BioMimetic Therapeutics Receives First Orthopedic Marketing Approval for Augment™ Bone Graft
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) announced today that it has
received approval from Health Canada to begin the marketing of its lead
orthopedic product, Augment™ Bone Graft, as an alternative to the use of
autograft in midfoot, hindfoot and ankle fusion indications in Canada.
"After rigorous pre-clinical and clinical evaluation of the product,
BioMimetic is now ready to introduce this novel, implantable biologic to
the marketplace,” commented Dr. Samuel E. Lynch, president and chief
executive officer of BioMimetic. "In the Canadian clinical study, we
observed 90% clinical success without the morbidity and extra operating
room time required to harvest autograft. We are proud to offer this safe
and effective product to Canadian surgeons, who will now be able to
offer their patients an alternative to the previous method of cutting
bone out of one site of their body and transplanting it to another site.”
Augment is a completely synthetic grafting system for bone regeneration
and is composed of a purified recombinant growth factor, recombinant
human platelet derived growth factor (rhPDGF-BB), and a synthetic
calcium phosphate matrix, beta-tricalcium phosphate (ß-TCP). The
combination of the two components of
Augment is key to the
overall effectiveness of the product. The rhPDGF-BB provides the
biological stimulus for tissue repair by stimulating the recruitment and
proliferation of new bone forming cells and blood vessels, while the
ß-TCP provides the framework or scaffold for new bone growth to occur.
Augment is the Company’s second product to receive marketing approval in
Canada. GEM 21S®, a grafting material for bone and periodontal
regeneration, was approved for use by the U.S. Food and Drug
Administration (FDA) and Health Canada in 2005 and 2006, respectively.
Augment and GEM 21S are both based on the Company’s platform
regenerative technology.
Joint Solutions Alliance Corporation (JSAC), a sales and distribution
company for orthopedic products headquartered in Burlington, Ontario,
Canada is the exclusive distributor of BioMimetic’s Augment Bone Graft
product in Canada. BioMimetic will also deploy product specialists in
the Canadian market to work collaboratively with the Joint Solutions
Team. The Company expects the product will be available to customers in
Canada within 30 days.
Augment Bone Graft Clinical Trial Results
Health Canada approval of Augment was based on results from a three
center, 60 patient open label trial in which all individuals were
treated with Augment. Patients were studied for nine months following
implantation of the product and were assessed for healing using clinical
and radiographic endpoints. Patients requiring fusions involving the
midfoot, hindfoot and ankle were all eligible for enrollment in the
study.
The results of the study demonstrated that 90% of the patients, which
included a large percentage of high risk individuals, achieved a
successful outcome based upon return to full weight-bearing and lack of
need for revision surgery. The radiographic fusion rate was 87% at nine
months after surgery. Based on a literature meta-analysis, the high
level of success achieved in the study is consistent with results
expected using autograft, the current gold standard for bone grafting
materials, but without the morbidity and extra operating room time
required to harvest autograft. The data from GEM 21S showing
periodontal bone regeneration was also included as supplementary
information demonstrating that the product does re-grow bone.
Clinicians are referred to the Augment package insert for additional
information on the use of this product.
About BioMimetic Therapeutics
BioMimetic Therapeutics is a biotech company utilizing recombinant human
platelet-derived growth factor (rhPDGF-BB) as its primary technology
platform. This molecule is a synthetic copy of one of the body's
principal agents to stimulate and direct healing and regeneration. The
mechanism of action of this platform technology suggests it may be
effective in a broad array of musculoskeletal applications, including
the repair of bone, ligament, tendon and cartilage. Through the
commercialization of this technology, BioMimetic seeks to become the
leading company in the field of orthopedic regenerative medicine.
BioMimetic received marketing approval from the FDA for its first
product, GEM 21S®, as a grafting material for bone and
periodontal regeneration following completion of human clinical trials,
which demonstrated the safety and efficacy of the rhPDGF-BB platform
technology. Additionally, the Company has completed and ongoing clinical
trials with its product candidates Augment and Augment Injectable
in
multiple orthopedic bone healing indications including the treatment of
foot and ankle fusions and the stimulation of healing of fractures of
the wrist.
GEM 21S is a trademark of Luitpold Pharmaceuticals, Inc., who now
owns those products and markets GEM 21S through its Osteohealth
Company in the United States and Canada.
For further information, visit www.biomimetics.com
or contact Kearstin Patterson, corporate communications, at 615-236-4419.
Forward-looking Statements
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are based on the current intent and
expectations of the management of BioMimetic Therapeutics. These
statements are not guarantees of future performance and involve risks
and uncertainties that are difficult to predict. 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 associated with our unproven preclinical and clinical
development activities, regulatory oversight, intellectual property
claims, litigation and other risks detailed in the company's filings
with the Securities and Exchange Commission, including the section
entitled "Risk Factors" in its registration statement on Form S-1.
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, or for changes made to this document by wire services or
Internet services.
For further information, visit www.biomimetics.com
or contact Kearstin Patterson, manager corporate communications, at
615-236-4419.
