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): February 23,
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 February 23, 2010, CryoLife, Inc.
(“CryoLife”) sent a letter to the shareholders of Medafor, Inc. (“Medafor”) and
issued a press release regarding the same. These documents are
available at www.cryolife.com/medaforoffer
and/or have otherwise been disseminated by CryoLife. The letter to
the Medafor shareholders and the press release, both dated February 23, 2010,
are attached hereto as Exhibits 99.1 and 99.2, respectively.
This filing and the exhibits
hereto 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 the Medafor shareholders dated February 23, 2010
|
|
|
99.2
|
Press
Release dated February 23, 2010
|
-2-
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: February
23, 2010
|
By:
|
/s/ D.A. Lee | |
| Name: | D. Ashley Lee | ||
| Title: | Executive Vice President, Chief | ||
| Operating Officer and Chief | |||
| Financial Officer | |||
-3-
EXHIBIT
99.1
Important
Information for Medafor Shareholders
February
23, 2010
Dear
Fellow Medafor Shareholder:
On February 18, 2010, CryoLife, Inc.
announced its earnings for the fourth quarter of 2009. Enclosed is a
copy of the press release for your information. In light of our
proposal to acquire Medafor for a combination of cash and CryoLife stock, we
want to ensure that Medafor shareholders have access to the latest information
about CryoLife, its financial performance, and its outlook for
growth. As you can see, CryoLife is continuing to thrive in very
demanding economic conditions. We increased our revenues for the
fourth quarter 2009 by 12 percent to a record of $28.6 million compared to $25.5
million for the fourth quarter of 2008. This was also the 12th
consecutive quarter of profitability for CryoLife. In addition to
reporting record annual revenues of $111.7 million and continued, consistent
profitability, our ability to significantly increase our cash balances through
strong operating cash flow of over $16.5 million in 2009 is a very encouraging
sign of the health of our business. Looking ahead, we expect to
achieve record revenues and operating earnings in 2010 by continuing to execute
on our strategy and invest in our growth. For additional details,
including our forward-looking disclaimer, please see the enclosed press
release.
We also want to update you regarding
developments in our litigation with Medafor. As you are aware, on
April 29, 2009, CryoLife filed a lawsuit against Medafor in the U.S.
District Court for the Northern District of Georgia alleging claims for, among
other things, breach of contract, fraud, negligent misrepresentation, and
violations of the Georgia Racketeer Influenced and Corrupt Organizations
Act. While the Court initially dismissed CryoLife’s fraud and
negligent misrepresentations claims, on February 18, 2010, the Court issued an
Order reinstating these claims against Medafor based on Medafor’s alleged
misrepresentations to CryoLife in the distribution agreement and after the
agreement was executed. We are pleased with the Court’s decision on
this matter and remain disappointed with Medafor’s breaches of our agreement
which forced this litigation. For a more complete description of the
litigation, please view our Form 10-K filed with the SEC on February 19, 2010,
which is available on our website, www.cryolife.com.
Finally, we wanted to alert you to a
new section on our website that is dedicated to addressing inaccurate and
misleading statements from Medafor regarding our proposal and
CryoLife. We are committed to ensuring that Medafor shareholders
receive full and accurate information and are dismayed by the inaccuracies in
Medafor’s communications with its shareholders. We have provided
corrections and/or clarifications to these statements at
http://www.cryolife.com/medaforoffer/medmiss.html. This section will
be updated as needed.
We continue to believe that a
combination of CryoLife and Medafor would create significant value for
shareholders of both companies. I look forward to communicating with
you again in the near future.
|
Sincerely,
|
|
| /s/ Steven 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.
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.
EXHIBIT 99.2
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 (February 23, 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.
Important
Information for Medafor Shareholders
February
23, 2010
Dear
Fellow Medafor Shareholder:
On February 18, 2010, CryoLife, Inc.
announced its earnings for the fourth quarter of 2009. Enclosed is a
copy of the press release for your information. In light of our
proposal to acquire Medafor for a combination of cash and CryoLife stock, we
want to ensure that Medafor shareholders have access to the latest information
about CryoLife, its financial performance, and its outlook for
growth. As you can see, CryoLife is continuing to thrive in very
demanding economic conditions. We increased our revenues for the
fourth quarter 2009 by 12 percent to a record of $28.6 million compared to $25.5
million for the fourth quarter of 2008. This was also the 12th
consecutive quarter of profitability for CryoLife. In addition to
reporting record annual revenues of $111.7 million and continued, consistent
profitability, our ability to significantly increase our cash balances through
strong operating cash flow of over $16.5 million in 2009 is a very encouraging
sign of the health of our business. Looking ahead, we expect to
achieve record revenues and operating earnings in 2010 by continuing to execute
on our strategy and invest in our growth. For additional details,
including our forward-looking disclaimer, please see the enclosed press
release.
We also want to update you regarding
developments in our litigation with Medafor. As you are aware, on
April 29, 2009, CryoLife filed a lawsuit against Medafor in the U.S.
