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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, 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.
AVITA Medical has announced the acceptance of six abstracts at the 44th Annual John A. Boswick Burn & Wound Care Symposium, showcasing the clinical benefits of the RECELL® System for burn treatment. Held in Maui from January 22-27, these presentations highlight the system's advancements in treating burn wounds. With pivotal clinical trials for vitiligo and soft tissue reconstruction complete, the company aims to leverage its innovative technology for broader patient benefits. The RECELL® System has received significant recognition and is now used in over 10,000 patients worldwide.
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.
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