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SEC Comment Letter for ADEZA BIOMEDICAL CORP (CIK 0000902482) — Nov 18, 2004

ADEZA BIOMEDICAL CORP (CIK 0000902482)
Date: Nov. 18, 2004 · CIK: 0000902482 · Accession: 0000000000-04-037076

AI Filing Summary & Sentiment

File numbers found in text: 333-118012

Date
September 2, 2004
Author
Not clearly detected
Form
UPLOAD
Company
ADEZA BIOMEDICAL CORP (CIK 0000902482)

Letter

Mail Stop 3-09 September 2, 2004 Emory V. Anderson President and Chief Executive Officer Adeza Biomedical Corporation 1240 Elko Drive Sunnyvale, California 94089

Re: Adeza Biomedical Corporation Registration Statement on Form S-1 File Number 333-118012

Dear Mr. Anderson:

We have reviewed your filing and have the following comments. Where indicated, we think you should revise your document in response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as detailed as necessary in your explanation. In some of our comments, we may ask you to provide us with supplemental information so we may better understand your disclosure. After reviewing this information, we may or may not raise additional comments.

Please understand that the purpose of our review process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.

FORM S-1

General

1. Please provide us proofs of all graphic, visual, or photographic information you will provide in the printed prospectus prior to its use, for example in a preliminary prospectus. Please note we may have comments regarding these materials.

2. Please note that when you file a pre-effective amendment containing pricing-related information, we may have additional comments. As you are likely aware, you must file this amendment prior to circulating the prospectus.

3. Please note that when you file a pre-effective amendment that includes your price range, it must be bona fide. We interpret this to mean that your range may not exceed $2 if you price below $20 and 10% if you price above $20.

4. We note that your website contains hyperlinks to several third- party websites. Please refer to Section II.B.1 of SEC Release No. 33- 7856 (Apr. 28, 2000), which discusses the Commission`s views concerning an issuer`s responsibility for statements made on hyperlinked third-party websites.

Table of Contents page

5. Please relocate the first paragraph on this page so that it appears somewhere after the Risk Factors section in the filing. It is not required by Item 502 of Regulation S-K.

Prospectus Summary, page 1

6. Your Summary section currently discusses only the positive aspects of your business, products, and strategy. Please balance the disclosure with a discussion of the difficulties you face and of the hurdles you must overcome to achieve the strategy objectives you list. You should mention, among other things, the amount of your accumulated deficit; your dependence on one product; and the fact that your strategy of expanding overseas will require you to obtain regulatory approval in foreign countries.

7. We note that substantially all of the text in the "Our Business" and "Our Primary Market" discussions is identical to the corresponding discussions in your Business section. Please revise these discussions so that they briefly summarize the information in your Business section. For example, it seems that the first five paragraphs of the "Our Business" discussion could be summarized by simply identifying the preterm labor test and the infertility test and briefly explaining what they do.

We assume that, pursuant to this comment, you will delete the disclosure referenced by some of our comments on your Summary section. If you do, please still address the comments to the extent the disclosure appears in other sections of your filing.

8. Please supplementally provide us with independent, third-party support for the following statements:

* The statement that your products are "innovative" (page 1); * "Preterm births have historically accounted for up to 85% of all pregnancy-related complications and deaths in the United States, and over $13 billion in costs were associated with the care of preterm or low birth weight infants in 2001" (page 1); * In recent years, preterm births "have occurred on average at a rate of over 1,300 per day, or 480,000 per year" (page 2); * The statistics contained in the three bullet points describing the three categories of women at risk for preterm labor on page 2 (1 million, 1.2 million, 2.8 million, and 50%); * "We believe approximately 10% to 15% of infertile women are classified as suffering from unexplained infertility where extensive tests for known factors have failed to reveal a cause" (page 44); and * The statistics contained in the "Induction of labor" and "Oncology - bladder cancer" discussions on pages 44-45.

Please highlight the relevant portions of the materials you send to us. Also, cite these sources in your document.

