Navigation Links
CryoLife Initiates Enrollment in U.S. Clinical Trial for BioFoam®
Date:10/24/2011

pated 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 an
'/>"/>

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

Page: 1 2 3 4 5 6

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:
*Name:
*Comment:
*Email:
(Date:11/18/2014)... November 18, 2014 Investor-Edge has initiated ... EXEL ), Geron Corporation (NASDAQ: GERN ), Tekmira ... (NASDAQ: GALE ), and XOMA Corporation (NASDAQ: ... be accessed at: http://investor-edge.com/register . The US ... note as the Dow Jones Industrial Average finished at 17,647.75, ...
(Date:11/18/2014)... , Nov. 18, 2014 Pressure BioSciences, ... announced the installation of its first two Barozyme ... subsequent potential sale. One system was placed in ... of Georgetown University while the other was placed ... In both settings, the Company believes the new ...
(Date:11/18/2014)... MUMBAI , November 18, 2014 ... thorough knowledge of the overall new requirements of application ... China but also provides the guidance ... approval for your products entry into the Chinese medical ... Chinese medical device market is one of segment market ...
Breaking Medicine Technology:Today's Review on Biotech Equities - Exelixis, Geron, Tekmira Pharma, Galena Biopharma, and XOMA 2Today's Review on Biotech Equities - Exelixis, Geron, Tekmira Pharma, Galena Biopharma, and XOMA 3Today's Review on Biotech Equities - Exelixis, Geron, Tekmira Pharma, Galena Biopharma, and XOMA 4Today's Review on Biotech Equities - Exelixis, Geron, Tekmira Pharma, Galena Biopharma, and XOMA 5Pressure BioSciences Ships First Two Barozyme HT48 Systems 2Pressure BioSciences Ships First Two Barozyme HT48 Systems 3Pressure BioSciences Ships First Two Barozyme HT48 Systems 4Pressure BioSciences Ships First Two Barozyme HT48 Systems 5Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China (2014 Edition) 2Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China (2014 Edition) 3Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China (2014 Edition) 4Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China (2014 Edition) 5Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China (2014 Edition) 6Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China (2014 Edition) 7Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China (2014 Edition) 8
... N.J., May 19 Ikaria Holdings, Inc., a ... it,has completed dosing of its Phase 1a trial ... The study was a Phase 1, randomized, ... a single bolus injection of IK-1001,in healthy volunteers ...
... IPSOGEN SA (Marseille and New,Haven), a cancer profiler ... breast cancers, announced today that researchers from,the University of ... the results of two studies on the Genomic Grade ... from May 30 to June 3, 2008. The data,indicate ...
Cached Medicine Technology:Ikaria Completes Dosing of Phase 1a Clinical Study for IK-1001 (Sodium Sulfide) for Injection 2Ikaria Completes Dosing of Phase 1a Clinical Study for IK-1001 (Sodium Sulfide) for Injection 3Ipsogen Announces Three Studies at the American Society of Clinical Oncology (ASCO) Meeting Extending the Utility of the Genomic Grade Index for Predicting Response to Chemotherapy in Breast Cancer 2Ipsogen Announces Three Studies at the American Society of Clinical Oncology (ASCO) Meeting Extending the Utility of the Genomic Grade Index for Predicting Response to Chemotherapy in Breast Cancer 3Ipsogen Announces Three Studies at the American Society of Clinical Oncology (ASCO) Meeting Extending the Utility of the Genomic Grade Index for Predicting Response to Chemotherapy in Breast Cancer 4
(Date:11/18/2014)... Haelle HealthDay Reporter MONDAY, ... experience a severe abusive head trauma before the age of ... new study. In addition, among those who survive ... the study found. Abusive head trauma includes shaken baby ... suffers head injuries, according to background information in the study. ...
(Date:11/18/2014)... Dennis Thompson HealthDay Reporter ... Daily low-dose aspirin therapy may not have significant heart-health ... The study, which involved more than 14,000 Japanese people ... heart-related deaths or non-fatal heart attacks and strokes between ... "It indicates that primary prevention with daily low-dose ...
(Date:11/18/2014)... Dennis Thompson HealthDay Reporter , ... stroke patients can safely take aspirin combined with a blood-thinning ... increase a patient,s risk of early death, according to a ... American Heart Association in Chicago. The report was also published ... of data from more than a dozen clinical trials revealed ...
