SAN DIEGO, Jan. 5 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced plans to launch a new premium advanced skin care product line to promote foot health and comfort for podiatry patients. Cardium's new MedPodium(TM) product line is an over-the-counter product portfolio for patients with the potential for foot disorders and ailments. MedPodium represents a new line of foot care products to broaden and complement Cardium's Excellagen topical gel product candidate platform, which is currently subject to a pending FDA 510(k) application submission for U.S. marketing clearance, for the management of wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, surgical wounds and certain other wounds.
The MedPodium patient care podiatric product line, which will initially carry six products, has been designed to promote foot health and comfort and support preventative care, self examination and early detection of foot ulcers, especially for diabetic patients with lower extremity neuropathy. The MedPodium product line has been formulated to include blended natural and botanical ingredients, and will have no artificial colors and fragrances. The various products contain exfoliants to promote the release of dead skin cells and stimulate the production of new skin cells, natural vitamin antioxidants, certain natural medicinals to aid in circulation as well as other nutrient-rich ingredients to promote soft and supple skin. Daily use of MedPodium's natural cremes and gels are intended to assist self examination and early detection of foot ulcers, which can potentially become a serious and chronic medical problem that can contribute to increased morbidity and mortality, without proper care and early treatment, especially for diabetic patients.
The commercial development of Cardium's MedPodium patient care product line is intended to provide a first line of defense for individuals at risk for foot ulcers and enhances and expands Cardium's product portfolio beyond the current Excellagen product candidate platform. Excellagen topical gel is a flowable fibrillar collagen protein-based matrix that is being developed as an advanced wound care management device for use by health care professionals to provide a moist protective barrier and stimulate the natural wound healing process through the promotion of cell migration and capillary in-growth to support tissue regeneration.
In early December, Cardium filed a 510(k) application for U.S. marketing clearance for the Excellagen product candidate which would cover: (1) ExcellagenXL that would be 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, and (2) ExcellagenFX that would be for use by health care providers in a clinical setting in 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 candidate is designed to allow for deeper administration and direct intimate contact with the wound bed in these more complex, irregular and difficult to access wounds.
"Based on our years of applied research and clinical study of diabetic foot ulcers and wound healing, it is now clearer than ever that prevention, early detection through self examination, and patient compliance for off-loading and prescribed medical therapy are essential for the prevention and management of chronic foot ulcers. The best way to avoid developing diabetic foot ulcers and their complications is through rigorous preventative care, and our new MedPodium product line seeks to provide patients with ways to support prevention, self examination and early detection, and provide comfort and promote soft and supple skin, consistent with industry guidelines for good foot health. We look forward to the commercial launch of our initial six MedPodium patient care products and, subject to FDA marketing clearance, our Excellagen product candidate platform that will also include two professional care products for use by podiatrists and other professional health care providers," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium.
American Diabetes Association
Guidelines to Promote Good Foot Care
The American Diabetes Association (ADA) has established guidelines to promote foot health and preventative care (http://www.diabetes.org/living-with-diabetes/complications/foot-care.html). Diabetic patients may develop lower extremity neuropathy which subjects patients to a higher potential for developing foot ulcers. Industry data reports that diabetes in the U.S. is the leading cause of lower extremity amputations, with these amputations occurring 10 to 30 times more in diabetics than the general population. Treatment of diabetic wounds is challenging and if they become chronic, the annual treatment cost in the U.S. is estimated to range from $20,000 to $27,000.
The ADA recommends that diabetic patients complete a foot exam at least annually - more often with foot problems - by a professional health provider, including a foot care specialist. Patients are urged to call or see a health care provider for cuts or breaks in the skin, ingrown nails, and if the foot changes color, shape, or just feels different.
General guidelines for diabetics to promote good foot health are summarized as follows: (1) carefully manage diabetes and keep blood glucose levels in a patient's target range: (2) undertake a self examination of feet daily, looking for red spots, cuts, swelling, and blisters using a mirror to see the bottom of each foot or ask someone for assistance; (3) be more active and plan a physical activity program with your health team; (3) ask about Medicare coverage for special shoes; (4) wash feet every day, and dry carefully, especially between the toes; (4) keep skin soft and smooth and rub a thin coat of skin lotion over the tops and bottoms of your feet, but not between toes; (5) If a patient can see and reach their toenails, trim them when needed and trim toenails straight across and file the edges with an emery board or nail file; (6) wear shoes and socks at all times, never walk barefoot, and wear comfortable shoes that fit well and protect feet making sure to check inside of shoes before wearing them to make sure the lining is smooth and there are no objects inside; (7) protect feet from hot and cold and wear shoes at the beach or on hot pavement and do not put feet into hot water; (8) always test water before putting feet in it just as you would before bathing a baby, and never use hot water bottles, heating pads, or electric blankets as they can burn feet without realizing; and (9) keep the blood flowing to the feet by elevating feet when sitting, wiggle toes and move ankles up and down for five minutes to stimulate blood flow at least two to three times a day, do not cross legs for long periods of time to avoid restricting blood flow and do not smoke.
Based on the unique properties of the highly purified and enhanced Type-I collagen protein used, the Excellagen topical gel product candidate requires storage at standard refrigeration temperatures (2 degrees C - 8 degrees C) and will be packaged in sterile, pre-filled single-use syringes for topical administration by health care professionals. 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.
ExcellagenXL is currently planned for use at one- to two-week intervals (with weekly outer dressing changes) and as an adjunct to surgical debridement. ExcellagenXL will be supplied in a kit configuration containing four single-use 1.0 cc syringes, each containing 0.5 cc of Excellagen gel, and four sterile flexible applicators to facilitate topical administration over the wound site. The ExcellagenFX kit will consist of one single-use 10.0 cc syringe containing 4.0 cc of Excellagen gel, and one single-use sterile flexible applicator designed for deeper administration at the wound site and is planned for use in more complex and difficult to access deep soft tissue wounds.
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.
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 the U.S. Food and Drug Administration will grant marketing clearance of the ExcellagenXL(TM) and ExcellagenFX(TM) product candidates or that we can successfully introduce these or additional products into advanced wound care markets; 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.
Cardium Therapeutics(TM) Generx®( ) and MedPodium(TM) 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