Navigation Links
Cardium Files FDA 510(k) Application for U.S. Marketing Clearance of ExcellagenXL(TM) Topical Gel and ExcellagenFX(TM) Flowable Collagen Protein-Based Matrix for Diabetic, Pressure and Venous Ulcers and Other Dermal Wounds
Date:12/3/2009

SAN DIEGO, Dec. 3 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) announced today that its wholly-owned subsidiary, Tissue Repair Company, submitted a 510(k) premarket notification filing with the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its Excellagen(TM) product candidate based on positive data from the Company's recently completed Phase 2b Matrix clinical study. Today's submission with the FDA covers ExcellagenXL(TM) and ExcellagenFX(TM), advanced wound care management medical devices comprising customized collagen protein-based topical gels designed for use by health care professionals for patients with dermal wounds, which can include diabetic ulcers, pressure ulcers, venous ulcers, tunneled/undermined wounds, surgical and trauma wounds, second degree burns, and other types of wounds.

(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)

The 510(k) submission is based in part on positive findings from the Company's Phase 2b Matrix clinical study, reported on October 14, 2009, demonstrating substantial improvements in wound healing responses in patients with non-healing diabetic foot ulcers following one or two applications of Excellagen, an enhanced, customized collagen-based gel matrix. ExcellagenXL is designed for use by health care professionals in a clinical setting and as an adjunct to standard of care topical wound therapy, which in the case of diabetic ulcers typically includes surgical debridement and off-loading. The ExcellagenFX kit is designed for use by health care providers in a clinical setting in the treatment of larger soft tissue or tunneling wounds that
'/>"/>

SOURCE Cardium Therapeutics
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Cardium Reports Non-Healing Wounds Continue to Challenge Patients and Healthcare Providers
2. Cardium Completes Initial Patient Evaluation Period for MATRIX Phase 2b Excellarate Clinical Study
3. Cardium Announces Completion of Patient Recruitment in Phase 2b Clinical Trial of Excellarate(TM) for the Potential Treatment of Diabetic Foot Ulcers
4. Cardium Reports on Applicability of Corgentin to Stem Cell Therapies: Independent Studies Indicate that Ad5IGF-1 Potentiates Stem Cells to Improve Cardiac Function After Heart Attack
5. Cardiums InnerCool Announces Positive Benefits of Cooling During Robotic-Assisted Prostate Surgery Published in Urology
6. Cardium Reports on Second Quarter 2008 Highlights and Financial Results
7. Cardium Announces Appointment of Paul A. Foster, M.D. to Lead Generx and Excellarate Late-Stage Development Activities
8. Cardiums Innercool Therapies Unit Announces Publication of Positive Effects of Early and Rapid Hypothermia Following Heart Attack
9. Cardium and Tissue Repair Companys Excellarate Candidate for Healing Diabetic Wounds Gains Media Focus in Multiple Regions Across U.S.
10. Cephalon Files Patent Infringement Lawsuit Against Teva Pharmaceuticals
11. Endologix Files Motion to Discontinue Court Proceedings Related to Alleged Patent Infringement
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/18/2014)... 2014 After 6 months of careful ... here - the new programme for the next Cool Chain ... our global Cool Chain series, has just been released! ... As the lines between supply chain, logistics, QA and ... that is broad and yet specific, focused and yet accessible, ...
(Date:9/18/2014)... Calif. , Sept. 18, 2014   ... ), a biopharmaceutical company leading the discovery and ... it has initiated its ATHENA natural history of ... life-threatening genetic kidney disease with no approved therapy. ... natural decline of renal function markers such as ...
(Date:9/18/2014)... , Sept. 18, 2014  RXi Pharmaceuticals ... biotechnology company focused on discovering, developing and ... needs using RNA-targeted technologies, today announced that the ... Geert Cauwenbergh , will present at ... Conference on Wednesday, September 24, 2014 at ...
