Avita Medical, Inc. - RCEL STOCK NEWS

AVITA Medical, Inc. (NASDAQ: RCEL) announced preliminary unaudited results for Q4 2021, reporting a 35% revenue increase to $6.9 million compared to $5.1 million in Q4 2020. As of December 31, 2021, the company held approximately $55.5 million in cash and marketable securities with no debt. The company completed enrollment in two pivotal clinical trials for its RECELL® System, aimed at treating vitiligo and soft tissue reconstruction, targeting FDA submissions in late 2022. Additionally, proof of concept was established in cell-based gene therapy for skin rejuvenation.

AVITA Medical has completed enrollment in its pivotal trial for the RECELL® System aimed at soft-tissue reconstruction, building on its existing burn treatment indication. This milestone is significant as it aligns with the company's focus on expanding treatment options for acute wounds. With a total addressable market of approximately $1 billion for soft tissue repair, the RECELL System could enhance options in the field while maintaining reimbursement compatibility. Topline data is expected in the second half of 2022.

AVITA Medical has announced promising preclinical results for its Spray-On Skin™ Cells, targeting skin rejuvenation and epidermolysis bullosa. Collaborating with the Houston Methodist Research Institute, they aim to reverse cellular aging, tapping into a $15 billion market. Additionally, partnerships with the University of Colorado School of Medicine highlight advancements in treating the rare skin disorder affecting 25,000-50,000 patients in the U.S., with potential annual care costs of $200K-$500K per patient. The company continues to innovate in regenerative medicine for unmet clinical needs.

AVITA Medical (NASDAQ: RCEL) has completed enrollment in its pivotal trial for the RECELL® System aimed at treating stable vitiligo, a skin condition affecting up to 2% of the population. The trial's completion is a significant step toward potential regulatory approval and commercialization slated for 2023. Dr. Mike Perry emphasized this milestone's importance for expanding RECELL's applications beyond burn treatment. The company plans to share topline data from the trial in the second half of 2022, highlighting the RECELL System's potential as a vital treatment option for vitiligo.

AVITA Medical (NASDAQ: RCEL) announced the adjournment of its 2021 Annual Stockholder Meeting set for December 14, 2021, due to insufficient quorum, with only 49% of shares represented. The meeting is rescheduled for December 22, 2021, at 1:00 p.m. PT. Valid proxies will remain valid unless revoked. The company continues to solicit votes to meet the quorum requirement for proposals filed with the SEC and ASX. If the quorum is not achieved again, additional costs will incur due to further adjournment.

AVITA Medical (NASDAQ: RCEL) announces upcoming presentations at major investor conferences. The company will present at the Canaccord Genuity MedTech Forum on November 18, 2021, at 10:30 AM EST, with a live webcast available. Additionally, AVITA will participate in the 33rd Annual Piper Sandler Virtual Healthcare Conference on December 2, 2021, with a replay accessible from November 22. AVITA Medical specializes in regenerative medicine, notably developing the RECELL® System for treating burns and chronic wounds using the patient’s own skin cells.

AVITA Medical (RCEL) reported a 39% increase in first-quarter revenue, reaching $7.0 million, up from $5.1 million in Q1 2021. Gross profit margin improved to 85% from 82%. Operating expenses decreased by 18% to $12.3 million, leading to a reduced net loss of $5.9 million ($0.24 per share), down from a loss of $10.2 million ($0.48 per share) last year. The company continues to face challenges due to hospital staffing shortages but sees ongoing enrollment in its soft tissue reconstruction trial. Revenue guidance for Q2 2022 remains at approximately $7.0 million.

AVITA Medical announced that the Centers for Medicare & Medicaid Services (CMS) has approved a new reimbursement code for its RECELL® System, effective January 1, 2022. This code allows separate payment for RECELL devices used in outpatient facilities, promoting access for Medicare burn patients. The new reimbursement structure aims to enhance treatment options and supports future indications, with a market opportunity of $450 million. Over the last three years, more than 85% of burn surgeons have been certified to use the RECELL System, which has shown significant reductions in donor skin requirements and pain.

AVITA Medical has announced a series of presentations showcasing the RECELL® System at upcoming burn conferences, highlighting its effectiveness and cost benefits in treating burns. The Southern Region Burn Conference will occur from November 4-7 in New Orleans, followed by the Northeast Region Conference on November 12-13 in Burlington, VT. Key data includes pediatric treatment outcomes and numerous case studies, emphasizing the system’s broad clinical utility. The RECELL System, FDA-approved since September 2018, uses a patient’s skin to promote healing and is positioned to address unmet needs in regenerative medicine.