Navigation Links
CryoLife Initiates Enrollment in U.S. Clinical Trial for BioFoam®

ATLANTA, Oct. 24, 2011 /PRNewswire/ -- CryoLife, Inc., (NYSE: CRY), a leading tissue processing and medical device Company focused on cardiac and vascular surgery, today announced that it has enrolled the first patient in its U.S. Investigational Device Exemption (IDE) clinical trial for its BioFoam® Surgical Matrix protein hydrogel technology.  In connection with the trial, BioFoam will be used as an adjunct to conservative measures of achieving hemostasis on newly resected liver parenchyma.

The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent. The feasibility investigation will be conducted at up to three investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group.  

"We are pleased to begin enrolling patients in our IDE study, which is a milestone in our efforts to obtain BioFoam approval for distribution in the U.S.," said Steven G. Anderson, CryoLife president and chief executive officer. "We have worked with FDA on two recent protocol amendments which we think should help speed enrollment into the pilot study. Once it is completed, assuming that the data is positive, we will begin planning for a larger pivotal study to support a PMA application for BioFoam with the FDA. We believe that BioFoam may hold promise for surgeons around the world and are encouraged by the early clinical experience in Europe."

Upon successful completion of the feasibility study in the U.S., and subsequent FDA and Department of Defense approvals, a follow-on prospective, multicenter, randomized, controlled pivotal study is planned.  It is currently anticipated that the pivotal investigation would enroll a total of 164 eligible subjects, 82 subjects in each treatment group across a maximum of 10 investigational sites. This data would then be used to support a U.S. Premarket Approval application to allow commercialization of BioFoam in the U.S.

The primary objective of the pivotal investigation will be to demonstrate a decrease in the time to achieve intraoperative hemostasis (a complex process that causes bleeding to stop) following open liver resection surgery in subjects receiving an application of BioFoam compared to a control group (standard topical hemostatic agent).  The secondary objectives of this investigation will be to compare time to hemostasis and the achievement of immediate hemostasis between the BioFoam group and control group to demonstrate that BioFoam is at least equivalent in performance.  

In Europe, CryoLife has completed a 55-patient prospective, multicenter, single-arm study of BioFoam at three centers in the United Kingdom, Germany, and France. The results from this study were presented at the Association of Surgeons of Great Britain and Ireland (ASGBI) Congress in May 2011.  The efficacy results show that the time to obtain hemostasis after an application of BioFoam compares favorably to results reported for related products.  Analysis of the safety endpoints defined for this study and the collection of adverse events were also consistent with data reported within historical literature.  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 USD and more than $100 million USD worldwide.

About BioFoam

BioFoam, a protein hydrogel biomaterial developed by CryoLife, contains an expansion agent that 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 can 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 Surgical Adhesive was developed.  BioFoam has received CE mark approval 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.

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. CryoLife'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.  CryoLife'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.  CryoLife'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 and was recently approved in Japan for use in the repair of aortic dissections.  CryoLife'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.  CryoLife distributes PerClot®, an absorbable powder hemostat, in the European Community. CryoLife, through its subsidiary Cardiogenesis Corporation, specializes in the treatment of cardiovascular disease and devices that treat severe angina.  Its market leading FDA-approved Holmium: YAG laser system and single use fiber-optic delivery systems are used to perform a surgical procedure known as Transmyocardial Revascularization (TMR). 

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.  Such forward-looking statements reflect the views of management at the time such statements are made and are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from current expectations.  These statements include those regarding our ability to enroll patients in the pilot study and the speed of such enrollment, our plans for a larger pivotal study to support a PMA application for BioFoam with the FDA, our belief that BioFoam may hold promise for surgeons around the world, our plans for a follow-on prospective, multicenter, randomized, controlled pivotal study subsequent to FDA and Department of Defense approvals, the anticipated number of eligible subjects that would enroll in the pivotal investigation, plans to use the data from the pivotal investigation to support a U.S. Premarket Approval application to allow commercialization of BioFoam in the U.S., and our estimates regarding the annual European and worldwide market opportunity 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 regulatory approval process and related studies can be time consuming and costly, and our ability to market and distribute BioFoam in the desired jurisdictions may be delayed or denied based on the results of these studies.  Studies may also be delayed if we are unable to successfully enroll the requisite number of patients in each respective study in a timely manner.  Based on changing conditions in our Company and in the economy generally, management may decide to terminate its pursuit of regulatory approval for BioFoam at any stage in the approval process, and our current plans and timeline for regulatory approval may be altered.  Also, BioFoam may not provide the anticipated medical benefits, may not ultimately be accepted by physicians and patients, and competing products and solutions may be developed that adversely impact future BioFoam sales.  Our estimates regarding the European and worldwide market for BioFoam may be incorrect and we may not be successful in our attempts to market BioFoam in Europe or in other parts of the world. The potential market for BioFoam could be impacted by a number of factors, including the effectiveness and relative cost of competing products, the impact of future surgical innovations and medical breakthroughs and the perceptions of surgeons and other medical professionals regarding the treatment of liver disease.  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 Dec. 31, 2010, 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:

