SEC Company Response from Sonoma Pharmaceuticals, Inc. (SNOA) (CIK 0001367083) (SNOA) — Jul 24, 2009
Sonoma Pharmaceuticals, Inc. (SNOA) (CIK 0001367083)
Date: July 24, 2009 · CIK: 0001367083 · Accession: 0000950123-09-025425
AI Filing Summary & Sentiment
File numbers found in text: 333-157776, 333-158539
Referenced dates: July 16, 2009, July 16, 2009, July 20, 2009, July 9, 2009
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CORRESP
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SEC CORRESPONDENCE LETTER
1320 Centre Street, Suite 202
Newton, MA 02459
Phone: 617-243-0060
Fax: 617-243-0066
July 24, 2009
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E., Mail Stop 3030
Washington, DC 20549
Attn:
Geoffrey Kruczek
Re:
Oculus Innovative Sciences, Inc.
Post-Effective Amendment to Form S-1
File No. 333-157776
Dear Mr. Kruczek:
I am securities counsel for Oculus Innovative Sciences, Inc. (the “Company”). I enclose for filing
under the Securities Act of 1933, as amended, Post-Effective
Amendment No. 2 to
Form S-1, File No. 333-157776, together with certain exhibits thereto (the “Amendment”).
The Amendment contains revisions that have been made in response to comments received from the
staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in their letter
dated July 20, 2009.
Set forth below are the Company’s responses to the Staff’s comments. The numbering of the
responses corresponds to the numbering of the comments in the letter from the Staff.
Comment 1.
Please revise your document to comply with all applicable
comments in our letter dated July 16, 2009 and any follow-up
letters regarding your registration statement on Form S-1,
File No. 333-158539. In your response to this letter, please
clearly indicate how and where you have applied each of those
comments in this registration statement.
Response 1.
The Company has revised the Amendment to comply with all
applicable comments contained in the Staff’s letter dated July
16, 2009 (the “July 16th Letter”). The following
indicates how and where the Company has applied each comment
which required revision to the document.
July 16th
Letter
Corresponding Change
Comment 2:
The Company has made the disclosure
in the Prospectus Summary more
prominent by including it as a
standalone paragraph and reversing
the order of the sentences so it now
reads:
“We do not have the necessary
regulatory approvals to market
Microcyn in the United States as a
drug, nor do we have the necessary
regulatory clearance or
July 16th
Letter
Corresponding Change
approval to market Microcyn in the United States as a
medical device for an antimicrobial or wound healing
indication. Our device product is cleared for sale in
the United States as a 510(k) medical device for
wound cleaning, debridement, lubricating, moistening
and dressing; is a device under CE Mark in Europe; is
approved by the State Food and Drug Administration,
or SFDA, in China as a technology that reduces the
propagation of microbes in wounds and creates a moist
environment for wound healing; and is approved as a
drug in India and Mexico.”
The Company notes that the disclosure is made
prominent by its positioning in a box with
substantial white space. The Company also believes
that relocating the statement that the Company does
not have the necessary regulatory approvals to market
Microcyn as a drug or a medical device for an
antimicrobial or wound healing indication as the
first sentence, in a separate paragraph, as one of
just four short paragraphs under the heading “About
Us” and as part of a single page summary, prominently
features the disclosure.
Additionally, the Company has revised the disclosure
under the heading “Description of Business” to
address the second bullet point of Staff Comment 2.
To assist the Staff’s review, the following table
indicates under which heading disclosure addressing
each regulatory issue raised by the Staff in its
Comment 2 appears:
Regulatory Issue
Under Heading
•
the FDA’s statutory and regulatory
requirements for approval of a new
drug and the requirements of a New
Drug Application;
Government Regulation
•
device classification information;
Medical Device Regulation
•
investigational device exemption
requirements;
Medical Device Regulation
•
obligations of a sponsor of an
investigational device exemption;
Medical Device Regulation
•
pre-market approval application
requirements and conditions of
approval;
Medical Device Regulation
•
duration of the process;
Government Regulation
Pharmaceutical Product Regulation
•
registration and labeling
requirements;
Medical Device Regulation
Pharmaceutical Product Regulation
•
advertising and promotion;
Medical Device Regulation
•
quality system regulation and
manufacturing of the product;
Medical Device Regulation
•
post-market reporting and
record-keeping requirements,
including medical device
reporting and reports
of corrections or removals;
Medical Device Regulation
•
import and export
requirements; and
Medical Device Regulation
•
potential sanctions for violations.
Medical Device Regulation
As described in the revised disclosure, particularly under the heading Market
Device Regulation, FDA regulations prohibit the advertising and promotion of a
medical device for any use outside the scope of a 510(k) clearance, pre-market
approval or for unsupported safety or effectiveness claims. The Company
respectfully notes that the Amendment is not intended to advertise or promote the
July 16th
Letter
Corresponding Change
Company’s product. Rather, the
Amendment’s purpose is to provide
investors with adequate information
about the Company’s business to
enable them to make an informed
investment decision. To that end,
Form S-1 requires that the Company
include, among other things, the
information required by Item 101 of
Regulation S-K. Item 101 requires,
in part, that the Company provide
investors with a narrative
description of the business.
In order to comply with this
disclosure requirement, the Company
must include information about its
business, including its products.
