Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - CRYOLIFE INC | cryolife8k12110.htm |
| EX-99.1 - LETTER - CRYOLIFE INC | cryolife8k12110ex991.htm |
| EX-99.2 - LETTER - CRYOLIFE INC | cryolife8k12110ex992.htm |
| EX-99.4 - INSERT - CRYOLIFE INC | cryolife8k12110ex994.htm |
| EX-99.5 - PRESS RELEASE - CRYOLIFE INC | cryolife8k12110ex995.htm |
EXHIBIT 99.3
25 Y
E A R S
CELEBRATING
25 YEARS OF RESTORING PEOPLE’S LIVES.
|
CryoLife
|
“Looking
back, I realize it never crossed our minds that preserved human tissues and
cells and a surgical adhesive would have such an enormous effect on patients
throughout the world.”
Steven
G. Anderson, Founder, President, and CEO, CryoLife
CryoLife is a pioneer in the processing
and preservation of human cardiac and vascular homografts used in heart and
blood vessel reconstructive surgery.
CryoLife
preserved tissues have dramatically improved and enhanced the lives of tens of
thousands of patients. CryoLife’s 25th anniversary booklet features
five of these patients who have had heart reconstructive surgery using CryoLife
preserved human tissues and, in some cases, our surgical
adhesives. We are humbled by their courage and, at the same time,
very proud to be an integral part of their lives. Special
relationships were formed between these patients and doctors and we felt it
appropriate that they have the opportunity to tell their
stories. Their stories are the story of CryoLife.
|
[Picture
of small boy and doctor]
|
[Picture
of doctor and young man]
|
|
[Picture
of woman and man]
|
[Picture
of doctor and young man]
|
|
25
Y
E A R S
|
[Picture
of doctor and woman]
|
[Picture
of doctor and small boy]
caption:
Photo taken in San Antonio on January 14, 2009
|
patient:
surgeon:
|
CARSON
JOHN
P. KUPFERSCHMID, M.D.
|
procedure
date:
04.18.07
|
|
overview:
Carson
had a complex congenital heart defect consisting of an obstruction of the
outlet (pulmonary) valve from the right side of the heart to the lungs.
His first operation was a temporary shunt to the lung arteries as a very
small infant. At age nine months he had a second operation which
completely reconstructed the defect utilizing a CryoLife pulmonary
homograft valve. His mother states that following the repair it was as if
“someone had placed an Eveready® battery in Carson and left the switch in
a permanent on position.” He continues to do well two years after
surgery.
|
||
SynerGraft®
|
[picture
of lab tech]
|
[picture
of lab equipment]
|
[picture
of lab tech with test tube]
|
CryoLife’s
CryoValve® SG human heart valve, using the proprietary SynerGraft®
decellularization technology was cleared for use by the Food and Drug
Administration in February 2008.
CryoLife’s
patented SynerGraft technology is a process that is applied to human transplant
tissues to remove the donor cells and cellular remnants that can stimulate
antibody production without compromising the integrity of the support structures
of the human tissues.
The
SynerGraft technology falls under the umbrella of a new scientific frontier that
includes “tissue engineering.” From the perspective of CryoLife’s
management, this technology and decellularized human tissues pave the way to a
technology revolution in future implantable medical devices.
In the
future, it is likely that modified tissues from animals (xenografts) will form
the basis of biological implants such as heart valves and vascular tissues that
will remodel themselves in
vivo into the patient’s own tissues.
|
patient:
surgeon:
|
CHRISTOPHER
JOHN
LAMBERTI, M.D.
|
procedure
date:
03.17.08
|
|
overview:
Christopher
had a congenital heart defect consisting of an obstruction of the outlet
(aortic) valve from the left side of the heart to the body. Two balloon
dilatations were done during infancy to temporarily open the valve. At age
ten months, his diseased valve was surgically replaced with a CryoLife
aortic homograft valve. At age six, he underwent a Ross Procedure, where
his own outlet (pulmonary) valve from the right side of the heart to the
lungs was used to replace the aortic homograft valve. A CryoLife pulmonary
homograft valve was used to replace his pulmonary valve. At age 17, an
aneurysm of his aorta was repaired and his pulmonary homograft valve was
re-replaced with another CryoLife pulmonary homograft valve.
Chris
is now a high school senior in San Diego. He is 6 feet 3 inches tall and
190 pounds. In the fall, he was the leading receiver on his football team.
He was voted to the second team all-league in the San Diego County
Southern Football League. Now he is averaging 16.2 points per game on his
high school basketball team.
|
||
CryoValve®
SG
|
[picture
of doctor in operating room]
|
[picture
of lady]
|
[picture
of doctor in operating room]
|
In
2000, Candy Murray (center) became the first recipient of the CryoValve
SG.
