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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) reported preliminary revenue estimates for Q2 2021, covering the period ending December 31, 2020. U.S. based RECELL® revenue is projected at $5.0 million, unchanged from the prior quarter but up 62% year-over-year. Total global revenue is also estimated at $5.1 million, consistent with the previous quarter and reflecting a 57% increase compared to the same quarter last year. Cash reserves decreased to approximately $59.8 million, down 9% from $65.8 million. The company enrolled 9 additional patients in its pivotal vitiligo study and added 7 new accounts, increasing the total to 93.
AVITA Medical (NASDAQ: RCEL) announced that its management will present at the J.P. Morgan 39th Annual Healthcare Conference on January 14, 2021, at 11:40 a.m. ET. The presentation will be accessible via a live audio webcast. Following the event, a replay will be available for 30 days on their website. AVITA Medical specializes in regenerative medicine, focusing on innovative treatments for burns and chronic wounds using their RECELL® System, which gained FDA approval in 2018. This system utilizes a patient's own skin cells to promote healing effectively.
AVITA Medical, Inc. (NASDAQ: RCEL) announced significant advancements in the effectiveness of its RECELL® System for burn treatment. Since FDA approval in September 2018, over 10,000 patients have been treated globally, with U.S. sales exceeding $27 million. At recent medical conferences, clinical data showcased the RECELL System's benefits, including a reduction of donor skin required for treatment and improved healing outcomes. The company aims to extend the system's use to other medical indications, highlighting its commitment to advancing burn care.
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.
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