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:1/23/2015)... 2015  Now available for sale, The Armor1 Ankle Roll ... ankle sprains by cushioning the ankle from an inversion ... the outside of any shoe type and allows the ... offering protection against sprains. With customers in physical therapy, ...
(Date:1/23/2015)... , Jan. 23, 2015  CytoSorbents Corporation (NASDAQ CM: ... CytoSorb® extracorporeal cytokine adsorber to reduce deadly inflammation ... receipt of $385,642, net of transaction costs, in ... Technology Business Tax Certificate Transfer Program sponsored by ...
(Date:1/22/2015)... 2015  ViewRay™, a privately held medical device company, announced ... agreement with ITOCHU Corporation (Tokyo Stock Exchange TYO: 8001) ... treatment of cancer in Japan . ... first and only MRI-guided radiation therapy system that images ...
Breaking Medicine Technology:The Armor1 Ankle Roll Guard is the New Breakthrough Solution for Ankle Sprain Prevention! 2CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 2CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 3ITOCHU Named the Exclusive Distributor for ViewRay's MRI-Guided Radiation Therapy System in Japan 2
(Date:1/22/2015)... Angelweddingdress is a famous wedding dress company offering many trendy ... on Facebook, Twitter, and Pinterest. The fans will have an ... lottery every week. , Moreover, the company has extended its ... Angelweddingdress homepage for more information. , Angelweddingdress is ...
(Date:1/22/2015)... 2015 Juvent Sports ( http://www.juventsports.com ) ... PGA Merchandise Show to bestow a Juvent Sports Achievement ... golfer, Arlene McKitrick. The award commemorated and congratulated McKitrick ... win. She won her first amateur tournament in 1979 ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 For over 20 years, ... Oceanside and Vista area has treated just about every ... personal injury circumstances. And for those same twenty-plus years, the ... of all those injuries with the best possible doctor. ...
(Date:1/22/2015)... La Jolla, Calif. (PRWEB) January 22, 2015 ... and Assemblymembers Susan Bonilla (D-Concord) and Kristin Olsen ... (CHI) for their leadership in advancing biotechnology, biomedical ... Mitchell, Bonilla and Olsen each received the “2014 ...
(Date:1/22/2015)... 2015 Payday lending practices in four ... cause financial distress to the states that permit them, ... University’s Center on Race and Wealth. , While they ... payday loans at the same time substantially depress economic ...
Breaking Medicine News(10 mins):Health News:Angelweddingdress Invites Its Customers To Follow It On Facebook, Twitter, And Pinterest 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 3Health News:Industry Leading Chiropractor in Oceanside Joins the Doctors on Liens Network 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2
... on bmj.com today (Tuesday 26 June) questions the ... well-controlled, non-insulin dependent (type 2) diabetes. ... Diabetes Association Conference, suggests that current guidelines for ... ,Non-insulin dependent (type 2) diabetes usually develops ...
... young son over the weekend, and then committed suicide ... has reported on its website, www.wwe.com, that the bodies ... in Atlanta, Georgia. ,The website also states ... County Sheriffs Department has confirmed that the deaths were ...
... Radcliffe, Emma Watson and Rupert Grint admit that they have ... do - drinking and smoking . ,However, the ... stars, is that they maintain their squeaky clean image by ... Watson, better known as the muggle-born witch Hermione Granger, says ...
... class of commonly prescribed antidepressants may be linked to ... and women . ,The antidepressant medications known ... inhibiting the protein that transports serotonin, a neurotransmitter involved ... the articles, and which has recently been discovered in ...
... has said that opium production in Afghanistan is soaring out ... over 90 percent of illegal opium, which is used to ... a BBC report, the cultivation of opium poppies increased dramatically ... international troops there, and adds that Afghanistan is unlikely to ...
... detaining those suspected of spreading the virus. But some of ... ,Like the Sudanese-born Lam Kuoth who was arrested earlier this ... in Victoria. ,But he was freed Monday a ... "very considerably. ,Detectives from the sexual crimes squad ...
Cached Medicine News:Health News:Questions Over Value of Glucose Monitoring for Non-insulin Using Diabetes Patients 2Health News:Common Antidepressants Linked to Increased Bone Loss in Older Adults 2Health News:Common Antidepressants Linked to Increased Bone Loss in Older Adults 3Health News:Man Accused of Spreading HIV Granted Bail in Australia 2
... Defibrillator was designed to be as easy ... and shares many of its features, including ... Philips HeartStart Home Defibrillator is an automated ... home use by untrained users. Although small ...
... imaging and an extraordinary combination of ... choice for the multi-specialty clinical environment. ... SSD-4000s software and hardware allows you ... exams while achieving high-quality results., ,The ...
... is a cost-effective, office-based ultrasound system. It ... quality of our more expensive ProSound models ... maneuvering in small exam rooms., ,The SSD-3500 ... data management system (iDMS) enables easy storage ...
Inquire...
Medicine Products: