WoundCare Therapeutics Corp is developing novel wound healing technologies based on trans-dermal and trans-mucosal hydrogel aggregates. In animal studies, their oxygenating hydrogel wound dressing was shown to significantly accelerate wound healing compared to regular dressings, reducing wound area by 80% after 7 days versus 29% for controls. A second animal study found their hydrogel formulation containing PDGF and BFGF proteins effectively removed scar formation in a rabbit ear model of excessive scarring. The company aims to license their technologies to partners who can commercialize products for wound healing and dermatology applications.

1. Novel Wound Healing TechnologyNovel Wound Healing Technology
WoundCare Therapeutics Corp
Dr. Pankaj Modi, PhD, MD

2. WoundCare Therapeutics Corp. is an emerging specialty company
focused on the development of a portfolio of wound management, plastic
surgery and dermatological products to provide patients and consumers
improved clinical outcomes. Develops high value products based on itsDevelops high value products based on its
innovative proprietary novel trans-dermal and trans-mucosalnovel trans-dermal and trans-mucosal Hydro-gel
Aggregate Technologies.
Has an ‘evolving’ strategy to …Has an ‘evolving’ strategy to …
Develop products in mature sectors where technologies can extend the value ofDevelop products in mature sectors where technologies can extend the value of
existing playersexisting players
Initial focusInitial focus in Wound Healing and Dermatological Products sectorsin Wound Healing and Dermatological Products sectors
License technologyLicense technology to potential partners that have means to bring productsto potential partners that have means to bring products
to marketto market
About WoundCare Therapeutics Corp

3. • Wounds may result from trauma or from a surgical incision. In addition,
pressure ulcers (also known as decubitus ulcers or bed sores), a type of skin
ulcer, might also be considered wounds.
• Wound healing is the process of repair that follows injury to the skin and other
soft tissues.
• The capacity of a wound to heal depends in part on its depth, as well as on the
overall health and nutritional status of the individual.
• Following injury, an inflammatory response occurs and the cells below the
dermis (the deepest skin layer) begin to increase collagen (connective tissue)
production. Later, the epithelial tissue (the outer skin layer) is regenerated.
• Dietary modifications and nutritional and herbal supplements may improve the
quality of wound healing by influencing these reparative processes or by
limiting the damaging effects of inflammation.
Wound and Wound Healing

4. Skin: structure and function
Largest organ of the body
Primary function is protective
Composed of several layers
• Epidermis and Stratum Corneum
• Dermis, containing the capillary
network
• Subcutaneous layer (hypodermis,
adipose layer
• All layers metabolically active
and susceptible to changes
Injury to skin and underlying
tissues causes wound to form

5. The Cell
• Repairs its self at night during
in approximately 3 hour time
period
• Balance of time is spent in
defensive mode mostly
against free radical damage
• Cellular forces take a cell on a
28 day journey in which
cellular forces survive, divide,
differentiate and the die
• Following the injury, the cells
begin to die and depletes
collagen in the deep layers to
form a wound

6. Chronic skin wounds:
Diabetic foot ulcers: $1.4 billion world wide
Venous stasis ulcers: $2.9 billion
Bed Sores (pressure) ulcers: $3.3 billion
Acute wounds:
Severe burns: $70 million
Partial thickness burns: $160 million
Trauma & surgical wounds: $1.8 billion
Types of Wounds and Market Potential
The total market for treating chronic wounds is
approximately $8.5 and is expected to increase by 7-10%
every year.

7. Wound Healing Process Sequence

8. Wound Healing Process (components)

9. Schematic Diagram of the
Phases of Wound Healing

10. • Inadequate Perfusion (poor circulation)
• Inflammation
• Metabolic Diseases
• Immuno-suppression
• Connective Tissues Disorders
• Arterial and Venous insufficiency
• Neuropathy
• Infection
• Edema
• Ischemia (oxygen insufficiency)
Factors Affecting Wound Healing Process

11. Wound Assessment
WOUND
ASSESSMENT
Lab tests:
TcPO2 Size, depth
location
Wound bed:
• necrosis
• granulation
Surrounding skin:
colour, moisture,
Wound edge
Odour or
exudate
Signs of
infection

12. • Identification of the hindrance to healing
• Adequate nutritional status
• Adequate perfusion and oxygenation
• High quality, research-based patient and wound
management
• Correction of the underlying cause of the problem
• Disease management
Wound Healing
Requirements

