AVITA Medical (ASX:AVH) - CEO, Mike Perry
CEO, Mike Perry
Source: AVITA Medical
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  • AVITA Medical (AVH) has received US Food and Drug Administration (FDA) approval for its premarket approval application for its RECELL Autogenous Cell Harvesting Device
  • The RECELL system is a device designed for the treatment of acute thermal burns
  • The company has updated the device in order to provide clinicians with a more efficient user experience and simplified workflow
  • The new system is expected to launch in the US in the second quarter of this year
  • Shares are trading 6.83 per cent higher today at $2.66 each at 12:19 pm AEDT.

AVITA Medical (AVH) has received US Food and Drug Administration (FDA) approval for its premarket approval application for its RECELL Autogenous Cell Harvesting Device.

The RECELL system is a device designed for the treatment of acute thermal burns.

It enables healthcare professional to produce a suspension of Spray-On Skin cells using a small sample of the patient’s own skin.

The company has updated the device in order to provide clinicians with a more efficient user experience and simplified workflow.

It reduced set-up steps by about a third and now allows for less support personnel when using the device.

The company reported 94 per cent of users believe the new system will allow for faster procedure preparation and more than 80 per cent believe there will be a faster learning process to become proficient with the system.

The new device is expected to launch in the US in the second quarter of this year.

CEO Dr Mike Perry said he is confident in the update.

“To ensure RECELL continues to meet the needs of our customers, we initiated a program to explore how we could improve the device, and then addressed those matters with this new system,” he said.

“Based upon research and human factors testing, we are confident that the new RECELL System will be positively received by the burn community.

“The enhancements will provide a range of benefits to clinicians using the device and in turn, patients will benefit as the procedure becomes more efficient.”

Shares were trading 6.83 per cent higher today at $2.66 each at 12:19 pm AEDT.

AVH by the numbers
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