CryoValve
SG is a human pulmonary heart valve processed using CryoLife’s patented
SynerGraft technology. More than 1,900 human pulmonary valves treated with the
SynerGraft process have been transplanted into patients throughout North America
since 2000. The CryoValve SG human pulmonary heart valve was cleared by the FDA
in February 2008.
In
February 2009, the FDA approved a new claim for the CryoValve SG pulmonary heart
valve. The new labeling claim relates to reducing a component of the immune
response in recipients of this valve.
Pulmonary
valves preserved by this process are most commonly used in complex cardiac
reconstruction procedures such as the Ross Procedure or right ventricular
outflow tract (RVOT) reconstruction.
[Picture
of young man and doctor]
caption: Photo
taken in San Diego on January 19, 2009
[Picture
of woman and doctor]
caption: Photo
taken in Oklahoma City on January 13, 2009
|
patient:
surgeon:
|
JAYCEE
RONALD
C. ELKINS, M.D.
|
procedure
date:
05.15.89
|
|
overview:
Jaycee
had a complex congenital heart defect consisting of several abnormalities
including an obstruction of the outlet (pulmonary) valve from the right
side of the heart to the lungs and underdevelopment of the main lung
arteries. At age four months, she had her first operation to enlarge the
lung arteries. Two more surgeries were necessary and, at four years old,
her fourth operation consisted of an implantation with a CryoLife
pulmonary homograft valve and artery. A fifth operation at age 18 required
replacement of her pulmonary homograft valve, however, the homograft
artery is still in place and functioning well.
|
||
BioGlue®
|
[picture
of BioGlue applicator]
|
[picture
of BioGlue applicator]
|
BioGlue
is the #1 surgical adhesive used for cardiac surgery in the world.
BioGlue,
a protein-based two component surgical adhesive, represents the Company’s first
protein hydrogel technology (PHT) product to be commercially introduced into
world markets. Since its introduction in international markets in 1998 and the
U.S. market in 2001, BioGlue has been used in more than 480,000 surgical
procedures worldwide.
|
patient:
surgeon:
|
PAUL
JOHN
D. OSWALT, M.D.
|
procedure
date:
10.29.07
|
|
overview:
Paul
had a congenital heart defect consisting of an obstruction of the outlet
(aortic) valve from the left side of the heart to the body. At age 18 he
underwent a Ross Procedure, where his own outlet (pulmonary) valve from
the right side of his heart to his lungs was used to replace his diseased
valve. A CryoLife pulmonary homograft valve was used to replace his
pulmonary valve. He is now a fully active 19 year-old student of space
physics.
|
||
HemoStase™
|
[lab
picture]
|
[lab
picture]
|
[lab
picture]
|
HemoStase
has a proven safety record, is easy to use, and has been shown effective in a
wide range of surgical procedures.
HemoStase
is a natural hemostatic product used for the control of surgical bleeding.
Available in a convenient ready-to-use applicator, HemoStase, unlike many
hemostatic agents, does not require additional operating room preparation or
special storage conditions. In addition, pre-clinical studies have shown that
HemoStase does not promote infection and absorbs within 24-48 hours of
application at the wound site, compared to other surgical hemostats which can
take three or more weeks to fully break down.
[Picture
of doctor and young man]
caption: Photo
taken in Austin, Texas on February 17, 2009
[Picture
of doctor and woman]
caption: Photo
taken in New York City on January 22, 2009
|
patient:
surgeon:
|
SUE
PAUL
STELZER, M.D.
|
procedure
date:
12.22.07
|
|
overview:
Sue
had the outlet (aortic) valve from the left side of her heart to her body
replaced with a valve constructed from animal tissue (xenograft) in 2001.
This prosthetic valve became infected, including some of her heart tissues
to which the valve was attached. At her second operation, the prosthetic
valve and a significant amount of her infected and destroyed heart tissue
was removed. The remaining defect in her heart was completely
reconstructed with a CryoLife aortic homograft valve. She recovered
completely and has fully returned to her active life, despite her
significant pre-existing disability with a connective tissue
disorder.
|
||
BioFoam®
|
[Picture
of BioFoam applicator]
|
[Picture
of doctor]
|
Over
the past four years we have received $5.4 million from the Department of Defense
for the development of BioFoam.
BioFoam
Surgical Matrix is a spin-off from CryoLife’s protein hydrogel technology
platform. Based on the same technology as BioGlue, it contains an expansion
agent which generates a mixed-cell foam that increases in volume by a factor of
three. Developed in conjunction with the U.S. Department of Defense, the foam
creates a mechanical barrier to decrease blood flow and pores for the blood to
enter, leading to enhanced hemostasis. Regulatory approvals are pending for use
in liver parenchymal sealing. The Company plans to continue conducting research
with BioFoam for future use in trauma surgery.
