Recent journal publications investigate the potential use of the RECELL System to treat
multiple dermatological conditions
Valencia, Calif., USA, and Melbourne, Australia, 19 September 2019 — AVITA Medical (ASX: AVH, OTCQX: AVMXY), a regenerative medicine company focused on the development and commercialization of innovative therapies leveraging the healing properties of a patient’s own skin, announced today data published in Aesthetic Plastic Surgery by the Department of Plastic Surgery at Peking Union Medical College Hospital exploring the use of the RECELL® Autologous Cell Harvesting Device (RECELL® System) in combination with dermabrasion to treat facial acne scars.1
The retrospective study analyzes the healing time and rate of postoperative complications of 78 patients with acne scars treated using dermabrasion with and without the RECELL System, revealing a statistically significant difference in healing time (P\ 0.001) between the two treatment regimens. Acne scars treated using dermabrasion healed more quickly on average with RECELL (5.27 ± 1.086 days) than without RECELL (average healing time of 12.30 ± 1.725 days). In addition, there were no postoperative complications, such as pigmentation and scar hyperplasia, and higher patient satisfaction rates (P< 0.001) for those patients treated with RECELL.
“It’s exciting to see physicians worldwide interested in studying the possible application of the RECELL System to advance patient care across a broad range of treatments,” said Andrew Quick, AVITA Medical’s Chief Technology Officer. “We look forward to continued collaboration within the global medical community as we explore the full potential of this regenerative technology platform to address unmet medical needs.”
Other recent publications investigating the use of the RECELL System in the treatment of dermatological
• “The use of noncultured regenerative epithelial suspension for improving skin color and scars: A report of 8 cases and review of the literature” by Jie Ren, PhD, M.D., and Jianlan Liu, PhD, Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China, et al. published in the Journal
of Cosmetic Dermatology2
• “The clinical efficacy of treatment using the autologous non-cultured epidermal cell suspension technique for stable vitiligo in 41 patients” by Bin Liu and Zhong-Hai Liu, Guangzhou New Centre Institute of Vitiligo, Guangzhou, PR China, and Hui-Heng Chen, Dongguan Eighth People’s Hospital & Dongguan Children’s Hospital, Dongguan, PR China, et al. published online in the Journal of Dermatological Treatment3
The RECELL® System, which uses a small amount of a patient’s own skin to prepare Spray-On Skin™ Cells at the point of care, is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of acute thermal burns in patients 18 years and older. In international markets, the RECELL® System is approved to promote skin healing in a wide range of applications including burns, acute and chronic wounds, scars, and vitiligo.
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ABOUT AVITA MEDICAL LIMITED
AVITA Medical is a regenerative medicine company focused on the development and commercialization of innovative therapies leveraging the healing properties of a patient’s own skin. With its novel technology platform, AVITA Medical is advancing the standard-of-care for burn patients and is poised to address unmet medical needs across a range of dermatological indications, including vitiligo, wounds and aesthetic rejuvenation. The company’s patented and proprietary collection and application technology prepares a REGENERATIVE EPIDERMAL SUSPENSION™ (RESTM) comprising the patient’s skin cells necessary to regenerate a natural healthy epidermis that can then be sprayed onto the areas of the patient’s skin requiring treatment. More information about AVITA Medical is available at www.AvitaMedical.com
AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On SkinTM Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point-of-care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and realworld use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE – RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.
In international markets our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, acute wounds, scars and vitiligo. The RECELL System is TGA- registered in Australia, CFDA-cleared in China, and has CE-mark approval in Europe.
To learn more, visit www.avitamedical.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.
FOR FURTHER INFORMATION:
Sam Brown, Inc.
Monsoon Communications Sarah Kemter
Phone +61 (0)3 9620 3333
Mobile +61 (0)407 162 530
1 Chen, Q., Yu, N., Liu, Z. et al. Aesth Plast Surg (2019). https://doi.org/10.1007/s00266-019-01481-8
2 Ren J, Liu J, Yu N, et al. The use of noncultured regenerative epithelial suspension for improving skin color and scars: A report of 8 cases and review of the literature. J Cosmet Dermatol. 2019;00:1–8. https://doi. org/10.1111/jocd.13071
3 Bin Liu, Hui-Heng Chen, Zhong-Hai Liu, Jing-Feng Liang, Ru-Jun Xue, Ping-Jiao Chen, Chang-Xing Li, Xiao-Dong Liang, Jie Deng, Rui-Xian Ye, Xi-Bao Zhang & Jing-Yao Liang (2019) The clinical efficacy of treatment using the autologous non-cultured epidermal cell suspension technique for stable vitiligo in 41 patients, Journal of Dermatological Treatment, DOI: 10.1080/09546634.2019.1619657