Regenerative medicine company Avita Medical has commenced the pivotal study of RECELL system for soft tissue reconstruction.
The company has recruited the first patient at the Arizona Burn Centre at Valleywise Medical Health Center in Phoenix, Arizona.
Avita has designed the study to assess the safety and effectiveness of the RECELL system when used as an adjunct to meshed autografts in patients undergoing reconstruction of skin defects not linked with a burn injury.
According to the company, skin grafting is the standard of care for full-thickness, soft tissue reconstruction, including post-trauma and post-surgical skin reconstruction.
Avita will enroll up to 65 patients at the multi-centre trial for comparing the clinical performance of conventional skin grafting to the use of the RECELL system along with widely meshed autografts on acute full-thickness non-burn skin defects.
The two primary effectiveness endpoints of the trial include superior donor skin-sparing, which will be assessed by comparing the actual expansion ratios of donor skin used to treat the wound.
The non-inferior incidence of healing by eight weeks post-treatment is the other primary effectiveness endpoint.
Avita will also gather additional long-term safety and effectiveness data during the 52-week study
Avita will also gather additional long-term safety and effectiveness data, including evaluation of scar outcomes and patient treatment preference, during the 52-week study.
In September 2018, the company first secured FDA approval for the RECELL System to treat acute thermal burns in patients 18 years and older.
Avita Medical CEO Dr Mike Perry said: “The commencement of this pivotal trial is an important milestone for AVITA and a critical step toward making the RECELL System broadly available to help patients heal from traumatic or soft tissue wounds with the use of less donor skin than the standard of care.
“We are pleased to have initiated this registration trial and to have enrolled the first patient in this study.”
In December 2019, Avita Medical secured the US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for a feasibility study of its RECELL system.
