Cardium Announces Plans to File FDA 510(k) Application for U.S. Marketing Clearance of ExcellagenXL(TM) Gel for Diabetic, Pressure and Venous Ulcers and Other Topical Wounds

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Mon Nov 2, 2009 10:30am EST

Cardium Announces Plans to File FDA 510(k) Application for U.S. Marketing
Clearance of ExcellagenXL(TM) Gel for Diabetic, Pressure and Venous Ulcers and
Other Topical Wounds




SAN DIEGO, Nov. 2 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex:
CXM) today announced plans to submit a 510(k) premarket notification with the
U.S. Food and Drug Administration (FDA) seeking marketing clearance of its
ExcellagenXL(TM) product candidate.  ExcellagenXL is an advanced wound care
management medical device, which is a customized collagen-based topical gel
designed for use by physicians in patients with topical wounds, which include
diabetic ulcers as well as pressure ulcers, venous ulcers, surgical and trauma
wounds, second degree burns, and other types of wounds.  The Company expects
to submit its FDA 510(k) application for ExcellagenXL during the current
quarter. 

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

The planned 510(k) filing is based in part on positive findings from the
Company's Phase 2b Matrix clinical study, reported October 14, 2009,
indicating that substantial improvements in wound healing responses were
observed in patients with non-healing diabetic foot ulcers following one or
two applications of ExcellagenXL.  The ExcellagenXL topical gel wound care
product is designed to promote a favorable environment for effective wound
management by providing a moist protective barrier as well as a micro-scaffold
that promotes cell migration and capillary in-growth.

ExcellagenXL is an advanced wound care device composed of highly-refined,
soluble bovine dermal collagen (Type I), which is modified to reduce
immunogenicity and promote its usefulness in wound settings.  ExcellagenXL is
planned for physician use in conjunction with standard of care wound therapy,
which in the case of diabetic ulcers typically includes surgical debridement
and off-loading.  ExcellagenXL is expected to be indicated for use at two-week
intervals (with weekly outer dressing changes) as an adjunct to surgical
debridement, and supplied in a sterile single-use syringe along with a sterile
flexible application needle to facilitate topical administration over the
wound site.  ExcellagenXL will be stored at standard refrigeration temperature
(2 degrees C - 8 degrees C).  

Cardium also announced plans to develop additional new product opportunities
by incorporating other agents into Excellagen formulations, including
antimicrobials, DNA and/or other biologics, which are designed to address
particular wound healing and other tissue repair applications.

"We are pleased to announce plans to submit our FDA 510(k) premarket
notification of our ExcellagenXL collagen-based topical gel.  The 510(k)
clearance process provides us with a potential near-term opportunity to
introduce this product into the rapidly-growing market for advanced wound
care.  Applying our specialized formulation know-how and the unique properties
of our collagen-based matrix technology, we also look forward to introducing
additional Excellagen-based products in the near future," stated Christopher
J. Reinhard, Chairman and Chief Executive Officer of Cardium.

About Cardium

Cardium is focused on the acquisition and strategic development of new and
innovative bio-medical product opportunities and businesses that have the
potential to address significant unmet medical needs and definable pathways to
commercialization, partnering and other economic monetizations.  Cardium's
investment portfolio includes the Tissue Repair Company and Cardium Biologics,
medical technology companies primarily focused on the development of
innovative therapeutic products for wound healing, bone repair, and
cardiovascular indications.  In July 2009, Cardium completed the sale of its
InnerCool Therapies medical device business to Royal Philips Electronics, the
first asset monetization from the Company's biomedical investment portfolio. 
News from Cardium is located at www.cardiumthx.com.

Forward-Looking Statements 

Except for statements of historical fact, the matters discussed in this press
release are forward looking and reflect numerous assumptions and involve a
variety of risks and uncertainties, many of which are beyond our control and
may cause actual results to differ materially from stated expectations.  For
example, there can be no assurance that  Excellagen, Excellarate or our other
candidates will prove to be sufficiently safe and effective, or that results
or trends observed in one clinical study or procedure will be reproduced in
subsequent studies or procedures, or that clinical studies even if successful
will lead to product advancement or partnering; that the Excellagen or
Excellarate product candidate offers the potential for simpler or more
cost-effective treatment for physicians and patients than other FDA-approved
products that currently are or will be on the market; that the Matrix clinical
study program or other human clinical trials can be conducted and completed in
an efficient and successful manner; that we can develop a DNA-based
orthobiologics product portfolio; that our products or product candidates will
not be unfavorably compared to competitive products that may be regarded as
safer, more effective, easier to use or less expensive; that FDA or other
regulatory clearances or other certifications, or other commercialization
efforts will be successful or will effectively enhance our businesses or their
market value; that our products or product candidates will prove to be
sufficiently safe and effective after introduction into a broader patient
population; or that third parties on whom we depend will perform as
anticipated.

Actual results may also differ substantially from those described in or
contemplated by this press release due to risks and uncertainties that exist
in our operations and business environment, including, without limitation,
risks and uncertainties that are inherent in the development of complex
biologics and in the conduct of human clinical trials, including the timing,
costs and outcomes of such trials, our ability to obtain necessary funding,
regulatory approvals and expected qualifications, our dependence upon
proprietary technology, our history of operating losses and accumulated
deficits, our reliance on collaborative relationships and critical personnel,
and current and future competition, as well as other risks described from time
to time in filings we make with the Securities and Exchange Commission.  We
undertake no obligation to release publicly the results of any revisions to
these forward-looking statements to reflect events or circumstances arising
after the date hereof. 

Copyright 2009 Cardium Therapeutics, Inc.  All rights reserved.

For Terms of Use Privacy Policy, please visit www.cardiumthx.com.

Cardium Therapeutics(TM) and Generx® are trademarks of Cardium Therapeutics,
Inc.

Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellagen(TM),
Excellarate(TM) and Osteorate(TM) are trademarks of Tissue Repair Company.



SOURCE  Cardium Therapeutics

Bonnie Ortega, Director, Investor/Public Relations of Cardium Therapeutics,
Inc., +1-858-436-1018, InvestorRelations@cardiumthx.com
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