SEC Comment Letter 0000000000-23-003510 to PIXIE DUST TECHNOLOGIES, INC. (CIK 0001962845)
PIXIE DUST TECHNOLOGIES, INC. (CIK 0001962845)
Date: April 7, 2023 · CIK: 0001962845 · Accession: 0000000000-23-003510
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United States securities and exchange commission logo
April 7, 2023
Yoici Ochiai
Chief Executive Officer
Pixie Dust Technologies, Inc.
2-20-5 Kanda Misaki-cho, Chiyoda-ku
Tokyo, 101-0061, Japan
Re:Pixie Dust Technologies, Inc.
Draft Registration Statement on Form S-1
Submitted March 8, 2023
CIK 0001962845
Dear Yoici Ochiai:
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 March 8, 2023
Market and Industry Data, page iii
1.We note your statements that (i) the accuracy and completeness of the information used in
reports of governmental agencies, market research reports, and industry publications and
surveys is not guaranteed and (ii) that you have not independently verified the data from
these sources. These statements appear to imply a disclaimer of responsibility for this
information in the prospectus. Please either delete these statements or specifically state
that you are liable for the information related to the market and industry data
FirstName LastNameYoici Ochiai
Comapany NamePixie Dust Technologies, Inc.
April 7, 2023 Page 2
FirstName LastName
Yoici Ochiai
Pixie Dust Technologies, Inc.
April 7, 2023
Page 2
Prospectus Summary
Business Overview, page 1
2.Substantially revise your summary to provide a brief overview of the key aspects of the
offering. In doing so, please clarify on the first page the business in which your company
is currently engaged, including the status of any products that you currently sell and state
the stage of development of your potential products that are discussed in the prospectus.
In doing so, include information regarding the hair loss medication you recently in-
licensed and began selling, and how that relates to your strategic plans. We note the
disclosure on page 31 and briefly in the Business section. The summary identify those
aspects of the offering that are the most significant and highlight those points in clear,
plain language. Refer to Item 3 of Form F-1 and the Instruction to Item 503(a) of
Regulation S-K.
3.In revising the summary, avoid overbroad statements of leadership and vision for your
future products, and balance disclosure of your strategic goals with equally prominent
disclosure of the potential risks your company faces. For example, the first sentence,
beginning "[w]e create and commercialize innovative consumer personal care products
and spatial materials," should be revised or deleted given the stage of your company. We
note the disclosure on page 2 that you "are an early-stage company and have not generated
significant revenue from any commercialization of [y]our proprietary technology
products," and that you "have generated revenues primarily from commissioned research
and development and solution services [you] provided to other companies including under
. . . collaboration arrangements."
4.We note the distinction on page 2 that your products are "consumer personal care products
for every day use." Prominently address the fact that you plan to characterize the relevant
products, which appear to be SonoRepro and kikippa, as personal care products and not
medical devices, and briefly address the significance of that distinction. Revise the
summary to briefly address the risks associated with certain of your products that also
could be characterized as medical devices. We note the risk factor on page 30, and the
disclosure that "as [y]our business grows, [you] may need to apply for approvals to market
certain products as medical devices in Japan." Clarify why the size of your company
impacts that decision.
5.Please revise to briefly describe technical terms or medical conditions at their first
use, including the following:
•spatial materials;
•mechanobiology;
•metamaterials;
•electromagnetic metamaterials;
•wave technology; and
•sensory and metamaterial technologies.
When defining these terms, please do so without using the term in the definition. We note
FirstName LastNameYoici Ochiai
Comapany NamePixie Dust Technologies, Inc.
April 7, 2023 Page 3
FirstName LastNameYoici Ochiai
Pixie Dust Technologies, Inc.
April 7, 2023
Page 3
your current definition of metamaterials.
Summary Risk Factors, page 3
6.Please revise to place the Risk Factors Summary immediately before your Risk Factors
section as required by Item 105(b) of Regulation S-K.
Use of Proceeds, page 52
7.You state that you intend to use the net proceeds from the offering for “working capital
and other general corporate purposes, which include developing and commercializing our
technologies and related products.” We also note your disclosure that you "have no
agreements or commitments for particular uses of the net proceeds from this
offering." Nonetheless, please revise to provide more meaningful and specific disclosure
of the intended use of proceeds and the approximate amounts intended to be used for each
such purpose, to the extent known. If you do not have a current specific plan for the
proceeds of this offering, please state this explicitly and discuss the reasons for the
offering. Refer to Item 3.C.1. of Form 20-F.
