AMNIOX Highlights Studies Finding CLARIX® FLO and CLARIX® CORD 1K Improving Foot and Ankle Outcomes
July 25 2016 - 10:00AM
Business Wire
Umbilical Cord Allograft Improves Outcomes in
Plantar Fasciitis Treatment and Tarsal Coalition Repair
AMNIOX Medical, Inc., a TissueTech, Inc. company, highlighted
the results of two studies presented at the American Orthopaedic
Foot & Ankle Society (AOFAS) Annual Meeting. Dr. David Garras
of Midwest Orthopaedic Consultants, an assistant professor at the
University of Illinois at Chicago, and Dr. Ryan Scott, of the CORE
Institute in Phoenix, presented Plantar Fasciitis Treatment with
Particulate Human Amniotic Membrane. Dr. Donald Covell, Dr. Bruce
Cohen, Dr. Kent Ellington, Dr. Carroll Jones, Dr. Hodges Davis and
Dr. Robert Anderson, all from OrthoCarolina Foot and Ankle
Institute in Charlotte, North Carolina, presented The Use of
Cryo-Preserved Umbilical Cord Plus Amniotic Membrane Tissue in the
Resection of Tarsal Coalition.
Dr. Garras’ findings concerned 60 patients treated with
ultrasound-guided injections of CLARIX® FLO particulate umbilical
cord and amniotic membrane. An interim review of patients who had
completed the full 18-week follow-up period demonstrated that all
treatments showed statistically significant reduction of foot pain
as well as an increase in Foot Ankle Ability Movement for both
daily living and sports subscales. Dr. Garras concluded CLARIX FLO
significantly decreased pain from baseline and improved overall
functional recovery.
Plantar fasciitis is the most common cause of heel pain
affecting 1 million patients annually. Conservative therapies are
ineffective in 10 to 15 percent of patients. Other available
treatments including corticosteroids and surgery can carry risks
such as plantar fascia rupture, biomechanical instability and
post-operative pain.
“The early results of this study are very promising with the
significant improvement in pain and function being demonstrated by
these patients,” said Dr. Garras. “For the large number of patients
that fail conservative therapies, this is a minimally invasive
treatment option with no apparent short or long-term side
effects.”
Dr. Covell presented a retrospective review of 14 patients who
received the CLARIX CORD 1K matrix as an interpositional graft
during tarsal coalition surgery. His findings included a median
89.5% improvement in pain with improved range of motion and no
infection or wound complications. Dr. Covell concluded CLARIX CORD
1K is a viable option for treatment of tarsal coalition.
A tarsal coalition is an abnormal connection of two or more
bones in the foot. The bones affected are located toward the back
of the foot and in the heel, and the connection of the bones can
result in a severe, rigid flatfoot. Although tarsal coalition is
often present at birth, signs of the disorder typically surface
during early adolescence when the foot may become stiff and
painful, and everyday physical activities are often difficult.
“Since incorporating the umbilical cord allograft as an adjunct
to many of our foot and ankle procedures we have observed
dramatically improved outcomes in a number of indications,” stated
Dr. Bruce Cohen. “This is just the first of several clinical
studies that will show the significant clinical benefits that
patients experience due to this unique technology.”
“Clinical evidence regarding umbilical cord tissue in
regenerative healing is continuing to accumulate,” said Tom Dugan,
Chief Executive Officer of Amniox Medical. “CLARIX CORD 1K and
CLARIX FLO are important options for physicians and the practical
applications are clear in this data.”
CLARIX FLO is the particulate form of CLARIX 100 and CORD 1K™
Regenerative Matrix. It is comprised of the Umbilical Cord and
Amniotic Membrane which are rich in collagen, fibronectin,
hyaluronic acid, growth factors and particularly heavy chain
hyaluronic acid (HC-HA). CLARIX FLO is the only available
injectable product to employ the benefits of umbilical cord,
providing higher volumes of the critical matrix proteins innate to
the tissue. CLARIX CORD 1K is the first umbilical cord allograft
commercially available for clinical transplantation.
In utero, wound healing occurs rapidly and with minimal scar.
This restorative ability is innate to placental tissues, including
umbilical cord and amniotic membrane. Heavy chain hyaluronic
acid/pentraxin-3 is the key protein complex present in these
tissues to orchestrate the healing process. Amniox Medical is the
first provider of a human tissue allograft composed of both
umbilical cord and amniotic membrane. Amniox utilizes its
proprietary CryoTek™ process, a cryopreservation technology, to
preserve the biological and structural integrity of the native
tissue and published studies have demonstrated that the CryoTek
process more effectively preserves the structural and biological
integrity of the tissue.
About Amniox Medical, Inc.
Founded in 2011 to serve the orthopedic and wound care markets,
Amniox Medical is dedicated to developing and marketing
regenerative therapies processed from umbilical cord and amniotic
membrane utilizing its proprietary CryoTek technology. This process
has been proven to preserve the innate biological and structural
properties of the matrix, which can then be transplanted to adult
wound and surgical environments. Amniox Medical procures its tissue
through elective donation following healthy live birth via Cesarean
section. Thorough donor screening is performed to ensure safety of
its products. For additional information, please visit
http://www.amnioxmedical.com
About TissueTech, Inc.
TissueTech, Inc., the parent company of Amniox Medical, Inc. and
BioTissue®, Inc., pioneered the development and clinical
application of regenerative, amniotic tissue-based products. Amniox
Medical develops and markets products for use in the
musculoskeletal and wound care markets; BioTissue develops and
markets products for the ophthalmology and optometry markets. The
National Institutes of Health (NIH) have supported TissueTech’s
research with more than 25 continuous years of research grants.
Since the company’s inception, clinicians have performed more than
200,000 human implants of the company’s products and published more
than 300 peer-reviewed studies supporting its technology platform.
The Company’s first product, AmnioGraft®, is the only tissue graft
designated by the FDA as homologous for promoting ophthalmic wound
healing while suppressing scarring and inflammation.
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For AMNIOX Medical, Inc.Chris Gale(646)
695-2883cgale@greentarget.com