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United States securities and exchange commission logo
July 6, 2021
Ron Kurtz, M.D.
President and Chief Executive Officer
RxSight, Inc.
100 Columbia
Aliso Viejo, CA 92656
Re: RxSight, Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted June 24,
2021
CIK No. 0001111485
Dear Dr. Kurtz:
We have reviewed your amended 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.
Amendment No. 1 to Draft Registration Statement on Form S-1 submitted
June 24, 2021
Our solution, page 5
1. We note your response
to prior comment 3 and 8 and reissue in part. We note your risk
factor disclosure on
page 56 where you state you "received a PMA for the LAL and LDD,
which is indicated for
the reduction of residual astigmatism to improve uncorrected visual
acuity after removal of
the cataractous natural lens by phacoemulsification and
implantation of the
intraocular lens in the capsular bag, in adult patients with pre-existing
corneal astigmatism of
> 0.75 diopters and without pre-existing macular disease" and your
disclosure on page 58
that "[t]he RxSight system has a CE Mark for improving
uncorrected visual
acuity by adjusting the LAL power to correct residual postoperative
refractive error,
including for -2.0 to + 2.0 diopters of sphere and -3.0 to -0.50 diopters of
Ron Kurtz, M.D.
FirstName LastNameRon Kurtz, M.D.
RxSight, Inc.
Comapany
July 6, 2021NameRxSight, Inc.
July 6,2 2021 Page 2
Page
FirstName LastName
cylinder and by changing lens curvature to introduce controlled
amounts of spherical
aberration (+/- 1 micron) and center near add (up to 2.0 diopters)
which is also registered
with the MHRA in the United Kingdom and in Mexico." The specific
parameters of your
RxSight system's approval should be clearly stated in your Business
section and
Prospectus Summary. Please revise your disclosure here and in the
Business section to
clearly state the patient population for which your RxSight system is
approved for in each
of your material jurisdictions or otherwise advise.
Investing in system enhancements to meet the evolving needs of doctors and
other providers as
well as patients, page 126
2. We note your response to prior comment 10 and reissue in part. Please
provide additional
details on where you are currently at in the research and development
process for the
lower cost LDD, including whether you have a working prototype, or
otherwise advise.
Reduction in "Outliers", page 138
3. We note your response to prior comment 1 and 12 and revised disclosure
on page 138
stating that the studies "included similar patient populations, study
design, follow-up
period and study endpoints." If you continue to disclose the specifics
of any of your
competitors' studies, please explain the studies in terms a lay
investor would understand
and include disclosure that would help an investor make a meaningful
comparison (e.g.,
number of subjects, trial design, statistical significance, serious
adverse events, etc.). In
addition, since these were not head-to-head studies please tell us why
it is appropriate to
include the computed ratios comparing your LAL to your competitor
products or revise
your disclosure as appropriate.
Intellectual Property, License Agreements, and Other Material Agreements, page
144
4. We note your response to prior comment 15, including your disclosure
that you "are
developing future products to which the intellectual property
in-licensed from CalTech
may be directed." Please update your disclosure to provide general
details on the specific
"future products" you may be developing or otherwise advise whether or
not you believe
the future products to be material.
5. We note your new disclosure on page 146 describing your agreement with
the Regents of
the University of California. Please update your disclosure to
describe who terminated the
agreement, including the reason if applicable. In addition, please
update your disclosure to
quantify the aggregate payments made to the Regents of the University
of California
under the agreement and clearly disclose if you are required to pay
additional royalty
payments or other ongoing payments to the Regents of the University of
California
following the termination in March 2021.
Exclusive jurisdiction, page 193
6. We note your revised disclosure in response to prior comment 17 states
that your forum
Ron Kurtz, M.D.
RxSight, Inc.
July 6, 2021
Page 3
selection provision designates the Court of Chancery of the State of
Delaware as the
exclusive forum for certain actions, including any derivative action. As
noted in our prior
comment 17, Section 27 of the Exchange Act creates exclusive federal
jurisdiction over
all suits brought to enforce any duty or liability created by the
Exchange Act or the rules
and regulations thereunder. If this provision does not apply to actions
arising under the
Exchange Act, please revise your disclosure to make that clear and also
ensure that the
exclusive forum provision in the governing document states this clearly,
or tell us how
you will inform investors in future filings that the provision does not
apply to any actions
arising under the Exchange Act.
You may contact Tracey Houser at (202) 551-3736 or Daniel Gordon at
(202) 551-3486
if you have questions regarding comments on the financial statements and
related matters. Please
contact Jason Drory at (202) 551-8342 or Tim Buchmiller at (202) 551-3635 with
any other
questions.
Sincerely,
FirstName LastNameRon Kurtz, M.D.
Division of
Corporation Finance
Comapany NameRxSight, Inc.
Office of Life
Sciences
July 6, 2021 Page 3
cc: Martin J. Waters, Esq.
FirstName LastName