Avita Medical Ltd. (AVMXY: OTCQX International) | Avita Medical Gains CE Mark for ReGenerCell® and ReNovaCell® to Complete Skin Healing Portfolio


Avita Medical Gains CE Mark for ReGenerCell® and ReNovaCell® to Complete Skin Healing Portfolio

Oct 06, 2015

OTC Disclosure News Service

Northridge, CA, and Cambridge, UK

Certification Applies to ReCell®, ReGenerCell® and

Avita Medical Ltd. (ASX: AVH),
a medical device company specializing in the treatment of wounds and skin
defects, today announced it has received CE Mark authorization to market in
Europe that will allow it to define and target its autologous cell suspension
technology for particular clinical market segments.


The approval follows and
expands the previous CE Mark approval of
ReCell®, a medical device that has mostly been deployed for
treating burns. Under the new CE Mark,
ReCell®, will remain focused on
acute wounds such as burns. A
new presentation,
ReGenerCell®, will target chronic wounds, such as
venous leg ulcers and diabetic foot ulcers. And a third presentation,
ReNovaCell®, will be aimed at the aesthetic arena, and will cover conditions
linked to pigmentation, as well as scar revision. The two new offerings have
been added to an updated CE certificate.


The three offerings will
vary in the size of wound they can cover, but will all deploy the same
approach: a safe means of converting a small sample of a patient’s skin to
create Regenerative Epithelial Suspension ™, which has been shown to be
effective in treating all three condition areas.


 “The CE Mark approval to introduce ReGenerCell®
and ReNovaCell® to our European markets will give greater clarity to medical
professionals who use our regenerative
medical treatment,” said Adam Kelliher, Chief Executive Officer of Avita
Medical. “This will allow us to focus on the particularities of each

CE Mark signifies
that products sold in the European Economic Area have been assessed to meet
high safety, health, and environmental protection requirements.

Avita Medical’s proprietary
ReCell®, ReGenerCell® and ReNovaCell®, technology allow physicians to quickly create, at
point of care,
Regenerative Epithelial Suspension (RES™) using a small sample of the patient’s skin that can
then be applied to the skin defect as treatment. The devices are typically used
in conjunction with traditional methods.



Avita Medical’s unique proprietary technology enables a clinician to
rapidly create, at point of care in approximately 30 minutes, Regenerative
Epithelial Suspension (RES™) using a small sample of the patient’s skin. RES™
is an autologous suspension comprising the cells and wound healing factors
thought necessary to regenerate natural, healthy skin. RES™ has a broad range
of applications and can be created using specific Avita Medical devices and
applied to select treatment indications:


·             ReCell®
for burn injuries, to repair for earlier definitive closure and superior

·             ReGenerCell® for
chronic wounds, to initiate
and promote healing in unresponsive wounds;

·             ReNovaCell®
for skin pigmentation defects,
to restore pigmentation and improve the appearance of scars and damaged skin.



Avita Medical develops and distributes regenerative products for the
treatment of a broad range of wounds, scars and skin defects. Avita’s patented
and proprietary collection and application technology provides innovative
treatment solutions derived from a patient’s own skin. The Company’s lead
product, ReCell®, is used in the treatment of a wide variety of burns, plastic,
reconstructive and cosmetic procedures. ReCell® is patented, CE‐marked for
Europe, TGA‐registered in Australia, and CFDA‐cleared in China. In the United
States, ReCell® is an investigational device limited by federal law to
investigational use. A pivotal U.S. trial is underway, with patient enrollment
completion anticipated by the end of 2015. To learn more, visit www.avitamedical.com.

Avita Medical Ltd

Adam Kelliher

Chief Executive Officer

Phone: +44 (0) 1763 269 772



Medical Ltd

Tim Rooney

Chief Financial Officer

Phone: + 1 (818) 356-9400



Avita Medical Ltd

Gabriel Chiappini

Company Secretary

Phone +61(0) 8 9474 7738




The Ruth Group

Lee Roth, Investor Relations

Kirsten Thomas, Public Relations

Phone: +1 (646) 536-7012 / +1 (508) 280-6592


/ kthomas@theruthgroup.com



Monsoon Communications

Rudi Michelson

Investor Relations / PR

Phone: +61 3 9620 3333


This release includes additional documents. Select the link(s) below to view.

Avita – ReGenerCell and ReNovaCell CE Mark FINAL 07Oct2015..pdf

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