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Nivalon Medical

ApplicationYoungstown, USAFounded 2020· One of 410 Application companies tracked by AMPulse

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