Navigation Links
Cardium Provides Update on Excellagen 510(K) Registration and Commercialization Plans
Date:8/2/2011

y Devro. In connection with that process, the Company also expects to eventually establish its own Device Master File with the FDA's Center for Devices and Radiological Health (CDRH) covering the Company's process for manufacturing its finished 2.6% formulated fibrillar collagen gel.

Excellagen is designed to be a cost-efficient, outcomes-focused medical device for the management of wound care. The Excellagen kit developed for initial launch consists of a set of four single-use prefilled syringes designed to be applied over a course of up to four treatment procedures. At each treatment procedure, Excellagen is topically applied to the debrided wound, and then covered with a non-adherent dressing. The Company believes that Excellagen provides a unique wound care option as there are no other collagen-based wound care management dressings available for professional use in the United States that are comparable to Excellagen in terms of its product format, formulation, and fibrillar nature. Other professional-use collagen-based products include powdered and granulated collagens that require mixing with sterile water prior to use, as well as a variety of sheet-based products.

"We look forward to working with the FDA to secure regulatory clearance and the commercial launch of Excellagen. We are continuing to work with potential new collaborative partners and to explore additional product opportunities for our Excellagen formulation," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium.

About Excellagen

The Company's Excellagen fibrillar collagen protein gel is designed to provide a physiologic formulation consisting of a biocompatible and biodegradable material that promotes effective wound management. Based on the unique properties of the highly purified, fibrillar Type I collagen protein used, Excellagen formulated collagen topical gel (2.6%) requires storage at standard refrigeration temperatures (2 d
'/>"/>

