cryolife8k12110.htm
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
washington,
d.c. 20549
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported): January 21,
2010
_______________________
CRYOLIFE,
INC.
(Exact
name of registrant as specified in its charter)
_________________________
Florida
|
1-13165
|
59-2417093
|
(State
or Other Jurisdiction
of
Incorporation)
|
(Commission
File Number)
|
(IRS
Employer
Identification
No.)
|
1655
Roberts Boulevard, N.W., Kennesaw, Georgia 30144
(Address
of principal executive office) (zip code)
Registrant's
telephone number, including area code: (770) 419-3355
_____________________________________________________________
(Former
name or former address, if changed since last report)
_________________________
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions (see General Instruction
A.2. below):
x
|
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
|
q
|
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
o
|
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
|
o
|
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
|
Section 8 Other Events
Item 8.01 Other Events.
On January 21, 2010, CryoLife, Inc.
(“CryoLife”) mailed a package to the shareholders of Medafor, Inc. (“Medafor”)
in relation to its proposal to combine the two companies. The package
included a letter to the Medafor shareholders, an introductory letter to
CryoLife’s 25th
Anniversary booklet, CryoLife’s 25th
Anniversary booklet, and an insert addressing compliance with Rule 165
promulgated under the Securities Act of 1933, as amended, all of which are
attached hereto as Exhibits 99.1, 99.2, 99.3 and 99.4,
respectively. CryoLife also issued a press release dated January 21,
2010, attached hereto as Exhibit 99.5, in conjunction with the
mailing. The documents are available at www.cryolife.com/medaforoffer
or have otherwise been disseminated by CryoLife.
This filing and the exhibits are
provided for informational purposes only and are not offers to purchase nor a
solicitation of offers to sell shares of Medafor or CryoLife. Subject to future
developments, CryoLife may file a registration statement and/or tender offer
documents and/or proxy statement with the SEC in connection with the proposed
combination. Shareholders should read those filings, and any other
filings made by CryoLife with the SEC in connection with the combination, as
they will contain important information. Those documents, if and when
filed, as well as CryoLife’s other public filings with the SEC, may be obtained
without charge at the SEC’s website at www.sec.gov and at CryoLife’s website at
www.cryolife.com.
Section
9 Financial
Statements and Exhibits
Item
9.01(d) Exhibits.
(a)
Financial Statements.
Not applicable.
(b) Pro
Forma Financial Information.
Not applicable.
(c) Shell
Company Transactions.
Not applicable.
(d)
Exhibits.
Exhibit
Number Description
99.1
|
Letter
to Medafor, Inc. Shareholders dated January 21,
2010
|
99.2
|
Introductory
Letter to CryoLife’s 25th
Anniversary Booklet dated May 2009
|
99.3
|
CryoLife,
Inc. 25th
Anniversary Booklet dated May 2009
|
99.4
|
Insert
addressing compliance with Rule 165 promulgated pursuant to the Securities
Act of 1933, as amended
|
|
|
99.5
|
Press
Release dated January 21, 2010
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, CryoLife, Inc. has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
|
CRYOLIFE,
INC. |
|
|
|
|
|
|
|
|
|
|
|
|
|
Date:
January 21, 2010
|
By:
|
/s/ D.A.
Lee |
|
|
Name: |
D.
Ashley Lee |
|
|
Title: |
Executive
Vice President, Chief |
|
|
|
Operating
Officer and Chief |
|
|
|
Financial
Officer |
|
cryolife8k12110ex991.htm
EXHIBIT
99.1
Important
Information for Medafor Shareholders
January
21, 2010
Dear
Fellow Medafor Shareholder:
You have
probably seen the headlines regarding CryoLife’s increased stake in Medafor and
our proposal to the Medafor board of directors to combine our two
companies. I wanted to take this opportunity to personally explain
why we have taken this action, why our proposal is financially and strategically
compelling, and what you can do to make your opinion heard.
We have
great regard for Medafor’s MPH® polysaccharide hemostatic technology, and we
believe it has significant, untapped growth potential. CryoLife
currently has the exclusive right to distribute this technology under the
private label HemoStase® within the U.S. for use in cardiac and vascular
surgery, and in many international markets for cardiac, vascular, and general
surgery, subject to certain exclusions. As Medafor’s largest
distributor, CryoLife achieved $6 million in sales of
HemoStase in 2009.
Unfortunately,
we do not believe that Medafor has the resources to maximize the potential of
this exciting technology on its own given the capital and other constraints
facing the company. At the same time, we believe it is critical that
Medafor fully develop this technology in order for Medafor shares to realize
their full potential value. We have acquired a large stake in Medafor
as a first step in our efforts to combine CryoLife and Medafor, drive additional
growth of HemoStase and related products, and deliver earnings and revenue
growth for CryoLife and Medafor shareholders.
