of wounds healed after 5 days

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of wounds healed after 5 days
Normal Skin
Wound Healing Stages
Stages overlap
Chronic wounds are “stalled” in the inflammatory phase
COLLAGEN MATURATION
MATRIX METALLOPROTEINASES
ENDOTHELIAL CELLS
EPITHELIAL CELLS
MATRIX PROTEINS
FIBROBLASTS
LYMPHOCYTES
MACROPHAGE
NEUTROPHILS
INFLAMMATORY CYTOKINES
CHRONIC
WOUNDS
PROTEOGLYCANS
PLATELETS
FIBRIN
Time after wounding
The Chronic Wound Epidemic
1.3-3 million people living in the United States have at least
one non-healing wound
10-15% of diabetics develop lower extremity ulcers of some
sort during their lifetime
100,000 limb amputations will be performed on diabetics
this year due to non-healing wounds
The prevalence of pressure ulcers in hospitals and skilled
nursing facilities in the US has been reported to range from
2.4% - 23%
Treating chronic wounds costs at least $5-10 billion per year
in the US
Lack of Safe Affordable Treatment Options
Regranex Gel (becaplermin)
0.01% recombinant platelet-derived growth factor (PDGF)
The only FDA-approved growth factor treatment for chronic
wounds
Black box 2008
Cost prohibitive for many patients
$586 per 15g tube (requires 2-3 tubes for a 2 cm2 wound)
Wound Vacuum Assisted Closure (VAC )
Limits patient movement
Expensive
REGRANEX Gel is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.
V.A.C. is a registered trademark of Kinetic Concepts, Inc.
Hyaluronic Acid (HA)
Glycosaminoglycan
consisting of repeating units
of D-glucoronic acid and acetyl-D-glucosamine.
Found in almost every
vertebrate organ and is
particularly abundant in skin
where it makes up a large
percentage of dermal
extracellular matrix.
Highly hygroscopic thus
contributing to tissue
hydration.
[C14 H21 N O11] n where n=1-25 thousand
Interacts with cell surface
receptors influencing cell
migration and proliferation.
Hyaluronic Acid (HA) and the Skin
Found in both the epidermis and
dermis
Fetal wounds which heal quickly
without scarring have high levels of
HA
Levels decrease in the epidermis with
age
In the elderly HA is found only in the
upper dermis contributing to the
dryness observed in aged skin
Levels decrease after UV exposure
After wounding HA breakdown
products stimulate keratinocytes to
release -defensin 2, thus protecting
the skin from infection
Critical to wound healing
web-books.com/eLibrary/Medicine/Physiology/Skin/Skin.htm
Hyaluronic acid (HA) is Crucial for
Proper Wound Healing
Upon injury:
INJURY
Hyaluronan synthase expression
is upregulated resulting in
increased levels of HA
HA breaks down and is
released
Lower weight HA signals through TLR4
with accessory molecules MD-2 and CD44
CD44
Lower molecular weight HA also binds receptor for hyaluronan
mediated motility expressed protein (Rhamm) resulting in increased
cell migration
Rhamm
TLR4
CD44
MD2
Plasma membrane
ERMs
Tyrosine
kinases
ERK 1,2
MyDBB
Cell migration
Ras
P38?
ERK?
PI3 kinase ?
IRAKs
TRAF6
P38
JNK
NF- B
SOCS3
MMP-13
TGF- 2
NF- B
Inflammatory cytokines
interferon
High molecular weight HA is
broken down into smaller
subunits by hyaluronidase
Subunits bind to and activate
cell receptors resulting in signal
transduction leading to:
Matrix metalloproteinase
(MMP) expression
Cell migration
Angiogenesis
Inflammation
Ionic Polymer Matrix (IPM) Wound Gel
-Delivering a more potent hyaluronic acid
Cleared for the US market in 2002 as
a medical device
2.5 % sodium hyaluronate (higher
concentration than that of other
products): non-immonogenic
Sodium Hyaluronate
Other ingredients:
hydroxyethylcellulose,
methylparaben glycol, polyethylene
glycol (all considered safe by
regulatory authorities and readily
available without prescription)
Ionic Polymer Matrix (IPM) Wound Gel
-Delivering a more potent hyaluronic acid
Cleared by the FDA for the following
indications: OTC: minor abrasions and
cuts
Under supervision of a healthcare
professional: leg ulcers, pressure
ulcers, diabetic ulcers, venous stasis
ulcers, and debrided wounds
Sodium Hyaluronate
Clear, viscous, odorless, and able to
absorb large amounts of fluid making
it useful for the removal of excessive
wound fluid exudate
Ionic Polymer Matrix (IPM) Wound Gel
-Delivering a more potent hyaluronic acid
Penetrates all layers of the skin
Uses patented IPM technology
resulting in deeper skin penetration
and wound hydration
Clinically proven to speed healing of
refractory ulcers
Sodium Hyaluronate
Partial Thickness Excisional Porcine Wound Study
% of wounds healed after 5 days
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
87%
53%
IPM Wound gel was
superior to placebo and
Hyalofill at days 3,5 and 6.
Graph represents percent of
wounds healed at day 5.
Hyalofill is a registered trademark of ConvaTec
7%
L.A.M. Ulcer
Matrix
Placebo
Leading
Marketed
Product
Mertz PM, Davis SC, et al. University of Miami School of Medicine Porcine Model Study
Clinical Evidence
(overview)
27 patients included in
study
53 non-healing ulcers
treated
13 different types of
ulcer
1 ml gel to 1 cm area
ulcer; maximum
4ml/day
25 weeks
….The Proof
Calciphylaxis Ulcer – 33 days
….continued
Stasis Ulcer – 34 days
….continued
Rheumatoid Ulcer – 64 days
….continued
Diabetic Ulcer – 66 days
Patient Questionnaire
27 patients responded
How difficult was your wound to heal
before using IPM Wound Gel?
Do you feel IPM Wound Gel aided in healing?
Ionic Polymer Matrix (IPM)…unique
characteristics
IPM encapsulates molecules
Can be used for transdermal delivery to targeted areas and
release into systemic circulatory system
Molecule of choice
Personal Female Lubricant
Incorporates vitamin B3 (Niacin)
Matrix has proven effective in areas including:



Vaginal Dryness
Pain during intercourse
Absence of feeling or sensation
THE FEMALE LUBRICANT MATRIX MAY BE USED FOR
PERSONAL INTIMATE PURPOSES BY WOMEN OF ALL
AGES
Motion Sickness
A patch system
Controlled release of the motion sickness drug over a 24hour period
Maximum protection against motion sickness
IPM transdermal method requires substantially smaller
amount of drug as compared to the oral dosage form
Patch wearers experience little or no drowsiness
Pain Relief
Incorporates diclofenac sodium, a nonsteroidal antiinflammatory (NSAID) with analgesic and antipyretic
properties
Used by patients with moderate to severe arthritic pain
Onset of pain relief is rapid (10-15 minutes) and longlasting (4-6 hours)
Transdermal delivery has fewer side-effects
Conclusions
Hyaluronic acid (HA) is depleted in the chronic wound
IPM Wound Gel delivers a high concentration of HA directly to
the wound bed
Clinically proven to speed healing of non-healing ulcers
Well tolerated by patients
Unique patented formula
5 US patents
IPM Wound Gel’s 2.5% HA far exceeds concentrations in
other commercially available products
…..continued
Unique matrix has multiple uses
Widespread possible applications
Pain relief
Motion sickness
Female lubricant