Avita Medical Ltd. (AVMXY: OTCQX International) | Avita Medical Announces U.S. FDA Doubles Patient Numbers Permitted for Compassionate Use of ReCell®

Avita Medical Announces U.S. FDA Doubles Patient Numbers Permitted for Compassionate Use of ReCell®

Oct 04, 2015

OTC Disclosure News Service

Northridge, CA and Cambridge, UK

Compassionate Use Cases Presented at TERMIS World
Congress

Avita Medical Ltd. (ASX: AVH), (OTCQX: AVMXY), a
regenerative medicine company specializing in the treatment of wounds and skin
defects, today announced approval from the U.S. Food and Drug Administration
(FDA) for the expansion of its Compassionate Use Investigational Device Exemption
(IDE) program for ReCell®.

The IDE supplement allows Avita
Medical to continue clinical evaluation of ReCell® on twice as many patients as
originally permitted under the IDE, now allowing for ReCell® treatment of a
total of 24 patients who have insufficient healthy skin available for standard
skin grafting of their injury. Investigational use of ReCell® in these patients
may be granted in cases where the treating physician believes that there is no
suitable treatment alternative. The IDE also allows the application of ReCell®
beyond burns and to larger, more serious defects than those previously studied
in the U.S.  

“Approval from the FDA for doubling
the number of compassionate use cases is not only a significant achievement for
Avita as we continue our pivotal U.S. trial of ReCell® in burns, it provides an
alternative treatment option for patients with no other skin-healing option,” Adam
Kelliher, CEO of Avita Medical, commented. “The ability to achieve definitive
closure of extensive injuries in this patient population can have a life-saving
impact.”

The FDA approved the initial
IDE for up to 12 subjects with life-threatening wounds in April 2014. Under the
original IDE, 12 compassionate use cases using ReCell® have been conducted with success at several leading institutions, including Wake Forest
Baptist Medical Center, Maricopa Medical Center, Walter Reed National Military
Medical Center and MedStar Washington Hospital Center. 

Individual case results have
been presented to the international medical community at various professional
meetings this year and last year, such as the Southern Region Burn Conference,
the 17th Biennial Congress of the International Society for Burn Injuries, the
47th Annual Meeting of the American Burn Association, Avita’s Skin Regeneration
Symposium, and the Military Health System Research Symposium.

Most recently, long-term results
from two early compassionate use cases were presented at the 2015
4th Tissue
Engineering and Regenerative Medicine International Society World Congress
(TERMIS) World Congress
,
held last month in Boston, MA. 

In the presentation at the
TERMIS World Congress, surgeons from Walter Reed National Military Medical
Center presented two complex trauma cases approved for compassionate use of ReCell®,
and compared results to two similar cases not using ReCell®. The cases involved
massive reconstruction using dermal regenerative templates, and the patients
had little available healthy skin to graft their defects closed. Their findings
indicated that using ReCell® in
these cases allowed for a greater skin graft expansion, thereby limiting donor
site morbidity and decreasing donor site burden by 65%. Further, they showed a
decreased time to complete healing of 50% relative to skin grafting without ReCell®
and achieved outcomes with
matching pigmentation.

ABOUT RECELL® AND RES™

ReCell® is Avita
Medical’s unique proprietary technology that enables a clinician to rapidly
create, at point of care in approximately 30 minutes, Regenerative Epithelial
Suspension (RES™) using a small sample of the patient’s skin. RES™ is an
autologous suspension comprising the cells and wound healing factors necessary
to regenerate natural, healthy skin. RES™ has a broad range of applications and
can be used to restart healing in unresponsive wounds, to repair burns using
less donor skin yet with improved functional and aesthetic outcomes, and to
restore pigmentation and improve cosmesis of damaged skin.

 

ABOUT AVITA MEDICAL LIMITED

Avita Medical develops
and distributes regenerative products for the treatment of a broad range of
wounds, scars and skin defects. Avita’s patented and proprietary collection and
application technology provides innovative treatment solutions derived from a
patient’s own skin. The Company’s lead product, ReCell®, is used in the
treatment of a wide variety of burns, plastic, reconstructive and cosmetic
procedures. ReCell® is patented, CE‐marked for Europe, TGA‐registered in
Australia, and CFDA‐cleared in China. In the United States, ReCell® is an
investigational device limited by federal law to investigational use. A pivotal
U.S. trial is underway, with patient enrollment completion anticipated by the
end of 2015. To learn more, visit www.avitamedical.com.

Avita Medical Ltd

Adam Kelliher

Chief Executive Officer

Phone: +44 (0) 1763 269 772

akelliher@avitamedical.com

 

Avita Medical Ltd

Tim Rooney

Chief Financial Officer

Phone: + 1 (818) 356-9400

trooney@avitamedical.com

 

Avita Medical Ltd

Gabriel Chiappini

Company Secretary

Phone +61(0) 8 9474 7738

gabriel@laurus.net.au

 

USA

The Ruth Group

Lee Roth, Investor Relations

Kirsten Thomas, Public Relations

Phone: +1 (646) 536-7012 / +1 (508) 280-6592

lroth@theruthgroup.com

/ kthomas@theruthgroup.com

 

 

Australia

Monsoon Communications

Rudi Michelson

Investor Relations/PR

Phone:+61 3 9620 3333

rudim@monsoon.com.au

 

 

 

This release includes additional documents. Select the link(s) below to view.

US FDA Doubles Patient Numbers Permitted for Compassionate Use of Recell..pdf

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