District Court for the Northern District of Georgia alleging claims for, among
other things, breach of contract, fraud, negligent misrepresentation, and
violations of the Georgia Racketeer Influenced and Corrupt Organizations
Act. While the Court initially dismissed CryoLife’s fraud and
negligent misrepresentations claims, on February 18, 2010, the Court issued an
Order reinstating these claims against Medafor based on Medafor’s alleged
misrepresentations to CryoLife in the distribution agreement and after the
agreement was executed. We are pleased with the Court’s decision on
this matter and remain disappointed with Medafor’s breaches of our agreement
which forced this litigation. For a more complete description of the
litigation, please view our Form 10-K filed with the SEC on February 19, 2010,
which is available on our website, www.cryolife.com.
Finally, we wanted to alert you to a
new section on our website that is dedicated to addressing inaccurate and
misleading statements from Medafor regarding our proposal and
CryoLife. We are committed to ensuring that Medafor shareholders
receive full and accurate information and are dismayed by the inaccuracies in
Medafor’s communications with its shareholders. We have provided
corrections and/or clarifications to these statements at
http://www.cryolife.com/medaforoffer/medmiss.html. This section will
be updated as needed.
We continue to believe that a
combination of CryoLife and Medafor would create significant value for
shareholders of both companies. I look forward to communicating with
you again in the near future.
|
Sincerely,
|
|
| /s/ Steven 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.
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.
To view a copy of the press release
that accompanied the letter go to www.cryolife.com/4Q2009Earnings.
Statements
made in this press release that look forward in time or that express
management's beliefs, expectations or hopes are forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of
1995. These statements include those regarding anticipated 2010
performance and statements regarding the expected impact of our net operating
loss carryforwards on our cash outlays for tax obligations. These
future events may not occur as and when expected, if at all, and, together with
our business, are subject to various risks and uncertainties. These
risks and uncertainties include that we are significantly dependent on our
revenues from BioGlue and are subject to a variety of risks affecting this
product, we are subject to stringent domestic and foreign regulation which may
impede the approval process of our tissues and products, hinder our development
activities and manufacturing processes and, in some cases, result in the recall
or seizure of previously cleared or approved tissues and products, our proposed
acquisition of Medafor poses a number of risks, Medafor’s management has
rejected our acquisition offer and refused to negotiate with us, and if we
attempt to launch a hostile offer to acquire Medafor we will incur significant
expense and may not succeed; in the event such a hostile offer does succeed, we
will not have the benefit of due diligence and may incur unanticipated costs or
liabilities, the lawsuit we filed against Medafor regarding our distribution
agreement with Medafor may adversely impact our relationship with Medafor and
could hinder our distribution of HemoStase or prevent us from distributing
HemoStase, healthcare policy changes, including pending proposals to reform the
U.S. healthcare system, may have a material adverse effect on us, uncertainties
related to patents and protection of proprietary technology may adversely affect
the value of our intellectual property, uncertainties related to patents and
protection of proprietary technology for products distributed by CryoLife may
adversely affect our ability to distribute those products, the tissues we
process and our products allegedly have caused and may in the future cause
injury to patients, and we have been and may be exposed to product liability
claims and additional regulatory scrutiny as a result, we are dependent on the
availability of sufficient quantities of tissue from human donors, our CryoValve
SGPV post-clearance study may not provide expected results, demand for our
tissues and products could decrease in the future, which could have a material
adverse effect on our business, the success of many of our tissues and products
depends upon strong relationships with physicians, consolidation in the health
care industry could lead to demands for price concessions or limits or eliminate
our ability to sell to certain of our significant market segments, our existing
insurance policies may not be sufficient to cover our actual claims liability,
we may be unable to obtain adequate insurance at a reasonable cost, if at all,
the loss of any of our sole-source suppliers could have an adverse effect on our
revenues, financial condition, profitability, and cash flows, intense
competition may affect our ability to operate profitably, regulatory action
outside of the U.S. has affected our business in the past and may affect our
business in the future, rapid technological change could cause our services and
products to become obsolete, continued fluctuation of foreign currencies
relative to the U.S. dollar could materially and adversely impact our business,
our credit facility limits our ability to pursue significant acquisitions, key
growth strategies may not generate the anticipated benefits, there are
limitations on the use of our net operating loss carryforwards, our ability to
borrow under our credit facility may be limited, we may not be successful in
obtaining necessary clinical results and regulatory approvals for services and
products in development, and our new services and products may not achieve
market acceptance, extensive government regulation may adversely affect our
ability to develop and market services and products, investments in new
technologies and acquisitions of products or distribution rights may not be
successful, if we are not successful in expanding our business activities in
international markets, we may be unable to increase our revenues, we are not
insured against all potential losses, and natural disasters or other
catastrophes could adversely affect our business, financial condition, and
profitability, and we are dependent on key personnel. These risks and
uncertainties include the risk factors detailed in our Securities and Exchange
Commission filings, including our Form 10-Q filing for the quarter ended March
31, 2009, our Form 10-Q filing for the quarter ended June 30, 2009, our Form
10-Q filing for the quarter ended September 30, 2009, our Form 10-K to be filed
for the year ended December 31, 2009 and the Company's other SEC filings. The
Company does not undertake to update its forward-looking
statements.
For
additional information about the company, visit CryoLife’s Web
site: www.cryolife.com.
END