Nivalon Medical
A medical technology company developing the world's first patient-specific, motion-preserving, metal-free spinal implants using AI-driven design and advanced ceramic 3D printing.
- CEO / Founder
- Todd Hodrinsky
- Team Size
- 1-10
- Stage
- Active
- Total Funding
- $1M
- Latest Round
- Grant
- Key Investors
- Youngstown Business Incubator (YBI)
Technology & Products
Key Products
EvoFlex™ Patient-Specific Ceramic Spinal Implants, AI-Driven Anatomical Modeling & Design Software, Motion-Preserving Intervertebral Solutions, 3D-Printed Zirconia-Toughened Alumina (ZTA) Ceramic Implants with Flexible Elastomeric Core
Technological Advantage
Leverages proprietary AI to translate patient CT scans into custom geometry and utilizes XJet NanoParticle Jetting technology to print zirconia-toughened alumina (ZTA) ceramic that mimics bone density, eliminates metal sensitivity, and incorporates a flexible elastomeric core to preserve natural spinal motion.
Differentiation
Value Proposition
Eliminates the 'one-size-fits-all' limitation of traditional implants by using AI to match a patient's unique anatomy, restoring natural biomechanics and reducing the risks of metal sensitivity and adjacent segment disease.
How They Differentiate
Nivalon differentiates by offering the world's first fully patient-specific, metal-free, motion-preserving spinal implants. Unlike competitors like Carlsmed who use AI for patient-specific titanium implants, Nivalon utilizes AI-driven design paired with XJet NanoParticle Jetting to create zirconia-toughened alumina (ZTA) ceramic implants with a flexible elastomeric core that mimics natural spinal motion.
Market & Competition
Target Customers
Orthopedic surgeons, neurosurgeons, specialized spine centers, and hospitals seeking advanced alternatives to traditional metal fusion hardware.
Industry Verticals
Medical Devices, Healthcare / Spinal Surgery, Additive Manufacturing (3D Printing), Biotechnology
Competitors
Carlsmed; Medtronic; NuVasive (Globus Medical)
Growth & Milestones
Growth Metrics
Produced world's first fully patient-specific, motion-preserving, metal-free spinal implant in January 2026; completed extensive independent pre-clinical validation at University of South Florida and University of Connecticut; preparing for NIH Phase II SBIR funding and FDA PMA clinical trials.
Major Milestones
Secured U.S. Patent US-12011336-B2 for 'Patient-specific spinal implants' in June 2024, Named a finalist and winner at the Youngstown Business Incubator (YBI) Shark Tank in 2025, Produced the world's first fully patient-specific, motion-preserving, metal-free spinal implant in January 2026, First-in-human procedures planned for 2026, including Co-Founder and CEO Todd Hodrinsky, Preparing for NIH Phase II SBIR funding and FDA PMA clinical trials as of January 2026
Notable Customers
Youngstown Business Incubator (Portfolio Company)
Recent coverage of Nivalon Medical
- Nivalon Medical develops patient-specific, motion-preserving ceramic spinal implant via 3D printing for 2026 clinical use
- Nivalon Medical is redefining spinal care by utilizing AI-driven design and XJet ceramic 3D printing to create the EvoFlex patient-specific implant.
- Nivalon Medical has produced the world's first patient-specific, metal-free ceramic 3D-printed spinal implant.