dijous, 22 de març del 2018

Avita touts ReCell use in treating flesh eating bacteria, announces Chinese trial

Avita Medical

Avita Medical (ASX:AVH) this week announced that its ReCell technology had been used to treat a patient with necrotizing fasciitis, and that it launched a Chinese trial of the device exploring its use treating second-degree burns.

The ReCell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, the company said.

The company said that a woman at Arizona’s Maricopa Integrated Health Systems Burn Center with necrotizing fasciitis, or flesh-eating bacteria, has been treated with its ReCell device.

Avita Medical said that the patient, Peoria, Ariz. resident Christin Lipinski, and her treating physician Dr. Kevin Foster appeared today in a local news conference to discuss use of the device for treating the bacteria.

The woman was treated with the ReCell device under an FDA approved compassionate use investigational device exemption program, according to a press release.

Earlier this week, the company announced it launched a randomized, controlled trial of its ReCell device in China exploring the device’s usefulness in treating second degree burns.

In the trial, which is being funded by the China National Health and Family Planning Commission, burn patients will be randomly selected to either receive treatment with the ReCell device, a standard-of-care treatment or one of two other treatments.

The study is being led by Dr. Dahai Hu of The First Affiliated Hospital of the Fourth Military Medical University, Avita Medical said.

Avita said it is also collaborating with Peking Union Medical College Hospital’s plastic surgery dpeartment to establish a ReCell training center in Beijing.

“We are pleased to be working with such prestigious organizations as the China National Health and Planning Commission, PUMCH and Sinopharm. Our initiatives within China are consistent with our evolving strategy of using data from controlled clinical trials and health economic studies to ensure that ReCell is effectively promoted and priced in all major markets,” CEO Dr. Michael Perry said in a press release.

Last month, Avita Medical said the FDA approved an expansion to the number of patients treatable by its ReCell device under the compassionate use investigational device exemption program by 20 individuals.

The post Avita touts ReCell use in treating flesh eating bacteria, announces Chinese trial appeared first on MassDevice.



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