Northridge, CA, Perth, Australia and Cambridge, United Kingdom, 2 March 2016 — Avita Medical Ltd, (ASX: AVH), (OTCQX: AVMXY), a regenerative medicine company specialising in new treatments for wounds and skin defects announced today the launch in Europe of two new products -- ReGenerCell™ and ReNovaCell™ -- through its expanded European distributor network.
The two new presentations of Avita’s regenerative medicine device, as extensions of its longstanding ReCell® brand, means the Company now has products specifically configured for three condition areas; burns, chronic wounds (targeted at diabetic foot ulcers and venous leg ulcers), and aesthetic applications (mainly repigmentation and scar revision). In advance of today’s formal launch, Avita received CE-mark approval for the ReGenerCell™ and ReNovaCell™ in October 2015.
Both ReGenerCell™ and ReNovaCell™ products employ the proven regenerative technology first developed for ReCell®. The three presentations of the device enable a clinician to prepare a Regenerative Epithelial Suspension (RES™) at the point of care in approximately 30 minutes, using a small sample of the patient’s own skin. The suspension is then applied to the recipient area to regenerate natural, healthy skin.
ReGenerCell™ is targeted to help combat chronic wounds, one of the largest challenges facing healthcare services worldwide, in particular, Diabetic Foot Ulcers (DFUs) and Venous Leg Ulcers (VLUs). ReGenerCell™ offers an alternative to conventional therapies and wound maintenance to clinicians and patients in their fight to achieve wound healing. Chronic wounds adversely affect the individual’s quality of life, and are a leading cause of burgeoning healthcare costs worldwide.
ReNovaCell™ restores natural pigmentation to the skin where it is absent as a result of vitiligo or damage to the skin. The launch of ReNovaCell™ provides a clinically proven solution to restore pigmentation in patients where other treatment options have failed. Indications include vitiligo, hyper and hypopigmentation and regenerating damaged skin.
ReGenerCell™ and ReNovaCell™ will complement ReCell® which will continue to be used in conjunction with conventional treatments for burns and reconstructive procedures. The three variants are differentiated by offering applicable wound coverage for each condition area.
“With the launch of ReGenerCell™ and ReNovaCell™ we are able to offer hope to a wider base of patients, and new treatment options to medical professionals,” said Avita Medical’s UK-based CEO, Adam Kelliher. “These new products demonstrate Avita Medical’s commitment to further pioneering the developing field of regenerative medicine, bringing to the market here-and-now solutions that can deliver benefit to patients today.”
Stocks of ReCell®, ReGenerCell™ and ReNovaCell™ are held in Europe to ensure a rapid local supply chain, with European-based technical support. Recent distributor appointments in the UK, France, Germany, Austria and Switzerland have increased the commercial reach of the Company.
Notes To Editors
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.
Issued for and on behalf of Avita Medical by Instinctif Partners.
For more information please contact:
Avita Medical Ltd
Chief Executive Officer
Phone: +44 (0) 1763 269770
Avita Medical Ltd
Chief Financial Officer
Phone: + 1 (818) 356-9400
Avita Medical Ltd
Phone +61(0) 8 9474 7738
Gemma Howe/Sue Charles
Phone +44 (0)20 7866 7860
Investor Relations / PR
Phone: +61 3 9620 3333
Sue CharlesManaging Partner