Navigation Links
Department of Defense Awards CryoLife $1.7 million to Develop BioFoam Hemostatic Technology
Date:4/6/2009

ATLANTA, April 6 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and tissue processing company, today announced it has been awarded approximately $1.7 million under the Department of Defense (DoD) Appropriations Bill to continue further development of CryoLife's protein hydrogel technology. Preclinical studies of CryoLife's BioFoam(R) Surgical Matrix, a protein hydrogel product under development for organ sealing, are nearing completion. This grant will help fund upcoming clinical studies of BioFoam in the United States.

In December 2008, CryoLife received conditional approval from the FDA to conduct the feasibility phase of the Company's BioFoam IDE submission for liver parenchyma sealing. Before beginning the feasibility study, the Company must receive final approval of the study protocol and related documents from the FDA and an additional approval of the same from the U.S. Department of Defense. The Company is in the final review process with the Department of Defense. The Company also filed a CE Mark submission with its Notified Body in December 2008 for BioFoam's 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. The Company also continues to conduct preclinical research with BioFoam for use in wound sealing in trauma surgery.

"Over the past four fiscal years the DoD has allocated a total of approximately $5.4 million to CryoLife for the development of protein hydrogel products," said Steven G. Anderson, CryoLife president and chief executive officer. "We are excited about advancing this product through the clinical process."

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 minimize 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 operations in liver resections. BioFoam is based on the same technology as BioGlue(R), a CryoLife product 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 received FDA clearance for the CryoValve(R) SG pulmonary human heart valve, processed using CryoLife's proprietary SynerGraft(R) Technology. 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. CryoLife distributes Hemostase MPH, 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 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. 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. The Company does not undertake to update its forward-looking statements.

For additional information about the Company, visit CryoLife's Web Site: http://www.cryolife.com.

    Media Contacts:

    D. Ashley Lee
    Executive Vice President, Chief Financial
    Officer and Chief Operating Officer
    Phone: 770-419-3355

    Katie Brazel
    Fleishman Hillard
    Phone: 404-739-0150


'/>"/>
SOURCE CryoLife, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. DaVita Wins Recruiting Department of the Year Award
2. Pennsylvania State Department of Health and Allegheny County Health Department Confirm Four Cases of Measles in Southwest Region
3. Pennsylvania Department of Health Helps Smokers Trying to Quit in Wake of Federal Cigarette Tax Hike
4. American Hospital Association Expands OnBase Endorsement to All Hospital Departments
5. Ottawa Regional Hospital and Healthcare Center Selects Allscripts to Automate and Connect Its Physician Offices, Emergency Department and Home Care Providers
6. Pennsylvania Department of Health Urges Greater Awareness of, Testing for Sexually Transmitted Diseases
7. Iguana Selected for Department of Defense IHE Demonstration at HIMSS 09
8. Pennsylvania State Department of Health Announces Three Cases of Measles in Southwest Region
9. Video: U.S. Department of Health & Human Services and Ad Council Launch National Lupus Awareness Campaign
10. Streamline Health to Deliver Hosted Document Workflow Solution to Leading West Coast University-Affiliated Surgery Department
11. U.S. Department of Veterans Affairs Awards Information Resource Management and Integrated Program Planning Contract to ICOR Partners
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... ... to revolutionize the emergency ambulance transport experience for the millions of people who ... Uber has disrupted the taxi industry through the use of technology. Now, SmartEMS ...
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, a ... and World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is ... to some of the world’s leading providers of cereal and other breakfast foods. Its ...
(Date:6/26/2016)... ... ... blind and certified personal trainer is helping to develop a weight loss fitness plan that ... the two major problems leading the fitness industry today:, , All ... They don’t eliminate all the reasons people quit their exercise program , ...
(Date:6/25/2016)... Austin, TX (PRWEB) , ... June 25, 2016 , ... ... Fellow of the American College of Mohs Surgery and to Dr. Russell Peckham for ... popular and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the largest ... as the Medical Director of its new Mesquite-Samuell Farm facility. , “We are ... Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Roche (SIX: RO, ROG; OTCQX: RHHBY) announced ... BRAHMS PCT (procalcitonin) assay as a dedicated testing solution ... this clearance, Roche is the first IVD company in ... sepsis risk assessment and management. PCT is ... levels in blood can aid clinicians in assessing the ...
(Date:6/23/2016)... 2016 Bracket , a leading clinical trial ... clinical outcomes platform, Bracket eCOA (SM) 6.0, at the ... – 30, 2016 in Philadelphia , Pennsylvania.  ... Assessment product of its kind to fully integrate with RTSM, ... eCOA 6.0 is a flexible platform for electronic clinical outcomes ...
(Date:6/23/2016)... 23, 2016 Revolutionary technology includes ... Oticon , industry leaders in advanced audiology and hearing ... Oticon Opn ™, the world,s first internet connected hearing ... IoT devices.      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ... number of ,world firsts,: , TwinLink™ - ...
Breaking Medicine Technology: