QuickView: Catalysts on the horizon
Avita is entering a 12-month period in which positive clinical, regulatory and commercial progress with ReCell, a ‘spray-on-skin’ medical device, could significantly boost investor and industry interest. A NICE technology assessment in September for acute burns, IDE submissions to the FDA for acute burns (Q314) and repigmentation (Q414), and the outcome of a 65-patient clinical study in chronic leg ulcers (Q215) are key potential catalysts. With a cash reach to Q115, possibly further with non-dilutive funding (eg US gov/military grants), progress with ReCell would enhance financing options.Avita Medical is engaged in the commercialisation of its regenerative product. Co. develops and distributes regenerative products for the treatment of a range of wounds, scars and skin defects. Co.'s patented and proprietary collection and application technology provides treatment solutions derived from a patient's own skin. Co.'s primary product, ReCell®, is used in the treatment of a 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 U.S., ReCell® is an investigational device limited by federal law to investigational use, and a pivotal U.S. approval trial is underway.
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