First-in-human procedures are planned for 2026, including Nivalon’s Co-Founder and CEO, Todd Hodrinsky.
Solutions designed to fix your own problems first carry higher stakes, and often far greater credibility, when they are applied to others.
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 motion with natural biomechanics and patient-specific design.
Their company, Nivalon Medical, provides solutions for spinal surgery and healthcare. The company recently developed a fully patient-specific, motion-preserving spinal implant built entirely without metal, using AI-driven design and advanced ceramic 3D printing.
Why traditional implants fall short
Unlike traditional implants manufactured in fixed sizes and made from metal alloys, Nivalon’s 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.
To match both human anatomy and natural biomechanics, the device combines a proprietary zirconia-toughened alumina (ZTA) ceramic architecture that behaves like bone with a flexible elastomeric core to mimic natural spinal motion.
The manufacturing process has been led by the Youngstown Business Incubator (YBI) and its Advanced Manufacturing and Engine Tech programs. They used XJet’s NanoParticle Jetting™ ceramic 3D printing technology, to manufacture the ceramic, load-bearing spinal implant architecture.
Independent pre-clinical validation & 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.
SEM analysis at UConn confirmed that the printed ZTA ceramic represents a new and distinct microstructural class of biocompatible implant material.
“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.“
The EvoFlex™ platform uniquely combines:
- Patient-specific, 3D-printed ceramic endplates matched directly to vertebral anatomy
- Bone-like ceramic material that eliminates metal corrosion, ion release, and imaging artifacts
- Flexible elastomeric core engineered to preserve native spinal motion
- Full MRI and CT compatibility
- Surgeon-controlled digital design workflow
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