13. Grade I – non-blanchable erythema
of intact skin. Discoloration of the
skin, warmth, oedema, induration
or hardness may also be used as
indicators in people with dark skin.
Grade II – partial-thickness skin loss
involving epidermis, dermis or both.
The ulcer is superficial and presents
clinically as an abrasion or blister.
Grade III – full thickness skin loss
involving damage or necrosis of
subcutaneous tissue that may extend down
to but not through underlying fascia
Grade IV – extensive destruction, tissue
necrosis or damage to muscle, bone or
supporting structures with or without full
thickness skin loss.
Classifying wounds: Grading by tissue Involvement

14. Describes the type of material present
In the base of the wound:
• Slough (yellow)
• Necrotic tissue (black)
• Infected tissue (green)
• Granulating tissue (red)
• Epithelialising (pink)
Clinical Appearance

15. • Wound assessment charts
• Frequency of assessment
• Wound dimensions
• Photography
• Treatment plan
• Change therapy
• Assessment of Diabetes
• Life style changes
• Monitoring nutrition intake
Monitoring healing progress

16. The purpose of
dressings:
• To aid debridement
• To remove excess
exudate
• To control bleeding
• To protect a wound
• To support healing
The ideal dressing
• A dressing that
creates the optimum
environment
• Wound debridement
• Wound cleansing
• Protect and heal
Dressing choice

17. Traditional wound dressings includes;
• Various cloth and fiber materials as exudates absorbents,
such as cotton pads
• Limited absorbency
• Requires frequent changing
• Limited ability to preserve sterility
• Scabs that form as the wounds heal tend to stick to the
dressings which can be painful and interfere with healing.
Limitations of Traditional Dressings

18. • Advanced polymer technology
• Non-adherent wound contact layer
• Highly absorptive
• Semi-permeable (allows oxygen transport)
• Adhesive and non-adhesive layers
• Environment for autolysis to debride
sloughy or necrotic wounds
• Occlusive --> hypoxic environment to
encourage angiogenesis
• Provides needed oxygen to cells to promote
faster and effective healing
• Waterproof
Need for Novel Dressing Technology to
Promote Faster and Effective Healing

19. • The novel Breathable Hydrogel Nano Particles Technology utilizes a
method of tissue super-oxygenation that provides oxygen to the tissues
to aid in the faster healing and cells revitalization process.
• Oxygen is provided to the tissue through microscopic bubbles and is
present at the concentration that is found in the blood.
• The oxygen in the micro-bubbles can be transported through the skin
when placed in contact with the skin.
• Such treatment increases the oxygen level in the interstitial fluids of the
sub-epithelial and dermal tissues and is immediately available to the
oxygen depleted cells, thereby inducing more rapid healing.
• This procedure is clinically proven for the treatment of sepsis and help
in healing the bedsores, skin lacerations, burns related infections and aid
in the prevention of gangrene formation.
WoundCare Therapeutics Technology

20. • Forms a film in situ sealing the wound and allowing
conformation to irregular wound surfaces
• Adheres to the wound but does not harm the healing tissue
• The dressing is moisture vapor and oxygen permeable
• The dressing releases the oxygen to the tissues
• Maintains sterility for longer time duration
• Substantially decreases the need for multiple dressing changes
• Active healing agents can be trapped between the nano-
particles to control the release of these actives to promote wound
healing
Attributes of the novel
Breathable Hydro-gel Technology

21. Oxygenated
Vasodialtor
Hydrogel LayerTop fibrous porous layer
Elastomeric Bottom Layer with Adhesive
Wound Healing Bandage
Actual Oxygenating Vasodilator Hydrogel Layer

22. Animal Studies; Study # 1
Mouse Footpad Model to Evaluate the Effectiveness of
Novel Wound Dressing Treatment
Materials and Methods Mice. Male Swiss-Webster mice weighing approximately 20g
Groups of 30 mice were wounded on the posterior tarsus of both feet by 5mm incision
between the Achilles tendon and the external finger.
The wounds were measured by a subjective scoring system (accepted wound healing
rating system) on a scale of 5 to 0.
5 is open and totally unhealed; 4 is a small slit; 3 is a closed wound with a scab; 2 is a
closed wound with scab shed; 1 is a healed wound with a visible scar; 0 is a healed
wound and no visible scar.

