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United States securities and exchange commission logo
September 24, 2021
Neil Dey
Chief Executive Officer and President
Bluejay Diagnostics, Inc.
360 Massachusetts Avenue, Suite 203
Acton, MA 01720
Re: Bluejay
Diagnostics, Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted September
8, 2021
CIK No. 0001704287
Dear Mr. Dey:
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
Prospectus Summary
Our Company, page 2
1. We note your response
to prior comment 4. Please revise to remove the statement that you
could have potential
FDA clearance in the fourth quarter of 2022 as this statement is
speculative.
Neil Dey
FirstName LastNameNeil
Bluejay Diagnostics, Inc. Dey
Comapany 24,
September NameBluejay
2021 Diagnostics, Inc.
September
Page 2 24, 2021 Page 2
FirstName LastName
Symphony Advantages, page 2
2. We note your revised disclosure regarding the 2016 Japan study
sponsored by Toray.
Please revise to explain the significance of the chemiluminescent
enzyme immunoassay
(CLEIA) method. For example, clarify whether this is the current
standard or method for
measuring serum IL-6 concentrations in the blood.
Symphony IL-6, page 48
3. We note your revised disclosure in response to prior comment 11.
Please revise to clarify
if you are conducting a single clinical study at the University of
Texas Southwestern
Medical Center and Parkland Memorial Hospital or if these are separate
clinical studies.
For each clinical study, please revise to disclose the study endpoints
and the number of
patients you plan to enroll. Please also disclose which clinical
studies are being conducted
at William P. Clements Jr. University Hospital and Zale Lipshy
Pavilion Hospital, when
they began, the number of patients and the study endpoints.
Intellectual Property, Proprietary Technology, page 50
4. We note your revised disclosure in response to our prior comment 13.
With respect your
related patents in international territories, please revise to
disclose the type of patent
protection granted for each technology such as composition of matter,
use or process, and
the patent expiration dates.
Notes to Condensed Consolidated Financial Statements
2. Significant Accounting Policies , page F-26
5. On page 37 you disclose the receipt of a $75,000 grant from the
Massachusetts Growth
Capital Corporation and we note that you recognized the full amount
for the period
ended June 30, 2021. Please disclose your accounting policy for grants
received.
You may contact Sasha Parikh at 202-551-3627 or Vanessa Robertson at
202-551-3649 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Deanna Virginio at 202-551-4530 or Ada Sarmento at 202-551-3798 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Cavas S. Pavri, Esq.