|
|
News Breaks
|
August 2, 2011
|
| 09:08 EDT |  | CXM |
| theflyonthewall.com: | Cardium Therapeutics reports on Excellagen news | | Cardium Therapeutics reported on the status of the 510 application seeking clearance from the FDA to market its Excellagen topical wound care management medical device comprising 2.6% formulated bovine Type I collagen gel for the treatment of dermal wounds. Cardium reports that in the second quarter it completed and submitted supplemental information related to the process for manufacturing the "market ready" Excellagen product candidate, which was a key requirement for clearance. While the FDA can always request additional information, the company believes that its filing addressed all outstanding requests. Cardium also reports that it has initiated production of commercial supplies for its Excellagen product candidate at Devro and fill/finish providers. Following initial market launch, and in order to improve coordination and manufacturing efficiencies associated with the Company's U.S.-based fill/finish and packaging providers, Cardium intends to transfer the final steps for formulated collagen manufacturing to a U.S.-based operation while continuing to utilize key starting materials (collagen in solution) produced and supplied by 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 covering the Company's process for manufacturing its finished 2.6% formulated fibrillar collagen gel. :theflyonthewall.com |
|
|
News For CXM From The Last 14 Days Check below for free stories on CXM the last two weeks.
There is 1 item on the Fly with pertinent information.
Sign up for a free trial to see the rest of the stories you've been missing. |
|
May 21, 2012
|
| 07:38 EDT |  | CXM |
|
|
|
|
|
Subscribe for More Information