9. Your filing refers to the following studies that have examined the Fetal Fibronectin Test:

* "numerous large, multi-center peer-reviewed clinical publications" that have demonstrated the clinical efficacy of your test, as you state at the bottom of page 2. * "peer-reviewed publications" that have confirmed the cost savings from your test, as you state at the bottom of page 45. * "a large, multi-center, peer reviewed clinical study" that demonstrated that your test was "the single strongest predictor of preterm birth at less than 35 weeks of pregnancy," as stated on page 46. * "A peer-reviewed, cost-benefit study published in 1999" that demonstrated the cost savings for hospitals, as stated on page 46. * "several peer-reviewed publications" regarding the Fetal Fibronectin Test as a predictor of delivery date, as stated on page 48.

Please supplementally provide us with copies of these studies, highlighting the relevant portions, and identify these studies by name in your filing.

10. Please explain what a reimbursement code is. Also, your statement that reimbursement for your test "has been regularly available through health plan organizations and most state Medicaid programs" gives the impression that reimbursement by third-party payors is no longer a difficulty you face. However, you state in the risk factor on page 8 entitled "Our quarterly revenues and operating results are subject to significant fluctuation . . ." that "acceptance . . . by third-party payors" may cause your operating results to fluctuate. Please revise these discussions to clarify whether acceptance by third-party payors is an ongoing challenge to your business.

11. We note that "the cost of medical care for a complicated birth ranged between $20,000 and $400,000 from delivery to hospital discharge." Please replace these figures with a price range for complicated births caused by preterm labor, which is your market. Also, cite the original source for this information rather than referring to it as "a 1994 publication cited by the March of Dimes."

12. Please explain how you calculated the $400 million and $1 billion annual potential market sizes, as stated on page 3. Cite any sources you relied upon, and provide us with marked copies of these sources.

Risk Factors

Because our revenues and financial results depend significantly on a limitied products line ..., page 7

13. We note your statement that you will lose revenues if your marketing activities are restricted. Is there any reason to believe your marketing activities may be restricted? In what circumstances are your marketing activities likely to be restricted?

Our quarterly revenues and operating results are subject to significant fluctuations..., page 8

14. Many of the bullet points included in this risk factor are sufficiently material to warrant an expanded discussion in a separate risk factor discussion. Additionally, some of the bullet points are already discussed as separate stand-alone risk factors. Please revise the list of bullets, discuss the items that may present material risks as stand-alone risks and delete them from this risk factor discussion. Similarly, revise "If the price and volume of our common stock experience extreme fluctuations, this could lead to costly litigation for us."

15. We note that you have stated you reliance on international sales and growth could cause significant fluctuations in your quarterly revenues and operating results. Given the statements that 97% of your product sales are from U.S. sales, tell us how you have relied on international sales and how that reliance presents a risk.

If third-party payors do not adequately reimburse our customers . . . , page 9

16. The last sentence in the first paragraph is somewhat confusing. Since reimbursement for your product "has been regularly available," as you state in the first part of the sentence, why is it relevant that "third-party payors are often reluctant to reimburse healthcare providers for the use of medical diagnostic products incorporating new technology," as you state in the second part of the sentence? Please revise to clarify.

If we fail to properly manage our anticipated growth . . . , page 9

17. We note your dependence on qualified personnel. Please discuss any material difficulties you have had in attracting, training, or retaining qualified personnel.

We will need to devote considerable resources to comply . . . , page

18. Please make this risk factor more specific by identifying the laws that are of particular concern. For example, which laws are especially difficult for your business to comply with? Also, we note that you may be at risk of being found to be in violation of laws that "have not been fully interpreted by the regulatory authorities or the courts." Are there any situations or factors that raise doubts as to whether or not you are in compliance? If so, please identify the laws describe the situation and discuss the potential consequences if you are found to not be in compliance.

If we are unable to maintain our existing regulatory approvals ..., page 11

19. Please provide independent third part support for your statement that the overall 510(k) clearance process usually takes three to twelve months.

20. We note that you engaged a third party to conduit an audit of the clinical study sites for protocol deviations and accuracy of data. Is this standard procedure or was this in response to some irregularities. We may have further comments after we have had an opportunity to review your response.

