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Breaking Medical Device Industry News

Friday, October 22, 2021




AVITA Therapeutics States 1st Patient Enrolled in Pivotal Study Evaluating the RECELL System for Repigmentation of Stable Vitiligo

AVITA Therapeutics Chief Executive Officer, “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.

AVITA Medical Receives U.S. FDA Investigational Device Exemption Approval of Pivotal Study Evaluating RECELL System for Soft Tissue Reconstruction

“FDA approval of our IDE for a soft tissue reconstruction pivotal clinical trial is an important next step in expanding the potential indications of our RECELL System technology platform. We are pleased with the strong interest expressed by the clinical community in participating in this study and we look forward to working with physicians and their patients upon study commencement,” said Dr. Michael Perry, Chief Executive Officer of AVITA Medical.

RECELL System Feasibility Study Results

The 26-week, single-arm, observational study included 16 patients treated at three hospitals in the United Kingdom, including Manchester Royal Infirmary, Kings College Hospital and Northwick Park Hospital.

AVITA Medical Announces U.S. National Market Launch of RECELL System

The U.S. sales team of Regenerative Tissue Specialists and Clinical Training Specialists that joined AVITA Medical in November 2018 has been trained and fully deployed across the U.S. in support of the nationwide launch of the RECELL System.

AVITA Medical Announces Commencement of Randomized Controlled Clinical Study of RECELL System in Treatment of Children with Burn Injuries

10/25/18: Avita Medical reports the clinical study is being conducted in Brisbane, Australia in collaboration with the Queensland University of Technology and Lady Cilento Children’s Hospital.

AVITA Medical Announces Acquisition of Manufacturing Facility to Support Planned U.S. Launch of RECELL Device

“Having direct control over the manufacturing of RECELL will ensure that we have the capacity to meet commercial demand, including the planned U.S. launch and the BARDA procurement, and provide us further control over our production processes and timelines,” said Dr. Michael Perry, Chief Executive Officer. “Acquiring this facility that has a track record of producing RECELL allows us to realize the benefits of inhouse production while maintaining the continuity of proven manufacturing and quality processes and systems.”

AVITA Medical Announces Presentation at ISPOR Meeting Validating Acute Burn Health Economic Model

“This first landmark economic model examines the continuum of definitive care in burns and can bring value to the burn community by estimating the likely economic impact of new treatments for burns,” said Pinar Bilir, IQVIA.

RECELL Pivotal Trial in Third-Degree Burns Meets Co-Primary Endpoints and Shows Statistically Significant Reduction in Donor Skin Requirements

ReCell pivotal, controlled clinical trial in the treatment of deep full-thickness (third-degree) burns with the RECELL® Autologous Cell Harvesting Device achieved its co-primary endpoints, demonstrating a statistically significant reduction in donor skin requirements versus standard of care while achieving comparable definitive wound closure.

RECELL Study in Facial Burns Shows Excellent Cosmetic Outcomes

4/13/18: Two presentations at the American Burn Association Meeting highlight potential of RECELL to improve patient care in difficult-to-treat burns.

RECELL Data Demonstrating Statistically Significant Reduction in Donor Skin Requirements and Pain, Increased Patient Satisfaction and Improved Donor Scar Outcomes for Second-Degree Burn Patients

RECELL Device presentations include data from pivotal trial and health economic results showing 44 percent reduction in total treatment costs compared to standard of care.

Avita Medical Announces Submission of U.S. FDA Premarket Approval Application for the ReCell Device for Treatment of Burn Injuries

September 28, 2018 Avita Medical announced today that it has submitted to the Food & Drug Administration (FDA) a Pre-Market Approval (PMA) application for its ReCell Autologous Cell Harvesting Device for treatment of burn injuries. The company reports that...

Avita Medical: New Randomized Trial Shows ReCell Heals Donor Sites Faster

June 19, 2017 Avita Medical advises deploying a suspension of cells generated from a ReCell® medical device onto a skin donor site can speed up healing by 30.7% and deliver a superior final outcome, according to the results...

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