Graphy Partners with FUGO for Shape Memory Aligner Production

South Korean Dental Materials Innovator and US 3D Printing Technology Developer Form Strategic Alliance

Graphy Inc. (KOSDAQ: 318060), a South Korean dental 3D printing materials manufacturer, announced on January 5, 2026, that it has entered into an exclusive strategic partnership with FUGO Precision 3D, a US-based next-generation 3D printing technology developer. The partnership aims to establish a mass production infrastructure for the world’s first shape memory aligner (SMA), combining proprietary materials science with advanced manufacturing capabilities.

About Graphy Inc.

Founded in 2017 and headquartered in Seoul, Graphy specializes in photopolymer resins for dental 3D printing applications, with a workforce of 51-200 employees. The company has gained global attention for its Tera Harz material series, particularly its shape-memory polymers for orthodontic applications. Graphy completed its IPO on the Korean Stock Exchange in 2024, directing proceeds toward photopolymer research and development. The company has obtained CE Mark certification and is currently pursuing FDA clearance, marking its transition from technology validation to industrial commercialization.

What Are Shape Memory Aligners and Why Do They Matter?

Orthodontic aligners—transparent removable appliances used for teeth straightening—have traditionally faced a fundamental limitation: conventional thermoformed aligners lose their corrective force when deformed during use and cannot return to their original shape. This force degradation necessitates frequent replacements, typically requiring 2-3 aligners per treatment stage.

Graphy’s shape memory aligner addresses this core problem through its Tera Harz TC-85 material, a shape-memory polymer activated at body temperature (approximately 37°C). When deformed, the aligner can recover its original geometry by immersion in warm water (around 60°C), thereby restoring its orthodontic force. This breakthrough delivers several clinical advantages:

• Reduction in aligners required per treatment stage: from 2-3 to just 1
• Shortened overall treatment duration
• Decreased replacement frequency and cost for patients
• More predictable treatment outcomes

The shape memory functionality is achieved through a molecular structure incorporating dual carbon backbones, allowing precise control over the material’s thermomechanical behavior.

Layer-less 3D Printing: Enabling Precision and Aesthetics

To maximize the advantages of shape memory aligner technology, high-quality manufacturing processes are essential. Conventional layer-by-layer additive manufacturing creates visible boundaries between successive layers, resulting in several quality issues:

• Visible layer lines compromising aesthetics
• Dimensional accuracy variations
• Surface roughness affecting patient comfort

FUGO’s proprietary centrifugal force-based continuous forming process eliminates discrete layers entirely by forming objects continuously rather than incrementally. This approach delivers:

• Optically clear, smooth surfaces
• Precision down to approximately 10 microns (superior to conventional layer-based methods)
• Continuous high-throughput manufacturing

Alex “Sasha” Shkolnik, Co-Founder and CTO of FUGO, commented: “In nearly four decades of working with advanced materials and printing technologies, Graphy’s shape-memory material stands out as something genuinely new. It unlocks possibilities in dental 3D printing that we have not previously encountered.”

Strategic Significance: Beyond Material Supply to Vertical Integration

This agreement transcends a conventional material supply relationship, structured instead as a long-term strategic alliance. Graphy is positioned as the exclusive provider of shape-memory materials optimized specifically for FUGO’s next-generation printing systems, encompassing:

• Joint R&D in materials and process co-optimization
• Synchronization of material formulation with printing dynamics
• Commercial readiness for large dental service organizations (DSOs) and laboratory networks

This vertical integration approach enables Graphy to transition from a materials manufacturer to a manufacturing ecosystem provider. For investors, this represents a clear shift from technology validation to industrial execution, with significant implications for revenue scalability and operating leverage.

The partnership’s practical focus centers on the US market, where FUGO is headquartered in California and large-scale DSO networks are well-established. However, dental medical devices require regulatory approval in each jurisdiction, meaning global expansion will require time. While Graphy has secured CE Mark certification in Europe and has applied for FDA 510(k) clearance in the United States, approvals from Japan’s PMDA, China’s NMPA, and other Asian regulatory bodies will follow separate timelines.

Un-Seob Sim, CEO of Graphy, stated: “This exclusive partnership with FUGO represents a turning point where Graphy’s shape-memory materials converge with world-class printing technology to create new industrial value. Through this collaboration, we are accelerating our global dental strategy and expect to deliver more tangible business results beginning next year.”

Regulatory Approval Remains the Key to Commercialization

However, dental medical devices face stringent regulatory approval requirements in each country, presenting the primary barrier to market penetration for innovative technologies. Material biocompatibility, clinical trial data, and manufacturing quality control are evaluated against different standards across jurisdictions. While Graphy has obtained CE Mark certification in the EU and is pursuing US FDA 510(k) clearance, approvals from Japan’s PMDA, China’s NMPA, and other Asian regulatory authorities require separate processes and multi-year timelines.

For shape memory aligner technology to achieve widespread clinical adoption, overcoming these regulatory barriers market-by-market will be essential. The Graphy-FUGO partnership represents a critical step from technology development toward industrialization, but true global expansion hinges on securing regulatory approvals across key markets.