FDA Approves Continued Access to ReCell® in US Burns Trial
Up to 60 US burns patients could be treated under the new Ruling
Northridge, CA, Perth, Australia and London, United Kingdom, 5 October 2016 — The US Food and
Drug Administration has approved Continued Access to ReCell, allowing US burn surgeons
participating in Avita Medical’s regulatory trial to treat new patients using the Company’s cell
harvesting device, while the marketing application is under preparation and review, the Company
said today.
Avita Medical Ltd (ASX: AVH), (OTCQX: AVMXY), a regenerative medicine company specialising in
new treatments for wounds and skin defects, said up to 60 new patients could be treated under the
the FDA’s approval of an application for ‘Continued Access to Investigational Devices.’ The Continued
Access provision of the FDA’s Investigational Device Exemption (IDE) guidance allows doctors to
access a medical device while the marketing application is under preparation and review, if ‘there is
a public need for the device,’ and ‘there is preliminary evidence that the device is likely to be
effective and no significant safety concern have been identified for the proposed indication.’ The
FDA’s principles on granting the Continued Access further state that ‘it could be contrary to public
health to prevent access to potentially safe and effective new devices during an evaluation period.’
Avita has already treated all the 30 patients required for its approval trial, being conducted at seven
leading burns centres across the US, and this group are now within a safety observation period.
Once that phase has been completed in early 2017, the Company will submit an application for Pre
Market Approval (PMA), and hopes its ReCell® device will get approval before the end of 2017. In
tandem to the approval process, the Company also has FDA approval of an IDE for Compassionate
Use, under which burn patients can be treated with ReCell® -- an autograft sparing device -- if their
life is in danger and there is no other treatment alternative. More than 30 American burn and
trauma victims, most with very large-scale injuries, have been treated to date under this protocol. Now, under Continued Access, the surgeons who participated in the trial will be able to access
ReCell®, for their patients who require grafting, but whose injuries do not meet the criteria for
Compassionate Use. Further, the surgeons will record the treatment in compliance with the approval
trial protocols, which will contribute to the body of clinical data being amassed around Avita’s
regenerative medical approach.
‘It is heartening that more US burns patients will now be able to receive our unique treatment
approach during the pre-approval period,’ said Andy Quick, Senior VP of Clinical Development. ‘But it
is also important that those surgeons who had adopted ReCell® into their practice will now be able
to again deploy the device and further see its effectiveness, beyond what they have seen to date.’
Adam Kelliher, Avita CEO, said the approval was a positive step within the context of Avita’s plans to
enter the US healthcare market, the world’s largest.
‘It is a very positive step that the FDA have decided that we comply with the guiding criteria for
Continued Access, under which eligible devices must be assessed as safe, effective and meeting a
real public need’, Kelliher said. ‘At the same time my team remains on track to meet our stated
objectives and achieve US market approval.’
News Release
-#- ABOUT AVITA MEDICAL LIMITED
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 regenerative product portfolio includes ReCell® for burns & plastic reconstructive
procedures, ReGenerCell® for chronic wounds and ReNovaCell® of restoration of pigmentation and
cosmesis. ReCell®, ReGenerCell® and ReNovaCell® are patented, CE-marked for Europe. ReCell® is
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, and a pivotal U.S. trial is well
underway aimed at securing FDA approval.
To learn more, visit www.avitamedical.com. AVITA’S REGENERATIVE TECHNOLOGY AND RES™
Avita Medical’s unique proprietary technology enables a clinician to rapidly create, at the 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
necessary to regenerate natural, healthy skin. RES™ has a broad range of applications and can be
used to restart healing in unresponsive wounds, to repair burns using less donor skin yet with
improved functional and aesthetic outcomes, and to restore pigmentation and improve cosmesis of
damaged skin.
