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Using Cardica’s Automated Anastomosis
Systems For Coronary Artery Bypass Graft (CABG) Surgery, Surgeons Are Now
Able To Replace Hand Sewing
Healthcare
Medical Instruments & Supplies
(CRDC-NASDAQ)
Cardica Inc.
900 Saginaw Drive
Redwood City, CA 94063
Phone: 650-364-9975
Dr. Bernard A. Hausen, M.D., Ph.D.
Co-Founder, President and CEO
Interview conducted by:
Lynn Fosse, Senior Editor
CEOCFOinterviews.com
Published – March 7, 2008
BIO:
Bernard A. Hausen, M.D., Ph.D.
President,
Chief Executive Officer and Co-Founder
Bernard A. Hausen, M.D., Ph.D. has been President and Chief Executive
Officer of Cardica since December 2000. Dr. Hausen co-founded the Company in
October 1997 and has served as a director and Chief Medical Officer since
inception. Dr. Hausen received a medical degree from Hannover Medical School
in Germany in 1988 and was trained there as a general and cardiothoracic
surgeon. Upon completion of his training, he received a Ph.D. degree in
Medical Physiology in 1999. From 1996 to 2000, he was employed as a Senior
Research Scientist in the Laboratory for Transplantation Immunology of the
Department of Cardiothoracic Surgery at Stanford University. Until Dr.
Hausen became a full-time employee of Cardica in October of 2000, he
remained responsible for all surgery-related research in that laboratory.
Company Profile:
Cardica is a leading provider of
automated anastomosis systems for coronary artery bypass graft (CABG)
surgery. By replacing hand-sewn sutures with easy-to-use automated systems,
Cardica's products provide cardiovascular surgeons with rapid, reliable and
consistently reproducible anastomoses, or connections of blood vessels,
often considered the most critical aspect of the CABG procedure. Cardica's
C-Port® Distal Anastomosis Systems are marketed in Europe and the United
States. The PAS-Port® Proximal Anastomosis System is marketed in Europe and
Japan and is being evaluated in a pivotal trial in the United States and
Europe. Cardica also is developing additional devices with Cook Incorporated
to facilitate vascular closure and other surgical procedures.
CEOCFO: What was your vision when you
founded Cardica and where are you today?
Dr. Hausen: “I am a cardiac surgeon by
training. One of the things that always struck me as odd in cardiac surgery,
as compared to other surgical interventions, is that we have not been as
aggressive in providing our patients with less invasive procedures
especially in coronary bypass grafting. Today nobody has their knee cut open
during knee surgery, and hernia repair is done laparoscopically. But
coronary bypass procedures, of which about a quarter of a million are done
in the US each year, are typically done by splitting open the sternum. I
thought there must be a way these cardiac procedures could be done less
invasively.
I observed early attempts at minimally invasive CABG by Heartport in the
90’s, but the procedure did not work as well as hoped due to the difficulty
of completing the anastomosis by hand suturing through small openings in the
chest called ports. I thought it would be beneficial to develop an
anastomotic device that could connect blood vessels without the need to hand
sew them – that would connect the vessels by pushing a button or turning a
knob and thereby greatly facilitating and enabling a truly less invasive
procedure. That was ten years ago.
More recently Intuitive Surgical developed a
robot to allow the surgeon to perform minimally invasive surgical procedures
but even with this new system, there were limitations in suturing the
anastomosis with the robot.
Today surgeons use our C-Port® Distal Anastomosis Systems for these CABG
procedures and find them to be truly enabling. Surgeons are now able to do
procedures that they either could not do even with the robot or that they
can do much quicker and with a better outcome. At the same time, the
anastomotic technology is being used for open chest surgical procedures to
replace hand sewing even with the sternum split. That is where the majority
of our revenue comes from today. Surgeons who typically would sew the
vessels together now use our devices to connect blood vessels. This results
in a much more consistent and reliable reproducible result than with manual
techniques.”
CEOCFO:
Tell us about your device; what are you providing for surgeons?
