| March
20 , 2006
BioMimetic Therapeutics Initiates
Clinical Trials with Novel Bio-active
Drug-device Combination Bone Graft
in Two Orthopedic Indications
GEM OS1™ Clinical Trials Initiated
in the United States, Canada and Sweden
Franklin, Tenn. – March 20,
2006 - BioMimetic Therapeutics, Inc.
announced today it has initiated three
clinical trials to evaluate GEM OS1™
Bone Graft for use in foot and ankle
fusion procedures and the treatment
of unstable distal radius fractures.
GEM OS1 is a unique bio-active drug-device
combination product that combines
a tissue growth factor, recombinant
human Platelet-Derived Growth Factor
(rhPDGF), one of the principal wound
healing stimulators in the body, with
a synthetic bone matrix, Beta-tricalcium
phosphate (_-TCP). BioMimetic is leveraging
the same combination drug-device technology
for orthopedic applications as it
utilized in its FDA approved product,
GEM 21S® Growth-factor Enhanced
Matrix for the treatment of periodontally
related defects and gingival recession.
"It is exciting to be a part
of the development of GEM OS1, a product
candidate that I believe has the potential
to improve patient outcomes in foot
and ankle fusion procedures, as well
as in other orthopedic indications,"
said lead U.S. investigator, Dr. Christopher
W. DiGiovanni, chief of foot and ankle
in the department of orthopaedic surgery
at Rhode Island Hospital and associate
professor at Brown Medical School
in Providence, RI. "As a foot
and ankle surgeon, I see a significant
number of lower extremity fusion procedures
that either do not heal or heal slowly,
often leading to prolonged recovery
times, increased patient morbidity,
and greater cost to the patient and
health care system. Based on pre-clinical
studies demonstrating the ability
of GEM OS1 to stimulate a broad range
of cellular events critical for the
initiation and progression of new
bone formation, this product candidate
appears well suited for bone regeneration
procedures."
GEM OS1
BioMimetic is developing GEM OS1 for
use in open surgical treatment of
fractures and bone fusions where the
use of bone graft, a material used
to augment bone healing, is indicated.
GEM OS1 is designed to be placed directly
into an open surgical site to stimulate
bone regeneration. The combination
of the two GEM OS1 components, rhPDGF
and -TCP, is key to the product’s
overall effectiveness. rhPDGF is intended
to provide the biological stimulus
for tissue regeneration by stimulating
the in-growth and proliferation of
osteoblasts, cells responsible for
the formation of bone, while -TCP
provides a framework or scaffold for
new bone growth to occur.
“We are pleased to be conducting
clinical studies with GEM OS1 in the
United States, Canada and Sweden,”
commented Dr. Samuel Lynch, CEO and
president of BioMimetic Therapeutics.
“Our ability to rapidly initiate
clinical studies in three countries
highlights the dedication and expertise
of our staff to advance products from
research into clinical development.”
About the Studies
A three center U.S. feasibility study
is being conducted at Rhode Island
Hospital in conjunction with Brown
Medical School, The University of
Rochester Medical Center and the University
of Medicine and Dentistry of New Jersey
(UMDNJ). The study’s objective
is to determine the preliminary safety
and effectiveness of GEM OS1 as a
bone regeneration device in foot and
ankle fusion procedures requiring
open surgery. The Company expects
that preliminary study results, which
will include up to 20 volunteer patients,
will be available in late 2006.
In addition to the U.S. study, the
Company also has initiated a three
center pilot clinical study in Canada
to evaluate GEM OS1 in foot and ankle
fusion procedures and a single center
clinical study in Sweden to evaluate
GEM OS1 in distal radius fractures.
Distal radius fractures, or fractures
of the wrist, are one of the world’s
most common fractures, especially
in elderly individuals with osteoporosis.
The Company anticipates completing
enrollment for both the Canadian and
Swedish studies by mid 2006.
Foot and Ankle Procedures
There are more than one million procedures
performed annually in the United States
involving fusions and corrective surgeries
of the foot and ankle. The indications
included as part of the GEM OS1 clinical
study program represent approximately
70,000 of this annual number. Foot
and ankle fusion procedures are performed
primarily in patients with severe
osteoarthritis, who do not respond
to more conservative treatments. In
a fusion procedure, the joint space
between adjacent bones is surgically
prepared and rigidly fixed with hardware
to stimulate a fusion, or permanent
connection of the two bone ends. This
fusion eliminates the pain associated
with the movement of the joint. Typically,
foot and ankle fusions are augmented
with bone graft harvested from the
patient, which is obtained as the
result of a second surgical procedure.
Harvesting bone graft material has
significant drawbacks, which include
the associated pain and potential
complications of this second surgery
and inconsistent volume and quality
of the harvested bone material. GEM
OS1 is a fully synthetic bone graft
substitute that eliminates the need
for this second surgery. The _-TCP
component of GEM OS1 fills the gap
between the bone surfaces and acts
as a scaffold for the formation of
new bone, while the rhPDGF, as shown
in pre-clinical studies, is designed
to stimulate the healing response
by attracting new bone cells and enhancing
the formation of blood vessels to
facilitate the tissue regeneration
process.
About BioMimetic Therapeutics
BioMimetic Therapeutics, Inc. develops
and commercializes bio-active drug-device
combination products for the healing
of musculoskeletal injuries and diseases,
including periodontal, orthopedic,
spine and sports injury applications.
BioMimetic received marketing approval
from the FDA in November 2005 for
its first product GEM 21S as a grafting
material for bone and periodontal
regeneration. A pivotal human clinical
trial demonstrated the safety and
efficacy of its platform technology
in this indication, resulting in significantly
faster healing and improved bone healing
on clinical X-rays. The Company’s
product and product candidates all
combine recombinant protein therapeutics
with tissue specific scaffolds to
actively stimulate tissue healing
and regeneration. The Company believes
its regenerative therapies will improve
the treatment options and quality
of life for millions of patients with
injuries or deterioration of bones,
cartilage, tendons or ligaments.
For further information, visit www.biomimetics.com
or contact Kearstin Patterson, manager
corporate communications, at 615-236-4419.
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