Curiteva Announces World’s First 3D Printed PEEK Device With Regulatory Clearance Reaches Full Commercial Launch in the United States
Curiteva, a privately held technology and manufacturing company based in Huntsville, AL announces the commercial launch of its Inspire Porous PEEK HAFUSE Cervical Interbody System.
The company pioneered and received clearance earlier this year on the world’s first 3D printed, fully interconnected porous PEEK interbody. This extraordinary advancement in additive manufacturing of polymers creates a new classification of interbody fusion devices with optimal characteristics for bony healing.
“We are very pleased with the positive surgeon feedback we received during our limited release in April. Now with full commercialization, the team is excited to see continued adoption of our novel 3D printed porous PEEK implant with HAFUSE Technology,” stated Mark Mohlman, EVP. “This launch is just the beginning as we continue to develop our additional lumbar portfolio scheduled for launch in 2024.”
The Inspire platform is manufactured with a proprietary, patented Fused Filament Fabrication 3D printer designed, programmed, and built by Curiteva. This ground-breaking additive process produces a fully interconnected and integrated porous structure traversing the entire implant to promote osseointegration, improve radiographic assessment, and deliver superior biomechanics. The first-to-market combination of the HAFUSE nanotechnology surface treatment and novel porous PEEK structure creates a hydrophilic, bioactive environment for cell attachment, proliferation, and healing in pre-clinical animal and in vitro studies.
“Curiteva received FDA clearance in February, initiated our alpha release in April and scaled to a commercial launch in July. I am proud of the entire Curiteva team for another milestone achievement, and grateful to our surgeons and distributors for their patience and support,” commented CEO Mike English.
The Inspire technology will be featured at the NASS meeting later this year.
About Curiteva:
Curiteva is a privately held technology and manufacturing company dedicated to advancing spine surgery and improving clinical outcomes by partnering with providers and suppliers to deliver innovative and intuitive implant systems to the market. Our business is founded on a commitment to building world-class manufacturing, accelerating research and development, maintaining lean operational discipline, and delivering novel technology to meet the evolving needs of our customers and the patients they serve. For more information, please visit www.curiteva.com
