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Co-Primary Endpoints Met in AVITA Medical's RECELL Trial
RECELL achieved statistically significant donor sparing over a control group.
Michael Barbella, Managing Editor
01.25.23
Breakthrough Device Designations Granted for AVITA Medical's RECELL System
The RECELL System was approved by the FDA in September 2018.
Michael Barbella, Managing Editor
01.13.23
First Patient Enrolled in AVITA Medical's RECELL System Study
Trial to enroll at least 65 U.S. patients to evaluate safety and effectiveness of a treatment for acute, non-burn skin injuries.
Business Wire
05.06.20
AVITA Medical Names Chief Financial Officer
New executive joins the company from Apple Tree Partners.
Business Wire
01.07.20
FDA Grants IDE Approval of Pivotal Study Evaluating AVITA Medical's RECELL System
First RECELL System clinical trial in the U.S. focused on acute soft tissue injuries, defects, and reconstruction.
Business Wire
10.28.19
AVITA Medical Appoints Interim CFO
The company's chief administrative officer will resume his former duties until a successor is found.
Business Wire
06.28.19
AVITA Medical Begins Clinical Study of RECELL System in Pediatric Burn Treatment
Randomized controlled study is being conducted in Brisbane, Australia.
Business Wire
12.11.18
AVITA Medical Receives FDA Approval of the RECELL System for Burn Treatment
Point-of-care regenerative medicine tech treats second- and third-degree burns using Spray-On Skin Cells product.
Business Wire
10.25.18
AVITA Medical Expands Management Team to Support U.S. Launch of RECELL Device
Company expects FDA to complete its review of RECELL by the end of the year.
Business Wire
08.29.18
AVITA Medical Acquires Manufacturing Facility to Support Planned U.S. Launch of RECELL Device
Facility is operated by a contract manufacturer that assembles the company’s RECELL device.
Business Wire
08.08.18
AVITA Medical Announces FDA Approval of Expansion of RECELL Compassionate Use Program
Expanded protocol allows treatment of up to 88 patients with life-threatening injuries.
Business Wire
03.02.18
FDA Approves New Continued Access Protocol for the ReCell Device for Burn Treatment
Approval facilitates enrollment and allows participation of additional burn centers.
Business Wire
10.19.17
FDA Approves Continued Access Protocol for ReCell Device for Burn Injury Treatment
Approval facilitates enrollment and allows participation of additional burn centers.
Business Wire
10.05.17
New Randomized Trial Shows ReCell Heals Donor Sites Faster
Skin donor sites heal just over 30 percent faster with ReCell in 106-patient randomized controlled trial.
Business Wire
07.11.17
R&D & Design
Avita Medical Wins CE Mark for New ReCell Device
Phase III trial for product is underway in the United States.
07.30.15
Breaking News
Getinge Donates Extensive Medical Equipment to Ukraine
Olympus Names Julien Sauvagnargues CEO of the Americas
Mark Pugh Assumes CEO Role at Theragenics
Art Taylor Named to Endologix Board of Directors
Michael Bourque Named Chief Financial Officer at Inogen
View Breaking News >
CURRENT ISSUE
March 2024
Evaluations for the EU: The Impact on Testing & Lab Services
A Matter of Fact for Medical Device Materials
The Sweet Science of Diabetes Technology
View More >