SOURCE Cardium Therapeutics
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Cardium and Tissue Repair Companys Excellarate Candidate for Healing Diabetic Wounds Gains Media Focus in Multiple Regions Across U.S.
2. Cardiums Innercool Therapies Unit Announces Publication of Positive Effects of Early and Rapid Hypothermia Following Heart Attack
3. Cardium Announces Appointment of Paul A. Foster, M.D. to Lead Generx and Excellarate Late-Stage Development Activities
4. Cardium Reports on Second Quarter 2008 Highlights and Financial Results
5. Cardiums InnerCool Announces Positive Benefits of Cooling During Robotic-Assisted Prostate Surgery Published in Urology
6. 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
7. Cardium Announces Completion of Patient Recruitment in Phase 2b Clinical Trial of Excellarate(TM) for the Potential Treatment of Diabetic Foot Ulcers
8. Cardium Completes Initial Patient Evaluation Period for MATRIX Phase 2b Excellarate Clinical Study
9. Cardium Reports Non-Healing Wounds Continue to Challenge Patients and Healthcare Providers
10. Cardium Presents at Tenth Annual Wound Healing: Science and Industry Conference on Matrix Wound Healing Clinical Development
11. 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
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/21/2014)... Nov. 21, 2014  Lexicon Pharmaceuticals, Inc. (Nasdaq: ... previously announced underwritten public offering of $50,000,000 of shares ... registration statement. The offering will consist of 49,751,244 shares ... $1.005 per share.  Lexicon has also granted the underwriters ... shares of common stock.  All of the shares in ...
(Date:11/18/2014)... Respiratory Motion and IMI Co announced today ... services providers in Japan , will ... respiratory depression monitor, the ExSpiron™. As part of this ... to connect the clinical community in promoting patient safety. ... innovative medical devices and new technology to the Japanese ...
(Date:11/18/2014)... and SAN DIEGO , Nov. ... a clinical stage biopharmaceutical company that discovers, develops ... with cancer, announced today that it filed an ... Food and Drug Administration (FDA) on Friday, November ... HPPI,s proposed clinical development of a patented formulation ...
Breaking Medicine Technology:Lexicon Announces Pricing Of Common Stock Offering 2Lexicon Announces Pricing Of Common Stock Offering 3Prominent Japanese Med Device Provider to be Respiratory Motion's Exclusive Partner for World's #2 Medical Market 2Prominent Japanese Med Device Provider to be Respiratory Motion's Exclusive Partner for World's #2 Medical Market 3Prominent Japanese Med Device Provider to be Respiratory Motion's Exclusive Partner for World's #2 Medical Market 4HedgePath Pharmaceuticals Files IND Application 2HedgePath Pharmaceuticals Files IND Application 3HedgePath Pharmaceuticals Files IND Application 4
... Calif., Nov. 11 Abaxis, Inc. (Nasdaq: ABAX ), ... today that Brenton Hanlon, Vice President, North American Medical Sales ... Annual New York Institutional Investor Forum on Friday, November 20, ... at The Grand Hyatt Hotel in New York City. , ...
... BOSTON, Nov. 11 Solos Endoscopy, Inc. (Pink Sheets: ... Breast Endoscopy System, the MammoView(TM), was featured in the ... Healthcare Purchasing News Magazine. The article focused on the ... procedures with minimal or no discomfort. , ...
Cached Medicine Technology:Solos Endoscopy, Inc.'s Breast Endoscopy System Featured in November Issue of Healthcare Purchasing News Magazine 2
(Date:11/21/2014)... Grants Pass, OR (PRWEB) November 21, 2014 ... and become thirsty. In winter, people rarely perspire and ... felt in winter to drink the eight glasses of ... Don’t be fooled, warns fresh water advocate Sharon Kleyne. ... and maintaining daily hydration is just as important.     ...
(Date:11/21/2014)... For many busy people, having their missing or ... of recovery from dental surgery that have traditionally been required ... of their youthful appearance. , But the dental implant ... and Woodland Hills, Calif., can provide someone with a full ... where the patient’s bone has deteriorated. , Dr. Saj Jivraj ...
(Date:11/21/2014)... (PRWEB) November 21, 2014 CDT ... the dental practice. It includes everything needed to process ... Procedure Coding with CDT , CDT 2015 codes are ... January 1, 2014 - December 31, 2014. Dental professionals ... and services on dental claims. There are significant changes ...
(Date:11/21/2014)... November 21, 2014 Even with years of ... to learn and room for growth, participating in two recent ... State Farm’s National Convention, a networking event with the leaders ... country, bringing back the latest and greatest in insurance news ... spotted Kirk and his team (Stacy, Anthony, Reina and Jacob) ...
(Date:11/21/2014)... November 21, 2014 CARE Surrogacy Center ... intended parents — and at the same time enhancing their ... of optimism for future parents across the globe, the company ... Prospective parents today are zoning in on the skyrocketing costs ... encumbering costs, are individuals over-stressing clinical success rates ? ...
Breaking Medicine News(10 mins):Health News:Our Bodies Need Eight Glasses of Water a Day Even in Winter Reports Fresh Water Advocate 2Health News:Our Bodies Need Eight Glasses of Water a Day Even in Winter Reports Fresh Water Advocate 3Health News:Anacapa Dental Art Institute Prosthodontists Develop New Technique to Offer Younger Appearance in Just One Visit 2Health News:Anacapa Dental Art Institute Prosthodontists Develop New Technique to Offer Younger Appearance in Just One Visit 3Health News:Anacapa Dental Art Institute Prosthodontists Develop New Technique to Offer Younger Appearance in Just One Visit 4Health News:Anacapa Dental Art Institute Prosthodontists Develop New Technique to Offer Younger Appearance in Just One Visit 5Health News:PMIC Announces CDT PLUS! 2015, the Ultimate Coding Reference for Dentists and Oral Surgeons 2Health News:Kirk Martin Insurance Agency Goes Local and National with State Farm 2Health News:CARE Surrogacy Center Reports on its Multiple Measures of Success 2Health News:CARE Surrogacy Center Reports on its Multiple Measures of Success 3
... energy sources to the eye may help delay retinal ... The transporters, SMCT1 and SMCT2, can circumvent the eyes ... bodies to a healthy eye, says Dr. Pamela Martin, ... diabetes, characterized by plenty of glucose but the inability ...
... Study supports effectiveness of the ultrasound-guided technique , ... minimally invasive procedure is a quick, inexpensive way ... report. , The researchers used ultrasound-guided percutaneous (through ... more than 2,000 people (average age 42) with ...
... Using a novel imaging technique to study autistic ... brain areas that govern social processing and learning by ... J. Lindner Center for Autism, North Shore-Long Island Jewish ... the annual meeting of the Radiological Society of North ...
... 28, 2007 (Oakland, CA) The National Heart ... over the next five years to establish a ... will leverage the collective cardiovascular expertise, diverse community-based ... Kaiser Permanente and eight other health plans in ...
... Card System to Revolutionize Adult Sexual Behaviors, ... Inc.,(SSPB) announced today it will launch the world,s ... Safe Sex Passport (SSP) on December,1st, in conjunction ... the,spread of Sexually Transmitted Diseases (STDs) by providing ...
... pleased to,announce that Gail Oliver has been named Vice ... this position, Ms. Oliver will lead,and manage the Loss ... development opportunities for this aspect of the,company,s portfolio., ... years. Most recently, she,has been serving as the Regional ...
Cached Medicine News:Health News:Transporters may help delay diabetes-related retinal damage 2Health News:Transporters may help delay diabetes-related retinal damage 3Health News:Saline Wash May Ease Shoulder Tendonitis 2Health News:Novel imaging technique shows gray matter increase in brains of autistic children 2Health News:National Heart Lung and Blood Institute creates national network to study cardiovascular disease 2Health News:Safe Sex Passport Launches to Provide Breakthrough Protection Against STDs and HIV 2
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: