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Oxford Performance Materials Receives Japanese Accreditation of Foreign Medical Device Manufacturer

March 21st, 2018


Oxford Performance Materials, Inc. (OPM), a leader in advanced materials science and high performance additive manufacturing (HPAM™), today announced that the Company has been granted Accreditation of Foreign Medical Device Manufacturer by the Japanese Ministry of Health, Labour and Welfare. This accreditation lays the groundwork for OPM’s expansion into the rapidly growing Asian healthcare market.

OPM’s OsteoFab® technology, which combines laser melting additive manufacturing technology, and OPM's proprietary OXPEKK® material formulations, offers 3D printed poly-ether-ketone-ketone (PEKK)-based medical implants addressing craniomaxillofacial (CMF), spine and other emerging orthopedic and neurologic indications. OPM’s OsteoFab products are currently sold on a global basis via various partnership arrangements.

The healthcare industry in Asia currently represents approximately 25% of the nearly $2 trillion global healthcare market and is expected to grow by 11.1% to $517 billion in 2018, representing one of the fastest growing regions in the world, according to Frost & Sullivan. OPM has long identified Asia as an attractive market as a result of demographic trends and a predictable regulatory and reimbursement environment. Additionally, Japanese healthcare companies have a deep appreciation for advanced technologies that can cost-effectively address the need for patient-specific medical solutions and improved clinical outcomes.

“OPM started regular exploration of the Asian market 10 years ago in order to deeply understand the reimbursement environments, potential markets and commercialization opportunities,” said Scott DeFelice, Chief Executive Officer and Chairman of the Board of Oxford Performance Materials. “This accreditation allows OPM to start an export program to initiate market development and advance our Asian business.”

About Oxford Performance Materials, Inc.

A recognized leader in advanced materials science, Oxford Performance Materials Inc. (OPM) was founded in 2000 to exploit and commercialize the world’s highest performing thermoplastics, with a focus on poly-ether-ketone-ketone (PEKK). OPM develops proprietary material, process, and application technologies and applies high performance additive manufacturing (HPAM™) to produce fully functional, end-use structural parts. OPM Biomedical is a pioneer in personalized medicine, 3D printing OsteoFab® cranial and facial implants as an OEM, and spinal implants and additional products on a contract manufacturing basis. OPM Biomedical is the first and only company to receive FDA 510(k) clearance to manufacture 3D printed patient-specific polymeric implants, and has a total of four 510(k) clearances in its portfolio. The OPM Materials business unit develops proprietary OXPEKK® thermoplastic products and other materials for biomedical, aerospace, defense, and industrial applications.

Posted in the category Biomedical.

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