Medical device maker AVITA Medical (ASX: AVH) has received good news this morning after the US Food and Drug Administration (FDA) said it had approved a program that could use more of its devices.
The FDA approved a significant increase in the number of patients who may be treated using the “RECELL Autologous Cell Harvesting Device” under a compassionate use Investigational Device Exemption (IDE) program.
As it stands, the RECELL Device is not approved for sale in the US and can only be used for investigational purposes as mandated by federal law.
AVITA says RECELL is a medical device designed to facilitate skin regeneration while minimising the amount of skin that must be “harvested” at the time of surgery.
By being able to reduce donor site skin requirements, accelerating the healing process and reducing the amount of tissue rejection, AVITA intends to serve the current need for better treatment options with regards to life-threatening burns and skin grafts.
If successful, AVITA’s RECELL technology could lead to significant improvements in how severe burns are treated, including reduced treatment time, less scarring and better pigmentation after treatment.
Under the FDA’s expanded program, up to 108 patients with severe burns may be treated using the RECELL Device, and up to 26 US burn centres could also participate in the program overall.
Today’s news from the FDA means that AVITA’s RECELL device will be used more frequently and could ultimately attain full FDA approval in the foreseeable future.
RECELL skin care
The RECELL Device is designed to enable medical professionals to produce what’s known as a “regenerative epidermal suspension” (RES) using a small sample of the patient’s own skin.
The autologous suspension contains cells necessary to regenerate skin cells and provides a new way to achieve permanent closure in burns and other wounds while reducing the amount of skin harvested at the time of surgery.
AVITA says that reducing donor-site skin requirements has important benefits from both clinical and health economic perspectives including better clinical outcomes for patients.
Eligible patients are deemed those who have insufficient healthy skin available for conventional skin grafting treatment or patients with no other available treatment options.
AVITA says that 82 patients have already been treated under the program with the company hoping to raise that number further with point-of-care providers utilising its RECELL device.
“The participation of these major US burn centres in the compassionate use program highlights the critical unmet need amongst patients with life-threatening burns, and we are pleased to make the RECELL Device available under this program,” said Dr Michael Perry, CEO of AVITA Medical.
“We are also encouraged by the fact that 24 US burn centres have treated patients with the RECELL Device through a combination of our clinical trials, continued access program, and compassionate use program, giving the product candidate broad exposure within the US burn community. Combined with the over 7,000 patients who have been treated with the RECELL Device globally, these programs provide us a large body of experience regarding the potential clinical benefits as well as the costs savings associated with use of the RECELL Device,” said Dr Perry.
This morning’s news helped AVITA’s shares to reach $0.089, up around 3.5%.