Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - CRYOLIFE INC | cryolife8k12110.htm |
| EX-99.1 - LETTER - CRYOLIFE INC | cryolife8k12110ex991.htm |
| EX-99.3 - BOOKLET - CRYOLIFE INC | cryolife8k12110ex993.htm |
| EX-99.4 - INSERT - CRYOLIFE INC | cryolife8k12110ex994.htm |
| EX-99.5 - PRESS RELEASE - CRYOLIFE INC | cryolife8k12110ex995.htm |
EXHIBIT
99.2
25
Years
Dear
Friends of CryoLife,
I first
heard about the cryopreservation of human heart valves (homografts) from Mary
Bowman, an Atlanta-based medical devices recruiter I had known for many years.
She told me that this technology was being used routinely at the University of
Alabama Medical School in Birmingham. Intrigued, I arranged a meeting with Dr.
Albert Pacifico, a pediatric cardiovascular surgeon, in the Cardiovascular
Surgery Department there.
During
our meeting, Dr. Pacifico told me why he felt that homograft valves were the
replacement of choice for children with congenital heart problems. He explained
that, unlike mechanical valves, the homograft valves did not require the use of
a blood thinner; they lasted longer than pig valves did in children; and, they
didn't have catastrophic failure modes like mechanical valves. The Alabama
preservation technique used antibiotics to reduce the bacteria on the valves and
DMSO as a cryoprotectant, and then the valves were frozen in liquid
nitrogen.
The
surgical techniques for transplanting human valves were developed
simultaneously, in 1967, in London, England by Mr. Donald N. Ross, F R.C.S, and
in Christ Church, New Zealand by Sir Brian Barrett-Boyes, F R.C.S. Both of these
surgeons became pioneers in the emerging surgical field of cardiac
reconstruction. Their development of the techniques to repair complex cardiac
abnormalities showed that human tissue valve transplants could be used by
surgeons to mimic and re-create the patient's anatomy. Both of these surgical
teams were using antibiotics to reduce the bacteria on the valves and then used
glycerol as a cryoprotectant agent prior to freezing the valves at liquid
nitrogen temperatures.
During
the fall of 1983, 1 contacted Bob McNally, a former colleague with whom I had
worked at Intermedics, Inc. Bob was living in Maidenhead, England and was
involved in clinical trials in Europe for new implantable medical devices. Bob
had a Ph.D. in Biomedical Engineering from The University of Pennsylvania and
was an expert in implantable medical devices. I asked him about Mr. Ross, the
chairman of cardiovascular surgery at the National Heart Hospital, and after
conducting additional research on the surgeon and initiating a literature search
on homograft valve transplantation, Bob and I decided that I should travel to
England and together we would contact Mr. Ross in an effort to learn more about
human heart valve transplantation.
Although
we were unable to see Mr. Ross, we did visit the homograft laboratory at
Harefield Hospital outside of London. The lab was located in one of
the open-air operating rooms that had been built for the survivors of Dunkirk –
in what we would call Quonset huts. I recall there were four or five
of them. We found two quite friendly ladies in one of the operating
rooms dissecting human hearts on a marble slab. The demonstrated how
to dissect an aortic valve and then showed us where the valves were stored in
antibiotics at room temperature in glass jars on metal bookcases. If the doctors
didn't use them within three weeks they were frozen in liquid nitrogen using
glycerol as a cryoprotectant. While we were there, we met Charles Yankah, M.D.,
a cardiovascular surgeon from Berlin, who was picking out the valves he was
going to implant later that week at the Berlin Heart Center.
It had
become apparent to us that the technology for preserving human heart valves was
unique, and that the patient benefits of human heart valves outweighed the
benefits of synthetic implantable devices by a considerable margin. The decision
was made to incorporate a company in January 1984, and Bob moved his family to
Bradenton, Florida, as I was living in Sarasota, Florida, at that time. Next, we
decided to hire a technician from the Alabama homograft laboratory and set up a
new small laboratory in Atlanta, Georgia, next to Hartsfield airport, which had
the most direct flights to major cities throughout the U.S.
In 1984,
we rented 2,400 sq. ft. in an industrial park near the Atlanta airport. After
additional research, we began preserving homograft heart valves and started
calling on cardiovascular surgeons throughout the U.S. In 1985, the first full
year we were in business, we had six employees and did about $900,000 in total
revenues.
In June
of 1993, I was introduced to Nick Kowanko, Ph.D., who was a chemistry professor
at Moorhead State Teachers College in Moorhead, Minnesota. Nick had invented a
very strong surgical adhesive that he wished to license to a medical products
company: The demonstration that he showed me was a compound that glued two
segments of filet mignon together instantly. He handed me the glued steak and
said, "pull the glue apart." Well, the bond did not break - but the steak tore
in half well away from the glue bond. I had seen a lot of surgery but I had
never seen a product like this. So Nick and CryoLife signed a license for the
development of this technology and ultimately BioGlue was introduced in Europe
in April of 1998.
Over the
past 25 years, as the company grew and matured, additional cardiovascular
products and technologies were added to the company's core business. The
development of the SynerGraft decellularization process, a process designed to
remove cells from tissues, pushed the company into the forefront of an emerging
implantable device technology called "tissue engineering."
Looking
back, I realize that 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. By our estimates, more than 160,000 tissues we
have preserved have been distributed for implantation.
There
have been almost 60,000 cardiac reconstructions performed using CryoLife
preserved cardiac tissues and more than half have been performed on children.
And, it is our estimate that more than 30,000 people have undergone limb saving
peripheral vascular surgery using a CryoLife preserved vascular graft. Since
BioGlue's successful introduction into European markets in 1998 and then into
the U.S. in 2001 this product has been used in 480,000 surgical procedures
around the world.
CryoLife's
25th anniversary booklet features a few of the patients who have had cardiac
reconstructive surgery using CryoLife preserved human tissues and, in some
cases, our surgical adhesives. Special bonds 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. We are humbled by their
courage and, at the same time, very proud to be an integral part of their
lives.
/s/
Steven G. Anderson
Steven G.
Anderson
Founder
and CEO
Atlanta,
Georgia
May,
2009
T (770)
419-3355
T (800)
438-8285 In the USA and Canada
F (770)
426-0031
1655
Roberts Boulevard NW
Kennesaw,
Georgia 30144
CryoLife.com