Zita:" AVITA Medical announced today that results from two
U.S. pivotal clinical trials and the U.S. Compassionate U
se program demonstrating the effectiveness and clinical benefits of the RECELL
® Autologous Cell Harvesting Device were presented at
the 2nd Changhai Academic Week for Burns Treatment in Shanghai, China. T
he results were presented by Jeffrey Carter, MD, FACS, Medical Director & Associate Professor of Surgery at University Medical Center Burn Center & Louisiana State University School of Medicine, New Orleans, LA. "As Burn Surgeons we cannot cho
ose our patie nts’ severity of injury, age, nor any combination of other
injuries or illness that complicate their course of care, said Dr. Carter. “Thanks to the RECELL device, we can choose to minimize the burden of patient donor sites, and offer a treatment that prov
ides repigmented wounds capable of becoming subtle scars to the most discerning eye."
Key highlights of Dr. Carter’s presentation included:
•
The pivotal, controlled clinical trial of the RECELL Device in the treatment of second-
degree burns
demonstrated
statistically significant reduction i
n donor skin requirements (97.5 percent
reduction)
and pain, increased patient satisfaction and im
proved donor scar outcomes.
•
The pivotal trial in third-
degree burns met its co
-primary endpoints and demonstrated statistically
significant reduction in donor skin requirements.
•
Results from two patients enrolled under Compassionate Use with second
-degree facial burns showed excellent cosmetic outcomes.
The presentation at the Changhai Academic Week follows the commencement this year of a government funded clinical trial of RECELL for the treatment of burns in China. The clinical trial entitled “Key Technique and Clinical Pathway for Burn Treatment” is a
controlled clinical trial in which burn patients are be ing randomized
for treat ment with either standard of care, the RECELL Device,
or one of two other treatments.
Also in 2018
, the Company collaborated with the Plastic Surgery Department of Peking Union
Medical
College Hospital (PUMCH), one of the most renowned hospitals in China, to establish a RECELL Device
training center based in Beijing. The training center is designed to standardize the
protocol for the use of RECELL, train surgeons in the use of t
he RECELL Device nationwide, and encourage the expansion of the use of this innovative treatment to hospitals across China. The first national training course encompassing the treatment of vitiligo and scars with the RECELL Device was completed last month at PUMCH.
In the U.S., the RECELL Device is an investigational medical device that is designed to enable medical
professionals to produce, at the point-/of -care, a REGENERATIVE EPIDERMAL SUSPENSION™ (RES
™)....." ENDE Zitat
Quelle:https://www.asx.com.au/asx/share-price-research/company/AVH
https://www.asx.com.au/asxpdf/20180627/pdf/43w2f72r1kckhg.pdf |
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