Avita Medical Ltd. (ASX: AVH), (OTCQX: AVMXY), 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 condition.”
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.
ABOUT RECELL®, REGENERCELL®. RENOVACELL®, AND RES™
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 outcomes;
- 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.
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 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.