Dr. Hausen: “Our C-Port anastomotic
device is a stapler -- a small cartridge connected to a handle that
activates the cartridge and deploys 13 staples circumferentially around a
graft, and thereby attaches the graft to the target vessel, which is
typically the coronary artery. The surgeon preps the graft, which is a vein
or artery from the chest, and attaches it to the cartridge, dissects the
coronary artery and then makes an incision and inserts our device into the
coronary artery and presses a button. Virtually within a few seconds, the
graft is connected to the coronary artery by means of these staples.”
CEOCFO: How
much of the potential medical community is using the device and how do you
get more surgeons to want it?
Dr. Hausen: “We only recently started
selling our C-Port system, so only a small percentage of surgeons are
currently using our devices, but that number is growing. The way to get
surgeons to adapt a technology is to educate them about the improved
outcomes. We have the best patency rates ever published for a vein graft
with long-term follow-up. We educate surgeons typically at conventions such
as the Society of Thoracic Surgeons convention, which recently took place in
Fort Lauderdale, Florida. At that conference, we had speakers,
presentations, symposia, workshops and a booth where we educated surgeons
about how our C-Port anastomotic devices connect blood vessels. Many
surgeons that have a specialty in cardiac surgery first had to undergo
general surgical training or residency where they were exposed to stapling
devices that have been around for about 20 years to attach the bowel or
other types of intra-abdominal procedures. They are familiar with the basic
concept of staples being used to connect tubular structures. What is special
about what Cardica has done is we have miniaturized that to a scale that
first seemed hard to obtain. Our staples are 0.5 millimeters in width –
difficult to see with the naked eye. Because a typical coronary artery is 1
to 3 millimeters in internal diameter, surgeons must get comfortable with
the application of familiar technology on a different scale. Therefore, we
have focused our efforts on educating them about a technology that connects
vascular structures.”
CEOCFO: Do
the surgeons realize the need for something better or do they need
convincing?
Dr. Hausen: “Many surgeons with vision
understand that if they want to compete with coronary stenting they need to
use a product that is far less invasive, such as our automated anastomosis
products.
Following a typical CABG procedure in which the sternum is split, patients
are immobilized for many months before they can be reintroduced into normal
everyday life because the procedure causes pain, instability and
insecurity. Often, the patient is put on a heart bypass machine, which
further drains their energy. With our C-Port devices, the CABG procedure
can be done without splitting the chest, by using only small incisions in
the chest wall. As a result, the patient is often able to leave the hospital
in one or two days and resume normal activity within a week. This represents
a dramatic change in the patient’s postoperative course.
Because connecting the blood vessel is such a critical part of the CABG
procedure, surgeons need to gain confidence that our technology offers them
results that are comparable to – or even better than -- those obtained by
hand-sewing the vessels. We have been able to document these benefits and
therefore have seen surgeons adopt our technology. Surgeons who are
aggressive and adopt new technology that is safe and effective are the ones
who are most successful in business.”
CEOCFO: Are
you able to work with and through groups like the American Heart
Association?
Dr. Hausen: “Yes. At the recent Society
of Thoracic Surgeons annual meeting, Cardica’s technology was used to train
young residents and attendings in modern surgical practices through STS
University. This course was a great success and gave us exposure to
experienced faculty and surgeons. The American Thoracic Society endorsed our
technology in a recent presidential address in which the departing president
made it clear that in order for cardiac surgery to survive, surgeons need to
evaluate and adopt new technologies and aggressively pursue less invasive
approaches. That is a great endorsement for Cardica. Also, there is a large
market for our technology. About a quarter million CABG procedures are done
in the US each year, and each one requires approximately five vessel
connections – representing over 1 million connections. Because Cardica is
the only company currently working in this space and providing these
anastomotic devices, we are the only place to go if a surgeon is interested
in using this new technology.”
CEOCFO: Is
cost a big factor in implementing the system?
Dr. Hausen: “Healthcare costs are
spiraling and hospitals are trying to be profitable so everything that gets
added to a procedure is eyed very carefully. The way to address that is to
show cost savings, and we have been able to do that. At the recent Society
of Thoracic Surgeons annual meeting, a surgeon from Genesis Medical Center
presented results from a cost analysis demonstrating how much money
Cardica’s technology is saving the hospital. Genesis Medical Center was
convinced by the data and has approved significant budgets to acquire
Cardica’s technology for that surgeons’ daily practice.”
