We have added Cardium Therapeutics, Inc. (CXM): NYSE Amex to our featured and our watch list today. As our subscribers know we just love the pharma tech plays specially the smaller ones as they could have potential for some big moves.
Cardium Therapeutics, Inc. (CXM): NYSE Amex
Cardium Therapeutics is focused on the acquisition and strategic development of new and innovative biomedical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetization’s. 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.
Possible Upcoming Catalysts
As most know cardium submitted an FDA 510(k) application for the use of Excellagen ™ in the potential treatment of diabetic and other chronic wounds on the 4th of December 2009 and have been waiting over a year to date for the approval. The FDA do not give any guide lines for 501k device approvals, so the news could come any time as there are no set dates.
About Excellagen ™
Excellagen™ 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. Excellagen is designed for use by health care professionals in patients with dermal wounds, which can include diabetic ulcers, pressure ulcers, venous ulcers, tunneled/undermined wounds, surgical and trauma wounds, second degree burns, and other types of wounds. In December 2009, the Company filed a 510(k) premarket notification with the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its Excellagen product candidate based on positive data from the Company’s recently completed Phase 2b clinical trial that demonstrated substantial improvements in wound healing responses in patients with non-healing diabetic foot ulcers following one or two applications of Excellagen. ExcellagenXL is designed for use by health care professionals in a clinical setting and as an adjunct to standard of care topical wound therapy, which in the case of diabetic ulcers typically includes surgical debridement and off-loading. The ExcellagenFX kit is designed for use by health care providers in a clinical setting for the treatment of larger soft tissue or tunneling wounds that may occur with pressure, venous and diabetic ulcers, and surgical wounds. The ExcellagenFX flowable matrix product allows for deeper administration and direct intimate contact with the wound bed in more complex, irregular and difficult to access wounds. Other categories of advanced wound care products are manufactured with alginates, hydrogels and hydrocolloids in structured, membrane or granular product configurations, or require hydration, mixing and reconstitution immediately prior to patient administration. The Company’s Excellagen fibrillar collagen protein gel is a physiologic formulation consisting of a bioactive and biodegradable material that promotes effective wound management by providing a moist protective barrier and stimulates the natural wound healing process through the promotion of cell migration and capillary in-growth to support tissue regeneration. The Company 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.
Excellarate Clinical Study
The Company recently reported data from the multi-center Matrix Phase 2b clinical trial of Excellarate™ for the potential treatment of patients with chronic non-healing diabetic foot ulcers. The study evaluated patients treated with the Excellarate product candidate (combination of Ad5PDGF-B and 2.6% collagen) or 2.6% collagen alone compared to patient who received only the protocol specified standard of care. Nearly half of patients (48%) receiving a one-time Excellarate treatment had complete wound closure by 12 weeks, compared to a 31% wound closure rate for standard of care. Among combined one and two dose groups of Excellarate approximately 41% of patients achieved complete closure by 12 weeks. In addition to overall wound closures by 12 weeks, the Phase 2b study also evaluated wound closure rates and trajectories following product administration in order to assess the timing and extent of bioactivity. The data revealed that patients receiving Excellarate exhibited early and rapid wound healing responses as evidenced by substantial reductions in wound radius over the first several weeks following product administration, which responses were both greater and faster than those observed among patients that had received standard of care. For example, a 108% relative improvement (decrease in ulcer radius) compared to standard of care was observed over the first week following administration of Excellarate, and a 50% relative improvement was observed as an average over the first four weeks.
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Product Development Pathway
Market for Excellagen
In a article back in may 2008 in Genengnews.com about active products in the wound care market costs the U.S healthcare system over $7 billion in 2007. If Cardium can even get a small part of that money from Excellagen™ that could mean some very interesting revenue for Cardium.
Financings
As of September 30, 2010 CXM had $7,700,648 in cash and cash equivalents and $1,425,000 in restricted cash.
Shares Outstanding
As of November 5, 2010; 78,566,750 shares of the registrant’s common stock were outstanding.
Shares Short
Shares Short (as of Nov 15, 2010) 3.15M Shares short prior month was 3.23M they are approximate figures and may not be 100% right.
Trading Range
The 52-wk trading range is $0.30 – $0.84 Shares finished at $0.40 yesterday 7th Dec 2010.
About Cardium
Cardium Therapeutics is focused on the acquisition and strategic development of new and innovative biomedical 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.
The Company’s business model is designed to create multiple opportunities for success while avoiding reliance on any single technology platform or product type, and to leverage Cardium’s skills in late-stage product development in order to bridge the critical gap between promising new technologies and product opportunities that are ready for commercialization. Consistent with our long-term strategy, we continue to pursue cost-effective acquisitions with strong value enhancement potential as our product opportunities and businesses are advanced and corresponding valuations established. We intend to consider various corporate development transactions designed to place our product candidates into larger organizations or with partners having existing commercialization, sales and marketing resources, and a need for innovative products. Such transactions could involve the sale, partnering or other monetization of particular product opportunities or businesses.
Investor Relations
Bonnie Ortega
Director of Investor Relations/Public Relations
12255 El Camino Real
Suite 250
San Diego, CA 92130
Phone: 858-436-1018
E-mail: investorrelations@cardiumthx.com
WebSite
http://www.cardiumthx.com/
In our opinion CXM could or may be a high return speculative play, with a possible FDA approval some time soon “No Time Frame” on its new and exciting product Excellagen ™ that could help millions of people world wide with this serious condition. There are many factors that are built into this speculative play like a possible delisting from the AMEX or more dilution for share holders. We think priced at $0.40 and a possible catalyst that could happen anytime this could be a fairly high risk and specutilive reward play.
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