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 A word from the President
On behalf of Biorthex Inc., it gives me great
pleasure to welcome you and introduce our company. Biorthex Inc. is a
Canadian company
incorporated in 1993, and which is organized under the provisions of the Companies Act (Quebec). Based in
Boucherville (suburb of Montreal), Biorthex Inc. specializes in the design,
development, production, manufacture and commercialization of orthopaedic
products and devices, with a focus on spinal disorders.
Biorthex's efforts are focused
on the commercialisation of its innovative spinal
interbody fusion implants, dirived from its Atipore™ technology platform and also the expansion of this
technology platform. Actipore™ is a porous
biomaterial derived from nitinol technology that permits bone cell
growth into the biomaterial's pores for a
rapid and solid attachment to bone
structure without the
need for bone grafting or ciment.
We now invite you to browse our
website and ask you to bookmark our home page so that you can visit us frequently
for current news and events. We hope you enjoy your visit.
Benoît Sicotte, Eng., M.B.A.
President and CEO
Company Profile 
Biorthex Inc. is a biotechnology company that designs, develops,
manufactures and markets innovative and proprietary surgical products for
the treatment of spinal disorders. The Company is dedicated to providing the
surgical community with safe, technologically proven and innovative spinal
implants for use in the treatment of spinal disorders, diseases and
injuries.
Our mission at Biorthex is to develop and market breakthrough products,
which will enhance the practice of orthopaedic surgeons and associated
healthcare professionals and thus, the quality of life of their patients.
In 1997, Biorthex commenced development of a porous nickel-titanium alloy,
Actipore™, to address the challenge of host bone to implant fixation.
Several years of research and development resulted in the production of a
unique ultra porous, biologically and biomechanically compatible nitinol
material. The material's isotropic porous structure, with inherent capillary
wicking pores, draws essential fluids and nutrients into the material thus
facilitating bone cell penetration and survival and allowing strong, rapid
growth of newly forming bone cells through its scaffold (three dimensional
networks of pores).
With similar mechanical properties to bone resulting in load sharing, as
well as MRI and CT scan compatibility, the abovementioned qualities lent
themselves ideally to the production of spinal interbody devices. As a
consequence, the Actipore™ interbody device project was born.
The use of Biorthex's innovative interbody fusion material, Actipore™,
enables a less invasive surgical procedure which may shorten hospital stay
and/or accelerate patient recovery and as a consequence, may allow a
reduction of overall cost of treatment compared to traditional methods.
Studies conducted so far indicate a fusion rate which is at least as good as
competitors' devices.
Biorthex offers three products derived from its
Actipore™ technology, two of them are advanced interbody fusion device
indicated for lumbar fusion : the Actipore™ PLFx system and the Actipore™
PLF system, the third Actipore™ ACF system is indicated for cervical fusion.
Biorthex is currently developing a fourth interbody fusion device, called
Actipore™ ALF for lumbar fusion via
anterior approach. Biorthex is also developing its Actipore™
technology to be use as a surface coating and components in hip and knee
implants
Company History
Biorthex was incorporated on November 9, 1993 and debuted operations in
1995.
On November 21st 1995, Biorthex entered into a licensing
agreement with the Montreal based Sainte-Justine Hospital under which
Biorthex was granted the exclusive worldwide rights to develop, manufacture
and commercialize both the Orthobiom system and the SpineCor brace line of
products.
On February 26th 1997, Biorthex was granted the exclusive
worldwide rights, except for Russia, to develop, manufacture and
commercialize Porous nickel-titanium alloy, commonly known as porous nitinol
and trademarked Actipore™. Biorthex thus initiated the technological
transfer relating to the manufacturing of the material in 1997, which was
completed in 2000.
Clinical trials on the SpineCor bracing system, a flexible brace that
stabilizes and corrects a scoliosis spine, were initiated in 1997 and the
line of products was launched in January 1999 worldwide. In December 2001,
with the objective of focusing more on interbody devices, Biorthex sold the
rights to the SpineCor line of products to the UK-based company The
SpineCorporation Limited in return for royalties on subsequent sales.
On February 23rd
2001, Biorthex obtained the IDE from the Food and
Drug Administration (FDA) permitting a clinical study for the Orthobiom
system.
On August 1st 2001, Biorthex obtained ISO certification and the
CE mark permitting to manufacture any metallic spinal implants throughout
the European Union. In September of the same year, Biorthex launched its
first Actipore™ implant, the Actipore™ PLF indicated for lower back pain. By
December, Biorthex had already signed six distributors in six different
countries and the first sales were initiated in January 2002.
In June
2002, Biorthex reorganized to focus on the development of its Actipore™
interbody fusion devices product line and abandon the idea of becoming a one
stop shop of all spinal diseases.
In July
2002, Biorthex launched its new implant Actipore™
ACF indicated for the treatment of spinal pathologies at the cervical level.
The first surgeries were completed successfully in Spain by Dr. David
Noriega. The first Canadian surgeries took place one year later and were
performed by Dr. Murty and Dr. Jarzem.
In
2003, Biorthex obtained approval from the FDA and Canadian TPD to initiate
two clinical studies on Actipore™ PLFx and
ACF.
On
April 13 2004, Biorthex stopped its North American clinical study on
Actipore™ PLFx and decided not to initiate
its study on Actipore™ ACF following the
announcement by the FDA to down-classify the interbody fusion devices to
class II, making clinical studies not mandatory anymore. Biorthex also
reorganized to focus on the development of its Actipore™
technology platform to eventually sell licenses or the whole technology.
In May
2004, Biorthex bought back the Actipore™ license
and worldwide patents from its Russian partner, making Biorthex the only
owner of the porous nitinol technology called Actipore™.
On
December 29th 2004, Biorthex
sold for $1 million its Orthobiom fusionless scoliosis system license and a
license for the use of Actipore™ for all
orthopaedics application in extremities (foot & hand) to Viscogliosi
Brothers from New York.
On
February 10th 2006, Biorthex
signed a research agreement with Nitinol Devices & Components (NDC) a
Johnson & Johnson subsidiary for the development of Actipore™
as a surface coating on titanium and cobalt-chrome substrate to be use in
hip and knee implants.
On
March 15th 2006, Biorthex sold a license for the use of Actipore™ for
dental applications in Europe to Vital Implant, a French company.
On
September 5th 2006, Biorthex
completed with success the first surgeries with its new Actipore™
ALF implant for the treatment of lumbar spinal disorder from an anterior
approach, performed in Belgium by Dr. Leflot.
On
September 6th
2006, Biorthex succeeded its ISO 13485:2003 certification audit without any
major or minor non conformity.
Management Team
Benoît Sicotte, Eng., M.B.A.
President and CEO
Mr. Benoît Sicotte holds a Bachelors degree in
Mechanical Engineering from the University of Sherbrooke and a Masters degree in Business Administration (M.B.A.) from the
Université du Québec à Montréal. Mr. Sicotte joined Biorthex in 1997 as
Vice-President, Research & Development. Before joining Biorthex Inc.,
Mr. Sicotte spent 13 years at Smith & Nephew, a worldwide manufacturer
and distributor in the field of medical products, and held several
positions such as Production Manager, Plant Manager and Export Manager.
Among the skills he has acquired over the years are people management,
business management, operations management as well as sales and marketing.
He has also gained extensive experience while working with the ISO and FDA
regulation requirements.
Ownership
Fonds de
Solidarité des Travailleurs du Québec (FTQ)
www.fondsftq.com
Lothian
Partners 27 SRAL
SPEQ Biorthex Inc.
Business Development Bank of Canada
www.bdc.ca
Antoine Gendreau-Turmel
National Bank Financial
www.nbfinancial.com
Spinal Partners II
Board of
Directors
Benoît Sicotte, President and CEO, Biorthex Inc.
René
Kurth, Fonds de Solidarité des Travailleurs du Québec
Philip Lang, Lothian
Stephane Le Bouyonnec, SPEQ Biorthex inc.
Charles Fong, Business Development
Bank of Canada
Dr. Charles H. Rivard, Founder
Contacts
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Administrative & Investor Relations
Customer Service & Manufacturing
Mr. Benoît Sicotte
30 de Chenonceau
Blainville, Quebec, J7B 1P6
Canada
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