Source:

Press release

June 15, 2021
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Recell system for extensive burns approved for use in children

Source:

Press release

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The FDA has expanded its approval of the Recell system in combination with meshed autografting to include treatment of acute full-thickness thermal burn wounds in pediatric patients, Avita Medical announced in a press release.

The Recell system uses Spray-On Skin cells, which contain a small amount of the patient’s own skin, to treat acute thermal burns. It was approved by the FDA for adult use in 2018.

FDA approval
The FDA has expanded its approval of the Recell system in combination with meshed autografting to include treatment of acute full-thickness thermal burn wounds in pediatric patients.

“We are pleased that the Recell system, with both its clinical and health economic benefits, can now more broadly support surgeons in treating full-thickness burns of all sizes, including treatment of patients over 1 month of age,” Mike Perry, PhD, CEO of Avita Medical, said in the release. “Supported by a substantive body of clinical evidence and peer-review publications, the Recell system is rapidly becoming the standard of care in burn treatment, and we are committed to pursuing and realizing the full potential of this innovative regenerative technology platform to address other clinical indications where significant unmet need exists.”

The Spray-On Skin cells used with the Recell system are prepared with a small skin sample that is then sprayed on second-degree burns or used with an expanded skin graft for third-degree burns.

The new indication is based on data from the Recell compassionate use and continued access studies. The system was found to reduce the mean number of pediatric grafting procedures to 1.6 treatments compared with 3.6 treatments in the National Burn Repository.