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AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) is a commercial-stage regenerative medicine company that is pioneering innovative solutions for skin restoration and wound care management. The company's flagship product, the RECELL® System, is a revolutionary device that transforms a small sample of a patient's skin into Spray-On Skin™ Cells within just 30 minutes. This technology aims to reduce or eliminate the need for skin grafts, providing an advanced treatment option for burns, full-thickness skin defects, and stable depigmented vitiligo lesions.
The RECELL System has gained regulatory approvals across several regions, including the U.S. Food and Drug Administration (FDA), Australia's Therapeutic Goods Administration (TGA), the European Union's CE-mark, and Japan's PMDA. However, AVITA Medical primarily focuses its marketing efforts in the United States, which hosts approximately 136 burn centers where the RECELL System is being rolled out.
The company has made significant strides recently, including the approval and launch of RECELL GO in the U.S., which boasts enhanced features to streamline the preparation of Spray-On Skin™ Cells, improving workflow efficiency and reducing the training burden on medical staff. This next-generation device is expected to further drive adoption and improve clinical outcomes.
AVITA Medical also holds exclusive rights to market and distribute PermeaDerm®, a biosynthetic wound matrix, in the United States, expanding its product portfolio beyond RECELL.
Financially, AVITA Medical has shown robust growth, with commercial revenue increasing significantly year-over-year. For the fourth quarter of 2023, commercial revenue surged by 50% compared to the same period in 2022. Despite a net loss due to increased operating expenses related to expanding its commercial and R&D efforts, the company remains optimistic about its financial stability and future growth.
The company continues to make strategic international inroads, including plans to launch in Japan through a distribution partner and future market expansions. In addition, AVITA Medical is engaged in various ongoing clinical trials to expand the indications and applications of the RECELL System further.
Overall, AVITA Medical remains at the forefront of transforming wound care management and skin restoration, committed to improving patient outcomes through its innovative products and strategic initiatives.
AVITA Medical (NASDAQ: RCEL) announced 15 presentations at the American Burn Association Annual Meeting, showcasing the efficacy and cost-saving benefits of the RECELL® System for treating burn wounds. The event, taking place April 5-8 in Las Vegas, is expected to attract over 2,000 burn care professionals. With real-world application data from over 15,000 patients, the RECELL System has proven advantageous over traditional methods. AVITA aims to expand RECELL's indications beyond burns to include soft-tissue repair and vitiligo, pending FDA approval.
AVITA Medical (NASDAQ: RCEL) announced the presentation of a clinical trial protocol for the RECELL® System at the Global Vitiligo Foundation Annual Scientific Symposium. This trial aims to assess the safety and effectiveness of RECELL in treating stable vitiligo lesions. With enrollment now complete, the company anticipates releasing results from its blinded, randomized study soon. Vitiligo affects 2% of the global population, significantly impacting patients' quality of life. The RECELL System, approved by the FDA in 2018, utilizes patients' skin cells for regenerative treatments.
AVITA Medical announced that the Biomedical Advanced Research and Development Authority (BARDA) has modified its contract to fund the ongoing pivotal clinical trial for the RECELL System aimed at soft tissue reconstruction.
The trial compares conventional autografting with RECELL in treating acute non-burn full-thickness skin defects, targeting fewer donor skin needs without compromising healing. BARDA’s support highlights the potential of RECELL in expanding treatment indications beyond burns, acknowledging its significance for patients suffering trauma.
AVITA Medical announced a group purchasing agreement with Premier, Inc. that facilitates the access of approximately 4,440 U.S. hospitals to its RECELL System for treating severe burns. This agreement allows Premier members to utilize special pricing and terms, ensuring timely patient treatment. The RECELL System allows healthcare providers to produce a suspension of Spray-On Skin™ Cells from a small skin sample for effective burn treatment. CEO Dr. Mike Perry highlighted the importance of this agreement for improving patient care.
AVITA Medical (NASDAQ: RCEL) reported strong financial results for the quarter ending December 31, 2021, with revenue increasing by 37% to $14.0 million. The fourth quarter saw a revenue growth of 35% to $6.9 million compared to the prior year. The company achieved significant milestones including FDA approval of the enhanced RECELL® system and completed enrollment for pivotal clinical trials aimed at soft tissue reconstruction and vitiligo. However, net losses widened by 52% to $8.5 million. Moving forward, AVITA projects a revenue of approximately $30 million in 2022, marking a 20% increase year-over-year.
AVITA Medical, Inc. (NASDAQ: RCEL) has received approval from Japan's Pharmaceuticals and Medical Devices Agency to market its RECELL® System for treating burns. This system significantly reduces the need for donor skin by preparing Spray-On Skin™ Cells from a small amount of the patient’s skin. With Japan being the second-largest healthcare market globally, this approval opens up opportunities for treating over 6,000 severe burn patients annually. COSMOTEC, part of M3 Group, is the distribution partner tasked with making the treatment widely available in Japanese medical institutions.
AVITA Medical, a regenerative medicine company, announced Dr. Mike Perry's presentation at the Cowen 42nd Annual Health Care Conference on March 8, 2022. The event will be accessible through the company website. AVITA specializes in technology for autologous skin restoration, addressing needs in burns and chronic wounds. Its RECELL System, FDA-approved since September 2018, utilizes a patient's skin cells to treat burns, minimizing donor skin requirements. It has shown to significantly improve clinical outcomes and cost savings, with over 10,000 patients treated worldwide.
AVITA Medical announced FDA approval for an enhanced version of its RECELL® Autologous Cell Harvesting Device, aimed at improving clinician efficiency in treating acute thermal burns. The new system simplifies workflows, reducing setup steps by one-third and requiring fewer support personnel. User surveys indicate 94% believe the device will speed up preparation, while over 80% expect a faster learning curve for new users. The product launch in the U.S. is slated for Q2 2022, reinforcing the company's commitment to advancing regenerative medicine solutions.
AVITA Medical (NASDAQ: RCEL) announced plans to release its financial results for the second half of 2021 on February 28, 2022, after market close. A conference call will follow to discuss these results. The company switched to a calendar year reporting system starting January 1, 2022. AVITA Medical is focused on regenerative medicine and offers the RECELL® System for treating burns by using a patient’s own skin cells, enhancing healing while reducing the need for donor skin.
AVITA Medical, Inc. (NASDAQ: RCEL) announced that CEO Dr. Mike Perry will present at the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference on February 15, 2022, at 10:30 a.m. EST. The conference aims to showcase advancements in regenerative medicine, particularly AVITA's RECELL® System for treating acute thermal burns. This innovative technology uses a patient's own skin cells to regenerate healthy epidermis, significantly reducing the amount of donor skin needed. The RECELL System is FDA-approved and has demonstrated superior clinical outcomes in over 10,000 patients globally.
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