AVITA Medical Announces RECELL® System Preliminary Data Focused on Vitiligo and Facial Acne Scars at the 24th Annual World Congress of Dermatology

AVITA Medical (ASX: AVH, OTCQX: AVMXY), a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration, announces new preliminary RECELL Autologous Cell Harvesting Device (RECELL System) data at the 24th annual World Congress of Dermatology Meeting June 10-15, 2019, in Milan, Italy. Three posters at the World Congress of Dermatology will highlight the potential use of the RECELL System for the treatment of vitiligo and facial acne scars.

Building on the foundation of long-term safety and efficacy of the RECELL System for the treatment of burn patients, we look forward to presenting data at the World Congress of Dermatology exploring the use of this innovative therapy for regenerative dermatology, said Dr. Michael Perry, AVITA Medicals Chief Executive Officer. We are committed to pursuing the full potential of the RECELL System as a meaningful treatment option to advance patient care in areas with significant unmet medical need.

The RECELL System, which uses a small amount of a patients own skin to prepare Spray-On Skin„¢ Cells at the point of care, is 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 wounds, scars, and vitiligo.

RECELL System Poster Presentations at World Congress of Dermatology

Poster Exhibition Date, Time (CET), Location

      Poster Title       Authors
June 11, 7:00 a.m. “ 6:30 p.m.       Treatment of Facial Acne Scars in      

Nanze Yu, et al.

June 12, 7:00 a.m. “ 7:30 p.m. Chinese Patients: Combination of Peking Union Medical
June 13, 7:00 a.m. “ 7:30 p.m. Dermabrasion and ReCell Technique. College Hospital
June 14, 7:00 a.m. “ 7:00 p.m. Beijing, China
June 15, 7:00 a.m. “ 1:00 p.m.
MiCo “ Milano Congressi
South Wing, Level 0                
June 11, 7:00 a.m. “ 6:30 p.m. Is Suction Blister Epidermal Grafting

Weiwei Li, et al.

June 12, 7:00 a.m. “ 7:30 p.m. a Simple and Reliable Way to Screen Beijing Tsinghua
June 13, 7:00 a.m. “ 7:30 p.m. Patients with Large Area Vitiligo for Changgung Hospital
June 14, 7:00 a.m. “ 7:00 p.m. ReCell Treatment? Beijing, China
June 15, 7:00 a.m. “ 1:00 p.m.
MiCo “ Milano Congressi
South Wing, Level 0                
June 11, 7:00 a.m. “ 6:30 p.m. Spontaneous Pigmentation Spots are

Zhi-Fei Liu, et al.

June 12, 7:00 a.m. “ 7:30 p.m. Signs of Successful RECELL Therapy in Peking Union Medical
June 13, 7:00 a.m. “ 7:30 p.m. Patients with Stable Large Area College Hospital
June 14, 7:00 a.m. “ 7:00 p.m. Vitiligo Beijing, China
June 15, 7:00 a.m. “ 1:00 p.m.
MiCo “ Milano Congressi
South Wing, Level 0                
 
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ABOUT AVITA MEDICAL LIMITED

AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medicals patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a REGENERATIVE EPIDERMAL SUSPENSION„¢ (RES„¢), an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medicals 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 Skin„¢ Cells using a small amount of a patients 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 real-world use in more than 7,000 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.

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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 and CFDA-cleared in China.

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 companys 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.

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