|Oxford CEO Scott DeFelice|
Oxford Performance Materials snagged an FDA OK for its 3-D printed spinal implant device, a win for the company as it adds to a string of regulatory approvals and builds out its offerings past skull and facial implants.
The South Windsor, CT-based company's SpineFab VBR implant system is geared toward the thoracolumbar regions of the spine and replaces collapsed, damaged or unstable vertebrae stemming from tumor or trauma. To get the FDA signoff, OPM put its device through "extensive static and dynamic mechanical testing" to make sure it could hold up under weight and pressure and meet requirements laid out by the agency, the company said in a statement. OPM already has FDA clearance for its cranial device and facial device, and the latest regulatory blessing represents a "key milestone" for the company, CEO Scott DeFelice said in a statement.
"This clearance serves as further confirmation of our ability to repeatedly build fully functional 3-D printed parts and mission critical robust structures," DeFelice said. "The introduction of our SpineFab system represents exciting news for the company's entry into the attractive spinal market, and this lays the foundation for future generations of load-bearing OsteoFab implants in the orthopedic industry."
|OPM's cranial implant--Courtesy of Oxford Performance Materials|
And the company is already charting plans to increase its industry footprint. OPM is in discussions with a number of distributors about marketing for its SpineFab VBR system and partnership options for orthopedic devices under development, it said in a statement. Zimmer Biomet ($ZMH) exclusively distributes OPM's cranial and facial devices.
The company's implants enter the market at a pivotal moment, as more med tech outfits look to 3-D printing to manufacture devices. To make its implants, OPM will use its own 3-D printing technology and a proprietary powder formulation, creating devices with bone-like attributes and ongrowth characteristics, the company said in a statement.
"Our OsteoFab process, which combines 3-D printing with a unique material chemistry, is causing the industry to rethink how implants are designed and manufactured," OPM Biomedical President Severine Zygmont said in a statement. "We can now envision devices that will promote bone tissue formation while being imaging friendly and anatomically desirable."
- read OPM's statement
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