AMNIOX Study Confirms Benefits of CLARIX FLO for Plantar Fasciitis

Study Demonstrates Decreased Pain and Improved Functional Recovery

ATLANTA–(BUSINESS WIRE)–AMNIOX Medical, Inc., a TissueTech, Inc. company, announced today the
results of a study demonstrating the application of its unique
cryopreserved human umbilical cord tissue for the treatment of patients
with plantar fasciitis. The findings were recently presented at the
American College of Foot and Ankle Surgeons in Las Vegas.

In this study, forty-three patients received injections of CLARIX FLO
human amniotic membrane and umbilical cord matrix, and were followed for
18 weeks. The authors concluded that injections of CLARIX FLO
significantly decreased pain from baseline and improved overall
functional recovery. Increasing dose resulted in better therapy outcomes.

The study, Particulate Umbilical Cord/Amniotic Membrane for the
Treatment of Plantar Fasciitis, was authored by Dr. Ryan Scott of The
CORE Institute in Phoenix, and Dr. David Garras of Midwest Orthopaedic
Consultants and an Assistant Professor at University of Illinois at
Chicago. Plantar fasciitis is the most common cause of debilitating heal
pain. It affects up to 1 million patients annually in the United States
and as many as 30 percent of those patients fail conservative therapy.
The condition is characterized by an accumulation of small tears in the
plantar fascia, causing the structure to weaken and become irritated,
often to the point of interfering in daily activities. Previously
available therapies have demonstrated inconsistent outcomes or have
negative side effects.

“These study results continue to demonstrate the compelling therapeutic
benefits of a human tissue matrix composed of both umbilical cord and
amniotic membrane,” said Tom Dugan, Chief Executive Officer of Amniox
Medical. “Furthermore, Amniox Medical is the only provider of an
injectable form of umbilical cord, allowing for the non-invasive
delivery of the biological components of umbilical cord, which have
proven regenerative properties.”

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

About TissueTech, Inc.

TissueTech, Inc., the parent company of Amniox Medical, Inc. and
Bio-Tissue®, 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; Bio-Tissue develops and markets products for the
ophthalmology and optometry markets. The National Institutes of Health
(NIH) have supported TissueTech’s research with more than 30 continuous
years of research grants. Since the company’s inception, clinicians have
performed more than 250,000 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.


For AMNIOX Medical, Inc.
Chris Gale
(646) 695-2883