BioMimetic Therapeutics, Inc. Initiates Enrollment in Augment™ Chronic Tendinopathy Clinical Trial

  BioMimetic Therapeutics, Inc. Initiates Enrollment in Augment™ Chronic
  Tendinopathy Clinical Trial

              Product Candidate Aimed at Large Tendinosis Market

Business Wire

FRANKLIN, Tenn. -- January 3, 2013

BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced it initiated
enrollment in a Phase II clinical trial to assess the safety and efficacy of
Augment™ Chronic Tendinopathy (ACT) as a treatment for lateral epicondylitis,
commonly known as tennis elbow. The randomized, controlled trial is expected
to enroll up to 100 patients at seven clinical sites in the U.S. and will
evaluate the safety and therapeutic potential of escalating doses of a
one-time injection of pure recombinant human platelet-derived growth factor
(rhPDGF-BB) homodimer solution into the extensor carpi radialis brevis (ECRB),
the tendon in the elbow that is generally the source of pain in tennis elbow.
The product candidate is aimed at the large tendinosis market for which there
is significant unmet clinical need with limited effective long-term treatments
currently available.

“We have seen promising pre-clinical data with ACT and believe the initiation
of this Phase II dose finding clinical trial is the logical next step in the
development of our sports medicine program,” said Dr. Samuel Lynch, BioMimetic
president and CEO. “ACT has the potential to help millions of patients
suffering from painful inflammation of the tendon at the outer border of the
elbow resulting from overuse of lower arm muscles or trauma.”

Study Design

The Phase II trial is designed as a randomized, ascending dose,
double-blinded, placebo controlled, multi-center study. The trial is expected
to enroll up to 100 patients ranging from 21 – 80 years of age, who will
receive a single injection into the ECRB. The injection will consist of either
a placebo or one of four different doses of rhPDGF-BB.

The primary efficacy endpoints will be derived from a combination of pain and
disability assessments as measured by the Visual Analog Scale (VAS),
Disabilities of the Arm, Shoulder and Hand (DASH) Score and the Patient Rated
Tennis Elbow Evaluation (PRTEE), along with sincerity of effort measured by
grip strength testing. These clinical outcome measures will be used to detect
changes in pain and function up to 24 weeks from baseline. Adverse event
reporting, including incidence, relationship with treatment and severity will
be recorded throughout the study to evaluate safety of the drug. The product
candidate will be reviewed by the U.S. Food and Drug Administration’s (FDA)
Center for Drug Evaluation and Research (CDER), which regulates
over-the-counter and prescription drugs, including biological therapeutics and
generic drugs.

The study is currently open for enrollment, and more information can be found
at The Company anticipates completing enrollment
around year end 2013.

Lateral Epicondylitis

Augment Chronic Tendinopathy (ACT) is being developed to treat chronic tendon
injuries, or tendinosis. The target indication for this clinical trial is
lateral epicondylitis, commonly referred to as tennis elbow. Lateral
Epicondylitis is an inflammation of the tendons that join the forearm muscles
on the outside of the elbow. The forearm muscles and tendons become damaged
from overuse, or in some cases trauma, leading to pain and tenderness on the
outside of the elbow. It is estimated that lateral epicondylitis currently
affects one to three percent of the total U.S. population (or approximately
three to nine million people), and there is no decisive effective standard of
care. Various conservative treatment options are available and include topical
and oral non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroid
injections, and autologous blood injection (PRP). These conservative treatment
options may be effective in short term pain relief and return to function, but
studies have shown that a significant portion of patients treated with
conservative therapies continue to have recurrent symptoms. Additionally, none
of the currently available therapies address the fundamental need to enhance
healing at the tendon-to-bone interface and improve long-term outcomes. Thus,
lateral epicondylitis is an indication that not only represents a large market
opportunity, but it is also one with a significant unmet clinical need. The
Company believes there is an opportunity for rhPDGF-BB to fulfill this unmet
clinical need and is currently testing this hypothesis in the clinic.

