October 27, 2004 Matthew M. Gosling
MGosling@hewm.com
Direct (650) 324-7159
Confidential For Use of the Commission Only Direct Fax (650) 324-6031
Via EDGAR and FedEx Main (650) 324-7000
Fax (650) 324-0638
Securities and Exchange Commission 24727-0008
Division of Corporation Finance
450 Fifth Street, N.W. - Mailstop 3-9
Washington, D.C. 20549
Attn: Mr. Gregory S. Belliston
RE: ADEZA BIOMEDICAL CORPORATION
AMENDMENT NO. 1 TO REGISTRATION STATEMENT ON FORM S-1,
FILED SEPTEMBER 21, 2004 (FILE NO. 333-118012)
Dear Mr. Belliston:
On behalf of Adeza Biomedical Corporation ("Adeza"), this letter responds
to the comments of the Staff of the Securities and Exchange Commission (the
"Staff") set forth in the letter dated October 7, 2004 in connection with the
filing of the above-referenced registration statement (the "Registration
Statement"). Adeza is concurrently filing Amendment No. 2 to the Registration
Statement (the "Amendment").
For your convenience, we are sending a copy of this letter, the Amendment
and supplemental materials in the traditional, non-EDGAR format, including a
version of the Amendment that is marked to show changes from the originally
filed Registration Statement, and will forward a courtesy package of these
documents to our examiners: Gregory Belliston, Suzanne Hayes and Jeffrey
Riedler.
The responses below correspond to the paragraph numbers of the Staff's
letter. The pages referenced below correspond to the page numbers in the hard
copy of the Amendment submitted to the Staff.
GENERAL
1. Adeza notes the Staff's comment.
PROSPECTUS SUMMARY, PAGE 1
2. Adeza has revised the Registration Statement as requested. See pages 1
and 2.
3. Adeza has revised the Registration Statement to remove the references in
the Prospectus Summary to expansion of the use of the Fetal Fibronectin
Test for specific additional indications. See page 1.
RISK FACTORS, PAGE 7
IF WE ARE UNABLE TO MAINTAIN OUR EXISTING REGULATORY APPROVALS...PAGE 11
4. Adeza has revised the Registration Statement as requested. See page 11.
POTENTIAL BUSINESS COMBINATIONS COULD REQUIRE SIGNIFICANT MANAGEMENT
ATTENTION...PAGE 17
5. Adeza has revised the Registration Statement as requested. See page 17.
USE OF PROCEEDS, PAGE 25
6. Adeza has revised the Registration Statement as requested. See page 25.
7. Adeza has revised the Registration Statement as requested. See page 25.
ONCOLOGY - BLADDER CANCER, PAGE 44
8. Adeza has revised the Registration Statement as requested. See page 45.
THE ADEZA SOLUTION, PAGE 45
9. Adeza has revised the Registration Statement as requested. See page 46.
In addition, Adeza is supplementally providing in the attached Exhibit A
independent, third party support for the certain additional statistical
data provided in response to the Staff's comment. Exhibit A identifies the
relevant statement, identifies the location of the statement and cites the
source supporting such statement. Also included in Exhibit A are copies of
all sources relied upon. In addition, Adeza has cited these sources in the
prospectus.
10. Adeza has revised the Registration Statement as requested. See page 47.
11. Adeza has revised the Registration Statement as requested. See page 47.
PRODUCTS UNDER DEVELOPMENT, PAGE 48
12. Adeza has revised the Registration Statement as requested. See page 49.
13. Adeza has revised the Registration Statement as requested. See page 50.
Adeza has removed the description of one of its studies because the results
of the study have not been published in a peer-reviewed publication.
14. Adeza has revised the Registration Statement as requested. See page 50.
EXPAND INTERNATIONAL SALES, PAGE 49
15. Adeza has revised the Registration Statement as requested. See page 51.
MANUFACTURING, PAGE 51
16. Adeza has revised the Registration Statement as requested. See page 53.
PREMARKET APPROVAL PATHWAY, PAGE 53
17. Adeza has revised the Registration Statement as requested. See page 54.
INTELLECTUAL PROPERTY, PAGE 54
18. Adeza has revised the Registration Statement as requested. See page 57.
LICENSE AGREEMENTS, PAGE 55
19. Adeza has revised the Registration Statement as requested. See pages 57
and 58.
PRINCIPAL STOCKHOLDERS, PAGE 73
20. Adeza has revised the Registration Statement as requested. See page 78.
UNDERWRITING, PAGE 83
21. Adeza supplementally advises the Staff that it has been informed that
UBS Securities LLC will not accept indications of interest, offers to
purchase or confirm sales electronically except for the indications of
interest accepted by UBS Securities LLC through its DealKey (SM) System.
ITEM 15. RECENT SALES OF UNREGISTERED SECURITIES, PAGE II-2
22. Adeza has revised the Registration Statement as requested. See page II-2.
ITEM 16. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES, PAGE II-3
23. Adeza has revised the Registration Statement as requested. See page 58.
DIRECTED SHARE PROGRAM MATERIALS
24. Adeza has elected not to pursue a directed share program and has removed
from the Registration Statement the description of the directed share
program.
* * *
Please contact me at (650) 324-7159, or Sarah O'Dowd at (650) 324-7045, if
you have any questions regarding the Amendment or the responses to the Staff's
comment letter.
Sincerely,
/s/ Matthew M. Gosling
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Matthew M. Gosling