SEC Comment Letter for FOXHOLLOW TECHNOLOGIES, INC. (CIK 0001217688) — Apr 6, 2005
FOXHOLLOW TECHNOLOGIES, INC. (CIK 0001217688)
Date: April 6, 2005 · CIK: 0001217688 · Accession: 0000000000-05-016519
AI Filing Summary & Sentiment
File numbers found in text: 333-118191
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October 1, 2004
Robert W. Thomas
President and Chief Executive Officer
FoxHollow Technologies, Inc.
740 Bay Road
Redwood City, California 94063-2469
Re: FoxHollow Technologies, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed September 17, 2004
File No. 333-118191
Dear Mr. Thomas:
We have the following comments to your filing. 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.
General
1. Disclose the basis for your belief that "angioplasty may
cause
tearing of the artery wall and ...may contribute to high rates of
plaque regrowth...."
2. We note your response to comment 8. If you retain the
discussion in the summary and elsewhere characterizing the
SilverHawk
system as a "safe and effective alternative" and describing the
"principal benefits" of safety and efficacy, you should expand the
disclosure to clarify that there are no comparative studies to
substantiate your beliefs that your procedure is safer or more
effective than angioplasty or stenting.
3. Define "patency rate" in the summary.
4. Please balance your discussion of your results from TALON
to
include a discussion of TALON data as a percentage of total
treatments.
Risk Factors
We have no long-term data regarding the safety - Page 8
5. Please explain some of the reasons why you cannot provide
assurance that the data collected from the TALON registry will be
compelling to the medical community so that investors can know how
to
evaluate information from this registry. Also disclose why you
have
no plans to conduct long-term studies. In the previous risk
factor,
disclose how the absence of any long-term studies will negatively
impact market acceptance of the SilverHawk.
Our ability to market the SilverHawk in the United States -
Page
9
6. Please quantify the number of people who experienced
serious
adverse events in connection with the coronary artery trials in
this
risk factor. Do you face any potential liability with these cases
that should be disclosed in this risk factor?
The use, misuse or off-label use - Page 12
7. We note your response to comment 11. Revise the disclosure
to
discuss any increased liability you incur given the fact that, in
spite of the serious adverse consequences that occurred in the
U.S.
clinical trials, you continue to sell a version of the SilverHawk
in
the EU for use in coronary arteries that does not include product
enhancements to minimize such consequences.
Management`s Discussion and Analysis of Financial Condition
and
Results of Operations
Results of Operations
Six Months Ended June 30, 2003 and 2004
Net Revenue - Page 28
8. We note your response to prior comment 23. If material,
when
citing more than one factor in explaining a change in a financial
statement line item, the amounts of the individual factors cited,
including offsetting factors, should be separately quantified
unless
it is not practical to do so. For example, if material, please
expand
your disclosure to quantify the impact that increased selling
prices
had on increased net sales.
Market Overview - Page 38
9. Please supplementally support your statement about 750,000
people in the US suffering from CLI.
TALON Registry - Page 45
10. Please explain in the first paragraph in this section that
TALON data may not reflect the experiences of most physicians and
patients.
Single Center Experience - Page 46
11. Please explain what consulting services these physicians
provided to you. Please explain what "unrelated capacities" means.
12. State the number of physicians who are also consultants
and
who invested in the 2004 preferred stock financing and the amount
of
stock they purchased collectively.
Warrants - Page 72
13. If you believe that these warrants will most likely be
exercised prior to the offering, revise the disclosure to so
state.
Financial Statements
Note 7. Royalty Obligations - Page F-16
14. We note your response to prior comment 49. Please note
that
this information should be disclosed to your investors if the
royalty
obligations have been or are expected to be material to your
results
of operations. Please revise or advise.
Note 10. Stock Option Plans - Page F-20
15. We note your revised disclosure in response to prior
comment
51 indicating the January 2003 grant. We further note from
Attachment
B that no shares were granted to non-employees in 2003 until
March.
Please revise to reconcile.
16. We note your response to prior comment 52. Refer to your
summary options granted table on page F-23. Provide supplemental
details of your calculation of weighted-average exercise price per
share for options granted during the 2004 June quarter.
17. We note your response to prior comment 53. See summary
table
representing options outstanding as of June 30, 2004 on page F-22.
If
true, please revise column heading entitled "Options Exercisable"
to
read "Options Vested."
18. We note your response to prior comment 54. Please expand
your
disclosure to include a summary of the details included in your
response of your retrospective fair value determination. We
continue
to defer our final evaluation of the stock-based compensation
recognized until the estimated offering price is specified and the
reverse stock split is reflected in the filing.
19. In reference to Attachment B, provided in response to
prior
comment 54, please expand your disclosure to include the number of
options granted to non-employees for each period presented as well
as
a brief description of the transactions that resulted in their
issuances.
Exhibits
20. Please file Dr. Simpson`s consulting agreement as an
exhibit
to the filing.
Closing Comments
As appropriate, please amend your registration statement in
response
to these comments. You may wish to provide us with marked copies
of
the amendment to expedite our review. Please furnish a cover
letter
with your amendment that keys your responses to our comments and
provides any requested supplemental information. Detailed cover
letters greatly facilitate our review. Please understand that we
may
have additional comments after reviewing your amendment and
responses
to our comments.
We urge all persons who are responsible for the accuracy and
adequacy
of the disclosure in the filings reviewed by the staff to be
certain
that they have provided all information investors require for an
informed decision. Since the company and its management are in
possession of all facts relating to a company`s disclosure, they
are
responsible for the accuracy and adequacy of the disclosures they
have made.
Notwithstanding our comments, in the event the company requests
acceleration of the effective date of the pending registration
statement, it should furnish a letter, at the time of such
request,
acknowledging that:
* should the Commission or the staff, acting pursuant to delegated
authority, declare the filing effective, it does not foreclose the
Commission from taking any action with respect to the filing;
* the action of the Commission or the staff, acting pursuant to
delegated authority, in declaring the filing effective, does not
relieve the company from its full responsibility for the adequacy
and
accuracy of the disclosure in the filing; and
* the company may not assert this action as defense in any
proceeding
initiated by the Commission or any person under the federal
securities laws of the United States.
In addition, please be advised that the Division of Enforcement
has access to all information you provide to the staff of the
Division of Corporation Finance in connection with our review of
your
filing or in response to our comments on your filing.
We will consider a written request for acceleration of the
effective
date of the registration statement as a confirmation of the fact
that
those requesting acceleration are aware of their respective
responsibilities under the Securities Act of 1933 and the
Securities
Exchange Act of 1934 as they relate to the proposed public
offering
of the securities specified in the above registration statement.
We
will act on the request and, pursuant to delegated authority,
grant
acceleration of the effective date.
We direct your attention to Rules 460 and 461 regarding
requesting acceleration of a registration statement. Please allow
adequate time after the filing of any amendment for further review
before submitting a request for acceleration. Please provide this
request at least two business days in advance of the requested
effective date.
You may contact Cindy Dalton at (202) 824-5308 or in her absence,
Brian Cascio at (202) 942-1791, if you have questions regarding
comments on the financial statements and related matters. Please
contact Jay Mumford at (202) 824-5348 or me at (202) 942-1880 with
any other questions.
Sincerely,
Peggy Fisher
Assistant Director
cc (via fax): David J. Saul
Philip H. Oettinger
FoxHollow Technologies, Inc.
Robert W. Thomas
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