SEC Comment Letter for CRYOCOR INC (CIK 0001125294) — Jun 20, 2005
CRYOCOR INC (CIK 0001125294)
Date: June 20, 2005 · CIK: 0001125294 · Accession: 0000000000-05-031015
AI Filing Summary & Sentiment
File numbers found in text: 333-123841
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June 17, 2005
Mail Stop 6010
Gregory M. Ayers, M.D., Ph.D.
Chief Executive Officer
CryoCor, Inc.
9717 Pacific Heights Blvd.
San Diego, California 92121
Re: CryoCor, Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed June 10, 2005
File No. 333-123841
Dear Mr. Ayers:
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
information so we may better understand your disclosure. After
reviewing this information, we may raise additional comments.
We welcome any questions you may have about our comments or
any
other aspect of our review. Feel free to call us at the telephone
numbers listed at the end of this letter.
Amendment No. 2 to Form S-1
Prospectus Summary, page 1
1. Please revise the discussion in the second paragraph to address
the fact that the anticipated filing of the application for
premarket
approval with the FDA for the treatment of AFL will be with your
CryoBlator catheter which was not used in the pivotal trial to
treat
any patients. Clarify that all patients in the pivotal trial for
AFL
were treated with either the Model 1100 or 1200 catheter, not the
CryoBlator catheter. Disclose that the company has recalled the
Model 1200 catheters from Europe and has removed them from
clinical
trial use under the Investigation Device Exemption previously
approved by the FDA.
Risk Factors, page 8
The FDA has expressed concern about many aspects of our clinical
trials..., page 12
2. In an appropriate place in your prospectus, please expand on
your
disclosure that the FDA has "expressed concerns" about many
aspects
of your clinical trials. Please be more specific about the
concerns
raised, when they were raised and the means by which the FDA
expressed these concerns. Disclose what steps, if any, the
company
has taken to address these concerns and what steps the company
plans
to take to resolve these issues.
Modifications to our cryoablation system and protocol during our
pivotal AFL trial..., page 12
3. Please revise the first sentence of the second paragraph to
clarify which "changes" were "granted regulatory approval" by the
FDA. Based on your current disclosure, it appears the FDA has
granted approval for submitting the AFL PMA with your CryoBlator
catheter instead of your Model 1100 or 1200 catheter. Please
revise
to clarify.
Business, page 48
U.S. Clinical Studies, page 64
4. We note your added disclosure on page 70. Please revise the
discussion in the section on page 65 discussing the AFL-02 Pivotal
Trial to identify the catheter used to treat the enrolled
patients.
Clarify that the catheters used to collect the data from the
clinical
trial, the Model 1100 and 1200 catheters, will not be the same
catheter used to submit the PMA application.
5. It appears from the disclosure on page 11 that the FDA has
advised
you that your chronic efficacy data will be considered an
important
factor for marketing approval and that it must meet the chronic
efficacy OPC for RF ablation. In light of this disclosure, it is
unclear why the similar disclosure that appears on page 66 is
based
only on the company`s "belief" rather than on information received
from the FDA. Please revise or advise.
Manufacturing, page 69
6. We note that you initiated a voluntary recall in Europe of
eight
lots of your Model 1200 catheter. Please revise to disclose how
many, if any, lots remain outstanding after the recall.
7. Please revise to describe the modifications made to the product
inspection criteria of the CryoBlator catheter.
8. Please revise to disclose when you received FDA approval to
include CryoBlator in your ongoing AF pivotal clinical trial.
Describe the mechanism through which FDA approval was acquired.
Consolidated Financial Statements, page F-1
Note 1. Summary of Significant Accounting Policies, page F-8
Revenue Recognition, page F-9
9. Please refer to prior comment 9 from our letter to you dated
May
25, 2005. In your disclosure you state that the consoles are
expensed upon shipment to the customer because there is no revenue
attributable to the console. Please revise your disclosure to
include the additional reasons that the consoles are expensed upon
shipment as stated in your response. That is, you have not
reclaimed
any of the consoles placed in the field and you have no intention
to
do so.
Note 4. Commitments and Contingencies, page F-16
Product Recall, page F-18
10. Please request your auditors to tell us why they did not
update
the opinion date for this note, as well as the portion of note 5
discussing the votes held by preferred shareholders in May 2005.
Note 5. Preferred Stock and Stockholders` Equity (Deficit), page
F-
19
Preferred Stock, page F-19
11. Please refer to prior comment 11 from our letter to you dated
May
25, 2005. We note the added disclosure in the last paragraph on
page
F-21. You state that the conversion of the preferred stock into
common stock is contingent upon the approval of the pricing
committee
of the Board of Directors, as well as the closing of the offering.
Please tell us whether or not the approval of the pricing
committee
will be completed prior to the date of effectiveness. If so,
please
modify the disclosure as appropriate to reflect their approval.
In
the alternative, please consider our prior comment concerning the
appropriateness of your pro forma presentations reflecting the
automatic conversion of the preferred shares into common shares if
there are still significant contingencies concerning the
conversion.
12. Please refer to prior comment 13 from our letter to you dated
May
25, 2005. Please tell us and disclose the value of the Series A
preferred stock and how you determined that value.
13. Please refer to prior comment 13 from our letter to you dated
May
25, 2005. We refer you to the calculation you provided to
determine
the incremental intrinsic value resulting from the antidilution
adjustments to the Series A, B and C preferred stock. Please tell
us
how you determined the amount related to the "FV of Common at
Preferred Issuance Dates," for each the Series A, B, and C
preferred
stock that you used to determine that there was no incremental
intrinsic value related to the antidilution adjustments. Please
also
tell us how you are calculating the amount to accrue for the
dividends and why. Please refer to Issue 10 of EITF 00-27.
* * *
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 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.
You may contact Traci Hornfeck at (202) 551-3642 or Kaitlin
Tillan, Assistant Chief Accountant, at (202) 551-3604 if you have
questions regarding comments on the financial statements and
related
matters. Please contact Eduardo Aleman at (202) 551-3646 or me at
(202) 551-3607 with any other questions.
Sincerely,
David Ritenour
Special Counsel
cc (via fax): Frederick T. Muto, Esq.
Matthew T. Browne, Esq.
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Gregory M. Ayers
CryoCor, Inc.
June 17, 2005
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