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SEC Company Response from CRYOCOR INC (CIK 0001125294) — Apr 5, 2005

CRYOCOR INC (CIK 0001125294)
Date: April 5, 2005 · CIK: 0001125294 · Accession: 0001193125-05-070178

AI Filing Summary & Sentiment

File numbers found in text: 333-123841

Date
April 5, 2005
Author
Cooley Godward LLP
Form
CORRESP
Company
CRYOCOR INC (CIK 0001125294)

Letter

VIA EDGAR Securities and Exchange Commission 450 Fifth Street, N.W. Washington, D.C. 20549-1004 Re: CryoCor, Inc. Registration Statement on Form S-1 (File No. 333-123841)

Dear Sir or Madam:

On behalf of CryoCor, Inc. (the “Company”), this letter is being provided supplementally in connection with the Company’s above-referenced Registration Statement on Form S-1 (the “Registration Statement”) relating to a proposed initial public offering (the “Offering”) of shares of the Company’s Common Stock. We are writing this letter as a courtesy to bring to the Staff’s attention an article (the “Article”) published by HMP Communications on March 3, 2005 in an issue of the EP Lab Digest. A reprint of the Article is attached for the Staff’s reference.

The Article was based on an interview given by Dr. Gregory M. Ayers, the Company’s Chief Executive Officer, on February 7, 2005, approximately one month prior to the publication of the Article. In December 2004, the Company began communicating with EP Lab Digest regarding a potential interview of Dr. Ayers because the Company planned to make a presentation regarding the CryoCor Cardiac Ablation System and the Company’s ongoing clinical trials for the treatment of atrial fibrillation at the AF (Atrial Fibrillation) Symposium in Boston, Massachusetts on January 14-15, 2005. Unfortunately, EP Lab Digest and Dr. Ayers were unable to schedule a mutually convenient time for the interview prior to the Symposium.

On January 26, 2005, Ms. Jodie Elrod, a reporter and editor of EP Lab Digest, again requested an interview with Dr. Ayers. Dr. Ayers agreed to give the interview with EP Lab Digest at that time, before the Company began pursuing any internal discussions relating to the Offering. Moreover, the interview took place before the Company held the organizational meeting with the proposed underwriters for the Offering.

According to its website (http://www.eplabdigest.com/eplab/), EP Lab Digest provides product, news and clinical updates for electrophysiology professionals and is designed to offer “both continuous education and a forum through which professionals share information on the best practices, the latest procedures, and ongoing concerns.” Generating awareness of, and informing and educating, electrophysiology lab professionals and physicians worldwide, regarding the Company’s technology and the advances the Company has made toward the treatment of Atrial Fibrillation and Atrial Flutter, the two most common and difficult to treat cardiac arrhythmias (which were the purposes of the Article), are crucial to the Company’s development for a number of reasons. These professionals have been, and continue to be, the primary referral sources for subjects for the Company’s pivotal trials studying the safety and efficacy of its technology in treating Atrial Fibrillation and Atrial Flutter, including the Company’s ongoing Atrial Fibrillation pivotal trial that is currently being enrolled. Enrolling appropriate subjects in that pivotal trial relatively quickly will obviously facilitate its more rapid completion. These professionals are also the primary potential users of the Company’s technology. The Article’s content was consistent with these critical purposes and largely limited to a discussion of the Company’s technology and its potential use in treating Atrial Fibrillation and Atrial Flutter.

In light of the timing, purpose and content of the interview and the Article, as well as the Article’s audience, the Company does not believe that the Article adversely impacts the Company’s obligations under the Securities Act of 1933, as amended, or the rules and regulations promulgated thereunder.

Securities and Exchange Commission

April 5, 2005

Page Two

If you have any questions regarding the Article or would like to discuss this further, please call me at (858) 550-6126 or Matt Browne at (858) 550-6045.

Sincerely,
Cooley Godward LLP

Show Raw Text
CORRESP
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filename1.htm

Correspondence

ATTORNEYS AT LAW

Broomfield, CO

720 566-4000

4401 Eastgate Mall

Palo Alto, CA

San Diego, CA

 650 843-5000

92121-1909

Reston, VA

Main         858 550-6000

 703 456-8000

Fax            858 550-6420

San Francisco, CA

April 5, 2005

www.cooley.com

415 693-2000

VIA EDGAR

JEFFREY T. HARTLIN

(858) 550-6126

Securities and Exchange Commission

jhartlin@cooley.com

Judiciary Plaza

450 Fifth Street, N.W.

Washington, D.C. 20549-1004

Re:
CryoCor, Inc.

