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:7/30/2015)... July 30, 2015  Amgen (NASDAQ: AMGN ... quarter of 2015. Key results include: , ... quarter of 2014 to $5,370 million, with 6 ... ® (etanercept), Prolia ® (denosumab), Sensipar ... XGEVA ® (denosumab). Unfavorable changes in foreign ...
(Date:7/30/2015)... , July 30, 2015  Cleveland Clinic President ... 2015 keynote address last month that industry is compelled ... order to gain the efficiencies—and develop the transformational innovations ... Dr. Barsoum,s comments were preceded by Doug Kohrs ... and OMTEC moderator, who stressed that industry must add ...
(Date:7/30/2015)... , July 30, 2015 ... new research report with market overview, trends, ... forecast, porter analysis, recent developments, competitive scenario ... Global Industry Insight: Biosensors Market Development and ... (Logo: http://photos.prnewswire.com/prnh/20150727/756778 ) Explore ...
Breaking Medicine Technology:Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 2Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 3Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 4Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 5Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 6Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 7Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 8Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 9Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 10Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 11Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 12Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 13Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 14Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 15Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 16Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 17Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 18Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 19Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 20Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 21Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 22Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 23Orthopaedic Surgery Reimbursement Shifts to Episode of Care 2Global Biosensors Market (Size of $12,964 Million in 2014) to Witness 10% CAGR During 2015 - 2020 2Global Biosensors Market (Size of $12,964 Million in 2014) to Witness 10% CAGR During 2015 - 2020 3Global Biosensors Market (Size of $12,964 Million in 2014) to Witness 10% CAGR During 2015 - 2020 4Global Biosensors Market (Size of $12,964 Million in 2014) to Witness 10% CAGR During 2015 - 2020 5
(Date:8/1/2015)... (PRWEB) , ... August 01, 2015 , ... Lume Wellness ... that is free to download on the Apple AppStore. , The app is ... even mood, thus acting as a tool to view personal health and use this ...
(Date:8/1/2015)... ... 01, 2015 , ... “ reTXT ” was featured on NewsWatch as part ... on the market for iOS, Android, and Windows. Joe Toohey, the host of AppWatch ... clarify, edit and delete any message including ones already sent. , While text messaging ...
(Date:7/31/2015)... ... July 31, 2015 , ... That’s right, ... are the STASH awards? The Significant Technological Achievements in Secretive Horticulture (or STASH) ... well as tried-and-true products that have stood the test of time. These include ...
(Date:7/31/2015)... York, New York (PRWEB) , ... July 31, 2015 , ... ... to strut their stuff, Super-Sod debuted their new type of sod called Leisure ... registered trademark application in process. , To commemorate introduction of this new type of ...
(Date:7/31/2015)... ... August 01, 2015 , ... Super Bowl 50 will emanate from Levi’s ... biggest day each year is the Super Bowl. In the two weeks that separate the ... the host venue. The 2016 Super Bowl game will mark the 50th time it has ...
Breaking Medicine News(10 mins):Health News:Lume Wellness Launches Health and Fitness Tracker iPhone App 2Health News:Correct Auto-Correct and Clarify the Unclear with reTXT Messaging App 2Health News:The High Times S.T.A.S.H. Awards Are in, Guess Who Took Home the Prize for “Best Grow System” 2Health News:Super-Sod Introduces Leisure Time(TM) Zoysia Grass with an Adirondack Chair Promotion 2Health News:Cheap 2016 Super Bowl Tickets at Levi's Stadium: Ticket Down Slashes Ticket Prices on Super Bowl 50 Tickets in Santa Clara, CA at Levi's Stadium 2
... findings show men have fewer long-term gastrointestinal side ... three-dimensional// conformal radiation therapy (3D CRT) for prostate ... used in the IMRT group. These and other ... today at the 48th Annual Meeting of the ...
... Sienna Miler says she won't give in to ... ,According to contactmusic.com, Miller has slammed critics who ... treat her differently from supermodel Kate Moss. ... thing, but with Kate Moss, it is deemed ...
... fish have been floating along the banks of the Yamuna ... pollution, creating a shortage of drinking// water in this historic ... river being reduced to zero as a result of sudden ... the quality of water has deteriorated drastically. ,This ...
... osteopathic physician and best known founder and editor ... has revealed the// secrets of some artificial sweeteners. ... and the FDA May Be Hazardous to Your ... sweetener industry. You can watch Dr. Mercola's latest ...
... indicated the current situation with both these viral infections in India. ... 9453 cases and 157 deaths as a whole including Delhi ... and NCR - one of the worst affected areas there ... reported from Delhi, NCR and other states. There were 1770 ...
... disease was first diagnosed on November 3, 1906. One ... focusing on neuroscience, immunology and vaccine research in an ... and progresses. Researchers at the Yerkes National Primate Research ... to advance the treatment and prevention of this progressive ...
Cached Medicine News:Health News:IMRT Versus 3D CRT For Prostate Cancer, New Long-Term Data Assesses Side Effects 2Health News:Yamuna Pollution Kills Thousands Of Fish 2
... 2000 Pipette is a synonym for pipetting ... robust design, and superior operating comfort. Its ... the measuring stroke and blow-out as well ... system ensures utmost accuracy and precision. Ejection ...
... from Thermo Labsystems was designed specifically to ... features such as the new fast dial ... microvolumes help to define this as a ... new interchangeable handle plate offers a custom ...
... Eppendorf Reference Series 2000 Pipette is a ... a compact and robust design, and superior ... used to operate the measuring stroke and ... Product features:Eppendorf "pipette/tip" system ensures utmost accuracy ...
... viscosity and density. Proven ergonomic design reduces hand fatigue, prevents injury. Dry ... 0.2-2 ... 2~5 Imprecision(%) ... 0.01 Dimensions: ...
Medicine Products: