Peer-reviewed Publication on the use of Grafix® in High-Risk Peripheral Arterial Disease Patients with Treatment Refractory ...
November 22 2016 - 5:00PM
Osiris Therapeutics, Inc. (NASDAQ:OSIR) announced today that a new
peer-reviewed manuscript by physician and surgeon Jonathan Smedley,
DPM, FACFAS, entitled “Wound Closure in Smoking Peripheral Arterial
Disease Patients with Treatment Refractory Ulcerations: A 12-month
Follow-up Case Series,” has been published in the International
Journal of Lower Extremity Wounds and is available on-line.
A 1-year, single-center effectiveness review was conducted on
the clinical outcomes in actively smoking peripheral arterial
disease (PAD) patients treated with Grafix® for use in the
treatment of refractory lower extremity ulcerations. Wound types
included chronic ischemic and neuroischemic ulcerations and wounds
of mixed venous and arterial etiology. Wounds were characterized by
an average size of 4.6 cm2 and a previous duration of 53 weeks with
a failure to respond to standard of care and other advanced
treatment measures. Eighty percent of the patients were
diabetic. Daily cigarette consumption for the patients ranged
from ½ pack to > 1 pack per day, and the mean ankle brachial
index for the group was 0.7. More than half of the patients
were not candidates for revascularization procedures.
Study Outcomes:
- All wounds reached complete closure and remained closed at the
12-month follow up
- The mean time to closure was 7.8 weeks with a mean graft use of
7.0 grafts
- The mean 4-week percentage of wound area reduction was
69.4%
- There were no adverse events attributed to the use of
Grafix
“Patients often times present with a variety of comorbid
conditions that pose challenges to wound care providers. Some
refractory wounds persist despite long term multidisciplinary
efforts to promote timely closure. Options such as Grafix allow us
to pursue management of these lower extremity ulcerations to the
point of resolution. This is extremely valuable, especially in the
high-risk diabetic population,” said Dr. Smedley.
About Grafix
Grafix is a cryopreserved placental membrane comprised of an
extracellular matrix (ECM) rich in collagen, growth factors, and
viable cells native to the tissue. Grafix is processed using
Osiris' proprietary technology; it is flexible and conforming and
designed for application directly to hard-to-treat acute and
chronic wounds, including but not limited to diabetic foot ulcers,
venous leg ulcers and thermal burns.
About Osiris Therapeutics
Osiris Therapeutics, Inc., based in Columbia, Maryland, is a
world leader in researching, developing, and marketing regenerative
medicine products that improve health and lives of patients and
lower overall healthcare costs. Having developed the world’s first
approved stem cell drug, the company continues to advance its
research and development in biotechnology by focusing on innovation
in regenerative medicine – including bioengineering, stem cell
research and viable tissue based products. Osiris has
achieved commercial success with products in orthopaedics, sports
medicine and wound care, including BIO4 ™, Cartiform®,
Grafix®, TruSkin ™ and Stravix™. Osiris, Grafix,
Cartiform, TruSkin and Stravix are registered trademarks of Osiris
Therapeutics, Inc. BIO4 is a trademark of Howmedica Osteonics
Corp.. More information can be found on the company's website,
www.Osiris.com. (OSIR-G)
Forward-Looking Statements
This press release may contain forward-looking statements. These
forward-looking statements may generally be identified by the use
of the words "may," "will," "expects," "anticipates," "believes,"
"estimates," and similar expressions, and involve a number of risks
and uncertainties. For a variety of reasons, actual results may
differ materially from those described in or contemplated by any
such forward-looking statement. Examples of forward-looking
statements may include, without limitation, statements regarding
the anticipated efficiencies and advantages of products or
services. Consequently, the reader is cautioned to consider all
forward-looking statements in light of the risks to which they are
subject.
For additional information, please contact:
Diane Savoie
Osiris Therapeutics, Inc.
(443) 545-1834
OsirisPR@Osiris.com
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