23. Treatments
The wound healing test bandage containing HA was made using
the medical grade HA and Collagen and elastin with rapid
acting topical anesthetics and combination of vasodilator and
oxygen generator (WondCare Therpeutic’s proprietary
formulation) under sterile conditions.
The bandage applied to the wound area after thorough cleaning
of the wound with IPA with gentle rubbing. The bandage was
secured on to the skin with the help of adhesive strips.
The comparator was regular dressing bandage which most
clinics use regularly on the surgical wounds.

24. Day 0 Day 3 Day 5 Day 7
Control 47.9 ± 6.1 ** 43.3 ± 6.5 39.8 ± 7.5 33.8 ± 6.9
% Change (9.54 ± 6.3) (16.9 ± 8.3) (29.4 ± 7.6)
Wound Healing 84.4 ±8.5 28.3 ± 7.3 19.6 ± 7.7 9.6 ± 7.1
Dressing (41.5 ± 5.3) (59.6 ± 5.7) (80.2 ± 5.8)
* mean values for wounds on day one had no statistically significant
differences
** values are mean ± SE of estimated wound area and range of estimated
wound area (cm or mm)
Epithelial damage (before)
Punch Biopsy
After treatment with Novel
Bandage- 72 hrs
RESULTS

25. Animal Study # 2; Novel Formulation with PDGF and BFGF Proteins in
Removal of Scar Formation in a Rabbit Ear Excessive Scar Model
Excessive cutaneous scarring in the form of hypertrophic scars and keloids is an area of
unmet clinical need and continues to pose significant functional, cosmetic, and
psychological problems .
Pre-surgical and surgical procedures. Rabbits were anesthetized. Three 8-mm wounds
were created with a trephine in the ventral surface of each rabbit ear to the depth of the
cartilage. The cartilage and overlying skin were removed from each wound. In dermal
repair investigations, all wounds were covered with a commonly used occlusive dressing.
Reconstituted PDGF-BFGF was diluted in sterile PBS diluent to the final working
concentrations and mixed with the novel formulation. Eight (8) rabbits were treated with
the novel formulation and 6 were treated with the placebo which did not contain any
actives but only the vehicle.
Scar thickness of each wound was measured with a micrometer at Day post-wounding
and continued twice weekly thereafter until sacrifice at Day 28 or 29. Gross appearance
of an elevated rabbit ear wound section with trichrome staining

26. Treatments # Rabbits Treated Healed Unhealed % improvements
After 4 weeks Scar Scar
Lightness Lightness
Formulation+PDGF 14 11 3 79% healed
Control 14 5 9 35% healed
(control) showing little
collagen and tissues after 4
weeks
Active treatment showing
substantial collagen and tissues after
4 weeks
Results

27. Human Study
Study to Evaluate the Safety and Efficacy of Novel Hydrogel Dressings with
Recombinant Human BFGFactor in Healing Diabetic Foot Ulcers
Aim The aim of the study was to evaluate the efficacy and safety of rhEGF or BFGF
hydro- gel applied topically in patients with Grade I or II (Wagner’s classification)
diabetic foot ulcers and to compare the time required for complete healing of the ulcer in
the test group and control group.
Inclusion criteria. Target ulcers were no less than 2 cm2 and no more than 50 cm2 in
area. Patients were expected to be available for the 15 week study period and had to be
able to adhere to the treatment regimen. Healthy men or women between the ages of 38
and 65 years at the time of consent were included. Included patients had controlled
diabetes mellitus (type 1 and 2) and foot ulcers. Ulcers that remained open without
healing for more than 2–3 weeks (irrespective of the ambulatory treatment administered)
were included. Patients had to have ankle brachial index (ABI) readings of ≥ 0.75.
Study Medication The active drug was formulated using the novel hydro-gel formulation
with rhEGF+HA with collagen and topical anesthetics; the placebo did not include the
active ingredients.

28. Wound Measurements Wound healing typically has been expressed as a change in
area over time. Wound measurements were divided into 3 major groups: ruler-based
assessment schemes, transparency tracings, and optical methods.
Skin biopsy Skin biopsy was done at baseline and after treatment to evaluate the
degree of healing.
Drug Administration The study drugs were administered by topical application as per
the procedure set forth in the study protocol. The visit at Day 0 constituted the study
medication administration day. The test group received Novel formulation of rhEGF
and the control group received placebo (without ant actives and were maintained on
antibiotics mainly). The study drug was provided in a gel base to allow for even
application (topically) on the ulcer using a sterile cotton swab. This was done twice
daily until the wound healed or until the end of Week 15, whichever was earlier.
Photography Measuring wound area using tracings of photographs has the advantage
of avoiding direct contact with the wound. The photographs were arranged sequentially
according to patient visits, and healing progress was monitored throughout the study
process.