 Registration Statement on Form
S-1 (File No. 333-123841)

 Dear Sir or Madam:

 On behalf of CryoCor, Inc. (the “Company”), this letter is being
provided supplementally in connection with the Company’s above-referenced Registration Statement on Form S-1 (the “Registration Statement”) relating to a proposed initial public offering (the
“Offering”) of shares of the Company’s Common Stock. We are writing this letter as a courtesy to bring to the Staff’s attention an article (the “Article”) published by HMP Communications on
March 3, 2005 in an issue of the EP Lab Digest. A reprint of the Article is attached for the Staff’s reference.

 The Article was based on an interview given by Dr. Gregory M. Ayers, the Company’s Chief Executive Officer, on February 7, 2005, approximately one month prior to the
publication of the Article. In December 2004, the Company began communicating with EP Lab Digest regarding a potential interview of Dr. Ayers because the Company planned to make a presentation regarding the CryoCor Cardiac Ablation System and
the Company’s ongoing clinical trials for the treatment of atrial fibrillation at the AF (Atrial Fibrillation) Symposium in Boston, Massachusetts on January 14-15, 2005. Unfortunately, EP Lab Digest and Dr. Ayers were unable to schedule
a mutually convenient time for the interview prior to the Symposium.

 On
January 26, 2005, Ms. Jodie Elrod, a reporter and editor of EP Lab Digest, again requested an interview with Dr. Ayers. Dr. Ayers agreed to give the interview with EP Lab Digest at that time, before the Company began pursuing any
internal discussions relating to the Offering. Moreover, the interview took place before the Company held the organizational meeting with the proposed underwriters for the Offering.

 According to its website (http://www.eplabdigest.com/eplab/), EP Lab Digest provides product, news and clinical updates for
electrophysiology professionals and is designed to offer “both continuous education and a forum through which professionals share information on the best practices, the latest procedures, and ongoing concerns.” Generating awareness of, and
informing and educating, electrophysiology lab professionals and physicians worldwide, regarding the Company’s technology and the advances the Company has made toward the treatment of Atrial Fibrillation and Atrial Flutter, the two most common
and difficult to treat cardiac arrhythmias (which were the purposes of the Article), are crucial to the Company’s development for a number of reasons. These professionals have been, and continue to be, the primary referral sources for subjects
for the Company’s pivotal trials studying the safety and efficacy of its technology in treating Atrial Fibrillation and Atrial Flutter, including the Company’s ongoing Atrial Fibrillation pivotal trial that is currently being enrolled.
Enrolling appropriate subjects in that pivotal trial relatively quickly will obviously facilitate its more rapid completion. These professionals are also the primary potential users of the Company’s technology. The Article’s content was
consistent with these critical purposes and largely limited to a discussion of the Company’s technology and its potential use in treating Atrial Fibrillation and Atrial Flutter.

 In light of the timing, purpose and content of the interview and the Article, as well as the Article’s audience, the Company does not
believe that the Article adversely impacts the Company’s obligations under the Securities Act of 1933, as amended, or the rules and regulations promulgated thereunder.

 Securities and Exchange Commission

 April 5, 2005

 Page Two

 If you have any questions regarding the Article or would like to discuss this further, please
call me at (858) 550-6126 or Matt Browne at (858) 550-6045.

 Sincerely,

 Cooley Godward LLP

 /s/ Jeff Hartlin

Jeff Hartlin

cc:
Gregory M. Ayers, M.D., Ph.D., CryoCor, Inc.

 Edward F.
Brennan, Ph.D., CryoCor, Inc.

 Gregory J. Tibbitts, CryoCor, Inc.

