Wright Announces Receipt of FDA Approvable
Letter
for
Augment
®
Bone
Graft
October 27, 2014
Filed by Wright Medical Group, Inc.
pursuant to Rule to Rule 425
Under the Securities Act of 1933
Deemed filed pursuant to Rule 14a-12
Under the Securities Exchange Act of 1934
Subject Company: Wright Medical Group, Inc.
Commission File No. 001-35823 |
Forward-Looking Statements
2
This press release contains forward-looking statements, as defined under U.S. federal
securities laws, Bone Graft, and the
positive effects such final approval is anticipated to have for patients, surgeons and our
business, our plans to address the FDA inspection requirements set forth in the approvable letter, our
revised 2014 guidance, and the potential for future growth in our business. These statements reflect
management's current knowledge, assumptions, beliefs, estimates, and expectations and express
management's current view of future performance, results, and trends.
Forward-looking statements may be identified by their use of terms such as anticipate,
believe, could, estimate, expect, intend, may, plan, predict, project, will, and other similar
terms. Forward-looking statements are subject to a number of risks and uncertainties
that could cause actual results to materially differ from those described in the forward-
looking statements. The reader should not place undue reliance on forward-looking
statements. Such statements are made as of the date of this press release, and we
undertake no obligation to update such statements after this date. Risks and uncertainties that
could cause our actual results to materially differ from those described in forward-looking
statements in this press release include the risk that we are
concerning,
among
other
things,
the
approvable
status
and
anticipated
final
PMA
approval
of
Augment
®
product quality or patient safety issues have an adverse impact on our product development plans, the
risk that we are unable to achieve our operations targets for the balance of fiscal 2014; and
the additional risks and uncertainties are discussed in our filings with the Securities and
Exchange Commission (including those described in Item 1A of our Annual Report on Form 10-K
for the year ended December 31, 2013, and as may be supplemented in our Quarterly Reports on
Form 10-Q). unable
to
complete
the
requirements
for
FDA
approval
of
Augment
®
Bone
Graft,
the
risk
that,
when
approved,
market
acceptance
of
Augment
®
Bone
Graft
is
less
than
anticipated,
the
risk
that |
Leverages direct
sales force, training capabilities
Further accelerate
growth
Bone repair, soft tissue
indications
Roughly a $300M U.S. Market Opportunity
Final approval subject to customary preapproval inspections
Assuming
satisfactory
completion
of
this
activity
and
receipt
of
a
final
approval
order
from
the
FDA,
commercial
sale
and
distribution
of
Augment
®
Bone
Graft
can
begin
in
the
U.S.
First clinically proven cost-effective alternative to
autograft for ankle and/or hindfoot fusion
3
Breakthrough biologic
Unique solution for
ankle and/or hindfoot fusion
Platform for future
growth opportunities |
Augment
®
Bone Graft
A Breakthrough Product!
In the North American pivotal trial, Augment
demonstrated equivalent safety & efficacy and less
pain compared to autograft.
Recombinant human platelet-derived growth factor
(rhPDGF) intended to provide biological stimulus for in-
growth and proliferation of osteoblasts (cells
responsible for bone formation)
Beta-tricalcium phosphate (
TCP) provides a
framework or scaffold for new bone growth to occur
Avoids unwanted bone formation in surrounding tissues
observed with BMP-based products
First
clinically proven, cost-effective alternative to autograft for
ankle and/or hindfoot fusion indications
4 |
Augment
adds high margin, breakthrough product to Wrights comprehensive suite
of biologic technologies WRIGHT
WRIGHT
Biologic
Biologic
Solutions
Solutions
Calcium Sulfate®
Technology
PRO-DENSE®
Technology
PRO-STIM®
Technology
DBM/CBM Technology
FUSIONFLEX®
Technology
GRAFTJACKET®
Matrix
Wedge Technology
IGNITE®
Technology
5 |
Augment
®
Accelerates Wrights Growth Opportunities
Demonstrated
results
Eliminates harvest
site complications
Patients avoid any
donor site pain
6
Hindfoot
Fusions
Ankle
Fusions |
Augment
®
Bone
Graft
rhBMP
Stem Cells
Demineralized
Bone Matrix
(DBM)
FDA approvable for
ankle and/or hindfoot
fusion indications
YES
Level I evidence
YES
Demonstrated safety
YES
?
Reliable/consistent
quality
YES
?
?
Available off-the-shelf
YES
Cost effective
(relative to autograft)
YES
7
Compelling Value Proposition |
In
ankle and/or hindfoot fusion procedures, delayed union / nonunion still a
major concern
Current literature suggests
nonunion rates for ankle/hindfoot
fusions are ~15-20%
(1)
Much higher rates (16-41%) in high
risk groups
(2)
:
smokers
diabetics
revision surgery
post-traumatics
Both a mechanical and biological
problem
8
1. Easley et al, JBJS 2000; Thordarson et al, Foot Ankle Int 2003; Haddad et al,
JBJS 2007 2. Frey et al, Foot Ankle Int 1994; Perlman and Thordarson, Foot Ankle
Int 1999; Myers et al, Foot Ankle Intl 2012 |
Autograft has been used to enhance fusion rates
Stimulates the biological
healing process
Fills any joint irregularities
(voids/gaps)
Acts as a scaffold for
new
bone formation
9
Iliac Crest Autograft Harvest |
But
autograft comes with a price
Harvest site
pain
~12% of patients who received autograft in Augment pivotal
trial had clinically significant harvest site pain at 24 weeks
~9% had clinically significant harvest site pain at 52 weeks
Increases
Complication
Potential
(1-4)
Up to 49% complication rate for iliac crest bone graft
Potential for more serious complications and infections
Higher
Procedure
Costs
Direct costs to harvest autograft include additional
surgeon/anesthesia/clinician time and instruments
Indirect cost of complications can further increase cost
Variable Quality
Variable quality across donor sites
Especially
problematic
for
compromised
patients
diabetics,
smokers, osteoporotics, elderly, etc.; these represent a
significant portion of foot & ankle patient population
10
1. Arrington ED, et al, Clin Orthop. 1996
3. Springfield DS, Orthopaedics 1992
2. Kurz LT, et al, Spine 1989
4. Fowler BL, et al, Am J Orthop. 1995 |
Augment
®
Bone Graft: A Proven Therapeutic Option
11
Effective
When used as bone graft substitute in
ankle and/or hindfoot fusion procedures,
Augment
®
Bone Graft was shown to
achieve comparable:
Clinical and functional improvements
in outcomes
Safe
Augment
®
Bone Graft offers:
Comparable safety profile to
autograft
Comparable clinical healing to
autograft
Augment offers a synthetic alternative to autograft that:
-
Eliminates
complications
and
morbidity
associated
with
autograft
harvest
-
Patients avoid any donor site pain associated with autograft harvest
|
IN
SUMMARY A Breakthrough Biologic that Accelerates Wrights Growth
Opportunities
12
Unique solution for
ankle and/or hindfoot
fusion
Breakthrough
biologic
Platform for future
growth opportunities |
For
additional information, please contact: Julie Tracy
Chief Communications Officer
julie.tracy@wmt.com
(901) 290-5817
www.wmt.com
NASDAQ: WMGI
13 |
Wright Announces Receipt of FDA Approvable
Letter for Augment
®
Bone Graft
October 27, 2014 |