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Avita Medical Completes Repigmentation Study Enrollment

Avita Medical Completes Repigmentation Study Enrollment

Northridge, CA, USA, Perth, Australia and Cambridge, United Kingdom, 15 March 2016 — Avita Medical Ltd. (ASX: AVH), (OTCQX:  AVMXY), a regenerative medicine company specialising in the treatment of wounds and skin defects, today announced that it has enrolled its final patient in a study to evaluate the optimal deployment of ReNovaCellTM in patients with pigmentation defects.

There are a variety of ways to prepare skin with pigmentation issues, such as vitiligo and piebaldism, to efficiently receive Regenerative Epithelial Suspension (RES™), as generated by Avita’s proprietary autologous cell harvesting device, ReNovaCellTM. Researchers at the Netherlands Institute for Pigment Disorders (Stichting Nederlands Instituut voor Pigmentstoornissen or SNIP) are exploring the effectiveness of three approaches: superficial full surface ablation; fractional laser treatment; and conventional (deep) full surface CO2 laser ablation.  With the 10-patient cohort now fully enrolled and treated, the researchers will look at the percentage of repigmentation on their recipient sites six months after ReNovaCellTM treatment, as well as patient and physician reported outcomes.

“We are always seeking to provide the best care for patients, using the least invasive approach to deliver optimal results,” said Andrew Quick, Avita Medical VP Research & Technology,“This study should give us real clarity on which ablation approach yields superior outcomes.”

Professor Albert Wolkerstorfer, Principle Investigator of the trial at SNIP and an affiliate of the University of Amsterdam, said: “Published data on patients treated with ReNovaCell show that it is a safe and effective treatment following CO2 laser ablation. In this study, we are evaluating the efficacy of ReNovaCell following each pre-treatment option, in order to inform the best method of treatment for future patients.”

The Company is increasing its research efforts into repigmentation because of the evident medical need, with the conditions affecting up to 2% of the population1 in some countries in which it is operating. China has some 1.8 million people afflicted by Vitiligo, and the conditions are, by their nature, more pronounced in non-Caucasian populations.

An earlier randomised controlled trial conducted by SNIP using ReNovaCellTM; showed a 70% success rate in repigmentation in the treated group, versus 0% amongst the control group. The RESTM; cellular suspension delivers the entire family of skin cell phenotypes, but crucially includes melanocytes, which govern skin colour. Melanocytes are delicate cells and other techniques, such as culturing, impair melanocyte viability and the cells’ ability to produce pigment. The speed by which ReNovaCellTM creates RESTM is understood to be the reason why the melanocytes retain this important attribute and thus support superior repigmentation.

1Alkhateeb A, Fain PR, Thody A, Bennett DC, Spritz RA. "Epidemiology of vitiligo and associated autoimmune diseases in Caucasian probands and their families." Pigment Cell Research 16, no. 3 (2003): 208-214

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, ReGenerCellTM for chronic wounds and ReNovaCellTM of restoration of pigmentation and cosmesis. ReCell®, ReGenerCellTM and ReNovaCellTM 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.

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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.
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Sue CharlesManaging Partner