About BioMimetic Therapeutics

BioMimetic Therapeutics (NASDAQ: BMTI) is a biotechnology company specializing
in the development and commercialization of clinically proven products to
promote the healing of musculoskeletal injuries and diseases, including
therapies for orthopedics, sports medicine and spine applications. All
Augment^® branded products are based upon recombinant human platelet-derived
growth factor (rhPDGF-BB), which is a bio-engineered form of PDGF, one of the
body's principal agents to stimulate and direct healing and regeneration.
Through the commercialization of this patented technology, BioMimetic seeks to
become the leading company in the field of regenerative medicine by providing
new treatment options for the repair of bone, cartilage, tendons and

BioMimetic has received regulatory approvals to market Augment^® Bone Graft in
Canada, Australia and New Zealand for use in hindfoot and ankle fusion
indications. Augment is pending regulatory decisions in the U.S. and European
Union for similar indications. The Company also markets a bone graft
substitute line of products for orthopedic indications called Augmatrix^TM
Biocomposite Bone Graft.

On November 19, 2012, BioMimetic and Wright Medical Group, Inc. entered into a
definitive agreement for a business combination of the two companies. The
transaction will combine BioMimetic’s breakthrough biologics platform and
pipeline with Wright’s established sales force and product portfolio to
further accelerate growth opportunities in Wright’s Extremities business. The
merger is subject to a vote by BioMimetic shareholders, and, if approved, is
expected to close in the first quarter of 2013.

For further information contact Kearstin Patterson, senior director of
corporate communications, at 615-236-4419.

Important Additional Information Regarding the Transaction

In connection with the proposed transaction, Wright filed a registration
statement on Form S-4 (the “Form S-4”) with the Securities and Exchange
Commission (“SEC”) on December20, 2012, but such registration statement has
not been declared effective by the SEC. BioMimetic will be mailing a proxy
statement/prospectus for its stockholders and each will be filing other
documents regarding the proposed transaction with the SEC. BEFORE MAKING ANY
and stockholders may obtain copies of the proxy statement and other relevant
documents filed with the SEC by BioMimetic free of charge at the SEC’s web
site at In addition, investors and stockholders may obtain copies
of the proxy statement and other relevant documents filed with the SEC by
BioMimetic (when they are available) by going to BioMimetic’s Investor
Relations page on its corporate website at

BioMimetic, Wright and their respective directors and executive officers and
other persons may be deemed to be participants in the solicitation of proxies
in respect of the proposed transaction. Information regarding BioMimetic’s
executive officers and directors, and their beneficial ownership of
BioMimetic’s common stock as of April12, 2012 is available in BioMimetic’s
proxy statement for its 2012 annual meeting of stockholders, which was filed
with the SEC on April27, 2012. Information regarding Wright’s executive
officers and directors is available in Wright’s proxy statement for its 2012
annual meeting of stockholders and its current reports on Form 8-K, which were
filed with the SEC on March27, 2012,August3, 2012 and November6, 2012,
respectively. Other information regarding the interests of such potential
participants in the proxy solicitation are included in the Form S-4 and will
be contained in the proxy statement and other relevant materials to be filed
with the SEC when they become available.

Forward-looking Statements

This press release contains forward-looking statements about our future
results of operations and financial position, product development programs,
business strategy, plans and objectives of management for future operations
that are not historical facts. The words “may,” “continue,” “estimate,”
“intend,” “plan,” “will,” “believe,” “project,” “expect,” “anticipate,”
“optimistic” and similar expressions may identify forward-looking statements,
but the absence of these words does not necessarily mean that a statement is
not forward-looking. There are many important factors that could cause actual
results to differ materially from those indicated in the forward-looking
statements, including that: (i) the Food and Drug Administration may not
approve Augment Chronic Tendinopathy and (ii) despite the Company’s future
marketing and commercialization efforts, Augment Chronic Tendinopathy may not
achieve broad market acceptance. Further, BioMimetic’s actual results and the
timing and outcome of events may differ materially from those expressed in or
implied by the forward-looking statements because of risks detailed in
BioMimetic’s recent annual and quarterly reports filed with the Securities and
Exchange Commission (SEC), including those factors discussed under the caption
"Risk Factors" in the Company’s Annual Report on Form 10-K filed with the SEC
on March 13, 2012, which are incorporated in this press release by this
reference. Except as required by law, BioMimetic undertakes no responsibility
for updating the information contained in this press release beyond the
published date, whether as a result of new information, future events or
otherwise, and has no policy of doing so.


BioMimetic Therapeutics, Inc.
Kearstin Patterson
Senior Director of Corporate Communications
615-236-4419 (office)
615-517-6112 (mobile)
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