Bio-cellulose Occlusive Wound Dressing

SCIENTIFIC DATA ON PRODUCT

PERFORMANCE

For chronic, moderately

exudating wounds

ARDOR BIOMED INDIA PVT LTD

Unit No:9, Sakthi Industrial Estate, Udumalpet Road, Pollachi – 642003
Ph: +91 99449 51234 Email: [email protected] Website: www.ardorbiomed.com
Cocoheal Advantage

• Accelerated Wound Healing

Cocoheal works on the principles of moist wound healing
which is shown to have at least 50% faster healing rate

• Versatile
Cocoheal is versatile enough to be used for multiple
wound conditions such as burns, diabetic ulcers,
pressure ulcers, ischemic wounds, venous ulcers etc.

• Infection Prevention
The coconut derived monolaurin
infused into Cocoheal is known to be a
wide spectrum anti-microbial and
helps prevent infection from external
sources

• Absorbs Exudates
The nano-porous structure of
Cocoheal helps absorb exudates from
wound bed

• Autolytic Debridement
The Occlusive nature of Cocoheal helps in autolytic
debridement of necrotic tissue at wound site

• Reduced Scars and inflammation

The moist environment maintained by Cocoheal helps faster re-
epithelization while reducing scar formation and inflammation

• Soothing
The application of Cocoheal to wound site provides an instant
relief by providing a cool and soothing effect
Pre-clinical Findings

COCOHEAL bio-cellulose occlusive wound dressing is a patented, first of its kind product
developed through biologic process for healing chronic wounds such as diabetic foot ulcers,
burns, pressure ulcers, ischemic ulcers etc. It works on the latest concept of moist wound
healing. It is an all-natural moisture dressing composed of 98% moisture and is incorporated
with coconut derived monolaurin for faster wound healing and skin regeneration. It has a
high nano-porous structure and acts as a temporary skin substitute. The monolaurin infused
within the cellulose matrix is classified as GRAS (Generally regarded as Safe) by USFDA and
aids in the skin regeneration while providing broad-spectrum protective effect from external
infections.

COCOHEAL is an indigenous product developed with support from the Government of

India’s Science & technology department’s research fund. It is approved by the Indian Drug
Control Authority CDSCO and ISO 13485 certified

Stability
Cocoheal bio-cellulose dressing has been extensively dressing is found to have one of the highest moisture
tested for all critical physical properties to establish holding capacity among wound dressings and is
the stability of the product throughout its lifecycle. It capable of holding moisture upto 60 times its weight.
has been tested for parameters such as Tensile It is also found to have a Moisture Vapor Transmission
Strength, Thermogravimetric analysis, X-Ray rate of 11088.31 g/m2/24h
diffraction (XRD) and Thermal Degradation. The
findings has ensured that the material meets the
required strength, Physical & thermal stability and
elasticity to deliver superior performance.

Water holding Contact Angle of less

capacity than 90 degree

Tensile test Thermogravimetric X-Ray Diffraction

Test Permeability
Tensile Strength 17.8 MPa Nano-characterization studies has been carried out on
Pyrolytic Decomposition 450℃ Cocoheal to study its structural construct using
Scanning Electron Microscope, Atomic Force
Elongation at Break 109%
Microscope and Energy-dispersive X-ray spectroscopy
Crystallinity 74% (EDS). It has been identified that Cocoheal has highly
uniform meso-porous and uniform matrix made of
naturally occurring polysaccharides with nano-fiber
diameters of 20 nanometers. EDS has confirmed high
Exudate Absorption & Moisture purity of the nano-fibers with no elemental impurities.
These results establishes the high water holding and
holding Capacity exudate absorption capacity of Cocoheal dressing. It
also helps in gaseous exchange and to replenish
Superior Hydrostatic properties are a requirement for oxygen to the wound site.
wound dressing to ensure it is capable of holding
enough moisture to deliver at the wound bed at a
controlled rate. The dressing should be capable of
absorbing and holding exudates from the wound bed.
It is also critical that the dressing has good hydrophilic
properties such that it adheres and conforms well to
the contours of the wound site. Cocoheal bio-cellulose
Pre-clinical Findings

Anti-microbial Properties Bio-degradability

The coconut derived compound Monolaurin found in Most of the Advanced Wound Care products currently
Cocoheal, has been tested for its anti-microbial available in the market currently are of petro-chemical
properties through zone of inhibition studies on origin and not bio-degradable. Our Cocoheal bio-
clinically isolated pathogens and it has shown to have cellulose dressing is 100% bio-compatible and bio-
a wide-spectrum effect on these organisms. degradable causing no harm to the environment in its
production process or post its useful life time. In fact,
we have identified that our dressing completely
degrades in landfill within 60 days time, reaching only
5% of its initial mass, with no recycling efforts.
Staphylococcus Escherichia Candida albicans Propionibacterium
aureus (MTCC 87) coli (MTCC 64) (MTCC 3017) acnes (MTCC 1951)

Accelerated Cell Regeneration

Cocoheal has been tested for bio-compatibility
through in-vitro studies on L929 fibroblast cell lines. It
was established that the cells viability increased by Biodegradability tests in landfill
upto 220% when compared to the control. This result
establishes that the monolaurin and bio-cellulose
works synergistically to accelerate cell proliferation Healing on Animal Models
while still maintaining anti-pathogenic properties.
As part of our pre-clinical studies, wound healing
properties of Cocoheal was tested on diabetic rat
models. Our product was compared with an already
well-established Advanced wound care product in the
market. It was observed that the wound periphery
started reducing from the 5th day of application for
Cocoheal treated rats. On the 15th day, it was
observed that the wound had completely healed with
very minimal scar formation and complete hair growth
Bio-Compatibility on the healed wound. Whereas, on the competing
product, the healing was incomplete on the 15th day
The bio-compatibility properties of Cocoheal was with no visible hair follicle formation.
studies using scratch test method, where fibroblast Histopathological studies on the regenerated dermis
cells were grown in-vitro on Cocoheal bed. It was layer were carried out following single blinded
identified that the fibroblast cells proliferated, closing procedure. It was revealed that there was mature
the scratch region within a time frame of 7days. MTT collagen formation with no evidence of inflammation.
assay carried out post this study established that there Healing scores were arrived at based on the quantity
was no dead fibroblast cells on the bed of Cocoheal. and type of collagen formation, rate of granulation
These findings establish the excellent bio- and inflammatory response. It was observed that
compatibility of the product. Cocoheal Bio-cellulose dressing scored better the
commercially available product.

Scratch test, live-dead staining, Hoechst fluorescence staining Wound healing & histopathological observation on rat models
Clinical Performance

Gender: M Age: 71 Wound since: Jan 2023

Wound Type: Diabetic Ulcer
Observation: Patient with diabetics for 20 years. Was recommended for foot
amputation after several grafting failures. Application of Cocoheal has helped
towards complete closure of tunneling wound.

Day 0 Day 21 Day 38

Gender: M Age: 67 Wound since: 3 Years

Wound Type: Diabetic Ulcer
Comorbidities: Blood pressure, kidney transplantation, Heart surgery with stent and
tablet

Day 0 Day 6 Day 18

Clinical Performance

Gender: M Age: 45 Wound since: 3 Months

Wound Type: Diabetic Ulcer
Comorbidities: Diabetics , Blood pressure, Renal failure for 3 years and undergoing
dialysis for 1 year.

Day 0 Day 9 Day 18 Day 34

Size: 10.5 sqcm Size: 8.10 sqcm Size: 4 sqcm Size: 1.26 sqcm

Gender: M Age: - Wound since: on date

Wound Type: 1st Degree burn
Observation: Re-epithelization was clearly visible on the 8th day. Patient felt
comfortable with considerable pain reduction after application of Cocoheal Dressing

Day 0 Day 8
Clinical Performance

Gender: M Age: 40 Wound since: 1 year

Wound Type: Silencer Burn

Background: Patient with diabetes for 8yrs got infected in right leg due to silencer
burn. Was recommended for foot amputation after several treatment. Application of
Cocoheal has helped towards healing of silencer burn wound in his leg.

Day 0 Day 20 Day 48

Gender: M Age: 53 Wound since: 5 years

Wound Type: Diabetic Ulcer
Observation: Patient with diabetic wound for 5yrs in his right leg. He was
recommended for skin transplantation. Followed various treatment for 3yrs .
Application of Cocoheal has helped towards healing of diabetic wound in his leg.

Day 0 Day 22 Day 32

Clinical Performance

Gender: M Age: 67 Wound since: 5 years

Wound Type: Diabetic Ulcer

Comorbities: Diabetic foot ulcer and varicose veins for 10Yrs. Patient affected with
diabetic foot ulcer for 5Yrs and Ayurvedic treatment. After the pplication of cocoheal
the diabetic wound got healed.

Day 0 Day 20 Day 37

Gender: M Age: 48 Wound since: I Year

Wound Type: Diabetic Ulcer
Observation: Observation: Patient with diabetes for 17yrs got infected in right leg due
to diabetes a year back. Took prescriptions and ointment for the wound. Application
of Cocoheal has helped towards healing of diabetic wound in his leg.

Day 0 Day 15 Day 28

Reviews
Recognitions

Product Development funded by Government of India’s BIRAC and

Startup India Grants

Ardor Biomed was recognized as one among

top 75 most innovative startups in India
creating substantial impact to the society by
the Startup India initiative. Ardor’s products
were shortlisted to be displayed at the
National Science Center, New Delhi, to
recognize scientific achievements during 75th
year of Indian Independence.

Ardor Biomed was recognized with the STAR

STARTUP 2022 award by the prestigious
Ramaiah Evolute program at Bangalore.

Ardor Biomed has been shortlisted as the only

Indian startup among top 15 in Asia-Pacific
region to participate in the grand finale pitch
fest to be held at Singapore on 5th Sept, 2022.
Hello Tomorrow is a global non-profit on a
mission to unlock the potential of deep
technologies to help solve some of the world's
toughest challenges. We have been
recognized as a deep tech Pioneer by the
scientific forum.

Innovation award was presented for

CocoHeal by The Honorable President of
India Smt. Droupadi Murmu, in the
presence of Honorable Union Minister for
Food Processing Industries, Shri Pasupati
Kumar Paras and Secretary to department,
Smt. Anita Praveen for utilization of Agro-
product in medical segment.
 Information

AVAILABLE SIZES

5cm X5cm 10cm X 10cm 15cm X 20cm

Instructions for use 1 2 3

1.Clean the wound bed and peri wound area using standard
cleaning procedures.
2.Debride the wound bed through surgical or enzymatic
procedures as deemed necessary.
3.Irrigate the wound bed post debridement with saline to
remove any particles present and pat dry with gauze or cotton.
4.Open the Aluminum foil cover
5.Remove the sterile poly pack from inside the Aluminum foil 4 5 6
cover. Open the sterile poly pack and remove the COCOHEAL
bio-cellulose dressing.
6.COCOHEAL bio-cellulose dressing can be trimmed to
necessary size if required, using a sterile scissors.
7.Place the dressing on the wound bed, such that the dressing
covers the entire wound bed and also up to 1 cm of the peri-
wound area.
8.Ensure that the dressing is in full contact with the wound bed
without any air pockets by applying a gentle force on the 7 8 9
dressing with 2 fingers in a motion that starts from center of
the dressing and radiating to the edges. Either side of the
dressing may be used.
9.Optionally, COCOHEAL bio-cellulose dressing can be covered
with gauze as a secondary dressing. The dressing has to be
replaced every 2-3 days depending on the wound conditions.