Clinical trial of ReCell 'Spray-on-Skin' for Serious Burns Victims demonstrates 'Game Changing' outcomes

STORY IN BRIEF:
For many decades, few new treatments have emerged for those suffering from serious burns, and standard treatment remains painful, slow-to-heal skin graft operations, often with poor aesthetic outcomes.

However, results of the latest Randomised Clinical Trial (RCT) involving the simple and quick-to-use ’Spray on Skin’ medical device, ReCell, represent a key step towards improved clinical outcomes for burns patients. www.AvitaMedical.com

"We are pleased to see further evidence that using a medical technology such as ReCell is not only clinically appropriate, but can also improve patient experience for burns victims at what is an extremely distressing time," - Mr Bruce Philp, consultant burns, laser and reconstructive plastic surgeon, Mid Essex NHS Trust.

This latest trial comes ahead of the expected approval of ReCell by the US Food & Drug Administration (FDA) in 2018.

WHAT IS ReCell®? HOW DOES IT WORK?
www.AvitaMedical.com/Patients/Burns-Patient/How-It-Works.
ReCell is a lunch box sized, battery powered medical device, used by burns surgeons for over a decade in the UK.
ReCell can 'short-circuit’ the body’s natural healing process to promote rapid healing across the wound.
It involves taking a small ’shave’ of healthy skin (the size and thickness of a postage stamp) from an unaffected area of the body in order to generate healthy, new skin by harvesting skin cells that are ‘freed up’ (disaggregated) as part of a liquid skin cell suspension (RES™) produced in around 30 minutes for spraying onto the burn site, promoting an instant healing response.
ReCell has been used for over 7,500 patients worldwide, so far.
The device is being stockpiled in the thousands by US defence preparedness body, BARDA* for emergency use in the event of a mass casualty involving burns. *Biomedical Advanced Research & Development Authority. www.AvitaMedical.com/2017/05/10/initial-pre-emergency-use-au...

RCT OUTLINE:
This RCT represents the first ‘skin sparing’ trial of its kind for years, and has achieved both clinical end points.
This was a multi-centre, within-patient RCT, involving 30 deep burns patients at 7 major burns centres in the USA.
Results: Using ReCell in combination with meshed a autograft meant 1/3 less donor skin was required, compared to treatment with a meshed autograft alone
Using ReCell enabled the skin graft to be stretched more widely, hence the ‘skin saving’ potential.

IMPLICATIONS:
For patients:
Treatment using ReCell has the potential to save healthy skin: less donor skin needs harvesting because ReCell enables the graft to be stretched more widely. For a very badly burned patient this is particularly significant.
Donor sites are smaller, and therefore less painful.
Cosmetic outcomes are superior, particularly in terms of pigmentation outcomes.

For Hospitals / The NHS:
A potential reduction in the number of painful skin graft operations needed to ensure wound closure for the patient, with all the associated savings in terms of time and resources (human, financial etc).

PATIENT CASE STUDIES:
- 2 year old treated for burns to chest and stomach - fully healed at 12 days, post treatment
- 12 year old female with 62% body surface area burns sustained due to vehicle fuel accident - discharged after 24 days

AVAILABLE FOR INTERVIEW:
Nicky Merrick, mother of toddler patient
12 year old female patient + her parent
Mr Bruce Philp, Consultant burns surgeon, NHS
Dr Jeffrey E Carter, US burns surgeon,
Dr Michael S Perry, CEO, Avita Medical
Andrew Quick, Senior VP, Clinical Development, Avita Medical

DOCUMENTS ATTACHED:
Press Release
Q&A Document
Before & After Images (patient case studies)
Infographic
Product Image

Please do not hesitate to contact us if regarding interview enquiries, and/or you would like further information or images.

Hannah Kapff / Siena Clarke
CURIOUS PR
hannah@curiouspr.com
siena@curiouspr.com
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M: +44 77477 94306
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