Breaking Medicine Technology:Europe's Biggest and Longest-Running Gathering of Life Sciences Logistics, Supply Chain & QA Professionals 2Regulus Initiates ATHENA Natural History of Disease Study in Alport Syndrome Patients 2Regulus Initiates ATHENA Natural History of Disease Study in Alport Syndrome Patients 3Regulus Initiates ATHENA Natural History of Disease Study in Alport Syndrome Patients 4Regulus Initiates ATHENA Natural History of Disease Study in Alport Syndrome Patients 5Regulus Initiates ATHENA Natural History of Disease Study in Alport Syndrome Patients 6RXi Pharmaceuticals to Present at the 7th Annual BioPharm America Conference 2RXi Pharmaceuticals to Present at the 7th Annual BioPharm America Conference 3
... MADISON, N.J., March 28, 2011 Quest Diagnostics Incorporated ... of diagnostic testing, information and services, announced today it ... subsidiary, Spark Acquisition Corporation, for all of the outstanding ... (Nasdaq: CRA ), one of the world,s ...
... (Nasdaq: VRUS ) today announced that it will ... Study of the Liver (EASL) on Saturday, April 2, 2011 ... Pharmasset,s progress on the programs that are the subject of ... a simultaneous webcast of this event via the internet, log ...
Cached Medicine Technology:Quest Diagnostics Commences Tender Offer for Acquisition of Celera 2Quest Diagnostics Commences Tender Offer for Acquisition of Celera 3Pharmasset to Webcast an Investor Event From the EASL Meeting 2Pharmasset to Webcast an Investor Event From the EASL Meeting 3
(Date:9/18/2014)... September 18, 2014 Relias Learning, the leader ... human services markets, today announced it has been named to ... private companies in America. , In the three-year period from ... up almost 2,000 spots on the Inc. 5000 list to ... , “The industries we serve continue to grow, and ...
(Date:9/18/2014)... PlatinumCode, a leading manufacturer and supplier ... the healthcare industry, announced earlier this month that ... their profits of the sale of eligible pink ... announcement, PlatinumCode has launched various marketing efforts to ... hospital labs with their popular “Pink Packs” of ...
(Date:9/18/2014)... “Awesome” is the way Emily W. describes her ... Internship Program at ARDX ( http://www.ardx.net ). Her ... as “Inspirational” and “Life-changing,” respectively. None of these ... be doing during their summer internship. Stacie was ... mindless tasks,” but, instead she was doing real, meaningful ...
(Date:9/18/2014)... HealthDay Reporter WEDNESDAY, Sept. 17, 2014 (HealthDay ... stress disorder symptoms are almost three times more likely to ... The findings don,t prove a direct link between PTSD ... also possible that certain women are prone to food addiction ... research seems to add to existing evidence connecting PTSD to ...
(Date:9/18/2014)... 18, 2014 Fit Body Boot Camp ... fitness business in the country and its popularity, as both ... to grow enormously in 2014. , The company’s annual ... taking place in Costa Mesa, CA on September 26 and ... conferences yet. Founder Bedros Keuilian, who is also considered the ...
Breaking Medicine News(10 mins):Health News:Relias Learning Named to Inc. 5000 List for Second Consecutive Year 2Health News:PlatinumCode Commits to Donating Five Percent of Profits from the sale of Pink Products to Support Breast Cancer Awareness 2Health News:ARDX Internship Helps Students to START on the Right Business Path 2Health News:ARDX Internship Helps Students to START on the Right Business Path 3Health News:ARDX Internship Helps Students to START on the Right Business Path 4Health News:PTSD Link to Food Addiction Seen in Report 2Health News:PTSD Link to Food Addiction Seen in Report 3Health News:With Fit Body Boot Camp World Conference Nearing, Founder Explains the Fitness Boot Camp Franchise’s Success 2Health News:With Fit Body Boot Camp World Conference Nearing, Founder Explains the Fitness Boot Camp Franchise’s Success 3
... Sales increase 73% over Third Quarter 2007, EMERYVILLE, ... ) today reported its financial results,for the three and ... of $12.2 million, or $0.21 per diluted share, for ... $0.6 million, or $0.01 per diluted share,in the same ...
... 6 Pharmos Corporation,(Nasdaq: PARS ) today reported results ... a net loss of $2.8 million, or $0.11 per,share, for ... $3.5 million,or $0.14 per share, in the third quarter 2007. ... The decrease in net loss for the third quarter ...
... and service levels were key reasons, says union,president, ... Paul N. Urick, R.Ph., announced today that the ... its Participating Employers Health,and Welfare Fund have agreed ... members pharmacy coverage through FutureScripts. UFCW Local,1776,s new ...