(Date:11/18/2014)... MONDAY, Nov. 17, 2014 (HealthDay News) -- Until recently, insect-transmitted ... America, but it has made its way to the United ... fatal illness is typically transmitted via the bite of the ... night. And now a new study suggests that common bedbugs ... bedbug can acquire and transmit the parasite. Our next step ...
(Date:11/17/2014)... CA (PRWEB) November 17, 2014 A ... thousands of patients throughout the country are turning back ... than ever before. This is because the company has ... to their already impressive collection of prescription and non-prescription ... who have incorporated Diet Doc’s best anti-aging ...
Breaking Medicine News(10 mins):Health News:Head Trauma in Abused Babies, Toddlers Can Have Lifelong Impact 2Health News:Head Trauma in Abused Babies, Toddlers Can Have Lifelong Impact 3Health News:Head Trauma in Abused Babies, Toddlers Can Have Lifelong Impact 4Health News:Daily Aspirin Fails to Help Older Hearts in Japanese Study 2Health News:Daily Aspirin Fails to Help Older Hearts in Japanese Study 3Health News:Long-Term Use of Aspirin Plus Blood Thinner Is Safe: Study 2Health News:Long-Term Use of Aspirin Plus Blood Thinner Is Safe: Study 3Health News:Bedbugs Could Be Potential New Source of Tropical Disease in U.S. 2Health News:Bedbugs Could Be Potential New Source of Tropical Disease in U.S. 3Health News:Best Anti-Aging Human Growth Hormone Therapy Safely and Naturally Restores Diet Doc Patients to More Youthful Levels 2Health News:Best Anti-Aging Human Growth Hormone Therapy Safely and Naturally Restores Diet Doc Patients to More Youthful Levels 3
... ... commitment to consumer privacy protection , ... Westlake Village, CA and San Francisco, CA (PRWEB) September 1, 2009 ... has been certified to display the TRUSTe Privacy Seal, which demonstrates its commitment to ...
... EDINBURGH, Scotland, September 1 Aircraft Medical,(Aircraft), the UK ... to its R&D, business development and sales teams since January ... staff is in line with the Company,s commitment to,expanding the ... business development and R&D activities. , ...
... The American Academy of Otolaryngology Head and ... only--national clinical practice guideline to help healthcare practitioners ... as dysphonia. The guideline emphasizes evidence-based management of ... prevalence of this common vocal health issue. ...
... , , DENVER, Aug. 31 ... of kidney care services for those diagnosed with chronic kidney disease ... leading health care industry publications, named Kent Thiry, Chairman and CEO ... Healthcare in 2009. , , (Logo: http://www.newscom.com/cgi-bin/prnh/20020729/DAVITALOGO ) ...
... NASHVILLE, Tenn., Aug. 31 Cumberland Pharmaceuticals Inc. (Nasdaq: ... on hospital acute care and gastroenterology markets, today announced that ... Global Life Sciences Conference in New York at 11:00 a.m. ... provide an update on the Company and its Caldolor product, ...
... Pa., Aug. 31 Endo Pharmaceuticals (Nasdaq: ENDP ) announced today ... Thursday, Sept. 10, 2009, at 2:40 p.m. EDT. Alan Levin, Chief Financial ... , The presentation will be webcast live and can be accessed ... , , About Endo , ...
Cached Medicine News:Health News:The People's Medicine Community Certified to Display TRUSTe Privacy Seal of Approval 2Health News:The People's Medicine Community Certified to Display TRUSTe Privacy Seal of Approval 3Health News:Aircraft Reports Material Expansion and Staff Increase 2Health News:National guideline released for the treatment of hoarseness 2Health News:National guideline released for the treatment of hoarseness 3Health News:DaVita CEO Kent Thiry Honored as One of Modern Healthcare's 100 Most Powerful People in Healthcare 2Health News:Cumberland Pharmaceuticals to Present at UBS Global Life Sciences Conference in New York on September 21, 2009 2Health News:Endo Pharmaceuticals to Present at Thomas Weisel Partners Healthcare Conference 2009 2
... end transcription services. Zodiac offers two ... either submitted over the phone via ... 24 hours a day, 7 days ... recorded on a digital handheld recorder ...
... Achieve high-speed productivity in the lab ... system, dedicated for pre- and post-analytical sorting ... HSS selectively decaps and then sorts primary ... to save time, labor, and eliminate ...
Cocoon Disposable Patient Warming Blankets are specially designed to prevent hypothermia and maintain normothermia in your patients. The soft warm coloured material is strong and resists tearing and ...
Similar to Model 530, but just 37 inches long and with only one drape....
Medicine Products: