AVITA Medical secures option for exclusive
licensing of emerging technologies
Preclinical research will pair AVITA Medical’s
Spray-On Skin™ Cells technology and expertise with the Gates
Center’s patent-pending combined reprogramming and gene-editing
methodology
AVITA Medical (ASX: AVH, NASDAQ: RCEL), a regenerative medicine
company with a technology platform positioned to address unmet
medical needs in therapeutic skin restoration, and scientists at
the Gates Center for Regenerative Medicine at the University of
Colorado School of Medicine announced today a preclinical research
collaboration to establish proof-of-concept and explore further
development of a spray-on treatment of genetically modified cells
for patients with epidermolysis bullosa (EB), with potential
applicability to other genetic skin disorders.
The partnership will pair AVITA Medical’s patented and
proprietary Spray-On Skin™ Cells technology and expertise with the
Gates Center’s innovative, patent-pending combined reprogramming
and gene-editing technology to allow cells to function properly.
Under the terms of the Sponsored Research Agreement (SRA), AVITA
Medical retains the option to exclusively license technologies
emerging from the partnership for further development and
commercialization. The Gates Center team is further supported by
the EB Research Partnership in New York, the Los Angeles-based EB
Medical Research Foundation, the London-based Cure EB Charity, and
government grants in a collaborative effort to rapidly develop and
translate this technology to the clinic for meaningful impact on
patient lives.
“The Gates Center is a leader in developing therapeutic
approaches for genetic skin diseases. Researchers at the Gates
Center have developed a powerful new approach for treating genetic
skin disorders and improving the lives of patients with
epidermolysis bullosa,” said Dr. Mike Perry, Chief Executive
Officer of AVITA Medical and adjunct professor at the Gates Center
for Regenerative Medicine. “We look forward to collaborating with
the team at the Gates Center on the expanded use of our technology.
This agreement marks an important milestone in AVITA’s mission to
harness the potential of regenerative medicine to address unmet
medical needs across a broad range of dermatological indications,
including genetic disorders of the skin.”
Epidermolysis bullosa is a group of rare and incurable skin
disorders caused by mutations in genes encoding structural proteins
resulting in skin fragility and blistering, leading to chronic
wounds and, in some sub-types, an increased risk of squamous cell
carcinoma or death. There are no approved curative therapies, and
current treatment is palliative—focused primarily on pain and
nutritional management, itching relief, wound care, and
bandaging.
“It’s very exciting to partner with AVITA Medical to help
advance our epidermolysis bullosa program,” said Director of the
Gates Center for Regenerative Medicine Dr. Dennis Roop. “We’re
looking forward to exploring a novel approach to delivering
gene-edited skin cells to patients that addresses current treatment
challenges.”
“We believe that Spray-On Skin™ Cells technology combined with
our genetically corrected cells has the potential to be game
changing in the treatment of this disease. This combination could
reduce time to treatment, lower manufacturing complexity, reduce
costs, and improve patient outcomes,” said Dr. Ganna Bilousova,
assistant professor of dermatology, who is a co-principal
investigator on this research program.
ABOUT THE CHARLES C. GATES CENTER FOR REGENERATIVE
MEDICINE
The Charles C. Gates Center
for Regenerative Medicine was established in 2006 with a gift in
memory of Denver industrialist and philanthropist Charles C. Gates,
who was captivated by the hope and benefit stem cell research
promised for so many people in the world. The Gates Center aspires
to honor what he envisioned—by doing everything possible to support
the collaboration between basic scientific researchers and clinical
faculty to transition scientific breakthroughs into clinical
practice as quickly as possible.
Led by Founding Director
Dennis Roop, Ph.D., the Gates Center is located at the University
of Colorado’s Anschutz Medical Campus, the largest new biomedical
and clinical campus in the United States. Operating as the only
comprehensive Stem Cell Center within a 500-mile radius, the Gates
Center shares its services and resources with an ever-enlarging
membership of researchers and clinicians at the Anschutz Medical
Campus, which includes University of Colorado Hospital, Children’s
Hospital Colorado, and the Veterans Administration Medical Center,
as well as the Boulder campus, Colorado State University, the
Colorado School of Mines, and business startups. This collaboration
is designed to draw on the widest possible array of scientific
exploration relevant to stem cell technology focused on the
delivery of innovative therapies in Colorado and beyond.
ABOUT THE UNIVERSITY OF COLORADO SCHOOL OF MEDICINE
Faculty at the University of
Colorado School of Medicine work to advance science and improve
care. These faculty members include physicians, educators, and
scientists at University of Colorado Hospital, Children’s Hospital
Colorado, Denver Health, National Jewish Health, and the Denver
Veterans Affairs Medical Center. The school is located on the
Anschutz Medical Campus, one of four campuses in the University of
Colorado system. To learn more about the medical school’s care,
education, research, and community engagement, visit its web
site.
ABOUT AVITA MEDICAL LIMITED
AVITA Medical is a regenerative medicine company with a
technology platform positioned to address unmet medical needs in
burns, chronic wounds, and aesthetics indications. AVITA Medical’s
patented and proprietary collection and application technology
provides innovative treatment solutions derived from the
regenerative properties of a patient’s own skin. The medical
devices work by preparing a REGENERATIVE EPIDERMAL SUSPENSION™
(RES™), an autologous suspension comprised of the patient’s skin
cells necessary to regenerate natural healthy epidermis. This
autologous suspension is then sprayed onto the areas of the patient
requiring treatment.
AVITA Medical’s first U.S. product, the RECELL® System, was
approved by the U.S. Food and Drug Administration (FDA) in
September 2018. The RECELL System is indicated for use in the
treatment of acute thermal burns in patients 18 years and older.
The RECELL System is used to prepare Spray-On Skin™ Cells using a
small amount of a patient’s own skin, providing a new way to treat
severe burns, while significantly reducing the amount of donor skin
required. The RECELL System is designed to be used at the point of
care alone or in combination with autografts depending on the depth
of the burn injury. Compelling data from randomized, controlled
clinical trials conducted at major U.S. Burn Centers and real-world
use in more than 8,000 patients globally, reinforce that the RECELL
System is a significant advancement over the current standard of
care for burn patients and offers benefits in clinical outcomes and
cost savings. Healthcare professionals should read the INSTRUCTIONS
FOR USE - RECELL® Autologous Cell Harvesting Device
(https://recellsystem.com/) for a full description of indications
for use and important safety information, including
contraindications, warnings, and precautions.
In international markets, our products are marketed under the
RECELL System brand to promote skin healing in a wide range of
applications, including burns, chronic wounds, and aesthetics. The
RECELL System is TGA-registered in Australia and received CE-mark
approval in Europe.
To learn more, visit www.avitamedical.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This letter includes forward-looking statements. These
forward-looking statements generally can be identified by the use
of words such as “anticipate,” “expect,” “intend,” “could,” “may,”
“will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,”
“target,” “project,” “continue,” “outlook,” “guidance,” “future,”
other words of similar meaning and the use of future dates.
Forward-looking statements in this letter include, but are not
limited to, statements concerning, among other things, our ongoing
clinical trials and product development activities, regulatory
approval of our products, the potential for future growth in our
business, and our ability to achieve our key strategic, operational
and financial goal. Forward-looking statements by their nature
address matters that are, to different degrees, uncertain. Each
forward- looking statement contained in this letter is subject to
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statement.
Applicable risks and uncertainties include, among others, the
timing of regulatory approvals of our products; physician
acceptance, endorsement, and use of our products; failure to
achieve the anticipated benefits from approval of our products; the
effect of regulatory actions; product liability claims; risks
associated with international operations and expansion; and other
business effects, including the effects of industry, economic or
political conditions outside of the company’s control. Investors
should not place considerable reliance on the forward-looking
statements contained in this letter. Investors are encouraged to
read our publicly available filings for a discussion of these and
other risks and uncertainties. The forward-looking statements in
this letter speak only as of the date of this release, and we
undertake no obligation to update or revise any of these
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20191124005098/en/
AVITA Medical U.S. Media Sam Brown, Inc.
Christy Curran Phone: +1 615 414 8668
christycurran@sambrown.com
O.U.S. Media Monsoon Communications Rudi Michelson
Phone: +61 (0)3 9620 3333 Mobile: +61 (0)411 402 737
rudim@monsoon.com.au
Investors: Westwicke Partners Caroline Corner
Phone: +1 415 202 5678 caroline.corner@westwicke.com
University of Colorado Anschutz Medical Campus Jill
Cowperthwaite jill.cowperthwaite@cuanschutz.edu
David Kelly david.kelly@ucdenver.edu
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