... room doctors, study says , , THURSDAY, Nov. 6 (HealthDay ... at the hands of peers, immediate one-on-one mentoring on ... their risk of becoming victims again, a new study ... for assault injuries -- including gunshot, knife and fist-fight ...
... mostly young children -- infected, bringing total to 79, CDC ... cases of people becoming infected with salmonella traced to dry ... , The outbreak, which started in 2006, marks the first ... source of the bacterial infection in people. , As of ...
... Company Reports Seventeenth Consecutive Quarter Of Growth In ... Inc.,(Nasdaq: GXDX ), a specialized laboratory services ... third quarter of 2008, which includes a,$2.5 million ... prior,periods. This compares to revenues of $16.2 million ...
Cached Medicine News:Health News:Onyx Pharmaceuticals Reports Third Quarter and Nine-Month 2008 Financial Results 2Health News:Onyx Pharmaceuticals Reports Third Quarter and Nine-Month 2008 Financial Results 3Health News:Onyx Pharmaceuticals Reports Third Quarter and Nine-Month 2008 Financial Results 4Health News:Onyx Pharmaceuticals Reports Third Quarter and Nine-Month 2008 Financial Results 5Health News:Onyx Pharmaceuticals Reports Third Quarter and Nine-Month 2008 Financial Results 6Health News:Onyx Pharmaceuticals Reports Third Quarter and Nine-Month 2008 Financial Results 7Health News:Onyx Pharmaceuticals Reports Third Quarter and Nine-Month 2008 Financial Results 8Health News:Onyx Pharmaceuticals Reports Third Quarter and Nine-Month 2008 Financial Results 9Health News:Onyx Pharmaceuticals Reports Third Quarter and Nine-Month 2008 Financial Results 10Health News:Pharmos Corporation Reports 2008 Third Quarter Results 2Health News:Pharmos Corporation Reports 2008 Third Quarter Results 3Health News:Pharmos Corporation Reports 2008 Third Quarter Results 4Health News:Pharmos Corporation Reports 2008 Third Quarter Results 5Health News:FutureScripts(R) Wins Business of UFCW Local 1776 for Pharmacy Benefits 2Health News:FutureScripts(R) Wins Business of UFCW Local 1776 for Pharmacy Benefits 3Health News:FutureScripts(R) Wins Business of UFCW Local 1776 for Pharmacy Benefits 4Health News:Counseling Can Combat Youth Violence 2Health News:Salmonella Outbreak Tied to Dry Dog Food Continues 2Health News:Salmonella Outbreak Tied to Dry Dog Food Continues 3Health News:Genoptix Reports Strong Financial Results for the Third Quarter and Raises Guidance for Full-Year 2008 2Health News:Genoptix Reports Strong Financial Results for the Third Quarter and Raises Guidance for Full-Year 2008 3Health News:Genoptix Reports Strong Financial Results for the Third Quarter and Raises Guidance for Full-Year 2008 4Health News:Genoptix Reports Strong Financial Results for the Third Quarter and Raises Guidance for Full-Year 2008 5Health News:Genoptix Reports Strong Financial Results for the Third Quarter and Raises Guidance for Full-Year 2008 6Health News:Genoptix Reports Strong Financial Results for the Third Quarter and Raises Guidance for Full-Year 2008 7Health News:Genoptix Reports Strong Financial Results for the Third Quarter and Raises Guidance for Full-Year 2008 8Health News:Genoptix Reports Strong Financial Results for the Third Quarter and Raises Guidance for Full-Year 2008 9Health News:Genoptix Reports Strong Financial Results for the Third Quarter and Raises Guidance for Full-Year 2008 10
... device for the qualitative detection of drug or ... device can detect up to nine of the ... minutes and requires only a few drops of ... maximize convenience and ease of use. TOX/See features ...
... TOX/See™ is a 1-step, hand-held, point-of-care device ... metabolites in human urine. The TOX/See device ... commonly abused drugs in 3 to 8 minutes ... Each TOX/See cassette is individually packaged to maximize ...
... TOX/See™ is a 1-step, hand-held, point-of-care device ... metabolites in human urine. The TOX/See device ... commonly abused drugs in 3 to 8 minutes ... Each TOX/See cassette is individually packaged to maximize ...
... device for the qualitative detection of drug or ... device can detect up to nine of the ... minutes and requires only a few drops of ... maximize convenience and ease of use. TOX/See features ...
Medicine Products: