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 Therapeutics (NASDAQ: RCEL) announced the appointment of Kathy McGee as Chief Operating Officer, effective December 1, 2020. Kathy brings over 25 years of experience in biopharmaceuticals, recently serving as President of CnA Consulting Group and holding leadership roles in Shire Pharmaceuticals and Advanced BioHealing. Her expertise in regenerative medicine is expected to enhance AVITA's ability to advance its product pipeline. The company's RECELL® System, which facilitates innovative skin restoration, has shown positive outcomes in treating severe burns and is well-positioned in various international markets.
AVITA Therapeutics, with ticker RCEL, announced its participation in the Piper Sandler 32nd Annual Virtual Healthcare Conference on December 1, 2020. The company specializes in regenerative medicine, focusing on autologous skin restoration for conditions like burns and chronic wounds. The RECELL® System, approved by the FDA in September 2018, allows for innovative treatment of burns using a patient’s own skin, significantly reducing donor requirements. AVITA's products are also CE-marked in Europe and TGA-registered in Australia.
AVITA Therapeutics (NASDAQ: RCEL) reported its fiscal Q1 2021 results ending September 30, 2020, with U.S. RECELL® revenue reaching $5.0 million, a 59% increase year-over-year. Total global revenue was $5.1 million, up 56% from the prior year. Procedural volumes grew by 27.2% to 496 and 9 new accounts were added, totaling 86. The net loss widened to $10.2 million, with a loss per share of $0.48. Cash reserves stood at $65.8 million. Due to COVID-19 uncertainty, the company is not providing financial guidance at this time.
AVITA Therapeutics, Inc. (NASDAQ: RCEL) held its 2020 Annual Meeting of Shareholders on November 9-10, 2020, voting to re-elect all five directors, including CEO Dr. Michael Perry. Shareholders ratified Grant Thornton LLP as independent auditors for the fiscal year ending June 30, 2021, and approved the 2020 Omnibus Incentive Plan. Additionally, the maximum annual cash fee pool for non-executive directors increased from A$450,000 to US$600,000. The company plans to issue shares in lieu of director fees and confirmed support for future advisory votes on executive compensation annually.
AVITA Therapeutics (NASDAQ: RCEL) has announced a preclinical research collaboration with Houston Methodist Research Institute to explore the combination of its Spray-On Skin™ Cells with advanced cellular aging reversal technologies. This initiative aims to create a novel method for skin rejuvenation, with potential applications in scar revision and wound healing. The partnership includes an exclusive licensing option for related technologies and anticipates an 18-month research program aimed at regulatory submission for Investigational New Drug applications.
AVITA Therapeutics (NASDAQ: RCEL) announced that David McIntyre will resign as Chief Financial Officer effective November 23, 2020, to pursue opportunities in New Jersey. McIntyre will assist the company until December 31, 2020, ensuring a smooth transition to Sean Ekins, the current Vice President of Finance, who will take over CFO responsibilities starting November 9, 2020. AVITA will begin an external search for a new CFO. The company is known for its RECELL System, a treatment for burns that was FDA approved in 2018 and has been effectively used in over 8,000 patients globally.
AVITA Therapeutics, Inc. (NASDAQ: RCEL) has announced a schedule change for its adjourned 2020 Annual Stockholder Meeting due to daylight savings adjustments. The meeting will now take place at 8:00 am AEDT on November 10, 2020, which remains at 1:00 pm Pacific Time on November 9, 2020. Stockholders are advised to read the definitive proxy statement filed with the SEC for important voting information. The RECELL System, the company’s first U.S. product, is notable for its innovative approach to acute thermal burn treatment.
AVITA Therapeutics, Inc. (NASDAQ: RCEL) announced a change in the date of its Q1 2021 earnings release and conference call to November 10, 2020. The conference call will occur at 1:30 p.m. Pacific time, where the company will discuss financial results and recent highlights. AVITA focuses on regenerative medicine, developing autologous skin restoration technologies like the RECELL System, approved by the FDA for treating acute thermal burns. The company emphasizes its innovative treatment solutions and aims to address unmet medical needs in burns and chronic wounds.
AVITA Therapeutics, Inc. (NASDAQ: RCEL) announced the adjournment of its 2020 Annual Stockholder Meeting originally scheduled for October 29, 2020, due to a lack of quorum. Only 49% of shares were represented, falling short of the required 50% majority. The meeting has been rescheduled for November 9, 2020, to gather more votes. During this time, the company is actively soliciting votes with the help of a proxy solicitor. Stockholders who have not yet voted are encouraged to do so by November 5, 2020. The company may incur additional costs if a quorum is not achieved at the adjourned meeting.
AVITA Therapeutics (NASDAQ: RCEL) announced its participation in two upcoming investor conferences: the Oppenheimer Fall MedTech Summit on November 12, 2020, and the Canaccord Genuity Virtual MedTech & Diagnostics Forum on November 19, 2020, at 8:30 a.m. ET. The company specializes in regenerative medicine, focusing on skin restoration using its patented RECELL System, approved by the FDA in September 2018 for treating acute thermal burns. AVITA is actively addressing various unmet medical needs in burns, chronic wounds, and aesthetics.
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