If we or any of our third-party manufacturers do not operate . . . , page 12

21. Please discuss any material difficulties you or any of your third- party manufacturers have had in complying with cGMP.

22. We note you are in the process of negotiating a longer-term renewal of your current month-to-month lease, and you might relocate some or all of your facilities. If you reach an agreement in these negotiations prior to effectiveness, please update or delete this paragraph, as appropriate.

We rely on a limited number of suppliers . . . , page 14

23. Please identify all of your material suppliers, file your agreements as exhibits, and discuss the material terms of the agreements in your Business section. We would generally consider any sole source supplier to be material. Also, identify the fulfillment provider. If you are substantially dependent on this party, file the agreement as an exhibit and discuss the agreement`s material terms in your Business section.

We depend on distributors to market and sell our products in over sees markets..., page 14

24. If you are substantially dependent on any one distributor, identify the distributor, file the agreement with this party as an exhibit and revise the business section to discuss the material terms of the agreement with this party.

If product liability suits or other claims . . . , page 15

25. In both this risk factor and the risk factor on page 16 entitled "If we use biological and hazardous materials . . . ," please state either (1) that you believe your liability insurance coverage is adequate for your current needs or (2) the amount of the insurance coverage limitation that applies to the risk being discussed.

We depend on the services of key personnel to implement our strategy . . . , page 16

26. Please state whether any of the individuals you name has plans to retire or leave the company for any reason in the near future.

Most of our operations are currently conducted at a single location . . . , page 16

27. The last sentence of this risk factor suggests your insurance coverage is not adequate. Please state the difference between the replacement value of your property and the amount of your insurance coverage.

Potential business combinations could require significant . . . , page

28. As currently worded, this risk factor could apply to any issuer or any offering. If you keep this risk factor in your filing, please revise it so it describes your situation more specifically. See Item 503(c) of Regulation S-K.

If we fail to obtain necessary funds for our operations . . . , page

29. The issues discussed in the last paragraph of this risk factor appear to be covered in the risk factor on pages 21-22 entitled "The future sale of our common stock . . . ." Please consolidate these disclosures and eliminate any duplicative information.

Our rights to use technologies and patents licensed to us by third parties . . . , page 19

30. Please identify your material licensors in this risk factor. Also, as stated in a comment below, you should discuss the material terms of these license agreements in your Business section.

If we are involved in intellectual property claims and litigation . . . , page 20

31. To the extent that you are aware you have any patents that are being infringed upon or that you have been notified of a third party`s belief that you are infringing on their patent(s), please revise to disclose the situation and potential consequences.

We may be subject to damages resulting from claims that we or our employees . . . , page 20

32. If you have been notified of a third party`s belief that your employees have disclosed trade secrets or other proprietary information of their former employers, please disclose the situation and potential consequences, including identifying which of your products may be affected.

The future sale of our common stock could dilute . . . , page 21

33. We note a number of your outstanding shares are subject to lock-up agreements. Please state the number of shares subject to lock-up agreements and state when the agreements expire.

Special note regarding forward-looking statements, page 25

34. Please delete the statement that investors "should not unduly rely on these forward-looking statements." This statement may appear to be a disclaimer of responsibility for the statements contained in your filing. It should be sufficient to state that actual results could differ materially from the forward-looking statements.

Use of Proceeds, page 26

35. We note you plan to use some proceeds for research and development activities. Please disclose the specific amounts from your offering proceeds that you intend to allocate for each project under development. Please also state your reasonable estimate as to which stage of development you expect these proceeds will take you as to each project.

36. We note you plan to relocate your Sunnyvale facility or lease additional property. If these actions will entail the acquisition of assets, please provide the information required by Instruction 5 to Item 504 of Regulation S-K.

37. Please identify with more specificity the uses that you currently categorize as "other general corporate purposes," and state how much of the proceeds you plan to put toward each such use.

