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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
RenovaCare Secures Patent Victory and Continues to Bolster IP Portfolio
U.S. Patent and Trademark Office dismisses challenge lodged by Avita Medical.
Business Wire
03.16.18
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
Avita Medical Names New Chief Financial Officer
Existing CFO assumes chief administrative officer position.
Business Wire
01.04.18
Avita Medical Names Chief Commercial Officer
New executive was most recently vice president of Marketing, Topical Dermatology, at Allergan.
Business Wire
09.13.17
Avita Medical Appoints New CEO
New leader had served as chief scientific officer of Novartis’ Cell and Gene Therapy Unit.
Business Wire
06.21.17
Avita Medical Announces Positive Results from Pivotal Trial
Co-primary endpoints achieved in study deploying ReCell in patients with severe burns.
Business Wire
06.02.17
Avita Medical Awarded $8 Million in BARDA Extension Deal
Additional non-dilutive funds to accelerate U.S. market approval and product launch.
Avita Medical Limited
06.29.16
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
Stanislav Glezer Joins Outcome Capital as Managing Director
Diality Names New Chief Technology Officer
Otolith Labs Rounds Out Executive Team With Chief Clinical Officer Hire
Medline Has Class I Recall of Sub-G Endotracheal Tubes
Foldax Releases Clinical Results for TRIA Mitral Surgical Heart Valve Using LifePolymer Material
View Breaking News >
CURRENT ISSUE
June 2024
Special Delivery for Drug-Device & Combination Products
A Roundtable on Medical Device Packaging & Sterilization
Medical Molders Are Specialized Sculptors
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