29. Treatments No of Patients Healed Unhealed % improvement
(12 weeks period)
Placebo (control) 30 4 25 13% healed
Novel formulation +rhEGF 30 27 3 90% healed
# of weeks of Formulation+RhEGF Placebo
Treatment Improvements (healed) Improvements (healed)
3 (30) 7 (23%) 1 (3%)
6 (30) 13 (43%) 2 (7%)
12 (30) 21 (70%) 2 (7%)
24 (30) 27 (90%) 4 (13%)
Results

30. Results This study established the safety and efficacy of the novel
rhEGF formulated gel and found that the gel healed diabetic foot
ulcers faster than the placebo.
This study advocates the use of novel formulation of growth
factor therapy in chronic wounds, such as diabetic foot ulcers,
where healing of the ulcer is a major hindrance.
Growth factor therapy would lead to prevention of leg
amputations and would serve as a major treatment therapy to
facilitate faster healing of chronic wounds and, thereby, wound
closure.
This novel formulation can also be helpful in treatment of other
non-diabetic hard heal wounds, surgical wounds, minor burns and
abrasions injuries.

31. Human Study # 2
Management of Pain in Acute and Chronic Wounds:
Improvement in Quality of Life
Aim: This study was conducted to assess the efficacy of the novel topical wound healing
therapy and improvements in various parameters related to pain in patients with acute
and chronic wounds.
Patients and Methods The study was conducted in the wound clinic of a university
hospital. It involved 50 patients suffering from acute (duration <6 weeks) and chronic
wounds (duration >6 weeks) who visited the once a week clinic on a particular day.
Patients responded to questions related to wound pain such as the onset, location, type,
and intensity using visual analogue and verbal reporting scales. Responses to statements
regarding aggravating and relieving factors and overall impact of pain on quality of life
were obtained using a 5-points scale where 5 = painful (very dependent life style because
of pain and movement restriction) and 1 = almost no pain
The study group comprised 37 (74%) men and 13 (26%) women ranging in age from 7 to
74 years. Trauma was the leading cause of wounds (33, 66%) and the majority of
wounds occurred in lower limbs (n = 39, 78%). Of the 50 patients studied, pain was
present in 46 (92%).

32. Treatment Plan All patients were given treatment with the novel wound healing
dressing which contained topical anesthetics of require strength and potency along with
the wound healing medications to reduce or eliminate the pain within few minutes of
application of the drug (cream with dressing).
All patients received treatment once a day as the daily in clinic visit to clean and
examination of their wounds and pain management. Nurses applied the bandages on the
wounds after proper cleaning of the wounds with antiseptic solutions.
All patients after the application of the novel dressing were asked to rate their pain after
30 min of their treatment on scales consisting of;
5 = severe excruciating
4 = very painful
3 = moderate pain al pain (very mild and of short duration)
2= mild pain
1= occasional
0= no pain

33. Chronic Wound # of Patients Pain score # of Treatments % improvements
Pain n=33 (score=4.3) 15 days 87%,
score=1.4
Acute Wound
Pain n=17 (score=4.5) 15 days 93%, score=1.2
Thus, the novel hydro-gel growth factor formulation with topical
anesthetic combination not only helped in reducing the pain and
improvement in the quality of life but also aided in healing the
wound faster than the traditional therapies.
Results

34. • Forms a film in situ sealing the wound and allowing conformation to irregular
wound surfaces
• Adheres to the wound but does not harm the healing tissue
• The dressing is moisture vapor and oxygen permeable
• Oxygen is provided to the tissue through microscopic bubbles and Hydro-gel
matrix
• The oxygen in the micro-bubbles can be transported through the dressing in to
the skin
• The dressing releases the oxygen to the tissues
• Maintains sterility for longer time duration
• Substantially decreases the need for multiple dressing changes Provides faster
healing and cells revitalization process
• The dressing provides pain relief on contact
• Clinically proven for the treatment of sepsis and in healing the bedsores, skin
lacerations, burns related infections and aid in the prevention of gangrene
formation.
Conclusions

35. Thank You