Management`s Discussion and Analysis of Financial Condition and Results of Operations

Results of Operations

Six months ended Jun

Show Raw Text
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>

Mail Stop 3-09

							September 2, 2004

Emory V. Anderson
President and Chief Executive Officer
Adeza Biomedical Corporation
1240 Elko Drive
Sunnyvale, California 94089

Re:	Adeza Biomedical Corporation
	Registration Statement on Form S-1
	File Number 333-118012

Dear Mr. Anderson:

	We have reviewed your filing and have the following comments.
Where indicated, we think you should revise your document in response
to these comments.  If you disagree, we will consider your explanation
as to why our comment is inapplicable or a revision is unnecessary.
Please be as detailed as necessary in your explanation.  In some of
our comments, we may ask you to provide us with supplemental
information so we may better understand your disclosure.  After
reviewing this information, we may or may not raise additional
comments.

	Please understand that the purpose of our review process is to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.  We
look forward to working with you in these respects.  We welcome any
questions you may have about our comments or on any other aspect of
our review.  Feel free to call us at the telephone numbers listed at
the end of this letter.

FORM S-1

General

1. Please provide us proofs of all graphic, visual, or photographic
information you will provide in the printed prospectus prior to its
use, for example in a preliminary prospectus.  Please note we may have
comments regarding these materials.

2. Please note that when you file a pre-effective amendment containing
pricing-related information, we may have additional comments.  As you
are likely aware, you must file this amendment prior to circulating
the prospectus.

3. Please note that when you file a pre-effective amendment that
includes your price range, it must be bona fide.  We interpret this to
mean that your range may not exceed $2 if you price below $20 and 10%
if you price above $20.

4. We note that your website contains hyperlinks to several third-
party websites.  Please refer to Section II.B.1 of SEC Release No. 33-
7856 (Apr. 28, 2000), which discusses the Commission`s views
concerning an issuer`s responsibility for statements made on
hyperlinked third-party websites.

Table of Contents page

5. Please relocate the first paragraph on this page so that it appears
somewhere after the Risk Factors section in the filing.  It is not
required by Item 502 of Regulation S-K.

Prospectus Summary, page 1

6. Your Summary section currently discusses only the positive aspects
of your business, products, and strategy.  Please balance the
disclosure with a discussion of the difficulties you face and of the
hurdles you must overcome to achieve the strategy objectives you list.
You should mention, among other things, the amount of your accumulated
deficit; your dependence on one product; and the fact that your
strategy of expanding overseas will require you to obtain regulatory
approval in foreign countries.

7. We note that substantially all of the text in the "Our Business"
and "Our Primary Market" discussions is identical to the corresponding
discussions in your Business section.  Please revise these discussions
so that they briefly summarize the information in your Business
section.  For example, it seems that the first five paragraphs of the
"Our Business" discussion could be summarized by simply identifying
the preterm labor test and the infertility test and briefly explaining
what they do.

We assume that, pursuant to this comment, you will delete the
disclosure referenced by some of our comments on your Summary section.
If you do, please still address the comments to the extent the
disclosure appears in other sections of your filing.

8. Please supplementally provide us with independent, third-party
support for the following statements:

* The statement that your products are "innovative" (page 1);
* "Preterm births have historically accounted for up to 85% of all
pregnancy-related complications and deaths in the United States, and
over $13 billion in costs were associated with the care of preterm or
low birth weight infants in 2001" (page 1);
* In recent years, preterm births "have occurred on average at a rate
of over 1,300 per day, or 480,000 per year" (page 2);
* The statistics contained in the three bullet points describing the
three categories of women at risk for preterm labor on page 2 (1
million, 1.2 million, 2.8 million, and 50%);
* "We believe approximately 10% to 15% of infertile women are
classified as suffering from unexplained infertility where extensive
tests for known factors have failed to reveal a cause" (page 44); and
* The statistics contained in the "Induction of labor" and "Oncology -
bladder cancer" discussions on pages 44-45.

Please highlight the relevant portions of the materials you send to
us.  Also, cite these sources in your document.

