- Avita Medical has received approval from the US FDA to conduct a trial of its Recell System.
- Recell is a device that enables healthcare professionals to produce a suspension of spray-on-skin cells using a small sample of the patient’s own skin
- The trial will aim to evaluate the safety and effectiveness of the System
- The trial is expected to begin in the next six months
Avita Medical has received approval from the US Food and Drug Administration (FDA) for its Recell System.
This will be in combination with meshed auto grafting for the treatment of acute full-thickness skin defects such as surgical wounds, lacerations and abrasions.
“FDA approval of our IDE for a soft tissue reconstruction pivotal clinical trial is an important next step in expanding the potential indications of our Recell System technology platform,” CEO, Dr Michael Perry said.
Skin grafting is the standard of care for soft tissue reconstruction, including post-trauma and post-surgical skin reconstruction. It requires the harvesting of donor skin which results in an additional wound for the patient.
Delayed healing, significant pain, risk of infection and scarring are just some of the side effects that are associated with using donor skin.
While skin grafting is commonly associated with burn treatment, in 2017 approximately 80 per cent of acute wounds that required a skin graft were non-burn related injuries. This accounted for more than 200,000 procedures in the U.S. alone.
Avita’s Recell system is the company’s first product. It’s a device that enables healthcare professionals to produce a suspension of spray-on-skin cells using a small sample of the patient’s own skin.
This suspension contains the cells that are necessary to regenerate the outer layer of natural and healthy skin.
Clinical trials have proven it to be effective in treating burns, chronic wounds, scar reconstruction and vitiligo (disease that causes skin colour loss in blotches).
“Based on the compelling safety and effectiveness of the Recell System in treating burn wounds, we believe our innovative technology is ideally positioned to be evaluated as a treatment to heal trauma and surgery related wounds,” Chief Technology Office Andy Quick said.
In this trial Avita will imitate a prospective, multi-centre, randomised controlled study to compare the clinical performance of conventional skin grafting both with and without the Recell System.
The primary endpoints are the occurrence of healing by eight weeks after the treatment, and the sparing of donor skin.
Healing will be evaluated by a qualified clinician and additional long-term safety and effectiveness data will be collected over the course of the study.
The study is expected to begin in the next six months.