Helicon Group Limited (ASX: HCG) of Australia received SFDA approval for ReCell®, a skin regeneration concept and device. Before the device can be imported to China, however, Helicon and the SFDA must resolve some importation issues because the device contains trypsin. ReCell treats burns and small wounds. It can also be used for cosmetic surgery, repairing scars.

The device harvests a patient’s own skin cells to treat the wounds, improving the color match with a patient’s skin and eliminating tissue rejection.

ReCell’s technology competes with epithelial autografts, which are skin cells taken from a patient and grown in a laboratory to form thin sheets of skin tissue. These sheets have the drawbacks of being difficult to apply and taking about three weeks to grow – which is about the time that scar tissue is forming. ReCells skin cells are available after five days, before scar tissue forms, and can be sprayed on. Also, the cells are obtained in a split-thickness biopsy, whose thickness is a fraction of a traditional skin graft, causing less damage to the patient.

The product was developed by Avita Medical (ASX: AVH), which was formed in February 2008 when Clinical Cell Culture and Visiomed Group Ltd. merged. Avita is developing a portfolio of tissue-engineering devices.

Helicon was responsible for managing the SFDA approval process for ReCell.

ReCell will be marketed to plastic reconstruction surgeons, dermatologists, burn specialists and cosmetic specialists in urban areas of China. There are more than 3000 cosmetic surgery clinics in China's major hospitals.

Avita Medical now has three products in the market. Besides ReCell, the company markets two spacers for asthma patients.

Helicon seeks niche biomedical market opportunities in North Asia, especially China. Helicon also recently in-licensed from EUSA Pharma a product called Collatamp, an implantable collagen device for the delivery of antibiotics to surgical sites. Helicon is preparing a submission to the SFDA on Collatamp.

Disclosure: none.