9. Your filing refers to the following studies that have examined the
Fetal Fibronectin Test:

* "numerous large, multi-center peer-reviewed clinical publications"
that have demonstrated the clinical efficacy of your test, as you
state at the bottom of page 2.
* "peer-reviewed publications" that have confirmed the cost savings
from your test, as you state at the bottom of page 45.
* "a large, multi-center, peer reviewed clinical study" that
demonstrated that your test was "the single strongest predictor of
preterm birth at less than 35 weeks of pregnancy," as stated on page
46.
* "A peer-reviewed, cost-benefit study published in 1999" that
demonstrated the cost savings for hospitals, as stated on page 46.
* "several peer-reviewed publications" regarding the Fetal Fibronectin
Test as a predictor of delivery date, as stated on page 48.

Please supplementally provide us with copies of these studies,
highlighting the relevant portions, and identify these studies by name
in your filing.

10. Please explain what a reimbursement code is.  Also, your statement
that reimbursement for your test "has been regularly available through
health plan organizations and most state Medicaid programs" gives the
impression that reimbursement by third-party payors is no longer a
difficulty you face.  However, you state in the risk factor on page 8
entitled "Our quarterly revenues and operating results are subject to
significant fluctuation . . ." that "acceptance . . . by third-party
payors" may cause your operating results to fluctuate.  Please revise
these discussions to clarify whether acceptance by third-party payors
is an ongoing challenge to your business.

11. We note that "the cost of medical care for a complicated birth
ranged between $20,000 and $400,000 from delivery to hospital
discharge."  Please replace these figures with a price range for
complicated births caused by preterm labor, which is your market.
Also, cite the original source for this information rather than
referring to it as "a 1994 publication cited by the March of Dimes."

12. Please explain how you calculated the $400 million and $1 billion
annual potential market sizes, as stated on page 3.  Cite any sources
you relied upon, and provide us with marked copies of these sources.

Risk Factors

Because our revenues and financial results depend significantly on a
limitied products line ..., page 7

13. We note your statement that you will lose revenues if your
marketing activities are restricted.   Is there any reason to believe
your marketing activities may be restricted?  In what circumstances
are your marketing activities likely to be restricted?

Our quarterly revenues and operating results are subject to
significant fluctuations..., page 8

14. Many of the bullet points included in this risk factor are
sufficiently material to warrant an expanded discussion in a separate
risk factor discussion.  Additionally, some of the bullet points are
already discussed as separate stand-alone risk factors.  Please revise
the list of bullets, discuss the items that may present material risks
as stand-alone risks and delete them from this risk factor discussion.
Similarly, revise "If the price and volume of our common stock
experience extreme fluctuations, this could lead to costly litigation
for us."

15. We note that you have stated you reliance on international sales
and growth could cause significant fluctuations in your quarterly
revenues and operating results.  Given the statements that 97% of your
product sales are from U.S. sales, tell us how you have relied on
international sales and how that reliance presents a risk.

If third-party payors do not adequately reimburse our customers . . .
, page 9

16. The last sentence in the first paragraph is somewhat confusing.
Since reimbursement for your product "has been regularly available,"
as you state in the first part of the sentence, why is it relevant
that "third-party payors are often reluctant to reimburse healthcare
providers for the use of medical diagnostic products incorporating new
technology," as you state in the second part of the sentence?  Please
revise to clarify.

If we fail to properly manage our anticipated growth . . . , page 9

17. We note your dependence on qualified personnel.  Please discuss
any material difficulties you have had in attracting, training, or
retaining qualified personnel.

We will need to devote considerable resources to comply . . . , page
10

18. Please make this risk factor more specific by identifying the laws
that are of particular concern.  For example, which laws are
especially difficult for your business to comply with?  Also, we note
that you may be at risk of being found to be in violation of laws that
"have not been fully interpreted by the regulatory authorities or the
courts."  Are there any situations or factors that raise doubts as to
whether or not you are in compliance?  If so, please identify the laws
describe the situation and discuss the potential consequences if you
are found to not be in compliance.

If we are unable to maintain our existing regulatory approvals ...,
page 11

19. Please provide independent third part support for your statement
that the overall 510(k) clearance process usually takes three to
twelve months.

20. We note that you engaged a third party to conduit an audit of the
clinical study sites for protocol deviations and accuracy of data.  Is
this standard procedure or was this in response to some
irregularities.  We may have further comments after we have had an
opportunity to review your response.

