Cardium to Launch MedPodium(TM) Product Line Initially Covering Six New Advanced Foot Care Products for Podiatry Patients to Com
January 05 2010 - 8:15AM
PR Newswire (US)
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. (Logo:
http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO) 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. About
Excellagen 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. 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 http://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 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. For Terms of Use Privacy Policy, please
visit http://www.cardiumthx.com/. 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.
http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO
http://photoarchive.ap.org/ DATASOURCE: Cardium Therapeutics
CONTACT: Bonnie Ortega, Director, Investor/Public Relations of
Cardium Therapeutics, Inc., +1-858-436-1018 , Web Site:
http://www.cardiumthx.com/
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