Devices Made from OXPEKK®-IG Implantable Thermoplastic Receive COFEPRIS Clearance

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Mexican Implantable Device Market Open to Oxford Performance Materials, Inc.

PEARLROD OXPEKK-IG

Manufacturas Solco set out to identify the leading implantable polymer technology and business partner for spinal implants. With OPM we were able to find both elements.

Oxford Performance Materials Inc. (OPM) is very pleased to announce that a spinal system manufactured with its OXPEKK®-IG long-term implantable biomedical thermoplastic has received COFEPRIS clearance. An entire spinal system has been manufactured and registered by Manufacturas Solco S.A. de C.V. from OPM’s OXPEKK®-IG materials, the firm’s long-term implantable grade of polyetherketoneketone (PEKK).

Manufacturas Solco is a leading Mexican manufacturer of medical implants that are used predominantly in the spine. OXPEKK®-IG has been approved by the Mexican regulatory entity COFEPRIS in a range of spinal implants including the “DENNIA OXPEKK®-IG” cervical fusion cage, the “WASPP OXPEKK®-IG” and “ADDER OXPEKK®-IG” lumbar fusion cages, the “LIXUS OXPEKK®-IG” interspinous process spacer, a dynamic pedicle rod called “PEARLROD OXPEKK®-IG”, the “MOBULA OXPEKK®-IG”, a total cervical disc replacement, as well as the lumbar and cervical corporectomy implants “LIBELLULA OXPEKK®-IG”.

In order to gain approval OPM and Manufacturas Solco have worked together on a development that involved extensive use of OPM’s considerable biocompatibility file that it provides to its customers. Development and design of the implants were made in cooperation with the surgeons from the Department of Spine Surgery of the Instituto Nacional de Rehabilitación (INR), which is the premiere Mexican authority in spine. In addition Manufacturas Solco undertook extensive clinical studies which were published in the Revista del Hospital Juárez de México.

“Gaining regulatory approvals is by definition a long term process that requires considerable investment and a diverse set of skills,” said Scott DeFelice, President and CEO of OPM. “Manufacturas Solco has been a perfect partner who strongly committed to the process and made the necessary investment to realize this important clearance. We are very pleased that Manufacturas Solco and OPM can now benefit from the commercial success that this clearance will bring.”

“Manufacturas Solco set out to identify the leading implantable polymer technology and business partner for spinal implants. With OPM we were able to find both elements. We are now pleased that the multiple product lines which have been developed with OXPEKK®-IG are moving quickly to the commercial phase and we look forward to capitalizing on the many market transforming technologies OPM has to offer,” said José Manuel Soldevila, President of Manufacturas Solco.

This latest COFEPRIS clearance is in addition to substantial previous clearances of implantable devices manufactured with OXPEKK®-IG. Previous clearances include US FDA, Korean FDA, ANVISA Brazil and CE marks which cover a great spectrum of the orthopedic marketplace. OPM’s regulatory focus will now increasingly turn towards Japan and emerging markets.

OPM’s OXPEKK®-IG product is a high-performance, ultra-pure thermoplastic with properties very similar to bone. The product is polyetherketoneketone (PEKK) and is within the class of polyaryletherketone polymers (PAEK). OXPEKK®-IG has been extensively implanted worldwide. The product is supported by comprehensive ISO 10993 biocompatibility and purity data. The biocompatibility data is available directly from OPM or in the firm’s extensive FDA masterfile, without any access fees. Given the long implantation history of OXPEKK-IG products, there are numerous clinically relevant studies on OXPEKK®-IG devices available for reference.

About Manufacturas Solco S.A. de C.V.
Manufacturas Solco S.A. de C.V. was founded in Mexico City in 1969 by Jose Manuel Soldevila Resendiz as a part of the Zimmer Orthopaedic LTD group.
In 1980 Manufacturas Solco transformed into a 100% Mexican company dedicated to the manufacture of orthopaedic implants, such as bone plates, screws, intramedular nails and Thompson stems.
Around 1975, and together with Dr. Eduardo Luque Reboyar Manufacturas Solco started to develop some spinal device concepts, including the now famous Luque bar for scoliosis treatment. Manufacturas Solco also started manufacturing a complete lumbar spine system for Dr. Eduardo Luque Reboyar and, thereafter dedicated substantial efforts to the design and manufacture of spinal implants.
Manufacturas Solco sells within the entire Mexican territory and exports to Guatemala, El Salvador, Nicaragua, Ecuador, Dominican Republic and Cuba.
Since 2001 Manufacturas Solco is ISO 9001 certified and in 2010 obtained their EAR Certificate from Obelis and was granted with the certification of Good Manufacturing Practices by the Mexican Ministry of Health.
Manufacturas Solco S.A de C.V. is a leading Mexican company that develops and manufactures new spine systems with orthopedic doctors and neurosurgeons, always aiming to be amongst the best and most innovative in their field.
For additional information, please visit http://www.solco.com.mx and http://spinnabiotech.com.

About Oxford Performance Materials, Inc. (OPM)
Founded in March 2000, OPM has rapidly become an industry leader in the ultra-high performance thermoplastic polymers market. The firm’s versatile OXPEKK® polymers are currently being used in medical, space and defense, semiconductor and industrial markets worldwide. OPM is ISO 9001:2000 and ISO 13485:2003 certified.
In February 2009 OPM was partially acquired by France’s leading chemicals producer, Arkema.
For additional information, please visit http://www.oxfordpm.com or http://www.arkema.com/opm.

About Arkema
A global chemical company and France’s leading chemicals producer, Arkema consists of three strategically related businesses: Vinyl Products, Industrial Chemicals, and Performance Products. Arkema reported sales of 4.4 billion euros in 2009. Arkema has 13,800 employees across 40 countries and six research centers located in France, the United States and Japan. With internationally recognized brands, Arkema holds leadership positions in its principal markets.

For additional information, please visit http://www.arkema.com.

OXPEKK® is a registered trademark of Oxford Performance Materials, Inc.

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Sibylle O'Brien
OPM
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