This requires the Company to make
statements which are necessarily
broader than those it may make when
marketing and promoting its
products. The second paragraph under
the heading “Our Business” clearly
lists the indications for which the
Company’s product has received
510(k) clearance. Further,
statements that are consistent with
the 510(k) clearances are clearly
marked as such. On the other hand,
statements that are based on the
Company’s reasonable beliefs and
conclusions use language such as “we
believe” and “suggests.” For
instance, under the heading “Our
Solution,” bullets four and five
each include a claim that “[o]ur
510(k) label states,” indicating
such statement is consistent with
our 510(k) clearances. In contrast,
the remaining bullets indicate that
“we believe” the stated claim or
that a set of facts “suggest” such
claim is true.
Common Stock to be registered, page 1
Comment 2.
Please clarify the number of shares registered for sale
on this registration statement that underlie each class
of your warrants.
Response 2.
The Company has revised the Amendment to clarify that it
registered an aggregate of 3,035,290 shares of common
stock which is comprised of 996,088 shares of common
stock, 869,658 shares of common stock underlying the
Series A Warrants and 1,169,544 shares of common stock
underlying the Series B Warrants.
Selling Security Holders, page 17
Comment 3.
According to your explanatory note, you are
deregistering 473,410 shares of common stock underlying
Series C warrants. However, your response to prior
comment 3 in your letter dated July 9, 2009 regarding
registration statement file number 333-158539 indicated
that you would “deregister 584,772 shares of common
stock” issuable upon exercise of the Series C warrants.
Please tell us the reason for the difference. Also tell
us how you arrived at the 584,772 number mentioned in
your response.
Response 3.
The Company is deregistering an aggregate of 584,772
shares of common stock underlying the Series C Warrants
that may be issued pursuant to the Purchase Agreement
dated February 6, 2009 (the “Purchase Agreement”). Of
the shares underlying the Series C Warrants, 473,410
were originally registered on the registration statement
file number 333-157776 and the remaining 111,362 were
originally registered on the registration statement file
number 333-158539. In the current Amendment, the
Company has reduced the total number of shares
registered to reflect the removal of 473,410 shares.
The reference to the 584,772 number in the Company’s
response to comment 3 in its letter dated July 9, 2009
was intended to capture the aggregate number of shares
underlying Series C Warrants that may be issued if all
of the Series B Warrants issued pursuant to the Purchase
Agreement are exercised. Upon closer examination, the
Company determined that only 473,410 of those shares
were registered on the registration statement file
number 333-157776.
Comment 4.
Please tell us whether any shares underlying the Series
C warrants were sold by the selling security holders.
Response 4.
Pursuant to the Purchase Agreement, for every two shares
of common stock an investor purchases upon exercise of a
Series B Warrant, the investor will receive one Series C
Warrant. The Series B Warrants will not be exercisable
until August 6, 2009, which is six months after
issuance, and therefore are not currently exercisable.
As a result, the Company has not issued any Series C
Warrants and the selling security holders have not sold
any shares underlying the Series C Warrants.
Comment 5.
Please disclose the identity of the natural person who
exercises the sole or shared voting and/or dispositive
powers with respect to the shares to be offered by
Cranshire Capital. It appears from note 5 to your table
that you have only identified the natural person who has
voting control over Downsview. Also disclose the
identity of the natural persons who exercise sole or
shared voting power with respect to the shares offered
by Rockmore. It appears from note 7 to your table that
you have only identified natural persons who share
dispositive power over the shares held by Rockmore.
Alternatively, tell us how Rockmore and its affiliates
operate their business such that no natural person
directly or indirectly exercises sole or shared voting
power.
Response 5.
The Company has complied with the
Staff’s comment.
Comment 6.
Please tell us whether any of the selling stockholders
is a broker-dealer or affiliate of a broker-dealer.
Response 6.
Based upon information provided
to the Company by the Selling Stockholders, none of the Selling Stockholders
is a broker-dealer or an affiliate of a broker dealer.
Comment 7.
Please revise the information in the fourth column of
your table regarding the number of shares Seamus
Burlingame will own after this offering. Given the
number of shares disclosed in columns two and three, it
is unclear how you determined that he will hold only
16,667 shares after this offering.
Response 7.
The Company has complied with the Staff’s comment.
Executive Compensation, page 41
Comment 8.
Please revise to include the disclosures required by Item
402(r) of Regulation S-K, including all required tables.
Response 8.
The Company has complied with the Staff’s comment.
Security Ownership, page 45
Comment 9.
It appears from your disclosure here and notes 5 and 6 to the
table that the number of shares beneficially owned by Robert
and Seamus Burlingame do not include the shares underlying
the Series A and B warrants they acquired in February 2009.
Given your disclosure on page 2 regarding when those warrants
become exercisable, it appears that the Burlingames may now
acquire the shares underlying those warrants within 60 days.
Also, given the exercise period for the Series A and B
warrants issued by you to the investors in the February 6,
2009 offering, it appears that those investors may now
acquire the shares underlying those warrants within 60 days.
Please update your beneficial ownership and selling
stockholders tables to include the shares underlying the
warrants as appropriate; see Rule 13d-3(d)(1)(i).
Response 9.
The Company has complied with the Staff’s comment.
Undertakings, page II-8
Comment 10.
Please include the undertakings required by Regulation S-K
Item 512(a)(5)(ii) and (a)(6).
Response 10.
The Company has complied with the Staff’s comment.
Exhibits
Comment 11.
Please tell us why exhibit 23.1 is not signed by the same
auditor that signed the report appearing on page F-1.
Response 11.
The auditor whose report appears on page F-1 and who signed
the consent is the same firm, Marcum LLP. The consent
included as exhibit 23.1 to the Amendment includes the
correct name.
If you have further questions or comments, please feel free to contact us. We are happy to
cooperate in any way we can.
Regards,
/s/ Amy M. Trombly