Navigation Links
CryoLife Receives CE Mark Approval for BioFoam(R) Hemostatic Technology

ATLANTA, Aug. 4 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and cardiovascular tissue processing company, today announced it has received CE mark approval for its BioFoam((R)) Surgical Matrix (BioFoam). The CE mark allows immediate, unrestricted commercial distribution of BioFoam 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. BioFoam is the second product from the Company's protein hydrogel technology platform to receive a CE mark.

CryoLife plans a controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy to support its initial marketing efforts. Based on the number of liver and spleen procedures performed annually in the European Community, CryoLife estimates the annual European market opportunity for BioFoam to be approximately $30 million and more than $100 million on a worldwide basis.

"We are excited about securing our first approval for the use of BioFoam in organ resection surgery and look forward to continuing our development efforts to bring BioFoam into the U.S. market," said Steven G. Anderson, CryoLife president and chief executive officer. "Over the past four fiscal years, the U.S. Department of Defense has allocated approximately $5.4 million to CryoLife for the development of products containing a protein hydrogel, which is the primary component of BioFoam."

In December 2008, CryoLife received conditional approval from the FDA to conduct the feasibility phase of the company's BioFoam IDE submission for liver parenchymal sealing. The feasibility phase will enroll a total of 20 subjects at two investigational sites in the U.S. Before beginning this phase, the Company must receive final approval of the study protocol and related documents from the FDA and an additional approval of the study from the U.S. Department of Defense. CryoLife is in the final stages of this approval process.

About BioFoam

BioFoam, a protein hydrogel biomaterial under development by CryoLife, contains an expansion agent which generates a mixed-cell foam. The foam creates a mechanical barrier to decrease blood flow and pores for the blood to enter, leading to cellular aggregation and enhanced hemostasis. It is easily applied and could potentially be used intraoperatively to control internal organ hemorrhage, limit blood loss, and reduce the need for future reoperations in liver resections. BioFoam is based on the same protein hydrogel technology platform from which BioGlue((R)) Surgical Adhesive was developed. BioGlue is approved by the U.S. Food and Drug Administration to control bleeding as an adjunct to sutures and staples 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.

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((R)) SG pulmonary heart valve, processed using CryoLife's proprietary SynerGraft((R)) technology, has FDA 510(k) clearance for the replacement of diseased, damaged, malformed, or malfunctioning native pulmonary valves. The Company's BioGlue((R)) 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. BIOGLUE Aesthetic(TM) 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(TM), a hemostatic agent, in much of the U.S. for use in cardiac and vascular surgery and in the European Community and Canada for cardiac, vascular, and general surgery, subject to certain exclusions.

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, including statements regarding the receipt and application of DOD funds and potential distribution timing and uses and applications for BioFoam. These future events may not occur as and when expected, if at all, and, together with the Company's business, are subject to various risks and uncertainties. These risks and uncertainties include that the Company may not receive all or any funds allocated under the DoD Appropriation, that BioFoam may not prove safe or effective for its intended uses, and that BioFoam development may not result in a commercial product on the time table anticipated, or at all. For additional risks impacting the Company's business, see the Risk Factors section of the Company's Annual Report on Form-10-K for the year ended December 31, 2008 and the Company's subsequent Form 10-Q filings. The Company does not undertake to update its forward-looking statements.

For additional information about the Company, visit CryoLife's Web Site:

    Media Contacts:

    D. Ashley Lee                               Katie Brazel
    Executive Vice President,                   Fleishman Hillard
    Chief Financial Officer and                 Phone: 404-739-0150
    Chief Operating Officer
    Phone: 770-419-3355

SOURCE CryoLife, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. CryoLife Reports Record Quarterly Revenues of $28.2 Million
2. CryoLife Announces Release Date and Teleconference Call Details for 2009 Second Quarter Financial Results
3. Department of Defense Awards CryoLife $1.7 million to Develop BioFoam Hemostatic Technology
4. CryoLife Announces Release Date and Teleconference Call Details for First Quarter 2008 Financial Results
5. William F. Northrup, III, M.D. Joins CryoLife as Vice President of Medical Relations and Education
6. Cryolife Victim Responds to Untrue Assertions of Cryolife
7. CryoLife Announces Additions to Management Team
8. Watson Pharmaceuticals Receives FDA Approval for Generic Toprol XL(R) 25 MG and 50 MG
9. Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for KRYSTEXXA(TM)
10. Hanger Orthopedic Group, Inc. Receives Upgrade From Moodys Investors Service
11. PharmaForce Inc. Receives FDA Approval for First Generic of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP
Post Your Comments:
(Date:11/24/2015)... ... 2015 , ... Chiropractic student Katie Benson received a $2,500 ... Park, Kansas. Benson, a fifth-trimester student in the university’s College of Chiropractic, accepted ... 16. , “Katie is very excited and greatly appreciative to receive the Standard ...
(Date:11/24/2015)... ... November 24, 2015 , ... Sir Grout of ... the TrustDale certification. The award recognizes good companies for excellence in service and ... and grout, and hard surface restoration company earned this recognition after a thorough ...
(Date:11/24/2015)... ... 24, 2015 , ... Bibliomotion is thrilled to announce the launch ... and Diversity by Nancy M. Schlichting, Chief Executive Officer of Henry Ford ... address the needs of patients and their families, shaped my desire to improve the ...
(Date:11/24/2015)... ... , ... Dr. Kevin Day, local family chiropractor in Warsaw , is ... season. During the Indiana winter months, Vitamin D deficiency can lead to Seasonal ... want to help provide the tools needed to combat it this year! , “Stress ...
(Date:11/24/2015)... ... ... life, Don Peck’s mother wondered if she was a descendant of Samuel Fuller, a passenger ... 25-year search for information, Don and his aunt discovered that she was not, in fact, ... it was Don’s father who was descended from not one, but four passengers on the ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... WuXi PharmaTech (Cayman) Inc. ("WuXi" or the ... capability and technology platform company serving the pharmaceutical, biotechnology, ... China and the United States ... meeting of shareholders held today, the Company,s shareholders voted ... the previously announced agreement and plan of merger (the ...
(Date:11/24/2015)... 24, 2015  In the pharmaceutical industry, companies want ... to quickly uncover new insights, tactics and strategies that ... --> However, organizations often find it ... and ensure that all rules and regulations are met ... major barrier to efficiently launching market research projects is ...
(Date:11/24/2015)... , Nov. 24, 2015  DILON Diagnostics and GE ... an agreement for DILON to distribute GE,s Discovery NM750b ... globe. The signing of this distribution agreement will provide Dilon,s ... Breast Imaging system and is considered an initial step ... healthcare solutions for clinicians and their patients. ...
Breaking Medicine Technology: