FDA Approval Expected Soon

The following article was published in the Ventura County Star (USA) on 27 August.
Not sure if it has been posted before.
People who are burned are often their own best ally when it comes to recovery. It is their skin, after all, that will be used to replace tissue damaged beyond repair.
In the worst of those cases, there isn’t enough skin to graft to the damaged tissue. Especially in those cases, but in more routine ones, as well, there may be another option soon. It's a device called RECELL, and it uses a patient's own skin cells to create a spray that is applied to the wound to regenerate healthy skin. And the device is gearing up for its U.S. release.
If all goes well, Avita Medical is hoping FDA approval comes as early as next month. The device, already approved for uses in other parts of the world, is manufactured exclusively in Ventura.
“These are exciting days for us,” the company’s Chief Administrative Officer Tim Rooney said.
Avita's presence in Ventura isn't new. The device has been manufactured in the city for several years by another company on a contract basis. When that company announced an out-of-state move, Avita decided the time was right to take over those operations.
“The devices that are coming out of Ventura are being used in China, Australia and throughout Europe,” Rooney said.
Avita assumed operations of its product July 1, the day its lease at 3007 Bunsen Ave. became effective. The 39-month lease includes options for two, three-year extensions, Rooney said. The move didn’t add jobs, yet, but he is hopeful once the product hits U.S. markets, they’ll need to hire more people. The jobs run the gamut and include scientific, regulatory, quality control and production positions.
The product was developed in Australia, where the company is co-based. The other location is Valencia.
Although the device is currently under FDA review, and by law limited to investigational use only, it has been used in roughly 80 "compassionate use" cases. In those scenarios, a surgeon can use a device or drug under investigational use after determining there's no other way to save a life or the proposed benefit outweighs the risks.
The results, and its potential, have created a lot of excitement in the burn community, Rooney said. Additionally, the outcomes of two successful controlled clinical trials were submitted to the FDA as part of the application process. Getting FDA approval would be “the single most significant milestone in the company’s history,” he said.
In using a patient's own skin cells, and because less skin is required from the donor site, RECELL is able to minimize complications that can arise at the donor site (infections, for example). Rooney said that each small skin sample processed through the device produces enough "Spray on Skin" cells to heal a wound up to 80 times its size.
The product can be used alone or with a graft. It also can be used with grafts that have been meshed, a process that involves punching holes into the graft to stretch it to up to two times its use. Used in conjunction with RECELL, grafts have been expanded by up to six times the original size, Rooney said.
"So the benefits are clear," he said. "We're using less skin than traditionally needed (under) the current standard of care, offering benefits in clinical outcomes and cost savings, all done at the point of care in as little as 30 minutes."
Want more information on RECELL? Check out the company's FAQ at https://bit.ly/2Ln8Vr6.