Webdisclosure.com

Search

CURITEVA Inspire(R) 3D Printed Trabecular PEEK(TM) With HAFUSE(R) Lumbar Interbody System Cleared by FDA

Directive transparence : information réglementée

22/01/2024 13:45

HUNTSVILLE, AL / ACCESSWIRE / January 22, 2024 / Huntsville, AL-based technology manufacturer Curiteva announced FDA 510(k) clearance of the Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System for use in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures. This marks the company's second FDA cleared 3D printed PEEK implant with HAFUSE, following the approval of the Inspire Trabecular PEEK Cervical Interbody Fusion System in February 2023. The Inspire Cervical implant represented the industry's first 3D printed PEEK device to receive regulatory clearance with over 1,000 successful implantations in more than 500 patients since the April 2023 launch. The company plans a commercial introduction of Inspire for TLIF and PLIF procedures in Q2 of this year.

The Inspire platform is manufactured with a proprietary, patented Fused Filament Fabrication 3D printer designed, programmed, and built by Curiteva. Founder and Chairman, Chad Falciani emphasized, "In addition to our proprietary printing operation, we have assembled an FDA Master File and implemented rigorous quality and process controls which demonstrates the process performance is extremely capable."

This ground-breaking additive process produces a fully interconnected and integrated trabecular PEEK lattice 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 trabecular PEEK structure creates a hydrophilic, bioactive environment for cell attachment, proliferation, and healing in pre-clinical animal and in vitro studies.

"Advancements in PEEK over the last decade were cost-prohibitive and operationally challenging to scale. Our experience and commitment to lean operational efficiency allowed us to accelerate our proprietary print operation resulting in over 7,000 implants now commercially available in inventory," added Falciani.

"Reported patient outcomes for Inspire cervical in the first 9 months reinforce our pre-clinical observations and we plan to publish those results later this year. Our work continues in earnest to develop additional spine portfolio products leveraging this proprietary technology. We are thankful for our partners at MCRA, Empirical, Promimic, and Evonik for their extraordinary support on this regulatory path we are forging to advance additive PEEK manufacturing to improve patient healing and outcomes in the spine and MSK space," commented CEO Mike English.

About Curiteva:

Curiteva is a privately held technology and manufacturing company based in Huntsville, AL. 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. Curiteva is pioneering 3D printing of Trabecular PEEK implants with a bioactive nano-surface to revolutionize how engineered structures and implant biomaterials accelerate immunomodulation, enhance healing, and improve patient outcomes. For more information, please visit www.curiteva.com

Contact Information

Kristen Kyzer
Director of Business Development
kkyzer@curiteva.com
256.213.1057

SOURCE: Curiteva

.

View the original press release on newswire.com.


12/02/2024 15:30
22/01/2024 13:45