Avita Medical ( NASDAQ: RCEL ) ( OTCPK:AVHHL ) said its RECELL System for soft tissue repair met the the co-primary goals as a result of updated analysis of data from its clinical trial.
RECELL achieved statistically significant donor sparing over control, one main goal. In addition, RECELL also met statistical non-inferiority for healing versus control, the other main goal.
Previously, Avita had said that the donor sparing goal had achieved superiority and that the healing main goal had missed non-inferiority.
Avita noted that re-verification resulted in corrections to the healing data, which led to a conclusion of non-inferiority for healing.
"These results reinforce the potential for RECELL to become a new standard of care for soft tissue repair,” said Avita CEO Jim Corbett. "We look forward to sharing the soft tissue repair outcomes with the FDA via our PMA submission expected in December 2022."
RECELL was approved in the U.S. in 2018 for acute partial-thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients. In February 2022, the FDA approved an enhanced RECELL System.
RCEL +8.66% to $5.90 premarket Nov. 10
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Avita stock rises as RECELL system for soft tissue repair meets both main goals in trial