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AVITA MEDICAL INC. (ASX: AVH)

AVITA Medical's RECELL System receives FDA approval for treating vitiligo.
RECELL offers a one-time treatment by delivering autologous skin cells to repigment depigmented areas in vitiligo patients.
The FDA granted a prioritized review through its Breakthrough Device program for this first-in-class treatment for repigmentation.

2023-06-19 08:37:00

AVITA Medical receives FDA approval for its RECELL System to treat full-thickness skin defects.
RECELL's expanded indication dramatically increases the company's market opportunity.
Commercial launch of the RECELL System is set to commence on July 1, 2023.

2023-06-08 09:29:00

Avita Medical announces their Q1 2023 financial results, reporting $10.6 million in revenue and a net loss of $9.2 million, or $0.37 per share.
These company financial results are reported in U.S. dollars, not Australian dollars as previously indicated by a third-party consensus data provider.
Avita Medical is a regenerative medicine company focused on the development and commercialization of devices and autologous cellular therapies for skin restoration, notably the RECELL System.

2023-05-17 08:42:00

AVITA Medical reported a 40% increase in commercial revenue, reaching $10.5 million for Q1 2023, compared to $7.4 million in Q1 2022.
The company expanded its field sales organization from 30 to 69, while FDA approvals for soft tissue repair indication and vitiligo indication are expected in June 2023.
Full year 2023 commercial revenue guidance remains unchanged, expected in the range of $49 to $51 million.

2023-05-12 08:33:00