the related amounts
from the statement of
cash flows. For example, we note that the change in inventories and
debt financing costs
appear incorrect.
Indebtedness, page 92
10. Please clarify whether you were in compliance with your debt covenants
under the SB
Credit Facility as of December 31, 2019.
Business
Toma Study, page 116
11. We note your disclosure on page 117 that the conditions of two
patients deteriorated
during the procedure, one of whom was stabilized on extracorporeal
membrane
oxygenation. Please disclose whether this event was determined to be
device- or
procedure-related.
General
12. Please supplementally provide us with copies of all written
communications, as defined in
Rule 405 under the Securities Act, that you or anyone authorized to do
so on your behalf,
present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
not they retain copies of the communications.
You may contact Jeanne Bennett at (202) 551-3606 or Kevin Kuhar at (202)
551-3662 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Chris Edwards at (202) 551-6761 or Irene Paik at (202) 551-6553 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: J. Ross McAloon