 Frederick T. Muto, Esq., Cooley Godward LLP

 Matthew T. Browne, Esq., Cooley Godward LLP

 NEWS BITS
Cardiovascular Screening Advised for Young Athletes Young athletes in Europe should be screened before competing in events to detect heart problems and reduce sport-related deaths, health experts said. A European Society of Cardiology report
recommends a physical examination, a complete medical history and an electrocardiogram (ECG), which provides an electrical recording of the heart. The report, which is published in the European Heart Journal, estimates that an ECG could cut heart
deaths linked to competitive sports in Europe by an estimated 50-70 percent. page 28 Genetic Breakthrough Could Make Pacemakers Obsolete Australian scientists said pacemakers could be obsolete within a decade after researchers managed to revive
heart tissue withered by cardiac arrests. The Sydney-based Children’s Medical Research Institute (CMRI) said the breakthrough involved injecting a virus containing two of the patients’ own genes into the scar tissue caused by heart attacks
known as fibroblasts. page 28 Medtronic Issues Notification Regarding Certain Importable Defibrillator Models Medtronic, Inc. said it is voluntarily advising physicians about a potential battery shorting mechanism that may occur in a subset of
implantable cardioverter defibrillator (ICD) and cardiac resynchronization there by defibrillator (CRT-D) models. In a letter physicians, Medtronic reported that nine batteries (0.01 percent, or approximately 1 in 10,000) have experienced rapid
battery depletion due to this shorting action. If shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function. There are no reported patient injuries or deaths. page 28 A PRODUCT,
NEWS AND CLINICAL UPDATE FOR THE ELECTRO PHYSIOLOGY PROFESSIONAL MARCH 2005 CryoCor’s Cardiac Cryoablation System and the Clinical Trial for Atrial Fibrillation: Interview with Dr. Gregory Ayers, Founder, President and CEO of CryoCor, Inc.
Interview by Jodie Elrod On February 7, 2005, EP Lab Digest spoke with CryoCor, Inc.’s Founder, President and CEO Gregory M. Ayers, MD, PhD, FACC to find out more information regarding the CryoCor Cardiac Cryoablation System and CryoCor
Clinical Trial for Atrial Fibrillation. Formed in Fall 2000, CryoCor, Inc. is headquartered in San Diego, California. First of all. I was very sorry to miss the presentation by former Senator Bill Bradley at CryoCor’s kickoff meeting before the
Boston Atrial Fibrillation meeting. What were some of the things he spoke about? For example, when was he diagnosed with AF? We brought Senator Bill Bradley in because we had been in contact for about a year, and as you may or may not be aware he
suffers from atrial fibrillation (AF). As a result of his AF, he actually backed out of the democratic primary in 1999. Therefore, we brought Senator Bradley to the meeting to describe the impact of atrial fibrillation on his life — to share
with the investigators and research coordinators how his life had been substantially altered by having AF and how he has been treated medically along the way. He is hopeful that our atrial fibrillation clinical trial will be able to show a curative
therapy that may help people like himself and have their AF cured and therefore no longer have it impact their life. At this meeting, the CryoCor™ Cardiac Cryoablation System, which is currently being evaluated in a FDA pivotal clinical trial,
was also discussed. I want to talk about the trial as well, but first, please describe how the system works. continued on page 6 Revolutionizing Treatment for AF: The MicroMaze Procedure Dudley Hudspeth, MD and Angela Szczublewski Desert
Cardiothoracic Surgeons Mesa, Arizona Dr. Dudley Hudspeth, a cardiothoracic surgeon who is located in Mesa, Arizona, describes how he has been using the MicroMaze procedure to cure atrial fibrillation in his patients. The procedure has been used at
several hospitals so far, including Banner Baywood Heart Hospital, Mesa General Hospital, as well as Banner Desert Medical Center. During the MicroMaze procedure, the physician begins by making four small incisions — about an eighth of an inch
each — into the patient’s chest. continued on page 10