CryoLife
and Medafor: A Strong Strategic Fit
We
believe that Medafor’s hemostatic technology serves as a perfect complement to
CryoLife’s product portfolio, particularly our BioGlue® technology. A
combination of our companies would allow us to offer surgeons a full range of
products to assist them in controlling and preventing bleeding. CryoLife’s
financial strength (positive cash flow and positive earnings growth), strong
direct sales force (45 direct sales representatives in the U.S. and direct sales
forces in the United Kingdom and Germany), international distribution network,
and experienced management team would allow us to drive additional growth of
Medafor beyond its current capabilities, and create greater value for all
shareholders.
Combination
of CryoLife and Medafor: Our Proposed Offer
On
January 13, 2010, we sent a letter to Medafor’s board of directors proposing to
acquire all of Medafor’s remaining outstanding shares for $2.00 per share, to be
paid in cash and stock, subject to completion of reasonable due
diligence. We believe the price we are offering is full and fair. In
fact, it represents a significant premium to that which we understand Medafor’s
management and board have recently offered to convert debt into equity, and is
equivalent to the value at which recent stock transactions have taken
place. It is also in line with the valuations of comparable public
companies and with recent comparable publicly-disclosed M&A
transactions.
While we
believe our initial proposal is a strong one, we welcome
further dialogue and are open to negotiation with the Medafor
board. As we indicated in our recent communication to Medafor, we do
not have the most current information regarding Medafor and its prospects, and
we are willing to negotiate in good faith to determine Medafor’s appropriate
value.
Negotiations
with the Medafor board would also allow us to determine the right mix of cash
and stock. We believe a cash/stock offer is appropriate and
attractive, as the cash component would provide Medafor shareholders with
immediate and certain value, while the stock portion would allow shareholders to
participate in future upside through continued ownership of the combined
company. We think the prospects for CryoLife are strong and that
Medafor shareholders will be able to realize additional value by owning our
stock. It is also important to note that ownership of CryoLife stock
would provide you with further liquidity, as you would be able to trade this
stock on the New York Stock Exchange. That said, given the current
economic climate, we recognize that cash may be more important to some
shareholders, and we are therefore prepared to evaluate how to best address
this.
Medafor’s
board has to date refused to enter into negotiations regarding our
proposal. Their refusal to
enter into discussions with us hurts Medafor shareholders as it impedes
your ability to receive a fair price for your shares. The goal of
this letter is simply to provide you with more information about our proposal
and encourage you to contact Medafor’s board to make your voice heard if you
have an opinion about Medafor’s future and our proposal.
WHAT YOU CAN DO
NOW
As Medafor’s largest shareholder, we
believe that it is important for every shareholder to communicate with the
Medafor board. If you have an opinion about
anything we’ve discussed in this letter, please contact your board members
today and let them know what you
think. The phone numbers and addresses for the Medafor board and
management are 877-633-2367 and 2700 Freeway Boulevard, Suite 800, Minneapolis,
MN 55430. Make sure your board knows where you
stand!
Enclosed
with this letter is a copy of CryoLife’s 25th
anniversary book, which provides information concerning CryoLife, its products
and services, and the thousands of people who have been positively impacted by
those products and services. If you would like more information about
CryoLife and its proposal to acquire Medafor, please visit
www.cryolife.com/medaforoffer or contact Nina Devlin at
212-704-8145. Additionally, if you would like to receive any future
communications via email, please send an email request to
medaforshareholderinfo@cryolife.com.
We are
optimistic that you will be as enthusiastic as we are about what CryoLife and
Medafor can accomplish together. I look forward to communicating with
you again in the near future.
Sincerely,
/s/
Steve G. Anderson
Steven G.
Anderson
Founder,
CEO and President
IMPORTANT
This
letter is provided for informational purposes only and is not an offer to
purchase nor a solicitation of offers to sell shares of Medafor or CryoLife.
Subject to future developments, CryoLife may file a registration statement
and/or tender offer documents and/or proxy statement with the SEC in connection
with the proposed combination of the two companies. Shareholders
should read those filings, and any other filings made by CryoLife with the SEC
in connection with the combination, as they will contain important
information. Those documents, if and when filed, as well as
CryoLife’s other public filings with the SEC, may be obtained without charge at
the SEC’s website at www.sec.gov and at CryoLife’s website at
www.cryolife.com.
cryolife8k12110ex992.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
cryolife8k12110ex993.htm
EXHIBIT 99.3
CELEBRATING
25 YEARS OF RESTORING PEOPLE’S LIVES.
“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]
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[Picture
of woman and child]
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[Picture
of man, woman and child]
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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.
