cryolife8k12110.htm
 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
washington, d.c. 20549
 
 
 
FORM 8-K
 


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.


- 2 - -

 
 
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

 
- 3 - -

 

 
 
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  

 



 
- 4 - -

 

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
 
 
 
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
 



 
 

 

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
 
 
 


N E W S   R E L E A S E
 
 
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.
 
 
 
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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,

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.

 
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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.


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