U.S. company creating patient-specific spinal implants Nivalon Medical Technologies has developed what it describes as the first fully patient-specific spinal implant that preserves natural motion without metal components. The device combines AI-driven design with advanced ceramic 3D printing, using a zirconia-toughened alumina (ZTA) structure and a flexible core to replicate spinal movement.
Conventional spinal implants typically come in preset metal sizes, but Nivalon’s approach tailors each device to the individual patient. Using CT scans, the implant is digitally modeled and 3D printed in ceramic to fit the patient’s spine precisely. This method aims to replicate the natural behavior of bone while minimizing complications commonly associated with metal implants, such as corrosion, uneven stiffness, ion release, and interference with imaging.
The company expects to begin first human procedures in 2026, with Co-Founder and CEO Todd Hodrinsky among the participants.
Nivalon Medical Banner. Image via Nivalon Medical Technologies.
Clinically Validated, Scalable, and Engineered for the Future
The EvoFlex system has been subjected to thorough independent preclinical evaluation, encompassing biomechanical, mechanical, biological, and surgical studies.
At the University of South Florida (USF), the implants were assessed using the Dynamic Investigation of Spine Characteristics (DISC) simulator, where results showed stiffness and motion patterns closely aligned with natural spinal function, confirming that the device preserves true physiological movement.
Tests at the University of Connecticut Institute of Materials Science (UConn IMS) showed that the ceramic-polymer design could endure forces up to 14.6 kN (approximately 1,490 kg/3,280 lbs) while maintaining structural integrity under progressive loading. Additional analyses, such as simulated body fluid immersion and SEM-EDX, indicated that the ZTA ceramic encourages uniform mineral deposition and biologically ion interaction.
Cadaveric surgical planning studies validated Nivalon’s digital platform, showing accurate bone realignment, sagittal balance restoration, and correct facet joint positioning even in complex multi-level reconstructions.
“I realized the problem wasn’t the surgeons—it was the implants,” said Hodrinsky. “We were trying to treat a living biological structure with industrial metal hardware that was never designed to behave like bone or properly follow natural spinal motion. We knew we could engineer something fundamentally better.”
Different sizes of the Nivalon medical device. Image via Nivalon Medical Technologies.
From Prototype to Patient Trials: Scaling a Ceramic Spinal Implant
Manufacturing on Demand
Achieved in collaboration with the Youngstown Business Incubator and through the use of XJet’s NanoParticle Jetting technology, the prototype marks the move from experimental development toward production-ready clinical manufacturing. Backed by two granted U.S. patents and six more pending, Nivalon is advancing toward NIH Phase II SBIR funding, FDA PMA trials, and plans to perform initial human procedures in 2026.
“This is more than a technical achievement—it’s personal,” said Hodrinsky. “The endplates for my own spine are now complete. This is the difference between living with chronic complications and restoring a normal, active life.”
Nivalon Medical Device. Photo via Nivalon Medical Technologies.
While EvoFlex has demonstrated technical feasibility in preclinical studies, several constraints remain. Human testing has not yet occurred, so long-term outcomes under real-world physiological loads are unknown. Broader clinical adoption will depend on reliable imaging, precise digital modeling, consistent additive manufacturing quality, and regulatory approval, including FDA PMA clearance.
3D Printing Enables Patient-Specific Spinal Implants
3D printing is transforming spinal care by making implants truly patient-specific, designed to match each individual’s anatomy and biomechanics. Additive manufacturing allows precise control over implant structure, improving bone integration, supporting natural motion, and enabling innovative therapeutic approaches.
This capability is already being realized in practice: in the U.S., the first surgeries using 3D printed porous PEEK spinal implants demonstrated FDA approval and marked the first fully interconnected porous PEEK implant cleared for commercial use. Elsewhere, researchers in Ireland are exploring electrically active, 3D printed scaffolds that combine soft biocompatible materials with electrical stimulation to support nerve repair after spinal injury. Still in early stages, these implants illustrate how AM can expand from structural to regenerative spinal therapies.
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Author: Paloma Duran
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