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1655
Roberts Boulevard, NW • Kennesaw, Georgia 30144
Phone
800.438.8285 • Fax 770.590.3753 • CryoLife.com
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cryolife8k12110ex994.htm
EXHIBIT
99.4
The
enclosed documents are provided for informational purposes only and are not
offers to purchase nor a solicitation of offers to sell shares of Medafor or
CryoLife. Subject to future developments, CryoLife may file a registration
statement and/or tender offer documents and/or proxy statement with the SEC in
connection with the proposed combination of the two
companies. Shareholders should read those filings, and any other
filings made by CryoLife with the SEC in connection with the combination, as
they will contain important information. Those documents, if and when
filed, as well as CryoLife’s other public filings with the SEC, may be obtained
without charge at the SEC’s website at www.sec.gov and at CryoLife’s website at
www.cryolife.com.
cryolife8k12110ex995.htm
EXHIBIT 99.5
FOR
IMMEDIATE RELEASE
Media
Contacts:
D. Ashley
Lee
Executive
Vice President, Chief Financial Officer and
Chief
Operating Officer
Phone:
770-419-3355
Nina
Devlin
Edelman
Phone:
212-704-8145
CryoLife
Sends Letter to Medafor, Inc. Shareholders
ATLANTA, GA (January 21, 2010) --
CryoLife, Inc. (NYSE: CRY), an implantable biological medical device and
cardiovascular tissue processing company, announced today that it has sent the
following letter to Medafor shareholders discussing its strategic proposal to
purchase the outstanding shares of Medafor:
Important
Information for Medafor Shareholders
January
21, 2010
Dear
Fellow Medafor Shareholder:
You have probably seen the headlines
regarding CryoLife’s increased stake in Medafor and our proposal to the Medafor
board of directors to combine our two companies. I wanted to take
this opportunity to personally explain why we have taken this action, why our
proposal is financially and strategically compelling, and what you can do to
make your opinion heard.
We have great regard for Medafor’s
MPH®
polysaccharide hemostatic technology, and we believe it has significant,
untapped growth potential. CryoLife currently has the exclusive right
to distribute this technology under the private label HemoStase®
within the U.S. for use in cardiac and vascular surgery, and in many
international markets for cardiac, vascular, and general surgery, subject to
certain exclusions. As Medafor’s largest distributor, CryoLife
achieved $6 million in
sales of HemoStase in 2009.
Unfortunately, we do not believe that
Medafor has the resources to maximize the potential of this exciting technology
on its own given the capital and other constraints facing the
company. At the same time, we believe it is critical that Medafor
fully develop this technology in order for Medafor shares to realize their full
potential value. We have acquired a large stake in Medafor as a first
step in our efforts to combine CryoLife and Medafor, drive additional growth of
HemoStase and related products, and deliver earnings and revenue growth for
CryoLife and Medafor shareholders.
CryoLife
and Medafor: A Strong Strategic Fit
We believe that Medafor’s hemostatic
technology serves as a perfect complement to CryoLife’s product portfolio,
particularly our BioGlue®
technology. A combination of our companies would allow us to offer
surgeons a full range of products to assist them in controlling and preventing
bleeding. CryoLife’s financial strength (positive cash flow and
positive earnings growth), strong direct sales force (45 direct sales
representatives in the U.S. and direct sales forces in the United Kingdom and
Germany), international distribution network, and experienced management team
would allow us to drive additional growth of Medafor beyond its current
capabilities, and create greater value for all shareholders.
Combination
of CryoLife and Medafor: Our Proposed Offer
On January 13, 2010, we sent a letter
to Medafor’s board of directors proposing to acquire all of Medafor’s remaining
outstanding shares for $2.00 per share, to be paid in cash and stock, subject to
completion of reasonable due diligence. We believe the price we are
offering is full and
fair. In fact, it represents a significant premium to that
which we understand Medafor’s management and board have recently offered to
convert debt into equity, and is equivalent to the value at which recent stock
transactions have taken place. It is also in line with the valuations
of comparable public companies and with recent comparable publicly-disclosed
M&A transactions.
While we believe our initial proposal
is a strong one, we welcome
further dialogue and are open to negotiation with the Medafor
board. As we indicated in our recent communication to Medafor, we do
not have the most current information regarding Medafor and its prospects, and
we are willing to negotiate in good faith to determine Medafor’s appropriate
value.