CEOCFO: Are
your products also available in Europe and Japan?
Dr. Hausen: “Our C-Port Distal
Anastomosis Systems are marketed in Europe and the United States, and our
PAS-Port® Proximal Anastomosis System is marketed in Europe and Japan and is
being evaluated in a pivotal trial in the United States and Europe.”
CEOCFO:
Tell us a little about your products.
Dr. Hausen: “During a bypass grafting,
typically two ends must be connected like a water hose – the aorta, which is
the largest blood vessel, and the small coronary artery. These are very
different types of connections, and we have two different products to
connect either end. The one to the aorta is the PAS-Port system, a large
vessel connector. Our C-Port system is a very small vessel connector and
connects the other end. These two products together provide the surgeon with
a systematic approach to mechanical coupling of blood vessels. We also
recently launched our new C-Port xA X-CHANGE Distal Anastomosis System in
the United States. The C-Port xA X-CHANGE system is a cartridge-based,
reloadable C-Port system that allows surgeons to attach multiple blood
vessel grafts using the same handle during a CABG procedure, which may
reduce costs.”
CEOCFO:
What is the financial picture for the company?
Dr. Hausen: “We are in a sound financial
position. We have raised over $100 million to date. We became a public
company in February 2006 and have just completed a secondary offering that
puts us in a favorable cash position. We have over $30 million in cash and
our sales are growing sequentially quarter over quarter. We are using our
funds to increase our sales force and therefore the revenue stream, and to
continue our product iterations and get more products on the market.”
CEOCFO: In
closing, why should investors pick Cardica out of the crowd?
Dr. Hausen: “For one, our C-Port
anastomotic system is proven to improve outcomes as assessed by vessel
patency rates. Two, we are in a billion dollar market and are the only
player in this market. Because of the regulatory environment and the time
involved in entering this market, we are protected from competition, as it
would take five to seven years for a competitor to enter the market. Three,
there is a lot of excitement about Cardica in the public market because we
can leverage our technology outside of vascular connections into other areas
in which staples are used to connect tissue. This is because our specialty
is to miniaturize the technology of stapling, giving us an edge over
potential competitors and allowing us to grow not just in the area of
coronary artery bypass surgery, but in other surgical areas.”
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“Today surgeons use our C-Port® Distal Anastomosis
Systems for these CABG procedures and find them to be truly enabling.
Surgeons are now able to do procedures that they either could not do even
with the robot or that they can do much quicker and with a better outcome.
At the same time, the anastomotic technology is being used for open chest
surgical procedures to replace hand sewing even with the sternum split. That
is where the majority of our revenue comes from today. Surgeons who
typically would sew the vessels together now use our devices to connect
blood vessels. This results in a much more consistent and reliable
reproducible result than with manual techniques.” - Dr. Bernard A. Hausen,
M.D., Ph.D.
“Following a typical CABG procedure in which the sternum is split, patients
are immobilized for many months before they can be reintroduced into normal
everyday life because the procedure causes pain, instability and
insecurity. Often, the patient is put on a heart bypass machine, which
further drains their energy. With our C-Port devices, the CABG procedure
can be done without splitting the chest, by using only small incisions in
the chest wall. As a result, the patient is often able to leave the hospital
in one or two days and resume normal activity within a week. This represents
a dramatic change in the patient’s postoperative course.” - Dr. Bernard A.
Hausen, M.D., Ph.D.
“Our C-Port anastomotic device is a stapler -- a small cartridge connected
to a handle that activates the cartridge and deploys 13 staples
circumferentially around a graft, and thereby attaches the graft to the
target vessel, which is typically the coronary artery. The surgeon preps the
graft, which is a vein or artery from the chest, and attaches it to the
cartridge, dissects the coronary artery and then makes an incision and
inserts our device into the coronary artery and presses a button. Virtually
within a few seconds, the graft is connected to the coronary artery by means
of these staples.” - Dr. Bernard A. Hausen, M.D., Ph.D. |
