VALENCIA, Calif., May 30, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for the RECELL GO™ System, its next-generation autologous cell harvesting device that harnesses the regenerative properties of a patient’s own skin to treat thermal b ...

VALENCIA, Calif., May 16, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ:RCEL, ASX: AVH))), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, invites shareholders and prospective investors to attend its investor webinar briefing and presentation by Jim Corbett, Chief Executive Officer, and David O'Toole, Chief Financial Officer, on May 21, 2024, at 4:00 p.m. Pacific Daylight Time / May 22, 2024, at 9:00 a.m. Australian Ea ...

VALENCIA, Calif., May 16, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ:RCEL, ASX: AVH))), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, invites shareholders and prospective investors to attend its investor webinar briefing and presentation by Jim Corbett, Chief Executive Officer, and David O'Toole, Chief Financial Officer, on May 21, 2024, at 4:00 p.m. Pacific Daylight Time / May 22, 2024, at 9:00 a.m. Australian Ea ...

财务数据和关键指标变化 - 第一季度商业收入为1.11亿美元,同比增长5.8%,但低于预期 [28][29] - 毛利率为86.4%,同比提升2.2个百分点 [30] - 总运营费用为2.68亿美元,同比增加7.4百万美元,主要是销售和营销费用增加 [30][31] - 净亏损为1870万美元,每股亏损0.73美元,去年同期为920万美元,每股亏损0.37美元 [32] - 截至3月31日,现金、现金等价物和可流动证券为6.81亿美元,较12月31日下降2.1亿美元 [32][33] 各条业务线数据和关键指标变化 - RECELL业务收入占比较高,但PermeaDerm等新产品收入占比将逐步提高 [30] 各个市场数据和关键指标变化 - 美国市场仍是主要收入来源,公司正在拓展澳大利亚和欧洲市场 [22][80] 公司战略和发展方向及行业竞争 - 公司致力于将RECELL打造成创面护理的标准疗法,并向创面护理综合解决方案公司转型 [15][16][20] - 通过整合RECELL、PermeaDerm等产品,提供创面护理全程解决方案 [16][19][20] - 正在开发创面床准备和真皮支架等新产品,扩大产品线 [15][16][17][18] - 正在推进RECELL GO和RECELL GO mini的监管审批和商业化 [22][23][24] - 正在拓展国际市场,包括欧洲和澳大利亚 [22] 管理层对经营环境和未来前景的评论 - 第一季度业绩低于预期,主要是全厚度皮损新适应症的VAC审批进度低于预期,以及烧伤业务低于历史水平 [8][10][12] - 采取加强临床培训和销售团队管理等措施,预计第二季度VAC审批将大幅增加 [14] - 相信RECELL GO的推出将大幅提升RECELL的使用效率和采用率 [57][58][59] - 有信心在2025年第三季度前实现现金流和利润平衡 [74] 问答环节重要的提问和回答 问题1 **Brooks O'Neil 提问** 询问Stedical分销协议带来的收入何时体现 [37][38] **David O'Toole 回答** 尚未给出具体指引,将在8月第二季度财报时提供更多信息 [38] 问题2 **Ryan Zimmerman 提问** 询问RECELL GO和全厚度皮损业务在下半年的贡献 [52][53][54][57][58][59] **James Corbett 回答** RECELL GO将大幅提升RECELL的使用效率和采用率,全厚度皮损业务也将获得显著增长 [57][58][59] 问题3 **Matthew O'Brien 提问** 询问下半年业绩大幅增长的信心来源 [69][70][71][72][73] **James Corbett 和 David O'Toole 回答** RECELL GO的推出和PermeaDerm的贡献将是主要驱动力,公司有信心实现下半年的业绩目标 [69][70][71][72][73][74]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39059 AVITA MEDICAL, INC. (Exact name of registrant as specified in its charter) Delaware 85-1021707 (State or other jurisdiction of (IRS ...

公司发展 - AVITA Medical, Inc.被确认为新兴增长型公司[2] 财务预期 - AVITA Medical, Inc.发布了关于2024年第一季度预期收入的更新[4]

AVITA Medical公司财务信息 - AVITA Medical公司将于2024年5月13日美国金融市场收盘后公布2024年第一季度财务结果[1] - AVITA Medical公司将于2024年5月14日澳大利亚东部标准时间上午6:30举行电话会议和网络直播，讨论财务结果和最近的业务亮点[1] AVITA Medical公司RECELL®系统信息 - AVITA Medical公司的RECELL®系统获得美国食品和药物管理局批准，用于治疗热烧伤和全层皮肤缺陷，以及稳定性脱色白癜风病变的再色素化，利用患者自身皮肤的再生特性创造喷雾式皮肤细胞，提供改变性解决方案[3] - RECELL系统在国际市场上获得批准，用于促进各种应用中的皮肤愈合，包括烧伤、全层皮肤缺陷和白癜风，已在澳大利亚获得TGA注册，欧洲获得CE标志批准，日本获得PMDA批准[4]

AVITA Medical, Inc.财务报告 - AVITA Medical, Inc.将于2024年5月13日发布2024年第一季度财务报告[1] - AVITA Medical, Inc.将于当天下午1:30（太平洋时间）举行电话会议和网络直播[1] RECELL® System批准情况 - AVITA Medical, Inc.的RECELL® System获得美国食品和药物管理局批准，用于治疗热烧伤和全层皮肤缺损，以及稳定脱色白癜风病变的再色素化[3] - RECELL® System在国际市场上获得批准，包括澳大利亚、欧洲和日本[4]

VALENCIA, Calif., April 10, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ:RCEL, ASX: AVH))), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced an update to its expected commercial revenue for the first quarter of 2024 and reaffirmed expectations for full-year 2024 revenue at the lower end of the previously provided guidance of US$78.5 million to US$84.5 million. For the quarter ended March 31, 2024, AVITA ...

VALENCIA, Calif., Feb. 29, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ:RCEL, ASX: AVH))), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced it has submitted its response to the U.S. Food and Drug Administration (FDA) for additional information requested in connection to its premarket approval (PMA) supplement for RECELL GO™. This submission resumes the substantive interactive review process under the Br ...