Negotiations with the Medafor board
would also allow us to determine the right mix of cash and stock. We
believe a cash/stock offer is appropriate and attractive, as the cash component
would provide Medafor shareholders with immediate and certain value, while the
stock portion would allow shareholders to participate in future upside through
continued ownership of the combined company. We think the prospects
for CryoLife are strong and that Medafor shareholders will be able to realize
additional value by owning our stock. It is also important to note
that ownership of CryoLife stock would provide you with further liquidity, as
you would be able to trade this stock on the New York Stock
Exchange. That said, given the current economic climate, we recognize
that cash may be more important to some shareholders, and we are therefore
prepared to evaluate how to best address this.
Medafor’s board has to date refused to
enter into negotiations regarding our proposal. Their refusal to
enter into discussions with us hurts Medafor shareholders as it impedes
your ability to receive a fair price for your shares. The goal of
this letter is simply to provide you with more information about our proposal
and encourage you to contact Medafor’s board to make your voice heard if you
have an opinion about Medafor’s future and our proposal.
WHAT YOU CAN DO
NOW
As Medafor’s largest
shareholder, we believe that it is important for every shareholder to
communicate with the Medafor board. If you have an opinion about
anything we’ve discussed in this letter, please contact your board members
today and let them know what you
think. The phone numbers and addresses for the Medafor board
and management are 877-633-2367 and 2700 Freeway Boulevard, Suite 800,
Minneapolis, MN 55430. Make sure your board knows where you
stand!
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Enclosed with this letter is a copy of
CryoLife’s 25th
anniversary book, which provides information concerning CryoLife, its products
and services, and the thousands of people who have been positively impacted by
those products and services. If you would like more information about
CryoLife and its proposal to acquire Medafor, please visit
www.cryolife.com/medaforoffer or contact Nina Devlin at
212-704-8145. Additionally, if you would like to receive any future
communications via email, please send an email request to
medaforshareholderinfo@cryolife.com.
We are optimistic that you will be as
enthusiastic as we are about what CryoLife and Medafor can accomplish
together. I look forward to communicating with you again in the near
future.
Sincerely,
Steven G. Anderson
Founder, CEO and
President
ADDITIONAL
IMPORTANT INFORMATION
This announcement is provided for
informational purposes only and is not an offer to purchase nor a solicitation
of an offer to sell shares of Medafor or CryoLife. Subject to future
developments, CryoLife may file a registration statement and/or tender offer
documents and/or proxy statement with the SEC in connection with the proposed
combination. Shareholders should read those filings, and any other
filings made by CryoLife with the SEC in connection with the combination, as
they will contain important information. Those documents, if and when
filed, as well as CryoLife’s other public filings with the SEC, may be obtained
without charge at the SEC’s website at www.sec.gov and at CryoLife’s website at
www.cryolife.com.
About
CryoLife, Inc.
Founded
in 1984, CryoLife, Inc. is a leader in the processing and distribution of
implantable living human tissues for use in cardiac and vascular surgeries
throughout the U.S. and Canada. The Company's CryoValve® SG
pulmonary heart valve, processed using CryoLife's proprietary SynerGraft®
technology, has FDA 510(k) clearance for the replacement of diseased, damaged,
malformed, or malfunctioning native or prosthetic pulmonary
valves. The Company’s CryoPatch® SG
pulmonary cardiac patch has FDA 510(k) clearance for the repair or
reconstruction of the right ventricular outflow tract (RVOT), which is a surgery
commonly performed in children with congenital heart defects, such as Tetralogy
of Fallot, Truncus Arteriosus, and Pulmonary Atresia. CryoPatch SG is
distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary
trunk, and pulmonary branch. The Company's BioGlue®
Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use
in adult patients in open surgical repair of large vessels. BioGlue
is also CE marked in the European Community and approved in Canada and Australia
for use in soft tissue repair. The Company's BioFoam®
Surgical Matrix is CE marked in the European Community for use as an adjunct in
the sealing of abdominal parenchymal tissues (liver and spleen) when cessation
of bleeding by ligature or other conventional methods is ineffective or
impractical. BIOGLUE Aesthetic™ Medical Adhesive
is CE marked in the European Community for periosteal fixation following
endoscopic browplasty (brow lift) in reconstructive plastic surgery and is
distributed by a third party for this indication. CryoLife
distributes HemoStase®, a
hemostatic agent, in much of the U.S. for use in cardiac and vascular surgery
and in many international markets for cardiac, vascular, and general surgery,
subject to certain exclusions.
For
additional information about the company, visit CryoLife’s Web
site:
www.cryolife.com.
END