Avita Medical, Inc. - RCEL STOCK NEWS

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.

AVITA Medical plans to release its fiscal Q1 2022 financial results on November 8, 2021, after market close. A conference call will follow to discuss the financial results and recent highlights. The RECELL System, the company's first U.S. product approved by the FDA in September 2018, treats acute thermal burns using the patient's own skin cells. This innovative technology addresses unmet medical needs in skin restoration, including burns and chronic wounds.

AVITA Medical has announced its participation in the 2021 Cantor Virtual Global Healthcare Conference on September 27, 2021, at 4:00 p.m. EDT. The audio webcast will be accessible via their website, with a replay available for 90 days post-event. AVITA focuses on regenerative medicine and has developed the RECELL System, a patented technology approved by the FDA for treating acute thermal burns. The system uses a patient’s own skin cells to promote healing, significantly reducing the need for donor skin.

AVITA Medical (NASDAQ: RCEL) announced its participation in the Lake Street 2021 BIG5 Conference on September 14, 2021. The company specializes in regenerative medicine, focusing on autologous skin restoration for burns, chronic wounds, and aesthetics. Its flagship product, the RECELL® System, approved by the FDA in September 2018, allows for innovative treatment using the patient’s own skin cells. AVITA aims to address significant medical needs with its patented technology, which has demonstrated promising clinical outcomes.

AVITA Medical (NASDAQ: RCEL) reported significant growth in Q4 FY2021, with total net revenue climbing 166% to $10.3 million, surpassing guidance of $6.0-6.2 million. The company achieved a gross profit margin of 80%, up from 77% year-over-year, and reduced net loss to $4.7 million ($0.19 per share) from $12.9 million ($0.60 per share) in Q4 FY2020. Full-year revenue rose 105% to $29.2 million, with total operating expenses decreasing by 10% to $51.9 million. FDA approval expanded the RECELL® System use for burn treatments, further enhancing market potential.

AVITA Medical announced FDA approval to amend its pivotal clinical trial for the RECELL® System, moving from a 3-arm study of 84 subjects to a streamlined single-arm design evaluating 23 subjects across 15 clinical sites. This change reflects confidence in the treatment's safety and anticipated efficacy in repigmenting stable vitiligo lesions. The new trial design aims for a timely market entry by H2 2023, targeting a significant unmet need affecting approximately 6.5 million people in the U.S. with no current cure for vitiligo.