Welcome to our dedicated page for Avita Medical news (Ticker: RCEL), a resource for investors and traders seeking the latest updates and insights on Avita Medical stock.
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 announced the acceptance of nine abstracts at the 43rd Annual John A. Boswick Burn & Wound Care Symposium, highlighting the clinical and cost-effectiveness of the RECELL System in treating burns. The symposium will take place from April 17-22, 2021, in Maui, Hawaii. CEO Dr. Mike Perry emphasized the system's versatility in treating varying burn depths and its benefits when combined with other surgical technologies. Data from randomized clinical trials and real-world use support the RECELL System as a significant advancement in burn treatment.
AVITA Medical (NASDAQ: RCEL) announced the acceptance of 15 abstracts showcasing the benefits of its RECELL System at the American Burn Association's upcoming annual meeting. This marks the highest number of presentations since the RECELL's FDA approval in 2018. Over 80% of U.S. burn surgeons are now certified in using the system, which demonstrates a growing adoption in treating diverse burn injuries. The findings emphasize both clinical outcomes and cost-effectiveness, supporting the RECELL System as a significant advancement in burn care.
AVITA Medical (Nasdaq: RCEL) has appointed Michael Holder as Chief Financial Officer effective March 22, 2021. Mr. Holder brings over 25 years of finance experience, previously serving as CFO at ImmuneCyte and CEO at Carolina Longevity Institute. His role will encompass global finance, accounting, M&A, and investor relations. CEO Dr. Mike Perry emphasized Holder's experience will enhance the leadership team. AVITA Medical focuses on regenerative medicine addressing burns and chronic wounds through its RECELL® System, FDA-approved since September 2018.
AVITA Medical, Inc. (Nasdaq: RCEL) has successfully completed an underwritten public offering, issuing 3,214,250 shares at US$21.50 each, totaling approximately US$69.1 million in gross proceeds. This includes shares from the underwriters' full exercise of their option to purchase additional stock. The funds will support product development and regulatory approvals. The offering was made under a previously filed shelf registration statement with the SEC. AVITA Medical is focused on regenerative medicine technologies, particularly the RECELL System for skin restoration.
AVITA Medical announced a registered public offering of 2,795,000 shares at a price of US$21.50 per share, potentially raising gross proceeds of approximately US$60.1 million. The underwriters have a 30-day option to purchase an additional 419,250 shares. The funds will be utilized for product development, seeking approvals for additional indications, and general corporate purposes. The offering is expected to close on March 1, 2021, subject to customary conditions.
AVITA Medical has announced an underwritten public offering of its common stock, with a possibility for underwriters to purchase an additional 15% of shares sold. The offering is subject to market conditions and aims to fund product development, seek additional approvals, and cover general corporate purposes. The company has previously filed a registration statement with the SEC, and joint book-running managers for the offering include Piper Sandler & Co. and Cowen and Company. AVITA Medical is known for its RECELL System, which provides innovative skin restoration treatments.
AVITA Medical, operating under ticker RCEL, will present at two upcoming investor conferences: the Cowen 41st Annual Healthcare Conference on March 4, 2021, and the Oppenheimer 31st Annual Healthcare Conference on March 16, 2021. Both presentations will be accessible via live audio webcasts on their investor relations website. AVITA focuses on regenerative medicine with the RECELL® System, designed for treating burns using a patient's own skin cells. The system was FDA-approved in September 2018, addressing significant clinical needs effectively.
AVITA Medical, Inc. (NASDAQ: RCEL) reported a strong second quarter for fiscal year 2021, ending December 31, 2020, with U.S. RECELL® revenue at $5.0 million, up 62% year-over-year. Total global revenue reached $5.1 million, a 57% increase from the previous year. The gross margin improved to 84%, driven by extended shelf-life and lower shipping costs. Operating expenses decreased to $10.4 million. Despite a net loss of $5.6 million, the company held cash reserves of $59.8 million. Due to COVID-19 uncertainties, the company did not provide future financial guidance.
AVITA Medical (NASDAQ: RCEL) announced its participation in the BTIG Virtual MedTech Conference on February 17, 2021, at 1:30 PM PT. The company focuses on regenerative medicine and utilizes its RECELL® System for skin restoration in burn treatment. The RECELL System allows for significant reductions in donor skin usage while enhancing recovery outcomes. Approved by the FDA in September 2018, it has been used in over 10,000 patients globally, showcasing its effectiveness compared to standard care.
For more information, visit www.avitamedical.com.
AVITA Medical, Inc. (NASDAQ: RCEL) plans to release its fiscal second quarter 2021 financial results on February 11, 2021, after market close. A conference call will follow at 1:30 p.m. PT to discuss these results and recent highlights. The company specializes in regenerative medicine, particularly for acute thermal burns, utilizing the RECELL® System, FDA-approved since September 2018. This system enables treatment using a patient's own skin cells, promising better clinical outcomes and cost savings. For further details, visit their website or join the conference call.
FAQ
What is the current stock price of Avita Medical (RCEL)?
What is the market cap of Avita Medical (RCEL)?
What is AVITA Medical, Inc.?
What is the RECELL® System?
Where is the RECELL System approved for use?
Is the RECELL System available for sale in the United States?
What recent advancements has AVITA Medical made?
What other products does AVITA Medical offer?
What are AVITA Medical's recent financial highlights?
Is AVITA Medical involved in any clinical trials?
Where is AVITA Medical headquartered?