The ReCell device from Avita Medical has earned FDA Expedited Access Pathway designation.
FDA's Expedited Access Pathway (EAP) program is making good on its promise to accelerate the regulatory process for urgent medical devices. The agency has just ok'd Avita Medical's ReCell Autologous Cell Harvesting Device for EAP eligibility. The ReCell device is used to treat burns.
The EAP program launched in April 2015 for PMA or de novo devices addressing serious conditions for which there are no good therapeutic or diagnostic options available or, if there are, the device must be a “breakthrough technology,” have important advantages over the alternatives, or be "in the best interest of patients," according to FDA’s description.
Accepted devices are expected to benefit from priority review, close input from FDA, and the ability to use postmarket data when possible.
According to a company press release, FDA's Center for Biologics Evaluation and Research (CBER) decided ReCell is EAP eligible because it may allow "significant, clinically meaningful advantages" over alternative burn treatments available in the United States. The ReCell device uses a small skin sample from the burn patient to create a Regenerative Epithelial Suspension (RES), which is then sprayed on the burned areas, all in a quick, 30-minute procedure. Recent data from a 12-case series showed that patients with large thermal burns treated with ReCell had a 63% shorter length of hospital stay versus age-matched averages.
Before gaining EAP status, Avita Medical executives anticipated FDA PMA approval in the third quarter of 2017. The EAP designation is expected to accelerate that timeline, though how much faster will depend on details of the data development plan to be discussed with CBER. The company has recruited 26 of the 30 patients needed for its FDA approval trial.
“The FDA’s decision that we meet the criteria tallies with our view that ReCell® is a unique offering for helping burns victims, and as such, approval would be preferable sooner than later,” Andrew Quick, Avita’s vice president of Research & Technology said in a company press release. “So we are very excited that we can now advance discussions with the Agency to determine exactly how this changes our timeframes.”
In recent months, a couple other devices, including an implantable artificial kidney from The Kidney Project at the University of California San Francisco and the Wearable Artificial Kidney developed by Victor Gura, MD, have earned EAP eligibility.
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[Image courtesy of AVITA MEDICAL]