crackedtooth schreef op 28 december 2010 15:18:
CXM sold most premarket due to delay in 510k
"The Company also provided an update with respect to planned commercialization of its Excellagen
topical gel wound care dressing, which comprises a specially formulated collagen matrix gel being
produced under a supply agreement with Devro Medical Limited, part of Devro PLC, a public limited
company registered in Scotland. Certain changes to the manufacturing process for the collagen
matrix being prepared at Devro will require modified regulatory submissions under the FDA 510(k)
process, which are expected to be filed in first quarter 2011.
exited .56 or so avg
"
first run .42 to .51
next .46 to .56 avg
New from today:
Cardium Reports Excellagen Matrix Clinical Study Results Accepted for Publication by Peer-Reviewed Journal, and Updates Product Plans <CXM.A>
pdf.reuters.com/pdfnews/pdfnews.asp?i... SAN DIEGO, Dec. 28, 2010 /PRNewswire/ -- Cardium Therapeutics (NYSE Amex: CXM) today reported
that data from the Company's Matrix Phase 2b clinical study has been accepted for publication in
the journal, Wound Repair and Regeneration and provided an update on plans for commercialization
of its Excellagen formulated collagen topical wound dressing.
(The clinical paper now accepted for publication is titled, "Formulated Collagen Gel Accelerates
Healing Rate Immediately after Application in Patients with Diabetic Neuropathic Foot Ulcers", and
was authored by nine investigators who participated in the Matrix study and Cardium researchers
and is expected to be published in early 2011. Excellagen formulated collagen topical gel wound
care dressing was studied in a controlled, double blind Matrix Phase 2b clinical study of chronic
diabetic lower extremity ulcers. Wounds treated with the Excellagen formulated collagen (2.6%)
topical gel showed a statistically significant acceleration of wound healing during the first week
following a one-time application compared to patients receiving standard of care therapy, a
response that was sustained over a 14 day period. The authors suggest that more frequent
applications of Cardium's Excellagen product candidate hold promise to significantly improve
overall incidence of complete wound closure.
The Company also provided an update with respect to planned commercialization of its Excellagen
topical gel wound care dressing, which comprises a specially formulated collagen matrix gel being
produced under a supply agreement with Devro Medical Limited, part of Devro PLC, a public limited
company registered in Scotland. Certain changes to the manufacturing process for the collagen
matrix being prepared at Devro will require modified regulatory submissions under the FDA 510(k)
process, which are expected to be filed in first quarter 2011.