- AVITA Medical Inc. (AVH) releases preliminary unaudited estimates of its top line results for its latest financial quarter
- AVITA’s total revenue increased 35 per cent to US$6.9 million, compared to US$5.1 million over the same quarter last year
- The company completed enrollment in two clinical trials with the goal of submitting premarket approval (PMA) supplements in 2022
- AVITA also completed enrollment of a clinical trial evaluating the safety and effectiveness of the RECELL® System
- AVITA Medical, Inc. (AVH) last traded at $3.14 per share before Tuesday’s market open
AVITA Medical Inc. (AVH) has released preliminary unaudited estimates of its top line results for its latest financial quarter having changed its fiscal year-end to December 31.
AVITA’s total revenue increased 35 per cent to US$6.9 million, compared with US$5.1 million over the same quarter last year.
As at December 31, 2021, AVITA had approximately US$55.5 million in cash and cash equivalents and US$49.3 million in short-term and long-term marketable securities, and no debt.
The company completed enrollment in two clinical trials with the goal of submitting premarket approval (PMA) supplements in 2022.
AVITA also completed enrollment of a clinical trial evaluating the safety and effectiveness of the RECELL® System for the re-pigmentation of stable vitiligo lesions.
This month, AVITA will complete enrollment of pivotal study of RECELL System for soft tissue reconstruction.
AVITA has established proof of concept with preclinical data in two areas of cell-based gene therapy, skin rejuvenation and epidermolysis bullosa.
CEO Mike Perry said the company’s recent successes in getting two pivotal clinical trials fully enrolled, and also demonstrating proof of concept in two other potential indications, underscored its commitment to further growing the market opportunities for its RECELL system.
“Looking ahead, we will be preparing our vitiligo and soft tissue dossiers to submit PMA supplement applications to the FDA in late 2022 for commercial launches for those indications in 2023,” said Dr Perry.
AVITA is a regenerative medicine company with a technology platform positioned to address medical needs regarding burns, chronic wounds, and aesthetics indications.
Its medical devices work by preparing an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis.
This autologous suspension is then sprayed onto the areas of the patient requiring treatment.
AVITA Medical Inc. (AVH) last traded on the ASX at $3.14 per share before market open on the 11th of January.