United States securities and exchange commission logo
August 14, 2020
Rodney W. Reum
Chief Executive Officer
Quara Devices Inc.
1712 Pearl Street
Boulder, CO 80302
Re: Quara Devices Inc.
Amendment No. 1 to
Offering Statement on Form 1-A
Filed August 5,
2020
File No. 024-11224
Dear Mr. Reum:
We have reviewed your amended offering 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 offering 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 offering statement and the
information you
provide in response to these comments, we may have additional comments.
Unless we note
otherwise, our references to prior comments are to comments in our June
24, 2020 letter.
Amended Offering Statement on Form 1-A
Summary
The Company, page 1
1. Refer to comment 1.
Your summary states you are "currently developing two product
platforms: one for
detection of bacterial infections and another for detection of viruses,"
and you state your
virus platform will focus initially on detection of the virus responsible
for COVID-19. In your
business section, however, on page 20, you clarify that you
expect to begin
shipping your devise for detecting bacteria in shrimp in 12 months, and,
on page 21, that
"development and testing" of your virus product for detection of corona
virus is expected in 12
months, at which time you will apply to the FDA for market
approval. It appears,
however, from your disclosure on page 24 that both products would
Rodney W. Reum
Quara Devices Inc.
August 14, 2020
Page 2
require FDA approval. Revise the summary to clarify in what time frame
you reasonably
expect to seek FDA approval for these products, highlight all material
hurdles in that
process including testing, and to disclose under what device class you
would seek FDA
approval.
2. Refer to comments 2 and 3. Our comments sought revised disclosure in
the summary, to
highlight this information for investors. Please revise the summary to
clarify the
information about your reliance on the purchase of technology from
Pebble Labs to
develop your products as requested in our comments.
The Company's Business
Overview, page 12
3. Refer to comment 6. You continue to state on page 12 that you have a
"functioning
prototype that has been demonstrated to quantitatively detect a
bacterial signalling
molecule that is produced by virulent bacteria." Disclose the basis
for this statement,
including any product testing. Your reference to the "Our Technology"
section, where
you make many statements about effectiveness, including, that your
"prototype device has
demonstrated the ability to obtain quantitative measurements of BAI-2
over a wide
concentration range in laboratory solutions using the FRET detection
protein" does not
explain how you determined your device accurately detects targeted
bacteria or viruses.
The Company's Business
Our History, page 13
4. Refer to comment 5. Revise the disclosure on page 13 or an appropriate
section of your
document to disclose the material terms of the OptiEnz Master Research
and
Development Agreement, including the payment terms and term.
V-Detect, page 24
5. On page 24, you state, "We believe we can develop our technology to show
high
sensitivity (low false positives) and high specificity (low false
negatives) to become a
FirstName LastNameRodney W. Reum
best-in-class portable device." Statements regarding "best-in-class"
imply an expectation
Comapany NameQuara
of regulatory Devices
approval andInc.
are inappropriate given the uncertainty of
developing your
Augustproduct
14, 2020and securing
Page 2 market approval. Please revise to delete this
claim.
FirstName LastName
Rodney W. Reum
FirstName LastNameRodney W. Reum
Quara Devices Inc.
Comapany
August 14, NameQuara
2020 Devices Inc.
August
Page 3 14, 2020 Page 3
FirstName LastName
You may contact Kristin Lochhead at 202-551-3664 or Al Pavot at
202-551-3738 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Abby Adams at 202-551-6902 or Mary Beth Breslin at 202-551-3625 with
any other
questions.
Sincerely,
Division of Corporation
Finance
Office of Life Sciences
cc: Heidi Mortensen