Press Releases - Nivalon Medical Produces the World’s First Fully Patient-Specific, Motion-Preserving, Metal-Free Spinal Implant Using AI and Advanced Ceramic 3D Printing

Rehovot, Israel – March 2, 2026

XJet 3D, a global leader in 3D direct material jetting solutions for advanced ceramic and metal production, today announced that Nivalon Medical Technologies Inc., in collaboration with the Youngstown Business Incubator (YBI), has produced the world’s first fully patient-specific, motion-preserving spinal implant using its NanoParticle JettingTM solution installed at YBI.

The breakthrough device, EvoFlex™, combines a proprietary zirconia-toughened alumina (ZTA) ceramic architecture that behaves like bone with a flexible elastomeric core to mimic natural spinal motion, creating a new category of spinal implant engineered to match both human anatomy and natural biomechanics.

First-in-human procedures are planned for 2026, including Nivalon’s Co-Founder and CEO, Todd Hodrinsky.

A Personal Mission Becomes a Medical Revolution

Standard spinal implants are mass-produced in fixed sizes, creating an inherent mismatch with the unique anatomy of individual patients. This leads to suboptimal load distribution, implant migration, and long-term complications. Metal sensitivities and adverse biological responses add further risk.

What began as a personal mission between Hodrinsky and co-founder Marcel Janse has evolved into a new paradigm for spinal care—one that replaces metal with bone-like ceramic, generic sizing with patient-specific design, and rigid fixation with natural biomechanics.

“We 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.”

Unlike traditional implants manufactured in fixed sizes and made from metal alloys, Nivalon’s EvoFlexTM implant is digitally designed directly from each patient’s CT data and 3D printed to precisely match their unique anatomy. The result is a bone-like ceramic structure that eliminates metal-related complications such as corrosion, ion release, stiffness mismatch, and imaging interference, while preserving natural spinal motion.

Clinically Validated Through Independent Biomechanical, Mechanical, Biological, and Surgical Testing

The platform has undergone extensive independent pre-clinical validation through biomechanical, mechanical, biological, and anatomical testing conducted at the University of South Florida (USF) and the University of Connecticut Institute of Materials Science (UConn IMS).

At USF, EvoFlex™ implants were evaluated on the Dynamic Investigation of Spine Characteristics (DISC) simulator under six degrees of freedom motion and physiologic spinal loading, demonstrating stiffness curves and motion profiles that closely replicate native human spinal behavior. These results confirm true motion preservation, not just mechanical articulation.

At UConn IMS, compression and shear testing demonstrated major improvements in structural performance. The latest design achieved compressive loads of 14.6 kN, equivalent to approximately 1,490 kg (3,280 lbs) of force, validating the ceramic-polymer architecture under physiologic and supraphysiologic loading. Shear testing further demonstrated enhanced interface integrity and controlled progressive failure behavior.

UConn IMS also conducted simulated body fluid (SBF) immersion and SEM-EDX analysis, confirming that the ZTA ceramic supports uniform mineral deposition and biologically relevant ion interaction, demonstrating bone-like surface behavior and long-term osseointegration potential. Unlike metals, the ceramic showed consistent, controlled, and predictable biological interaction.

In addition, cadaveric pre-operative and post-operative surgical planning studies validated the accuracy of Nivalon’s digital design platform. In a complex four-level spinal reconstruction, the system successfully demonstrated precise virtual bone repositioning, restoration of sagittal balance, and proper facet joint alignment, confirming the platform’s ability to anatomically reconstruct and rebalance the spine with high precision.

Advanced Ceramic Manufacturing Enabled by the Youngstown Business Incubator

This milestone was achieved through a strategic collaboration with the Youngstown Business Incubator (YBI) and its Advanced Manufacturing and Engine Tech programs. Using XJet’s NanoParticle Jetting™ ceramic 3D printing technology, Nivalon successfully developed and manufactured the pure, high-density, load-bearing ceramic spinal implant architecture, representing the most advanced medical application to date of XJet’s NPJ platform, in both application and material innovation.

“We are proud to have Nivalon and YBI as XJet solution users and innovation drivers, and to witness a breakthrough that brings real impact to implant manufacturing. XJet’s goal goes beyond measuring adoption metrics; it is to empower innovation that was previously impossible, and to enable unlimited scalability in real-world manufacturing that benefits everyone. We are honored to be part of this journey and look forward to seeing Nivalon and YBI’s innovation reach the end-use market.”

“For us, XJet represents a best-in-class platform for producing high-performance ceramic implants and is a key enabler of our personalized approach.” Hodrinsky added. “Unlike many additive manufacturing processes that rely on polymer-based binders, XJet utilizes a water-based system, which we believe results in cleaner material properties and improved biocompatibility after sintering. Additionally, NPJ allows for exceptional resolution and surface detail, which is critical when replicating the complex anatomical contours of vertebral endplates including complex lattice structures for bone integration and polymer bonding to the material. This level of accuracy directly contributes to better implant fit and performance.”

Clear Path to Market Impact

This prototype represents the transition from research into scalable clinical manufacturing. With two issued U.S. patents and six additional patents pending, Nivalon is preparing for NIH Phase II SBIR funding, FDA PMA clinical trials, and first-in-human procedures in 2026.

“This is more than a technical achievement—it’s personal,” said Hodrinsky and Janse. “The endplates for my own spine are now complete. This is the difference between living with chronic complications and restoring a normal, active life.”

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