Selected Financial Information and Operating Data, page 59
8.We note your financial statements are chronologically ordered from left to right, while
Financial Information and MD&A are chronologically ordered from right to left. Please
revise your filing so that financial statements and other data presented in tabular form are
read consistently in the same chronological order throughout the filing. Refer to SAB
Topic 11.E.
Management's Discussion and Analysis of Financial Condition and Results of Operations, page
61
9.We note your financial statements include a convenience translation for the most recent
fiscal year and subsequent interim period. Please revise your MD&A to remove any
reference to U.S. dollar period over period changes so that your filing is presented on a
consistent basis, including both tabular and narrative references. Likewise, remove
references to convenience translation amounts that are not included in your financial
statements.
Business, page 76
10.Please revise this section to provide the basis for these statements or remove them:
•"We expect that, over time, the world of Digital Nature will construct an environment
inseparable from both computers and non-computers, building a computational nature
that transcends language and phenomenon with information processes unique to
living organisms."
•"We believe kikippa can change casual TV viewing into an activity that could
FirstName LastNameYoici Ochiai
Comapany NamePixie Dust Technologies, Inc.
April 7, 2023 Page 4
FirstName LastName
Yoici Ochiai
Pixie Dust Technologies, Inc.
April 7, 2023
Page 4
potentially assist cognitive-impaired individuals in performing everyday tasks
through sound stimulation." As kikippa is potentially being commercially launched in
the second quarter of 2023, it appears you should know whether this is feasible or
not. Revise the statement to provide a reasonable basis for this belief or eliminate the
assertion.
•Your statement that there is "growing awareness of iwasemi among architectural
firms, construction companies, and other distributors and consultants of construction
materials."
•"We believe we were among the first companies to focus on the Angle of Arrival
(“AOA”) function of Bluetooth 5.1 . . . ."
•"[A]nd [we] have been developing technology and accumulating know-how to bring
it to the stage where it can be used in real-life environments."
•"We believe the technology developed as a result of these efforts has opened up a
new product area of low cost and high accuracy for location positioning technologies,
whereas existing location positioning technologies were either high cost and high
accuracy or low cost and low accuracy. We further believe that this technology can
not only replace the existing positioning technology in industry, but also open up a
wide range of new applications."
11.Please revise your business section to provide a discussion of the sources and availability
of raw materials used in your operations. Refer to Item 4.B.4 of Form 20-F.
12.We note your references to several collaborations and agreements related to licensing,
manufacturing and distribution throughout your prospectus. We note, for example, your
work with the University of Tsukuba, Tohoku University, your collaboration with
Shionogi & Co., your relationship with Itoki and referenced research and development
collaboration agreements with companies you do not specifically name, among others.
Please revise to describe the material terms for all your material agreements, including, to
the extent applicable: (i) the rights and obligations of each party; (ii) the upfront license
fees paid; (iii) the annual license maintenance fees to be paid; (iv) the duration of the
agreements; (v) the aggregate amount of any milestone payments under the agreements
and the amounts paid to date; (vi) the royalty fees and royalty terms, and (vii) termination
provisions. Refer to Item 4.B.4 and 6 of Form 20-F. Please also file the agreements as
exhibits or tell us why you do not believe it is required. Refer to Item 8.a. of Form F-1 and
Item 601(b)(10)(ii) of Regulation S-K.
13.We note your disclosure regarding the market and competition for each of your products.
Please provide additional context regarding your competitive position and, to the extent
known, identify they types of products and companies with whom you compete, or, to the
extent your product is not yet commercialized, your future competition.
FirstName LastNameYoici Ochiai
Comapany NamePixie Dust Technologies, Inc.
April 7, 2023 Page 5
FirstName LastName
Yoici Ochiai
Pixie Dust Technologies, Inc.