If we or any of our third-party manufacturers do not operate . . . ,
page 12

21. Please discuss any material difficulties you or any of your third-
party manufacturers have had in complying with cGMP.

22. We note you are in the process of negotiating a longer-term
renewal of your current month-to-month lease, and you might relocate
some or all of your facilities.  If you reach an agreement in these
negotiations prior to effectiveness, please update or delete this
paragraph, as appropriate.

We rely on a limited number of suppliers . . . , page 14

23. Please identify all of your material suppliers, file your
agreements as exhibits, and discuss the material terms of the
agreements in your Business section.  We would generally consider any
sole source supplier to be material.  Also, identify the fulfillment
provider.  If you are substantially dependent on this party, file the
agreement as an exhibit and discuss the agreement`s material terms in
your Business section.

We depend on distributors to market and sell our products in over sees
markets..., page 14

24. If you are substantially dependent on any one distributor,
identify the distributor, file the agreement with this party as an
exhibit and revise the business section to discuss the material terms
of the agreement with this party.

If product liability suits or other claims . . . , page 15

25. In both this risk factor and the risk factor on page 16 entitled
"If we use biological and hazardous materials . . . ," please state
either (1) that you believe your liability insurance coverage is
adequate for your current needs or (2) the amount of the insurance
coverage limitation that applies to the risk being discussed.

We depend on the services of key personnel to implement our strategy .
. . , page 16

26. Please state whether any of the individuals you name has plans to
retire or leave the company for any reason in the near future.

Most of our operations are currently conducted at a single location .
. . , page 16

27. The last sentence of this risk factor suggests your insurance
coverage is not adequate.  Please state the difference between the
replacement value of your property and the amount of your insurance
coverage.

Potential business combinations could require significant . . . , page
17

28. As currently worded, this risk factor could apply to any issuer or
any offering.  If you keep this risk factor in your filing, please
revise it so it describes your situation more specifically.  See Item
503(c) of Regulation S-K.

If we fail to obtain necessary funds for our operations . . . , page
17

29. The issues discussed in the last paragraph of this risk factor
appear to be covered in the risk factor on pages 21-22 entitled "The
future sale of our common stock . . . ."  Please consolidate these
disclosures and eliminate any duplicative information.

Our rights to use technologies and patents licensed to us by third
parties . . . , page 19

30. Please identify your material licensors in this risk factor.
Also, as stated in a comment below, you should discuss the material
terms of these license agreements in your Business section.

If we are involved in intellectual property claims and litigation . .
. , page 20

31. To the extent that you are aware you have any patents that are
being infringed upon or that you have been notified of a third party`s
belief that you are infringing on their patent(s), please revise to
disclose the situation and potential consequences.

We may be subject to damages resulting from claims that we or our
employees . . . , page 20

32. If you have been notified of a third party`s belief that your
employees have disclosed trade secrets or other proprietary
information of their former employers, please disclose the situation
and potential consequences, including identifying which of your
products may be affected.

The future sale of our common stock could dilute . . . , page 21

33. We note a number of your outstanding shares are subject to lock-up
agreements.  Please state the number of shares subject to lock-up
agreements and state when the agreements expire.

Special note regarding forward-looking statements, page 25

34. Please delete the statement that investors "should not unduly rely
on these forward-looking statements."  This statement may appear to be
a disclaimer of responsibility for the statements contained in your
filing.  It should be sufficient to state that actual results could
differ materially from the forward-looking statements.

Use of Proceeds, page 26

35. We note you plan to use some proceeds for research and development
activities.  Please disclose the specific amounts from your offering
proceeds that you intend to allocate for each project under
development.  Please also state your reasonable estimate as to which
stage of development you expect these proceeds will take you as to
each project.

36. We note you plan to relocate your Sunnyvale facility or lease
additional property.  If these actions will entail the acquisition of
assets, please provide the information required by Instruction 5 to
Item 504 of Regulation S-K.

37. Please identify with more specificity the uses that you currently
categorize as "other general corporate purposes," and state how much
of the proceeds you plan to put toward each such use.

Management`s Discussion and Analysis of Financial Condition and
Results of Operations

Results of Operations

Six months ended Jun