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nanoMAG LLC Wins New NSF Funding For Development of Bioabsorbable Orthopaedic Implants Made of High-Strength Magnesium Alloys

February 1, 2012 By AxoGen, Inc.

LIVONIA, Mich. – nanoMAG LLC, Livonia, Mich.,
the developer of novel lightweight, high-strength magnesium alloy technology,
has been awarded new funding from the National Science Foundation (NSF) for
further research and application development of its unique material. A contract
extension with the NSF will support research work on bioabsorbable biomedical
implants for orthopaedic applications. nanoMAG LLC, a subsidiary of Thixomat
Technologies LLC, made the announcement from their new manufacturing facility
in Livonia, Mich.

“Were encouraged by the continued support weve received from the NSF as we take the
next major step toward commercialization of our new nanoMAG™ technology in
biomedical fields,” said Stephen LeBeau, president of nanoMAG. “We are very
excited to continue working closely with a major orthopaedic supplier developing
nanostructured magnesium alloys of exceptional strength/density and specialty
chemical compositions for tailoring to optimum biodegradation rates, while
maintaining biocompatibility.

Under the
new grant, the upcoming animal testing will be performed in collaboration with
the NSF Engineering Research
Center for
Revolutionizing Metallic Biomaterials (ERC-RMB) as a small business innovation
partner. The ERC-RMB, headquartered at North Carolina A&T State University
(NCAT), Greensboro, N.C.,
will receive $25 million from the NSF and the state of North Carolina over the next five years to
establish a major center for multi-disciplinary research and development for
metallic biomaterial implants. This research is being conducted at four major
universities including NCAT, University
of Pittsburgh, University
of Cincinnati, and the Hannover Medical
School in Germany.

The
nanoMAG strategy is to partner with industry leading biomedical implant makers
to design and develop metallic implants to be bioabsorbable, according to
LeBeau. These implants are developed using proprietary alloys of magnesium and
other compatible elements which provide the appropriate strength and bone
support while healing occurs, after which the implant dissolves and is absorbed
by the body. The manufacturing process is a miniature version of the larger
industrial molding machines that over 50 Thixomat licensees use today to
produce millions of consumer parts per year.

The
quality of patient care available with current orthopaedic medical implants is
limited by the properties of the structural materials used in their design and
construction. According to LeBeau, biomedical device practitioners seek
tailor-made materials that can be produced in closely tracked lots with
consistent quality and exacting properties to match the application. With
state-of-the-art plastic absorbable implants, there is a gap in obtaining
hardness levels sufficient for structural support and for rugged fixation into
the bone. The lower mechanical properties and hardness of todays plastic
implants limit their use to smaller fixations or reconstructive surgeries. In
addition, LeBeau noted that plastics can leave an acidic local environment
which retards bone reconstruction. Current metal implants that use materials
such as titanium or cobalt solve the problems of low strength and hardness, but
are not bioabsorbable. For durable metal implants which must be removed after
the bone heals, or in the case of pediatric patients who outgrow their
implants, a secondary surgical procedure is required which is both costly and
involves additional risks and pain for the patient.

nanoMAG
offers a bio-absorbable magnesium alloy which is strong and can be reabsorbed,
thus offering a source of nutrients for bone regrowth. nanoMAG magnesium alloy
also offers a stiffness level close to that of bone. nanoMAG has created an
alloy containing elements that are naturally found in the body and incorporate
a design that appropriately controls the rate of dissolution. As a result, the implant
can supply the necessary temporary structural reinforcement while avoiding the
complications associated with current permanent metal alloy implants, says
LeBeau. Magnesium is a naturally occurring element in the body and is in fact
prescribed in combination with calcium and phosphorus in numerous supplemental
vitamins to help maintain bone strength.

According
to nanoMAG, magnesium alloy implants are designed to be strong and dissolve
over months as the bone recovers its original strength. The density and
strength of the nanoMAG magnesium material resembles human bone more than other
currently popular implant materials such as plastics or competitive metals.
nanoMAG partners have suggested applications such as screws, staples, tacks,
wire, rods, plates, and 3D shapes for ligament fixations, craniofacial
implants, and small bone implants . “These new magnesium parts could radically
change how orthopaedic implants are made and used,” said LeBeau.

The
overall market for orthopaedic implants is $37 billion worldwide (2010
estimate) with $14 billion for reconstruction devices and $4 billion for trauma
fixation devices. Approximately 60% of the market is U.S. based and growth is estimated
at 12%-13% per year.

Strong
growth is seen in craniofacial repairs including jaw and facial reconstruction
as well as dental implants (15%) and small bone implants (12%) driven by new
innovative solutions. The market size for small bone and craniofacial repairs
is estimated to be approximately 1.8 to 2 million procedures per year with a
total value of $4.3 billion.

nanoMAGs
business plan is to align with strategic industry partners. The company will
provide expertise in magnesium alloy design and fabrication. The OEM customer
will then take the product through early animal validation studies, FDA
regulatory approval, and ultimately to market and distribution. nanoMAG will be
a value- added supplier of medical implants with unique chemical composition
and structural characteristics to meet specific surgical procedures and patient
requirements. The strategic partner will be responsible for sterilization and
packaging for shipment to the market.

nanoMAG is
actively seeking development partners to test and validate early pre-production
samples tailored to end-use markets.

About
nanoMAG LLC

nanoMAG LLC, based in Livonia,
Mich., is a subsidiary of
Thixomat Technologies LLC, a company with more than 20 years of experience in
the research, development, and marketing of technologies for the production of
products utilizing magnesium alloys. nanoMAG supplies precision magnesium sheet
and short-run specialty alloys to diverse industries including automotive, aerospace,
biomedical, and military. nanoMAG magnesium sheet provides 100% higher strength
and improved toughness over conventional magnesium, while also providing the
strength of carbon steel sheet at one-fourth the weight. For more information,
visit www.nanoMAG.us.

About
Thixomat Inc.

Thixomat Inc., based in Livonia,
Mich., is the developer of the
Thixomolding® process which produces injection molded products from magnesium
stock. The process permits the manufacture of net or near-net shape parts
requiring little finishing. There are more than 50 Thixomat licensees and more
than 400 Thixomolding® machines have been sold worldwide. More information is
available at www.thixomat.com.

Posted by Sean Fenske, Editor-in-Chief, MDT

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