April 7, 2023
Page 5
SonoRepro, page 79
14.To the extent you do not plan to market your SonoRepro and kikippo devices as medical
devices, but instead as personal care devices, it appears you should revise the prospectus
to remove any references to potential treatment of disease or medical conditions. For
example, on page 79, you state that the SonoRepro "personal scalp care device . . . may be
particularly useful for individuals suffering from androgenetic alopecia ("AGA"), or male
pattern baldness." You then cite a study of ultrasound affecting male pattern baldness,
and state that "SonoRepro was developed based on non-contact vibrotactile stimulation
with ultrasound, one of [y]our proprietary wave control technologies." Revise to remove
the disclosure regarding the study and the statement regarding the "usefulness" of the
device for persons suffering from alopecia. Please also revise the kikippa section to
remove any claims and studies related to the audio speaker's gamma waves potentially
improving dementia or otherwise assisting cognitively impaired individuals. We note the
disclosure in the last full paragraph on page 82 that you "may elect to, or may be required
to apply for regulatory approvals to market and sell the product as a medical device in
Japan or other jurisdictions where [you] sell the product. Util [you] obtain the required
regulatory approvals, [you] will not make any medical device claims relating to
[kikippa]."
15.Should you retain any information regarding clinical studies in your document, revise the
disclosure to provide all material information about each study. We note, for
example, your disclosure that the results of your SonoRepro clinical study indicated a
"significant decrease in the telogen hair and a significant increase in the anagen hair in the
irradiated group." Please disclose the sponsor of the study, number of participants,
whether statistical significance was demonstrated and the p-values supporting statistical
significance. The first time you use the term p-value please explain what it measures and
the p-value that you have to achieve in order to conclude a statistically significant result.
Collaboration and Commercialization, page 80
16.We note your disclosure in the first paragraph of this section regarding the medication for
treating hair loss that you began selling in January 2023, and the license for store-based
distribution that you obtained in December 2022. The only other discussion of this
product appears to be in the risk factor on page 31. Please revise your business section to
fully discuss this product, as required by Item 4.B.1. of Form 20-F. Please include in your
disclosure the background of the product's development, its mechanism of action, the
regulatory requirements to commercialize the product, what requirements you have yet to
satisfy, the anticipated costs to commercialize the product and your anticipated timing.
FirstName LastNameYoici Ochiai
Comapany NamePixie Dust Technologies, Inc.
April 7, 2023 Page 6
FirstName LastName
Yoici Ochiai
Pixie Dust Technologies, Inc.
April 7, 2023
Page 6
kikippa, page 81
17.Revise this section and the VUEVO discussion to provide a more complete description of
these products and their current stage of development. For example, you mention in the
third paragraph on page 81 that kikippa is a speaker. Describe the actual product, such as
the inputs, how it is powered and controlled, the types of controls, and the outputs, if any.
State the dimensions. We note you plan to launch kikippa in the second quarter of 2023,
as disclosed on page 82. As you state in the same paragraph that you are testing a
prototype, please update the anticipated timing. Finally, revise to provide additional detail
regarding the anticipated costs, steps and timing for the testing and development needed to
commercialize each of the products.
Collaboration and Commercialization, page 82
18.We note your plans that you to market kikippa and VUEVO initially in Japan and expect
to expand overseas in the future. Please disclose the overseas jurisdictions in which you
intend to market these products and the regulatory approvals you are required to satisfy in
those jurisdictions.
VUEVO, page 83
19.Please revise the graphic on page 84 to clarify what the photo represents. For example,
clarify if the graphic is a printout of the actual output from one of your prototypes. If not,
revise the caption to specifically identify how the graphic was generated and what is
depicted.
iwasemi, page 85
20.Substantially revise this section to provide additional information about the development
and structure of this product. You state that "iwasemi is a sound-absorbing material [you]
developed by applying [your] proprietary engineering technologies to acoustic
metamaterial technologies." Clarify how much of your own development contributed to
these products, as opposed to your adaptation of existing acoustic metamaterials. Explain
your research and testing that lead to these products. In your revisions, provide a more
complete explanation of metamaterials. You currently state that "metamaterials are
artificially created substances with properties that do not exist in nature," which is
circular.
FirstName LastNameYoici Ochiai
Comapany NamePixie Dust Technologies, Inc.
April 7, 2023 Page 7
FirstName LastName
Yoici Ochiai
Pixie Dust Technologies, Inc.
April 7, 2023
Page 7
Market and Competition, page 87
21.We note your statement that "According to a report by Global Informati