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.

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Company Profile top

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 top

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. A study regarding the effect of e liquids is also being carried out.

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 and to investigate the effects.

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 old 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 the 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.

Management Team top

, Eng., M.B.A.
President and CEO

holds a Bachelors degree in Mechanical Engineering from the University of 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 Director 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.

Sylvain Allard, Eng.,
Vice-President Technology

Mr. holds a Bachelors degree in Metallurgical Engineering from Montréal École Polytechnique and is completing a Master degree in Business Administration (M.B.A.) from Sherbrooke University. Mr. Allard joined Biorthex Inc. in 2002 as Production Director to which was added the sales responsibilities in 2004. Prior to joining Biorthex Inc., Mr. Allard's early career was in powder metallurgy for QMP a world renowned industry leader for its expertise in this field. Mr. Allard worked for 12 years at QMP, where he developed a global perspective of a manufacturing company having occupied numerous positions such as Process Engineer, Customer Service Specialist and different management positions in Production, Process Technology and Quality Control. Technical and Operations Management are among Mr. Allard skills which Biorthex Inc. can capitalise on.

Ownership top


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 top


Charles Fong, Business Development Bank of Canada

 

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