Expansion of Skin Regenerative Device Treatment Adds 20 Patients

Avita Medical (Valencia, CA) announced that the US Food and Drug Administration (FDA) approved an additional 20 patients for treatment with the RECELL Autologous Cell Harvesting Device under its FDA Compassionate Use Investigational Device Exemption program. As the fifth expansion to the protocol, up to 88 patients with life-threatening injuries and severe burns can be treated with the skin regeneration device. Patients eligible for this Compassionate Use program include those with insufficient healthy skin available for standard skin grafting and whose treating physicians believe there is no suitable alternative treatment.

To date, 64 cases using the skin regeneration device have been conducted at several institutions across the nation. The company recently submitted a Pre-Market Approval application to the FDA for the device’s treatment of burn injuries in September 2017.

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