Numerous presentations were made today during the Regenerative
Strategies Forum at the 2012 American Orthopaedic Foot and Ankle Society
(AOFAS) annual meeting in San Diego, CA which supported the safety,
effectiveness, clinical need, biologic rationale and cost effectiveness
of Augment™ Bone Graft from BioMimetic Therapeutics, Inc. (NASDAQ: BMTI).
Regenerative Strategies and Emerging
Technologies Pre-meeting Presentations
The forum included lectures by numerous leading foot and ankle surgeons
covering regenerative strategies related to foot and ankle surgery. The
following presentations highlighted the clinical and pharmaco-economic
need and biologic rationale for Augment Bone Graft as an alternative to
autograft.
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Augment Bone Graft: Worldwide Clinical Evidence was presented
by Timothy Daniels, MD and focused on the compelling evidence,
generated from multiple clinical studies involving over 600 patients,
supporting the safety and effectiveness of Augment Bone Graft in
promoting bone healing. Dr. Daniels reviewed Augment Bone Graft’s
clinical trials conducted throughout the United States, Canada and
Europe and recognized the product as the first orthobiologic with
compelling level 1-5 evidence in foot and ankle fusions, concluding
that in his opinion it had been demonstrated to be a safe and
effective alternative to autograft
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Pain after Bone Graft Harvest: Are All Sites the Same? was
presented by Judy Baumhauer, MD, president of the AOFAS. Dr. Baumhauer
reviewed results of patient reported outcomes of acute and chronic
pain from bone grafts harvested from different anatomical sites in the
body to determine if harvest site location influenced levels of pain
experienced by patients. The results presented demonstrated that
harvesting autogenous bone graft causes clinically significant acute
pain in 35 percent of patients and clinically significant chronic pain
in up to 20 percent of patients, regardless of the anatomic harvest
site. Because Augment Bone Graft does not require harvesting
autogenous bone graft, the patient is spared the pain associated with
this procedure. Christopher DiGiovanni, MD will also elaborate on the
findings in this study and their implications for foot and ankle
surgeons later in the conference.
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Establishing the Relationship between Clinical Outcome and Extent
of Osseous Bridging by CAT Scan Assessment in Isolated Hindfoot and
Ankle Fusions was presented by Mark Glazebrook, MD and
analyzed data from the Augment Bone Graft pivotal trial correlating
clinical outcomes assessed by the patient and surgeon with the
radiologic outcomes (osseous bridging on CT scans) assessed by a
blinded musculoskeletal radiologist. The data presented demonstrated a
strong correlation between the degree of osseous bridging on CT scans
and improvement in clinical outcome scores. This analysis also
substantiated the use of CT scans to assess the primary endpoint of
bone fusion in BioMimetic’s pivotal clinical trial.
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Concept of Relative Deficiency of Growth Factors in Hindfoot
Fusions was presented by Sheldon Lin, MD and reported clinical
results demonstrating that diabetic patients with poor bone healing
have deficiencies in growth factors, specifically platelet-derived
growth factor (PDGF) and vascular endothelial growth factor (VEGF).
These patients are therefore more prone to complications, including
non-unions, in hindfoot fusion surgery. The study suggests a
correlation between lower levels of PDGF and poorer bone healing. This
finding supports the biologic rationale for use of Augment to increase
local PDGF levels in patients, such as diabetics, who may be at
increased risk for delayed healing or non-union.
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Does Bone Graft Work in Foot and Ankle Surgery? was presented
by Christopher DiGiovanni, MD. Dr. DiGiovanni reviewed results from a
meta analysis of published, peer-reviewed literature assessing the
effectiveness, and necessity, of bone grafting in foot and ankle
fusions. The odds of successful union for patients treated with
autograft were one-and-a-half- to three-times higher than for patients
treated without graft. This observation supports the use of autograft
as the positive control in Augment Bone Graft’s pivotal trial, which
demonstrated that the two products have equivalent efficacy. Further
analyses of the data are ongoing.
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Analysis of Cost for Autologous Bone Graft for Foot and
Ankle Surgery was presented by Nicholas Abidi, MD and reported
research findings from a study analyzing hospital budgetary impact
costs for autogenous bone graft harvest and bone graft substitutes.
Preliminary findings from the study demonstrated that actual
incremental costs and budgetary impact associated with operating room
time, graft harvesting supplies and complications are likely
under-realized by hospitals. Dr. Abidi also presented a cost
calculator by which hospitals may assess the true cost of autogenous
bone graft in their institution relative to other orthobiologic
alternatives.
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Bone Marrow Concentrate/Stem Cell for Fusion was presented by
Michael Pinzur, MD and reported a new paradigm for bone healing
stressing the importance of regulatory molecules such as rhPDGF-BB in
combination with stem cells from bone marrow aspirate and tissue
scaffolds. Dr. Pinzur noted that rhPDGF-BB and VEGF increase growth
and recruitment of stem cells and new blood vessel formation leading
to improved healing of bone defects and surrounding soft tissue
injuries.
AOFAS Annual Meeting Presentations and Poster
In addition to the above presentations given today at the regenerative
forum, the following presentations related to the clinical need for
Augment or Augment™ Injectable Bone Graft will be presented later during
the AOFAS annual meeting.
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Outcomes of Hindfoot Surgery Augmented with Injectable Bone Graft:
Results of a Multi-centered Randomized Control Trial will be
presented by Timothy Daniels, MD, the lead advisory investigator for
this clinical trial. Dr. Daniels will review study results from the
Company’s Canadian Augment™ Injectable Bone Graft trial. The Company
plans to release the results provided during this presentation in a
press release after market close on Thursday, June 21, 2012. Slides
from the presentation will be filed as an 8K following the AOFAS
meeting.
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Clinical Decision Making on the Need for Autologous Bone Graft:
Results of a Nationwide Survey among Orthopaedic Foot and Ankle
Surgeons will be presented by Judy Baumhauer, MD. This study
reviews results from a survey which determined that both clinical and
radiologic factors important to foot and ankle surgeons play a
critical role in the decision to use bone graft or orthobiologics,
such as Augment Bone Graft.
Exhibit Booth
In addition to these surgeon presentations at the AOFAS annual meeting,
BioMimetic will host a commercial exhibit booth #401 in the Sapphire
Ballroom at the Hilton Bayfront Hotel from June 21 – 23.
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
an 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 ligaments.
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 AugmatrixTM Biocomposite Bone Graft.
For further information contact Kearstin Patterson, senior director of
corporate communications, at 615-236-4419.
Forward-looking Statements
This press release contains forward-looking statements about our future
results of operations and financial position, product development
programs, business strategy, budgets, projected costs, 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 factors related to: (i) the FDA
may not be satisfied with the Company’s amendment to its PMA and may
determine such PMA is not approvable or require additional clinical
trials; (ii) despite the Company’s future marketing and
commercialization efforts, Augment and Augmatrix may not achieve broad
market acceptance; and (iii) the EU regulatory authorities may determine
that the CE Mark for GEM 21S was improperly granted and may not approve
the CE Mark for Augment as a medical device. 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,
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.
