Avita Medical Inc Stock Price, News & Analysis

AVITA Medical (NASDAQ: RCEL) has appointed James Corbett as its new Chief Executive Officer, effective immediately. Mr. Corbett, who previously served on the Board, brings nearly 40 years of life sciences experience, including leadership roles at Microtherapeutics and Boston Scientific. His appointment comes as the company looks to capitalize on growth opportunities with its RECELL® System, which has shown significant advancements in treating acute burns. Corbett succeeds Dr. Michael Perry, who has led the company since June 2017. This leadership change aims to strengthen strategic direction and commercial growth.

AVITA Medical (NASDAQ: RCEL) announces an investor webinar on September 20, 2022, led by CEO Dr. Mike Perry and CFO Michael Holder. The session will present highlights from the June 2022 quarter, showcasing a 39% increase in commercial revenue year-over-year, alongside updates on its developmental pipeline. The webinar will conclude with a Q&A session. AVITA's RECELL System, FDA-approved for the treatment of burns, demonstrates significant clinical benefits and cost savings, positioning the company as a leader in regenerative medicine.

AVITA Medical announced positive topline results from a pivotal trial evaluating the RECELL® System for treating stable vitiligo. The study demonstrated that 56% of RECELL treatments resulted in over 50% repigmentation, compared to just 12% for standard treatment. Additionally, 36% of RECELL treatments achieved at least 80% repigmentation, establishing super-superiority. The company plans to submit an application to the FDA by the end of 2022.

AVITA Medical announced that its RECELL System has received insurance coverage in Japan for treating acute burns, with reimbursement aligned to U.S. pricing. The approval from the Japanese MHLW marks a significant step for AVITA and its partner, COSMOTEC, in launching the product in Japan. The RECELL System utilizes a patient's own skin to prepare Spray-On Skin™ Cells, reducing donor skin needed for treatment. AVITA aims to leverage this opportunity to enhance clinical outcomes and cost savings, supporting burn patients' recovery.

AVITA Medical, Inc. (NASDAQ: RCEL) announced a poster presentation on the RECELL® System for treating stable vitiligo at an upcoming conference in Santa Barbara, CA, scheduled for August 19-21, 2022. The presentation will focus on the cell characterization and potential clinical benefits of the RECELL platform. CEO Dr. Mike Perry expressed hopes for the FDA’s review, indicating that the RECELL System could provide a significant treatment option for vitiligo patients. Additionally, AVITA is completing a pivotal trial for the RECELL System, anticipating FDA approval in 2023.

AVITA Medical reported its second quarter financial results for 2022, showing commercial revenue of $8.2 million, a 23% increase from the previous year. Total revenue, including BARDA revenue, was $8.3 million, down from $10.3 million due to a decrease in BARDA contributions. Gross profit margin improved to 83%. Year-to-date commercial revenue reached $15.7 million, up 39%. However, the net loss increased 33% to $6.3 million, and total operating expenses grew by 3%. The company projects commercial revenues of $30 million for the year, excluding BARDA revenue.

AVITA Medical announced positive topline results from its pivotal trial evaluating the RECELL System for soft tissue reconstruction, targeting donor skin harvesting reduction. The trial showed statistically superior donor sparing (p<0.001) versus conventional skin grafting. Although the healing endpoint did not achieve statistical non-inferiority, healing results were comparable. The company plans to submit a PMA supplement to the FDA by the end of 2022 and anticipates significant market potential, with a total addressable market of approximately $1 billion for soft tissue repair.

AVITA Medical (NASDAQ: RCEL) will release its second quarter 2022 financial results on August 11, 2022. A conference call and webcast are scheduled for 2:00 p.m. PT / 5:00 p.m. ET to discuss these results. AVITA Medical focuses on regenerative medicine and offers the RECELL® System for treating acute thermal burns using patients' own skin cells. This technology is FDA-approved and has shown significant improvement in clinical outcomes.

AVITA Medical (RCEL) reported financial results for Q1 2022, showing a significant 61% increase in commercial revenue to $7.4 million compared to Q1 2021. However, total revenue was $7.5 million, down from $8.8 million in the prior year due to a decline in BARDA revenue. The company reported a net loss of $9.5 million, a 58% increase from the previous year's loss. Looking ahead, AVITA expects 2022 commercial revenue of approximately $30 million, a 20% increase year-over-year, despite reduced BARDA revenues.