United States securities and exchange commission logo
December 30, 2021
Robert M. Hayes
Chief Executive Officer
Sharps Technology Inc.
105 Maxess Road, Ste. 124
Melville, New York 11747
Re: Sharps Technology
Inc.
Draft Registration
Statement on Form S-1
Submitted December
3, 2021
CIK No. 0001737995
Dear Mr. Hayes:
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 submitted December 3, 2021
Company Overview, page 5
1. We note your disclosure
that Sharps Provensa is a FDA-cleared safety syringe. Please
disclose when you
received FDA clearance/approval and the indicated use(s) for the
device.
2. We note your disclosure
that you "anticipate that [you] will commence receiving orders
for and producing
commercial quantities of [y]our Sharps Provensa upon and subject to
successful completion
of this offering." Please revise to clarify if you have received any
orders to date and
include risk factor disclosure, if appropriate.
Robert M. Hayes
FirstName LastNameRobert M. Hayes
Sharps Technology Inc.
Comapany30,
December NameSharps
2021 Technology Inc.
December
Page 2 30, 2021 Page 2
FirstName LastName
Market Opportunity, page 5
3. Please balance your disclosure that each automated assembly line is
designed to produce
75 million units per year by discussing your current manufacturing
capacity and your
capacity if you are able to consummate the purchase of the assets or
shares of Safegard.
Risk Factors, page 8
4. We note that the closing of your purchase of the Safegard assets or
shares is to occur no
later than February 28, 2022, following which, if not exercised, your
option will
expire. Please include a risk factor discussing the material risks
related to the option
agreement for the purchase of Safegard Medical's stock or assets.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Summary of Significant Accounting Policies
Stock-Based Compensation Expense, page 22
5. Since your common stock is not publicly traded, please revise to
disclose how you
determined the fair value of the common stock underlying your stock
options issued
as compensation and restricted stock awards. Describe in detail the
valuation
methodology and significant assumptions that you used in estimating
the fair value of the
options issued during the periods presented.
6. Once you have an estimated offering price or range, please explain to
us the reasons for
any differences between the recent valuations of your common stock
leading up to the
initial public offering and the estimated offering price. This
information will help
facilitate our review of your accounting for equity issuances. Please
discuss with the staff
how to submit your response.
Results of Operations, page 27
7. We reference the disclosure on page 19 and 20 that you have devoted
substantially all of
your resources to the research and development of your safety syringe
products. Please
revise to provide quantitative or qualitative disclosure that provides
more transparency as
to the type of research and development expenses incurred during each
period presented
(i.e., by nature or type of expense) which should reconcile to total
research and
development expense on the Statements of Operations.
8. We reference the disclosures that attribute the increases in payroll
and consulting
expenses to increased salaries and number of employees and
consultants. Please revise to
provide more clarify on the nature of employee and consultant
positions that contributed
to the increase and consider quantifying the number of employees added
during each
period.
9. We reference your presentation of payroll and consulting expenses as a
separate line item
in the Statement of Operations. Yet you also attribute the increase in
research and
Robert M. Hayes
FirstName LastNameRobert M. Hayes
Sharps Technology Inc.
Comapany30,
December NameSharps
2021 Technology Inc.
December
Page 3 30, 2021 Page 3
FirstName LastName
development expense for all periods presented to the increase in cost
of labor. Please tell
us why you do not consistently allocate payroll expenses between the
expense
categories in the Statement of Operations.
Business
Background and Overview, page 30
10. We see that you entered into an asset/share purchase agreement with
Safegard for
the option to purchase either the stock of Safegard or certain assets
of Safegard, which
expire if not exercise prior to February 28, 2022. Tell us how you
considered Rule 3-05
of Regulation S-X in determining whether the financial statements of
Safegard are
required to be included in the registration statement.
Business
Intellectual Property, page 34
11. Please revise to include a more fulsome discussion of your two
outstanding patent
applications including potential expiration dates, applicable
jurisdictions, whether the
patent applications are owned or licensed and the type of patent
protection that is being
sought.
Management, page 35
12. For the background disclosure of Paul K. Danner and Timothy Ruemler,
please describe
the business experience of each during the past five years including
their principal
occupations and the name and principal business of any corporation
where they were
employed. Refer to Regulation S-K Item 401(e)(1).
Policies and Procedures for Related Party Transactions, page 40
13. Please disclose the standards that will be applied in determining
whether to approve any
of the transactions described in this section. Refer to Item
404(b)(1)(ii) of Regulation S-
K.
Financial Statements for the year ended December 31, 2020
Statements of Operations and Comprehensive Loss , page F-3
14. We note you present non-cash stock-based compensation as a separate
line item in your
income statement. Please modify your statement of operations for all
periods to present
the expense related to stock-based payment arrangements in the line or
lines as cash
compensation paid to the same employees. Refer to SAB Topic 14:F.
General
15. 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,
Robert M. Hayes
Sharps Technology Inc.
December 30, 2021
Page 4
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 Kristin Lochhead at 202-551-3664 or Terence O'Brien at
202-551-3355
if you have questions regarding comments on the financial statements and
related matters.
Please contact Tyler Howes at 202-551-3370 or Tim Buchmiller at 202-551-3635
with any other
questions.
Sincerely,
FirstName LastNameRobert M. Hayes
Division of
Corporation Finance
Comapany NameSharps Technology Inc.
Office of Life
Sciences
December 30, 2021 Page 4
cc: Arthur Marcus, Esq.
FirstName LastName