The response addresses various questions and incorporates data from in-house testing to support the PMA supplement and fulfil the additional information request, which we received in October of 2023. Upon receipt by the FDA, the application of the PMA supplement resumes its 180-day real time review, with 90 days remaining in the review period. Therefore, we expect FDA approval on
“RECELL GO will enhance our capabilities and reach to continue our already impressive growth,” said
The supplement follows the original PMA of its RECELL Autologous Cell Harvesting Device and subsequent PMA supplements.
About
In international markets, the RECELL System is approved to promote skin healing in a wide range of applications including burns, full-thickness skin defects, and vitiligo. The RECELL System is TGA-registered in
To learn more, visit www.avitamedical.com.
Forward-Looking Statements
Statements in this press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements generally may be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” and similar words or expressions, and the use of future dates. Forward-looking statements in this press release include but are not limited to statements concerning our product development activities and regulatory approval of our products. These statements are made as of the date of this release, and the Company undertakes no obligation to publicly update or revise any of these statements, except as required by law. For additional information and other important factors that may cause actual results to differ materially from forward-looking statements, please see the “Risk Factors” section of the Company’s latest Annual Report on Form 10-K and other publicly available filings for a discussion of these and other risks and uncertainties.
Investor & Media Contact:
Phone +1-661-904-9269
investor@avitamedical.com
media@avitamedical.com
Authorized for release by the Chief Financial Officer of
Source:
2024 GlobeNewswire, Inc., source