AVITA Medical, Inc. (AVHHL) (NASDAQ: RCEL, ASX:AVH) (the “Company”), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today announced preliminary unaudited estimates of its top line results for the three months ended December 31, 2021.
Preliminary Results for the Quarter ended December 31 and Recent Updates:
• Total revenue increased 35% to $6.9 million in the quarter ended December 31, 2021, compared to $5.1 million over the same quarter in the prior year
• As of December 31, 2021, the Company had approximately $55.5 million in cash and cash equivalents and $49.3 million in short-term and long-term marketable securities, and no debt
• Effective December 2021, the Company changed its fiscal year-end to December 31
• Completed enrollment in two clinical trials with the goal of submitting premarket approval (PMA) supplements in 2022 • In December 2021, completed enrollment of pivotal clinical trial evaluating the safety and effectiveness of the RECELL® System for the repigmentation of stable vitiligo lesions • In January 2022, completed enrollment of pivotal study of RECELL System for soft tissue reconstruction (trauma)
• Successfully established proof of concept with preclinical data in two key areas of cell-based gene therapy – skin rejuvenation and epidermolysis bullosa.
“Our recent successes in getting two pivotal clinical trials fully enrolled, and also demonstrating proof of concept in two other potential indications, underscore our commitment to further growing the market opportunities for the RECELL system,” said Dr. Mike Perry, AVITA Medical Chief Executive Officer. “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.”