SAN DIEGO, Jan. 5 /PRNewswire-FirstCall/ -- Cardium Therapeutics 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.
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.
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.
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.
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.
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 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.
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