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.
First-in-human procedures are planned for 2026, including Nivalon's Co-Founder and CEO, Todd Hodrinsky.
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 a pure ceramic, load-bearing spinal implant architecture.
SEM analysis at UConn confirmed that the printed ZTA ceramic represents a new and distinct microstructural class of biocompatible implant material.
This marks a medical industry first: a fully ceramic, metal-free, load-bearing spinal implant manufactured with repeatable, reliable, and scalable production methods.
A Personal Mission Becomes a Medical Revolution
"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."
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.
Revolutionary Engineering Solution
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
This is the first fully ceramic, patient-specific spinal implant platform ever developed.
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."
About Nivalon Medical Technologies Inc.
Welcome to Nivalon Medical, where innovation meets precision in spinal healthcare. Our mission is to lead innovation in spinal surgery and healthcare through personalized solutions that enhance surgical precision, shorten recovery times, reduce complications, and improve long-term quality of life. We are committed to revolutionizing the way spine conditions are diagnosed and treated.
With years of research and development behind us, we are committed to leading the next generation of spinal healthcare. Learn more at www.nivalonmedical.com.
About the YBI
YBI is a globally recognized economic development nonprofit, advancing innovation and growth across Ohio and beyond. Through a flexible suite of high-quality entrepreneurial services and resources, YBI supports startups, small businesses, and manufacturers at every stage of development.
The mission of the YBI Engine Tech Incubator Program is to empower technology driven startups with tailored incubation and acceleration services that guide entrepreneurs with access to industry experts, commercialization assistance, pitch deck development, introductions to marquee customers and any other needs that may arise. The goal is simple – to help, not hinder, startups. For more information, visit ybi.org.
YBI's Advanced Manufacturing program offers hands-on support to enable companies to integrate additive manufacturing, adopt emerging technologies, and enhance their production capabilities. YBI is home to the Center of Excellence for Advanced Manufacturing and serves as a lead partner of the Youngstown Innovation Hub for Aerospace & Defense, led by America Makes.
Contact:
Todd Hodrinsky
Co-Founder & CEO
Nivalon Medical
www.nivalonmedical.com
Cell: 860-634-1790
Jessica Sprowl
Director, Marketing & Communications
YBI
Cell: 330-719-4032
SOURCE YBI; Nivalon
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