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#ASX Announcements
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Added 4 years ago

AVITA Therapeutics and the Houston Methodist Research Institute Enter into Collaboration to Explore Novel Approaches for Skin Rejuvenation

 

Preclinical research will pair AVITA Therapeutics’ Spray-On Skin™ Cells with Houston Methodist Research Institute’s technologies to reverse cellular aging

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#ASX Announcements
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First Patient Enrolled in AVITA Therapeutic’s Pivotal Study Evaluating the RECELL System for Repigmentation of Stable Vitiligo

 

Valencia, Calif, USA, and Melbourne, Australia, September 14, 2020 — AVITA Therapeutics, Inc. (NASDAQ: RCEL, ASX:AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today the initiation of the pivotal study assessing the use of the RECELL® System to treat stable vitiligo with the enrollment of the first patient at Miami Dermatology and Laser Institute in Miami, FL. The study will evaluate the safety and effectiveness of AVITA Therapeutic’s RECELL System to repigment skin in patients who have vitiligo that has been stable for at least one year.

“The initiation of the vitiligo clinical study is a milestone in advancing AVITA Therapeutic’s pipeline to leverage the utility and full potential of our innovative RECELL technology platform to address unmet medical needs in dermatological applications,” said Dr. Mike Perry, AVITA Therapeutic Chief Executive Officer. “Globally, there have been several published case series and pilot randomized clinical trials reporting positive results with the use of RECELL for treating patients with stable vitiligo and repigmenting depigmented skin lesions. We are pleased to initiate this pivotal study as a next step toward offering a treatment option for the millions of Americans who live with vitiligo.”

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#Business Model/Strategy
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The satisfaction of FIRB Condition for Proposed Redomiciliation

 

AVITA Medical Limited is pleased to announce that it has received confirmation from the Foreign Investment Review Board (FIRB) that the Commonwealth has no objection in relation to AVITA Therapeutics, Inc. (Avita US) acquiring all of the issued shares of the Company under the proposed scheme of arrangement to effect a re-domiciliation of the Company and its subsidiaries from Australia to the United States of America.

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#ASX Announcements
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AVITA Medical Reports Third Quarter Fiscal 2020 Financial Results and Company Update

Corporate Update Our commercial efforts in Q3 progressed well with quarterly growth exceeding 20% across both procedural volume and U.S. RECELL System revenue. Q3 represents our strongest quarter since launching in the United Avita Medical Limited c/o Mertons Corporate Services Pty Ltd Level 7, 330 Collins Street, Melbourne Victoria 3000 Page 2 States in January last year reflecting strong customer uptake, even with the COVID-19 pandemic beginning toward the end of the quarter. In the quarter ended 31 March 2020, we also added nine new customers and certified an additional 21 surgeons, bringing our total to 69 customers and 205 certified burn surgeons, together with progressing our ongoing clinical investigations with first patient enrollment in our soft tissue and pediatric partial thickness studies. All of these factors collectively demonstrate ongoing high interest in the RECELL System, together with consistent usage and acceptance across our growing customer base.

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##FDA
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AVITA Medical Receives U.S. FDA Investigational Device Exemption Approval of Clinical Feasibility Study to Evaluate RECELL System for Vitiligo



 

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