The
Science
of
CryoLife
|
[Picture
of doctors]
|
[Picture
of medical device]
|
[Picture
of medical device]
|
Steven
Goldstein, Ph.D. and K. Umit Yüksel, Ph.D., are the developers of the
SynerGraft® Process and BioGlue®
Our
biomaterials technology and product development group is primarily involved with
the translation of existing core technology platforms into medical devices to
meet a variety of clinical needs. The current product focus is directed at the
development of animal tissue derived devices employing adaptations of the
Company’s decellularization technologies. The group also investigates
opportunities to improve existing operational processes by assessing,
developing, refining, and integrating new or emerging technologies.
Opportunities for more effective homograft tissue decontamination processes,
improvements to tissue cryopreservation, and a variety of processing initiatives
are under evaluation.
[Picture
of doctors]
caption: Steven
Goldstein, Ph.D. and K. Umit Yüksel, Ph.D. Photo taken at CryoLife
headquarters on October 9, 2008
[Picture
of doctors]
caption: William
F. Northrup III, M.D. and Prof. Sir Magdi Yacoub, F.R.S, F.R.C.S conduct a wet
lab on the Ross Procedure with the Root Technique. Photo taken on
October 10, 2008, during the Ross Summitt.
Educational
Programs
for
Surgeons
|
[Picture
of Mr. Donald N. Ross, F.R.C.S.]
|
[Picture
of doctors]
|
Mr.
Donald N. Ross, F.R.C.S. was an honored guest during The Ross Summit
2008
CryoLife
has made a significant commitment to partner with various academic training
programs and cardiac surgical societies and associations in their new Thoracic
Surgery Education Reform Initiative. Specifically, the Company is building an
educational program for surgeons focused on advanced techniques for heart and
blood vessel reconstruction.
This
program is directed by William F. Northrup III, M.D., Vice President of
Physician Relations and Education. Dr. Northrup conducts monthly surgical
workshops at the Company’s corporate headquarters focused on the implant
techniques for aortic homografts as a platform for developing expertise in all
surgical procedures of the aortic root.
THE ROSS
SUMMIT
The
Company’s educational highlight of each year is the Ross Summit that is held at
Company headquarters in the fall. The conference focuses on the Ross Procedure
and related operations. The faculty is comprised of cardiac surgeons,
cardiologists and basic scientists from major universities and important
academic and community programs from around the world who assemble once each
year to exchange ideas and surgical techniques related to their
specialties.
Since
the inception of the Company in
1984,
CryoLife has preserved tissues
from
more than 100,000 donors.
Donor
Services
|
[Picture
of man and boy]
|
[Picture
of woman and child]
|
[Picture
of man, woman and child]
|
More
than half of the cardiovascular tissues CryoLife preserves are used in the
complex cardiac reconstruction procedures performed in children and young adults
throughout North America.
The
donation of organs and tissues is the most generous gift a family can give.
CryoLife is cognizant of the trust these families have placed in the Company to
preserve the tissues of their loved ones to benefit those patients who are most
in need. CryoLife works with about 70 organ procurement groups and tissue banks
throughout the U.S. who are committed to the life-saving and life-enhancing
benefits of tissue donation through transplantation. The goal is to maximize
opportunities for donated tissue to benefit those patients in need.
The
Company’s advanced cryopreservation and decellularization technologies have made
CryoLife a worldwide leader in tissue preservation techniques that improve and
enhance clinical outcomes. Since the inception of the Company in 1984, CryoLife
has preserved tissues from more than 100,000 donors. It is believed that more
than 160,000 tissues have been distributed for implantation in patients
throughout North America and Europe.
[Picture
of man and boy]
We do not
practice or render medicine or provide or render medical services or advice and
the information contained in this booklet should not be considered medical
advice. You should always talk to your health care professional for diagnosis
and treatment. To the extent you are a medical professional, this booklet is
provided for your information and education only and is not to be used as a
substitute for your medical judgment. The individuals pictured in this book are
recipients of CryoLife processed tissue or their implanting surgeons. Please
note that results may vary.
CryoLife,
CryoLife logo, SynerGraft, CryoValve, BioGlue, BioFoam, HemoStase are trademarks
of CryoLife, Inc. Eveready is a registered trademark of Eveready
Battery Company, Inc. © CryoLife, Inc. 2009. All rights reserved.
 |
1655
Roberts Boulevard, NW • Kennesaw, Georgia 30144
Phone
800.438.8285 • Fax 770.590.3753 • CryoLife.com
|