 6 COVER STORY
MARCH 2005 INTERVIEW Continued from page 1 Independent of heat load, we can hit -90 degrees Celsius and hold this temperature because the console dynamically adjusts the driving pressure of the liquid nitrous. There are three components of our
system to treat AF in the electrophysiology lab. There is the console, which provides pre-cooled or liquid nitrous oxide to the catheter and controls its delivery to optimize the boiling process in the second component of the system, which is the
disposable catheter. The disposable catheter transfers the liquid nitrous oxide to the tip of the catheter — a metallic tip — that serves as a boiling chamber for the nitrous oxide. When N2O boils at the tip of the catheter, we achieve -90
degrees Celsius, freezing the tissue. The catheter also is a conduit for removing the spent refrigerant, which is nitrous oxide in the gaseous state. The console then receives the spent gaseous nitrous oxide. The third component of the system is a
sheath, which is a long tube that allows the EP physician to open and then maintain the opening of a small hole in the septum between the upper chambers (or atria) of the heart. Through that sheath, the physician is able to deliver our CryoCor
CryoBlator™ catheter into the left atrium to deliver the therapy for AF. The sheath is not under the clinical trial, per se, as it is 510k cleared; what is actually being tested is the console and the catheter with the indication of treating
atrial fibrillation. As I mentioned, the nitrous oxide boils in the tip of the catheter, under monitoring by the console to make sure that the boiling occurs under optimal conditions, to achieve and maintain the -90 degrees Celsius. The process is
actually pulling heat from the tissue, freezing the cell. When the cells are frozen, you end up with an acellular region with normal protein structures, inhibiting electrical conduction of any impulses that would have passed through that area.
Basically, to optimize this process, you have to first achieve a cold enough temperature to freeze the cell; equally as important is to maintain that temperature long enough to allow the cell to thoroughly freeze. How is the cryoablation system
unique from other systems currently available? What makes our system unique is that we have the power to do what I mentioned. Independent of heat load, we can hit -90 degrees Celsius and hold this temperature because the console dynamically adjusts
the driving pressure of the liquid nitrous. It is about thoroughly freezing the cell and what this results in is our system being considered a second-generation cryoablation system. This system is already CE Mark approved in Europe and has been
commercially available for use there since 2002. What have been the success rates there? First, it is a limited commercial use to collect additional clinical data, both for publication and also because the clinical data from Europe has allowed us
over the past couple of years to make critical modifications to our system. We wanted to make sure that the “average” user who is not being told exactly how to use the system, as is the case in a clinical trial, is able to use it and get
adequate clinical results. Regarding the success rates, it is somewhat variable by arrhythmia. For atrial flutter and ventricular tachycardias, we see results that are at least comparable to radiofrequency (RF) ablation. While I can’t make
these statements as a specific claim, I can tell you that 15 centers in Europe that have been using our system say their procedure times are less, the patients do not feel pain, their fluoro time is reduced, and they feel that the procedure is safer
with cryo. With respect to atrial fibrillation, our efficacy results are again at least equivalent to their experience with RF ablation. They see the same ability to diminish fluoroscopy time and diminish the pain to the patient during the
application. The procedure times are equivalent to maybe slightly longer than RF procedures. Most importantly, they see no substantive complications associated with the use of cryo for AF ablation. We have not seen in the 500-600 patients treated in
Europe over the past couple of years any substantial negative effects of cryo. We do not see stenosis, thromboembolic events, perforations, pericarditis, esophageal fistulas — we see none of the complications that are associated with RF energy.
It appears that since we do not affect extracellular proteins, we do not get a significant scarring effect — we just get rid of the cells. How many patients are enrolled in the clinical trial so far? How many sites are involved? When did
enrollment begin? The enrollment began in late December 2004. Over the period of December and early January, we had some sites with IRB approval to begin the study. We anticipate expanding that to 20–22 centers, similar to our flutter pivotal
trial that we completed in early November of last year. Therefore, these additional centers are beginning to get IRB approval and are getting ready to start enrollment. How long will the trial go for? When do you think you might hear from the FDA
about approval? Our anticipation is to complete enrollment in the year 2005, and then there is a 1-year follow-up period. I know we have not publicly disclosed the design of the study; the reason we have not disclosed it is because we are in what we
believe to be a competitively advantaged position — we are the only company enrolling today in a pivotal trial for AF, and for competitive reasons we do not want to disclose the design of our trial. So this trial for atrial fibrillation differs
from the one that was done last year for atrial flutter? Correct. I can fully disclose the See INTERVIEW page 8 Model 2020 Cryoablation Console Articulating CryoArm™ Precooler at end of the articulating arm optimizes system efficiency and
performance. CryoCor Model 2020 Cryoablation Console and Articulating CryoArm™.

 8 COVER STORY
MARCH 2005 The CryoBlator’s integrated articulation lever and locking brake facilitate precise catheter placement and easy fingertip control. Model 1200 Series Articulation Lengths (in centimeters) Catheter Tip Lengths (in millimeters) The
CryoCor CryoBlator catheter. INTERVIEW Continued from page 6 We are developing a catheter where a single catheter can be used to treat atrial fibrillation using a variety of clinical techniques in the EP lab. Through this new catheter, our main
objective is to be able to give the electrophysiologist a single tool in which they are able to reduce the procedure times from where they are today. design of the atrial flutter trial; there were 160 patients enrolled at 22 sites. Those sites
enrolled in the trial over a 10-month period of time, and enrollment was completed in late October. The atrial flutter trial has a six-month follow-up period. In addition, the trial design is identical to the most recently approved device from
Biosense Webster for their cooled-tip RF catheter. Our results look very promising. We are in the process of filing our modules for the PMA and anticipate our final module will be filed in late June. We would anticipate approval for this