AVITA Medical Shares Climb On Topline Results From Soft Tissue Reconstruction Study, Sees PMA Submission By Year-end

AVITA Medical RCEL announced topline results from its pivotal trial evaluating the safety and effectiveness of the RECELL System combined with meshed autograft for reduction of donor skin harvesting in soft tissue reconstruction.

Skin grafting is the standard of care for soft tissue reconstruction, including post-trauma and post-surgical skin reconstruction while it requires the harvesting of donor skin, resulting in an additional wound to the patient.

The study design included co-primary endpoints, according to the pairwise comparisons where each subject received both RECELL used in combination with widely-meshed skin grafting and the Control treatment of conventional skin grafting.

The donor sparing endpoint was met, showing a superior ratio of treated injury area to donor site area (p<0.001) with RECELL versus Control, However the healing endpoint did not reach pre-specified statistical non-inferiority.

Dr. Mike Perry, Chief Executive Officer, commented: “Our study has shown statistically superior donor sparing and comparable healing rates for RECELL treatment of soft tissue injuries. The RECELL System has been used to effectively treat serious burn injuries and we anticipate that the RECELL System will be well-positioned to treat patients with soft-tissue injuries, pending FDA review and approval.”

AVITA Medical plans to submit PreMarket Appoval (PMA) supplement for this new indication to the regulatory agency by the end of 2022.

The Company also plans to submit detailed results from the trial for peer-reviewed publication.

Price Action : AVITA Medical shares are trading around 3 percent higher at $8.10 on Thursday during after-hours session.