Cardium Therapeutics (AMEX: CXM) has been battling for nearly two years to receive 510(k) clearance from the FDA to market and sell their Excellagen professional-use, sterile, syringe-based advanced wound care product for the management of diabetic foot ulcers and other dermal wounds and that positive news was finally announced on Monday, sending shares up more than 223% to a high of 0.42 on trading volume that topped 9 million. The good times spilled over into Tuesday for the small biomedical company as shares climbed to a high of 0.52 before closing the day at 0.40 as many shareholders who had grown accustomed to shares in the mid-0.20 range opted to take their profits.
Shares continued to drop on Wednesday, moving around the 0.36 – 0.39 level, and while the fall may be a bit disconcerting for longtime shareholders it could represent a perfect opportunity for those investors looking to find a favorable entry mark.
What makes CXM so attractive isn’t just the fact that they will now be able to market and sell Excellagen; it’s also the fact that the small bio-tech has managed to travel the long road without accumulating massive debt. CXM is currently carrying minimal debt while holding about $4.4 million in cash, an enviable position for a company that now has a real opportunity to generate revenues.
In all likelihood those revenues will initially come from the treatment of diabetic foot ulcers (DFUs) which represent an $800 million market opportunity in the United States alone. Given the fact that the incidence of diabetes continues to climb on a global scale, with an estimated 300 million expected to have the disease by 2025, the unique ability of Excellagen to significantly accelerate wound healing among those who develop DFUs compared to patients receiving standard of care therapy could truly establish it as a preferred method of treatment in the medical field.
Just as exciting as the opportunities in the DFU market, CXM has already begun to look for ways to establish the Excellagen technology platform to additional wound care and product opportunities. In their press release announcing the 510(k) clearance CXM also noted that Excellagen had been “cleared for use in the management of other dermal wounds including partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds.”
By gaining this additional clearance Excellagen isn’t limited to the 1.3 million Americans who are expected to develop DFUs; these other dermal wounds open the door to an additional 92 million patients that could be treated with the Excellagen technology platform.
This technology platform has a distinct advantage over other collagen-based wound management products available for professional use in the United States in that the manufacturing process of the Excellagen product allows for sterile fill of ready-to-use, single-use syringes for topical application rather than the more common collagen-based products that include granulated collagens that require mixing prior to use. What CXM was able to show in their Matrix clinical study was that “formulated collagen can significantly accelerate reductions in wound radius immediately following application compared to standard of care therapy in diabetic foot ulcers, and can support platelet activation and release of the wound healing protein, Platelet-Derived Growth Factor (PDGF).”
By opting for this form of treatment the 1 in 5 patients who currently require amputation due to DFUs becoming infected could be dramatically reduced.
In addition to Excellagen CXM is also advancing their late-stage/registration Aspire clinical study for their Generx angiogenic therapy as a potential new treatment option for patients with myocardial ischemia due to advanced coronary disease. This DNA-based angiogenic therapy is designed to stimulate and promote the growth of supplemental collateral vessels to enhance myocardial blood flow (perfusion) following a one-time intracoronary administration from a standard cardiac infusion catheter in patients who have insufficient blood flow due to atherosclerotic plaque build-up in the coronary arteries. CXM has already received clearance from the Russian Ministry of Health and Social Development to commence a Phase 3 registration study for Generx and favorable findings related to the Aspire study could be useful for optimizing and broadening commercial development pathways in other industrialized countries.
CXM is also working to expand their MedPodium product line of premium science-based, easy to use medicinals, neurologics, metabolics, nutraceuticals and aesthetics designed to promote and manage personal health. CXM has created MedPodium Health Sciences, Inc. as a wholly-owned subsidiary designed to develop their nutraceutical and healthy lifestyle products as well as acquire complementary business assets having existing revenues and channels of distribution. MedPodium Health Sciences will also handle the sales and distribution of Excellagen, an obvious benefit to shareholders.
It has been a long road for CXM and their shareholders and with a number of obstacles placed before them during this journey share price has been hammered yet it appears as if they are beginning to see the light at the end of the tunnel. FDA clearance alone should trigger favorable investor interest and as the company advances their efforts to market and sell Excellagen and in turn move forward with their other endeavors shares should climb nicely. By all indications shares are a bargain right now and there’s no reason to believe that CXM won’t aggressively pursue the revenue opportunities that are now before them.