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

The Ruth Group
Nick Laudico / Zack Kubow
646-536-7030 / 7020

SOURCE CryoLife, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. CryoLife Announces First Implant of Combination Aortic-Mitral Allograft Heart Valve at the Cleveland Clinic
2. CryoLife Receives FDA Approval to Begin U.S. Clinical Trial for BioFoam(R)
3. CryoLife Reports Record Quarterly Revenues of $28.2 Million
4. CryoLife to Present at Upcoming Investor Conferences in New York
5. CryoLife to Present at 21st Annual Piper Jaffray Health Care Conference
6. CryoLife Provides Initial 2010 Financial Guidance
7. CryoLife Enters into Worldwide Distribution and Manufacturing Agreements with Starch Medical for Novel Hemostatic Agent
8. CryoLife Receives Japanese Regulatory Approval for BioGlue Surgical Adhesive
9. CryoLife Announces Release Date and Teleconference Call Details for 2010 Third Quarter Financial Results
10. CryoLife Begins Distribution of Blood-Clotting Agent PerClot® in Europe
11. CryoLife to Present at Lazard Capital Markets 7th Annual Healthcare Conference
Post Your Comments:
(Date:10/9/2015)... -- AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX ) today announced ... Society of Emergency Medicine (EuSEM) meeting to be held October ... the Lingotto Congress Centre in Turin, Italy ... medicine practitioners in the world with over 2000 delegates in ... previously announced phase 2 bunionectomy trial will also be included.  ...
(Date:10/9/2015)... October 9, 2015 El ,JCA-Mauvernay Award 2015, ... y Junko Takita    --> ... los doctores Yutaka Kondo y ... Award 2015, se ha otorgado a los doctores ... ™ , una compañía biofarmacéutica global con sede enSuiza, presentará el ...
(Date:10/8/2015)... , Oct. 8, 2015  Ardelyx, Inc. ... focused on gastrointestinal and cardio-renal diseases, today announced ... candidate, tenapanor, will be presented at the 2015 ... findings will include measures of sustained response in ... blind, placebo-controlled, randomized Phase 2 trial. The meeting ...
Breaking Medicine Technology:
... ,, NEW YORK , Aug. 3 ITelagen, a ... it was selected by Manhattan ,s Physician Group (MPG) to host, ... includes hosting of patient data in ITelagen,s SAS-70 Type II certified datacenter ... for staff members. , , ...
... PHILADELPHIA , Aug. 3 ... a safe, isotope-free alternative to traditional radiation therapy ... focus of 14 clinical research studies presented at ... Meeting.  According to Xoft, Inc., the clinical benefits ...
Cached Medicine Technology:
(Date:10/9/2015)... ... October 09, 2015 , ... The Asthma and Allergy Foundation of America ... Control and Prevention (CDC) to improve the knowledge and skills of underserved adults with ... a project by the CDC and allows AAFA to continue vital efforts to educate ...
(Date:10/9/2015)... New Orleans, LA (PRWEB) , ... October 09, ... ... firm with offices serving New Orleans and the surrounding communities, is initiating a ... shelter and medical care for unwanted animals in southern Louisiana. , Animal ...
(Date:10/9/2015)... (PRWEB) , ... October 09, 2015 , ... ... States, is welcoming individuals from all walks of life to save money on ... set price of $25 per month per medication, individuals and families can receive ...
(Date:10/9/2015)... (PRWEB) , ... October 09, 2015 , ... ViewPoint Center, ... Awareness Week. For many teenagers facing mental illness, the stigma associated with mental illness ... , ViewPoint Center understands the importance of supporting teens with mental illness ...
(Date:10/9/2015)... ... October 09, 2015 , ... Ryan ... and largest recreational dispensaries in Colorado, says the latest figures on the state’s ... and maturing into a legitimate industry. , Last month, according to ...
Breaking Medicine News(10 mins):
... vitamin D and multiple sclerosis in African Americans, a team ... discovered that vitamin D levels in the blood are lower ... Americans who do not. "It seems relatively clear," said ... Multiple Sclerosis Center, director of the UCSF Neurodiagnostics Center and ...
... May 27 (HealthDay News) -- Whether or not a woman ... seven years before she even conceives, new research suggests. ... that routine evaluations of blood sugar and body weight -- ... risk for the condition, according to the report published in ...
... to 10% of all breast cancers are monogenic in origin. ... BRCA1, BRCA2 or other high-risk genes. In this edition of ... 2011; 108(19): 323 30), Alfons Meindl of the Klinikum rechts ... the pathogenesis and treatment of hereditary breast and ovarian cancer ...
... 27 (HealthDay News) -- Youngsters who do not get enough ... overweight, a new study has found. Conversely, when ... mass index (BMI) and a significant drop in their risk ... lower BMIs resulted from differences in fat mass (not any ...
... By Amanda Gardner HealthDay Reporter , THURSDAY, May ... in more sedentary jobs, they,re packing on the pounds, and ... epidemic, new research suggests. Staring at the computer for ... 120 to 140 fewer calories a day than they did ...
... EAST LANSING, Mich. While recent studies have shown ... women overturning physicians, long-held beliefs that the hormone ... by which estrogen induces high blood pressure was unclear. ... found long-term estrogen exposure generates excessive levels of the ...
Cached Medicine News:
The world's first automatic computation program analyzes massive amount of measurement data and computes "the most comfortable value" for the patient....
... The Ultramatic Rx Master is ... years of reliable service and ... that measurably improve procedures. It ... need and want most, including ...
Maddox Rod, short handle (12cm)...
Snellen 10' Eye Test Chart....
Medicine Products: