T h e R e v o l u T i o n i n

S k i n R e g e n e R aT i o n

ReCell is an innovative clinical solution used for the treatment of a wide range of wounds, burns, scars and skin defects.

The technology takes advantage of the regenerative capability of skin. Working with a small site-matched sample of the patient’s healthy skin, ReCell produces a cell suspension that stimulates skin growth.

The cell suspension, which is sprayed onto an affected area to be treated, contains the appropriate mixture of healthy cells to promote healing (keratinocytes), skin structure (fibroblasts), vascularity (colour), pigmentation (melanocytes) and texture.

ReCell® Spray-On Skin™ is a revolutionary technology that provides the ability to regenerate, repair and restore areas of damaged, scarred or discoloured skin.

ReCell’s innovative, self-contained and autologous process creates a viable cell suspension from a thin, split-thickness skin shave biopsy. The ReCell suspension is available in under 30 minutes for immediate use and can cover a wound 80 times1,2,3 the size of the skin sample.

The delivered cell suspension enables quick epithelialisation of the wound, usually in 5 to 7 days1,4,5. A site-matched skin sample allows reintroduction of the patient’s own skin cells that will develop natural texture, vascularity (pinkness) and pigment.1, 4-9

The use of ReCell enables cell processing at the site of treatment without the use of specialised laboratory staff. The process is both cost and time efficient.

THE REVOLUTION IN SKIN REGENERATION

THE CONCEPT

ReCell is used to facilitate quick epithelialisation of acute wounds, in isolation or in association with standard wound repair techniques. Rapid healing reduces the risk of long-term scarring, inflammation and redness.10

ReCell can be used alone in wounds where the dermis of the skin has not been damaged. When the damage is deeper, ReCell can be used in combination with traditional skin grafting techniques to help improve wound healing.3,11 The use of ReCell provides all the cells from the actively regenerating layer of skin.

The cell suspension also contains the cells needed to allow the skin to return to its original colour and texture.

It is a self-contained autologous-based process.

ReCell delivers a FULL complement of the patient’s own cells:• Keratinocytes• Basal cells• Fibroblasts• Melanocytes• Langerhans cells

Delivered in situ using the patient’s own skin:• No need for a laboratory• No waiting time• No extra costs

It is the best one-step intra-operative clinical solution available today to patients.

WHY

Langerhans cell

corneumgranulosum

spinosum

basale

Stratum

basal membranemelanocyte

Epidermis

Dermis

Hair bulb

Hair follicle

Detail of epidermis

Rete ridges

M.erector pili

Sweat gland

Hypodermis

WHY IS UNIQUE

The Procedure

COmPOSITION OF SUSPENSION

Cells collected from dermal-epidermal

junction include:

• Keratinocytes

• Melanocytes

• Fibroblasts

• Langerhans cells

• Un-differentiated Basal cells

These cells:

• Are not yet terminally differentiated

• Are highly proliferative

• Cultured in-situ

• Migrate evenly across the wound bed

• Provide rich signalling matrix

• Approx. 2.8 million viable cells derived from

2 cm2 skin shave biopsy*

1. 2.

3. 4.

5. 6.

1. Take a thin, split thickness shave biopsy,

0.15 - 0.2 mm in depth, of site matched skin

2. Skin sample incubated in the ReCell

Enzyme solution for approx 15 mins

3. Skin sample removed from incubator,

mechanically agitated to separate cells

4. Cells rinsed and collected using ReCell

Buffer Solution

5. Cells filtered and suspension drawn up

6. ReCell Suspension sprayed or dripped on

wound - cover with recommended dressing

Cells are appliedto the treatment area.

Immediately the cells start to multiply and will form the first layer of skin within 7 days.

After 4 to 6 weeks, the cells form the proper thickness and the pigment cells (melanocytes) begin to release the melaninthat gives skin colour. This process will continue overthe next few months.

WHAT WILL HAPPEN?

*Lang E. 2006. “ReCell® yields, viability and uniformity of Spraying” (White Paper).

The Kit

Technical specifications

maximum coverage per kit: 320 cm²

Adults: approximately 2%

Children: approximately 4%

Processing time: Approximately 30 minutes after skin sample is taken, the cell

suspension is ready for application

Indication: ReCell is intended to be used to disaggregate cells from a patient’s

split-thickness skin sample and to collect these cells into suspension

for reintroduction to the patient. The cells can be used for autologous

application to the prepared wound bed as determined by a physician

Clinical Applications: • Treatment of burns and skin-graft donor sites

• Remodeling of scar

• Reintroduction of pigmentation, e.g. stable vitiligo, leukoderma

• Restoration of damaged skin, e.g. acne scar, sun damage (wrinkles)

• Healing of chronic wounds

Contraindications: Infected or necrotic wounds, unstable vitiligo

Skin sample specifications: Thin, split-thickness shave biopsy of 0.15 mm - 0.2 mm depth

Delivers a 1:80 expansion ratio

0120

Pre-treatment PreParation

materials required

• Steriledrapes,gowns,gloves

• Protectiveeyewear(ifapplicable)

• Skinbiopsyinstrument

(e.g.dermatomeorguardedknife)

• Appropriateanaesthesia

• Fineforceps

Patient selection

• Stablecondition,noinfection

• Expectimprovementnotperfection

• Nohistoryofkeloidsorscargoing

intodermalarea

Wound bed preparation

• Sterilefield

• Clean-nonecrotictissue

• Infectionfree

• Pinpointbleeding

Dressings

• Primarydressing-smallpore,lowabsorbent,

non-adherent,non-toxictocells

• Secondarydressing-moderatelyabsorbent,

minimaladherence,lowshear,readilyremovable

www.avitamedical.comDressings anD Post treatment guiDelines

• Preventthetreatedareafromgettingwetwhilethewoundisstillopen• Refrainfromstrenuousactivity• Donotremoveprimarydressingbeforeday5

• Ensureprimarydressingremovalisatraumatic• Oncetheareahashealed,massageusingagentlemoisturiseratleasttwice

aday

• Avoiddirectsunexposureatleast4weeksfollowingtreatment

selF test

Press ( ) button and wait 30 secs( )=successful( )=devicefailure-use anotherdevice

DevicewillturnOFFafter30secs

a - PrePare enzyme solution

•Usinga10mLsyringe add10mLsterilewater toenzyme•Mixgently(DONOTSHAKE)•Placesolutioninincubator wellmarkedA

Enzyme solution

B - PrePare BuFFer solution

•Usinga10mLsyringe drawup10mLBuffer Solutionusinga10mL syringe•Dispenseall10mLinto wellB

Buffersolution

C - insert Cell strainer into Well C

Tip:Placegentlyinto wellC

D - oPen remaining items

•Openremainingitemsinto sterilefield

take skin sample•Takethin,spilt-thicknessshavebiopsy(0.15-0.2mmindepth). Skin sample size Treatment Area 1cmx1cm upto80cm2

2cmx2cm upto320cm2

Heat enzyme•Runtestagainbypressing( )•When( )shows,pressplay()buttontoheattheEnzyme

incubate skin sample•Whenorangelight( )changesto ,insertskinsampleintoincubatorwellfor15minutes

Draw up Buffer solution•Usinga5mLsyringeandbluntneedledrawupappropriatevolumeofBufferSolutionfromwellB

TreatmentArea BufferSolutionVolumeUpto80cm2 1.5mL

80cm2-160cm2 2.5mL160cm2-320cm2 4.5mL

test scrape•Removeskinsamplefromincubatorandplaceontray•Gentlyscrapetotestifthecellsdisaggregate,DONOTcompletescraping

•Ifcellsdonotcomeaway-incubateforafurther5-10minutesandrepeatstep

Deactivate reCell enzyme•RinseskinsamplebrieflyinwellB

scrape cells•Placeskinsampleontraydermalsidedown•UsingBufferSolutioninthe5mLsyringe,placeafewdropsontotheskinsample

•Scrapethoroughlytodisaggregatecells

rinse and aspirate•AddremainingBufferSolutionfromthe5mLsyringeontothetrayusingthesolutiontorinsethescalpelandtrayintoonecorner

•Usingthe5mLsyringeandbluntneedle,aspiratethecellsuspensionandagainrinsethetrayintoonecorner

Filter cells•FiltercellsuspensionthroughwellC•Removecellstrainer Tip:Tapcellstraineroverwell

Draw up reCell suspension•Useanewsterile5mLsyringewithbluntneedledrawupReCellsuspensionfromwellC

Dressings•Ensurethedressingsarecutandpreparedforimmediateapplicationoncethecellsuspensionisapplied

apply reCell suspension to wound bed•Ifspraying,connectspraynozzletothesyringe•Ifdripping,leavebluntneedleinplace

N.B. Spraying of less than 2 mL suspension is not recommended.

CellVolume RecommendedApplicationMethod1.5mL Drip2.5mL SprayorDrip4.5mL Spray

www.recell.info

set uP

Position dressing below

wound

9

10

11

12

EUROPEAvitaMedicalEuropeLtd(Manufacturer)

1stFloor,UnexHouse132-134HillsRoad

CambridgeCB28PA

UNITEDKINGDOMT.+44(0)1223341150F.+44(0)1223341170

E.cs.eu@avitamedical.com

Step by Step GuidelinesAlways refer to the Instructions for Use

before using ReCell®

1

2

3

4

5

6

7

8

9

10

11

12

1

2

3

4

5

6

7

8

stage 1: reCell skin Processing stage 2: reCell suspension Preparation stage 3: reCell suspension Delivery

Pre-treatment PreParation

materials required

• Steriledrapes,gowns,gloves

• Protectiveeyewear(ifapplicable)

• Skinbiopsyinstrument

(e.g.dermatomeorguardedknife)

• Appropriateanaesthesia

• Fineforceps

Patient selection

• Stablecondition,noinfection

• Expectimprovementnotperfection

• Nohistoryofkeloidsorscargoing

intodermalarea

Wound bed preparation

• Sterilefield

• Clean-nonecrotictissue

• Infectionfree

• Pinpointbleeding

Dressings

• Primarydressing-smallpore,lowabsorbent,

non-adherent,non-toxictocells

• Secondarydressing-moderatelyabsorbent,

minimaladherence,lowshear,readilyremovable

www.avitamedical.comDressings anD Post treatment guiDelines

• Preventthetreatedareafromgettingwetwhilethewoundisstillopen• Refrainfromstrenuousactivity• Donotremoveprimarydressingbeforeday5

• Ensureprimarydressingremovalisatraumatic• Oncetheareahashealed,massageusingagentlemoisturiseratleasttwice

aday

• Avoiddirectsunexposureatleast4weeksfollowingtreatment

selF test

Press ( ) button and wait 30 secs( )=successful( )=devicefailure-use anotherdevice

DevicewillturnOFFafter30secs

a - PrePare enzyme solution

•Usinga10mLsyringe add10mLsterilewater toenzyme•Mixgently(DONOTSHAKE)•Placesolutioninincubator wellmarkedA

Enzyme solution

B - PrePare BuFFer solution

•Usinga10mLsyringe drawup10mLBuffer Solutionusinga10mL syringe•Dispenseall10mLinto wellB

Buffersolution

C - insert Cell strainer into Well C

Tip:Placegentlyinto wellC

D - oPen remaining items

•Openremainingitemsinto sterilefield

take skin sample•Takethin,spilt-thicknessshavebiopsy(0.15-0.2mmindepth). Skin sample size Treatment Area 1cmx1cm upto80cm2

2cmx2cm upto320cm2

Heat enzyme•Runtestagainbypressing( )•When( )shows,pressplay()buttontoheattheEnzyme

incubate skin sample•Whenorangelight( )changesto ,insertskinsampleintoincubatorwellfor15minutes

Draw up Buffer solution•Usinga5mLsyringeandbluntneedledrawupappropriatevolumeofBufferSolutionfromwellB

TreatmentArea BufferSolutionVolumeUpto80cm2 1.5mL

80cm2-160cm2 2.5mL160cm2-320cm2 4.5mL

test scrape•Removeskinsamplefromincubatorandplaceontray•Gentlyscrapetotestifthecellsdisaggregate,DONOTcompletescraping

•Ifcellsdonotcomeaway-incubateforafurther5-10minutesandrepeatstep

Deactivate reCell enzyme•RinseskinsamplebrieflyinwellB

scrape cells•Placeskinsampleontraydermalsidedown•UsingBufferSolutioninthe5mLsyringe,placeafewdropsontotheskinsample

•Scrapethoroughlytodisaggregatecells

rinse and aspirate•AddremainingBufferSolutionfromthe5mLsyringeontothetrayusingthesolutiontorinsethescalpelandtrayintoonecorner

•Usingthe5mLsyringeandbluntneedle,aspiratethecellsuspensionandagainrinsethetrayintoonecorner

Filter cells•FiltercellsuspensionthroughwellC•Removecellstrainer Tip:Tapcellstraineroverwell

Draw up reCell suspension•Useanewsterile5mLsyringewithbluntneedledrawupReCellsuspensionfromwellC

Dressings•Ensurethedressingsarecutandpreparedforimmediateapplicationoncethecellsuspensionisapplied

apply reCell suspension to wound bed•Ifspraying,connectspraynozzletothesyringe•Ifdripping,leavebluntneedleinplace

N.B. Spraying of less than 2 mL suspension is not recommended.

CellVolume RecommendedApplicationMethod1.5mL Drip2.5mL SprayorDrip4.5mL Spray

www.recell.info

set uP

Position dressing below

wound

9

10

11

12

EUROPEAvitaMedicalEuropeLtd(Manufacturer)

1stFloor,UnexHouse132-134HillsRoad

CambridgeCB28PA

UNITEDKINGDOMT.+44(0)1223341150F.+44(0)1223341170

E.cs.eu@avitamedical.com

Step by Step GuidelinesAlways refer to the Instructions for Use

before using ReCell®

1

2

3

4

5

6

7

8

9

10

11

12

1

2

3

4

5

6

7

8

stage 1: reCell skin Processing stage 2: reCell suspension Preparation stage 3: reCell suspension Delivery

Key Success Factors

BenefitsReCell is transforming today’s standard of care for the treatment of acute wounds (e.g. 2nd degree burns) by improving patient outcome and reducing the overall management costs.

can:• Improve aesthetic outcome1, 4-9

• Be used with all skin types

• Site match (blend) with surrounding skin

• Limit skin sample size and depth required (1:80 ratio)1-3,5

• Allow treatment of larger areas

• Increase the availability of healthy skin for successive treatments

• Speed up the healing1,4,5

• Minimise hypertrophic scarring

• Reduce nursing care required

• Minimise the need for dressing changes

• Reduce the use of drugs (pain management)

• Reduce patient discomfort1,2

• Shorten hospital stay2

• Reduce the number of outpatient/inpatient follow-up visits

• Reduce the need for secondary procedures

Post Operative Care Careful removal of dressings

Protect the healed area

Keep area moisturised

Use suncreen

Procedure Thin split-thickness skin shave biopsy

Wound bed preparation

- Keep demabrasion to pin point bleeding

- Viable dermis, vascularised wound bed

Good haemostasis

Dressing (non adherent, small pore, no silver)

Patient selection Stable condition, no infection

Expect improvement not perfection

No history of keloids or scar going

into dermal area

Insert image

1. Conti E, Wood F, Leclerc-Chalvet M. ReCell®: Indications, Clinical practice and Expected outcome. Journal of Wound

Technology. April 2009(4):59-62.

2. Gravante G, Difede M, Araco A, et al. A randomized trial comparing ReCell® system of epidermal cells delivery versus

classic skin grafts for the treatment of deep partial thickness burns. Burns. 2007;33(8):966-972.

3. Wood F. Chapter 6: ReCell. In: Hyakusoku H, Orgill DP, Teot L, Pribaz JJ, Ogawa R, eds. Color Atlas of Burn

Reconstructive Surgery. Heidelberg Springer-Verlag; 2010:26-37.

4. Cervelli V, Spallone D, Lucarini L, Palla L, Brinci L, De Angelis B. Treatment of stable vitiligo hands by ReCell system: a

preliminary report. European Review for Medical and Pharmacological Sciences. Aug 2010;14(8):691-694.

5. Graham JS, Stevenson RS, Mitcheltree LW, et al. Medical management of cutaneous sulfur mustard injuries. Toxicology.

2009;263(1):47-58.

6. Cervelli V, De Angelis B, Balzani A, Colicchia G, Spallone D, Grimaldi M. Treatment of stable vitiligo by ReCell system.

Acta Dermatovenerologica Croatica. 2009;17(4):273-278.

7. Cervelli V, De Angelis B, Spallone D, Lucarini L, Arpino A, Balzani A. Use of a novel autologous cell-harvesting device

to promote epithelialization and enhance appropriate pigmentation in scar reconstruction. Clinical and Experimental

Dermatology. 2009;35(7):776-780.

8. Goodman GJ. An Automated Autologous Cell Transplantation Method for the Treatment of Hypopigmented Scarring.

Dermatologic Surgery. 2008;34(4):578-581.

9. Mulekar SV, Ghwish B, Al Issa A, Al Eisa A. Treatment of vitiligo lesions by ReCell® vs. conventional melanocyte

keratinocyte transplantation: a pilot study. British Journal of Dermatology. 2008;158:45-49.

10. Deitch EA, Wheelahan TM, Rose MP, Clothier J, Cotter J. Hypertrophic burn scars: analysis of variables. J Trauma. Oct

1983;23(10):895-898.

11. Anderson JR, Fear MW, Phillips JK, et al. A preliminary investigation of the reinnervation and return of sensory function

in burn patients treated with INTEGRA((R)). Burns. May 2 2011.

Clinical References

Ref

eren

ces

What Avita medical offers to clinicians• Clinical training on the use of ReCell• OR Support during first ReCell procedure• Access to recellnet.org web platform - Network of experienced users - Ongoing clinical updates - Research working groups • Patient dedicated brochures on the benefits of ReCell• Direct link to ReCell webpage• Dedicated communication to patient through skinnet.info

Choose Avita Medical as your partner.Together we can explore new innovative frontiers

in the clinical management of your patients.

Avita medical (ASX:AVH) is a publicly listed medical technology company that develops and distributes regenerative and tissue-engineered products for the treatment of a broad range of wounds, scars and skin defects.

Avita medical’s mission is to create a leading global healthcare company in the field of regenerative medicine and tissue engineering by providing highly differentiated and cost-effective clinical solutions which addresses the needs of patients, clinicians and healthcare systems.

Using patented and proprietary tissue harvesting, collection and application technologies, the company is able to provide innovative treatment solutions derived from the patient’s own skin. The company’s lead product, ReCell has been designed for use in a wide variety of burns, plastic, reconstructive and cosmetic procedures.

Avita medical

Training & marketing

T H E R E V O L U T I O N I N

S K I N R E G E N E R AT I O N

Websitewww.avitamedical.comwww.recell.info

Brochure Leaflet

EUROPEAvita Medical Europe Ltd (Manufacturer)1st Floor, Unex House132-134 Hills RoadCambridgeCB2 8PAUNITED KINGDOMT. +44 (0) 1223 341150F. +44 (0) 1223 341170E. cs.eu@avitamedical.com

AmERICAAvita Medical Americas LLC9221 Corbin Ave, Suite 220 Northridge, CA 91324 UNITED STATES OF AMERICAT. +1 818 356 9400F. +1 818 356 9416 E. cs.am@avitamedical.com

ASIA PACIFICAvita Medical Asia PacificGround Floor234 Churchill AvenueSubiacoWA 6008AUSTRALIAT. +61 (0) 8 9389 0700F. +61 (0) 8 9389 0733E. cs.ap@avitamedical.com

mENAAvita Medical Middle East & North AfricaPO Box 39324Nuzha - 73054Kuwait CityKUWAITT. +965 22441342F. +965 22441393E. mena@avitamedical.com

ITALYAvita Medical Italia S.r.l.Viale Monza,13320125 Milan - ITALyT. +39 02 28172 200F. +39 02 28172 299E. cs.it@avitamedical.com

© Avita Medical 2012The ReCell® Autologous Cell Harvesting device is subject to pending patent and design applications of Avita Medical - ReCell® and Spray-on Skin™are registrered trademarks.

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