AVITA Medical Inc. has won U.S. Food and Drug Administration (FDA) premarket approval (PMA) for the RECELL GO System, a next-generation autologous cell harvesting device that harnesses the regenerative properties of a patient’s own skin to treat thermal burn wounds and full-thickness skin defects.

AVITA Medical Inc.已获得美国食品和药物管理局（FDA）对RECELL-GO系统的上市前批准（PMA），该系统是一种下一代自体细胞采集设备，可利用患者自身皮肤的再生特性来治疗热烧伤和全层皮肤缺陷。

The company claims RECELL provides clinicians and patients with several advantages over traditional skin grafting, including improved healing, using significantly less donor skin;1 reduced pain, faster closure, and an improved aesthetic appearance at the RECELL-harvested donor site;2 fewer procedures required for definitive closure;3 and reduced hospitalization for burns covering less than 50% of the total body surface area.2,3,4.

该公司声称，与传统植皮相比，RECELL为临床医生和患者提供了几个优势，包括改善愈合，使用更少的供体皮肤；1减少疼痛，更快闭合，改善RECELL收获供体部位的美学外观；2最终关闭所需的程序减少；3并减少烧伤住院率，烧伤面积不到全身表面积的50%.2,3,4。

RECELL GO introduces enhanced features that streamline the preparation of Spray-On Skin Cells. This next-generation device significantly reduces the training burden on medical staff, improves workflow efficiency in the operating room, and controls the RECELL Enzyme incubation time to ensure optimal cell yield and viability.

。这种下一代设备显着减轻了医务人员的培训负担，提高了手术室的工作效率，并控制了RECELL酶的孵育时间，以确保最佳的细胞产量和活力。

These advancements simplify the user interface, enabling medical teams to provide quality care readily and consistently to their patients..

这些进步简化了用户界面，使医疗团队能够轻松一致地为患者提供优质护理。。

'FDA approval of RECELL GO marks a paradigm shift in the treatment of partial-thickness and full-thickness wounds,” AVITA Medical CEO Jim Corbett said. “By streamlining processes and enhancing operational efficiency with the use of RECELL GO, clinicians can now treat a greater number of patients and more broadly experience the proven benefits of RECELL technology.

AVITA Medical首席执行官吉姆·科贝特（JimCorbett）说：“FDA批准RECELL-GO标志着治疗部分厚度和全厚度伤口的范式转变。”。“通过使用RECELL-GO简化流程并提高运营效率，临床医生现在可以治疗更多的患者，并更广泛地体验RECELL技术已被证实的益处。

We believe that this transformative shift will empower more clinicians to achieve optimal outcomes for their patients, driving greater adoption, and fundamentally redefining wound care management. It's GO time for a new era in wound care.'.

我们相信，这种变革性的转变将使更多的临床医生能够为患者取得最佳结果，推动更多的采用，并从根本上重新定义伤口护理管理。是时候开创伤口护理的新时代了。”。

The company has already launched RECELL GO in top U.S. burn treatment centers, and other existing accounts will be converted to RECELL GO throughout the year. New accounts will receive RECELL GO with their first order, eliminating the need for conversion.

该公司已经在美国顶级烧伤治疗中心推出了RECELL GO，其他现有账户将在全年内转换为RECELL GO。新客户将收到第一笔订单的RECELL GO，无需进行转换。

The approved supplement follows the original PMA of RECELL Autologous Cell Harvesting Device and subsequent PMA supplements.

批准的补充剂遵循RECELL自体细胞采集装置的原始PMA和随后的PMA补充剂。

AVITA Medical is a commercial-stage regenerative medicine company developing wound care management solutions and skin restoration devices. At the forefront of its platform is the RECELL System, approved by the FDA for treating thermal burn wounds and full-thickness skin defects, and for repigmentation of stable depigmented vitiligo lesions.

AVITA Medical是一家商业再生医学公司，开发伤口护理管理解决方案和皮肤修复设备。其平台的最前沿是RECELL系统，经FDA批准用于治疗热烧伤伤口和全层皮肤缺损，以及用于稳定的脱色白癜风病变的再着色。

RECELL harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin Cells, delivering a solution at the point-of-care. This technology serves as the catalyst for a new treatment paradigm enabling improved clinical outcomes. AVITA Medical also holds the exclusive rights to market, sell, and distribute PermeaDerm, a biosynthetic wound matrix, in the United States..

RECELL利用患者自身皮肤的再生特性，在皮肤细胞上产生喷雾，在护理点提供解决方案。这项技术是一种新的治疗模式的催化剂，可以改善临床结果。AVITA Medical还拥有在美国营销、销售和分销PermeaDerm（一种生物合成伤口基质）的独家权利。。

In international markets, the RECELL System is approved to promote skin healing in a wide range of applications including burns, full-thickness skin defects, and vitiligo. The RECELL System is TGA-registered in Australia, has received CE mark approval in Europe and has PMDA approval in Japan.

在国际市场上，RECELL系统被批准用于促进皮肤愈合的广泛应用，包括烧伤，全层皮肤缺陷和白癜风。RECELL系统是在澳大利亚注册的TGA，已在欧洲获得CE标志批准，并在日本获得PMDA批准。