Strong even when wet, and regenerating bone:
a surgical adhesive that genuinely bonds
Biological Surgical Adhesive for Bone and Dental Applications
Conventional fibrin glue is weak in wet conditions, and PMMA bone cement does not truly bond — a long-standing unmet need in orthopaedics and dentistry. Novelglue proposes a medical material built on a different idea: one that holds its adhesive strength when wet and does not impede bone regeneration.
The problem, and how we solve it
⚠ Limits of current technology
- ✕ Fibrin glue is weak — being derived from human plasma, it requires infection-risk management. Its adhesive strength is also low at 2–5 kPa[4], and weaker still in wet conditions.
- ✕ PMMA bone cement is a filler — it fixes bone mechanically but shows no chemical adhesion. The heat of polymerisation (over 70 °C) has been noted as a risk of thermal necrosis in the surrounding bone tissue[6].
- ✕ Cytotoxicity of cyanoacrylates — set against strong adhesion, the heat of polymerisation and the cytotoxicity of degradation products remain a concern.
- ✕ No true bone adhesive exists — there is no genuine bone adhesive for comminuted fractures or articular cartilage repair, leaving an unmet need in clinical practice.
✓ What Novelglue changes
- ✓ 63 kPa of adhesion in wet conditions[our own test value] — in physiological saline, more than ten times the wet adhesive strength of fibrin glue (2–5 kPa[4]).
- ✓ Free of blood products and animal origin — removing both infection risk and the burden of obtaining patient consent.
- ✓ Promotes bone regeneration — can be made into a bone putty when kneaded with β-TCP. In a rat femur study, bone formation began in the defect at 3 weeks and cortical bone regeneration was confirmed at 5 weeks.
- ✓ Tissue regeneration through EGF activity — the EGF-like activity of the FP2 domain is expected to promote tissue regeneration.
Technical data
Every performance figure below is our own test value (not peer-reviewed, at the R&D stage). Test conditions are given in the notes column for each item. The comparison figure for fibrin glue comes from Spotnitz 2014[4], and PMMA thermal necrosis from Szoradi 2024[6].
63 kPa
Tensile adhesion when wet
Our own test value (in physiological saline) / for comparison: fibrin glue 2–5 kPa [4]
0.2 MPa
Adhesion on dry surfaces
Adhesion to dry surfaces such as skin
5 weeks
Bone regeneration in rats
Cortical bone regeneration in a 1.5 mm femoral defect
Low
Acute toxicity
LD50 estimated at 1.41 g/kg (OECD 129)
| Metric | Value |
|---|---|
| Tensile adhesion when wet | 63 kPa |
| Adhesion on dry surfaces | 0.2 MPa |
| Bone regeneration in rats | Cortical bone formed at 5 weeks |
| LD50 (estimated) | 1.41 ± 0.146 g/kg |
| IC50 | 1.08 ± 0.30 mg/mL |
Note: the bone regeneration data come from joint research with Kyoto University School of Medicine (AMED translational research programme).
Where it can be used
Synthetic bone putty (kneaded with β-TCP)
Filling and bonding a comminuted fracture or bone defect at the same time. Combined with β-TCP it promotes bone regeneration.
Meniscus and articular cartilage repair
Bonding tissue fragments to each other in a wet environment. Non-clinical testing is under way in joint research with a university school of medicine (AMED translational research programme).
Adhesive restoration in dentistry
As a substitute for bonding agents used in wet conditions, with the dental adhesive market in view.
Surgical sealant
As a tissue-bonding and haemostatic material replacing sutures. No consent form is required, making it easy to adopt in practice.
Market and positioning
Surgical sealants and adhesives
About US$ 5.4 bn
2030 forecast
Bone adhesives
About US$ 2.0 bn
2034 forecast
Dental adhesives
About US$ 5.9 bn
2033 forecast
How it differentiates
Novelglue sits in the high safety × high adhesive performance quadrant.
Development status
This is currently at the research and development stage. Timing for clinical application or commercialisation is undecided.
Selected for the AMED translational research programme
Non-clinical testing in the bone and cartilage fields under way as Seeds H (Kyoto University School of Medicine, co-investigator) and Seeds A (university school of medicine, lead).
Basic safety data obtained
ISO10993-5 (cytotoxicity), ISO10993-3 (genotoxicity, Ames/micronucleus), ISO10993-4 (haemolysis), LPS removal step and endotoxin testing, scratch assay.
Accumulating animal study data
Bone regeneration assessment in a rat femur model (bone formation begins at 3 weeks, cortical bone regeneration at 5 weeks).
Retesting at GLP/GMP grade
Considering ISO10993-10 (sensitisation and irritation), ISO10993-6 (implantation) and long-term toxicity/carcinogenicity testing in line with PMDA guidance.
Note: this has not reached the stage of PMDA approval, clinical trials or clinical studies. Everything on this page is at the research and development stage.
The evidence behind it
References
About our own test values
The Novelglue performance figures on this page (63 kPa when wet, 0.2 MPa on dry surfaces, LD50, IC50 and so on) are all test values from our own research and development stage, not values published in peer-reviewed papers. The bone regeneration data come from joint research with Kyoto University School of Medicine (AMED translational research programme). Detailed test conditions and internal reports can be provided following an NDA. The prior-art data used for comparison — fibrin glue at 2–5 kPa and PMMA thermal necrosis — are based on the peer-reviewed literature below.
- Kawakami Y., et al. Development of the FP121 series: Hybrid proteins mimicking marine adhesive proteins with cell adhesion and proliferation activity. Materials & Design, 2025. ScienceDirect →
- Farrar D.F. Bone adhesives for trauma surgery: A review of challenges and developments. International Journal of Adhesion and Adhesives, 2012, 33, 89–97. DOI →
- Bojedla S.S.R., Rajasekar B. Biodegradable and Biocompatible Adhesives for the Effective Stabilisation, Repair and Regeneration of Bone. Bioengineering, 2022.
- Spotnitz W.D. Fibrin Sealant: The Only Approved Hemostat, Sealant, and Adhesive. ISRN Surgery, 2014, 203943. DOI →
- Kang E.Y., et al. Poly(methyl methacrylate) in Orthopedics: Strategies, Challenges, and Prospects in Bone Tissue Engineering. Polymers, 2024, 16(3), 367. DOI →
- Szoradi G.T., et al. Polymethyl Methacrylate Bone Cement Polymerization Induced Thermal Necrosis at the Cement–Bone Interface. Applied Sciences, 2024, 14(24), 11651. DOI →
- Choi J., et al. Sticky organisms create underwater biological adhesives driven by interactions between EGF- and GlcNAc-containing polysaccharides. Nature Communications, 2025, 16(1). DOI →
Joint research and technical documentation
Please get in touch about detailed technical documentation for the surgical adhesive (following an NDA), samples or joint research.