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01 | DIRECT NANOFUSE EVIDENCE
Laboratory Studies
Investigations of material properties and osteogenic activity under controlled experimental conditions.
FEATURED PUBLICATION | 2025 | IN VITRO
Kingsley R Chin 1, Chukwunonso C Ilogu, Sukanya Chebrolu, William M Costigan, Erik Spayde, Vito Lore, Douglas P Beall, Robby Lane, Josue P Gabriel, Aditya Humad, Jason A Seale.
This in vitro study compared the osteoinductive potential of recombinant BMP-2, bioactive glass (BAG), demineralized bone matrix (DBM), and a composite nano-BAG + DBM formulation (NanoFuse DBM) using a C2C12 alkaline phosphatase assay. Results demonstrated that wet/frozen DBM produced the highest alkaline phosphatase activity, while NanoFuse DBM at higher concentration exceeded the assay’s detection limit and outperformed BMP-2, DBM + gel, and BAG-based formulations. BMP-2 showed comparatively lower osteogenic activity at the tested dose, and BAG alone exhibited minimal induction. Overall, the findings suggest that NanoFuse DBM provides robust, dose-dependent osteoinductive activity and may represent a safer and more effective alternative to BMP-2 and traditional graft materials for spinal fusion and other orthopedic applications, warranting further in vivo investigation.
02 | DIRECT NANOFUSE EVIDENCE
Animal Studies
Preclinical evaluations of spinal fusion and new bone formation
2015. Rabit spinal fusion model
International Journal of Biomedical Materials Research. 2015 July;3(3)
James F. Kirk, Gregg Ritter, Michael J. Larson, Robert C. Waters, Isaac finger, John Waters, John H. Abernethy, Dhyana Sankar, James D. Talton, Ronald R. Cobb
This study evaluated NanoFUSE® DBM in a 64-rabbit lumbar spinal fusion model using radiographic, histologic, and mechanical assessments. At 24 weeks, NanoFUSE® DBM combined with autograft demonstrated 94% radiographic fusion, comparable to autograft alone (94%), versus 61% with NanoFUSE® DBM alone.
2013. Mouse Ectopic Bone Model
Cell Tissue Bank. 2013 Mar;14(1)
Osteoconductivity and osteoinductivity of NanoFUSE(®) DBM
James F Kirk 1, Gregg Ritter, Chad Waters, Sonoko Narisawa, José Luis Millán, James D Talton
This study demonstrated new bone formation following implantation of NanoFUSE® DBM into mouse thigh muscle, providing in vivo evidence of osteoinductive activity. Complementary laboratory studies demonstrated osteoblast attachment and proliferation on the material.
03 | CLINICAL USE & INVESTIGATIONS
Clinical Studies
Published clinical studies evaluating the use of NanoFUSE® in spinal fusion and other orthopedic procedures
2026. InSpan
J Spine Surg . 2026 Sep 30;12(9):149.
Sandra Thompson, Vito Lore, Erik Spayde, Taylor Headley, Jordan Acosta, Hope Estevez, Sukanya Chebrolu, Jason A Seale, Kingsley R Chin
This two-patient clinical report describes the use of NanoFUSE® Biologics combined with autograft and InSpan® interspinous fixation during revision surgery for failed lumbar interspinous implants.
2025. Sacrix
Spine J . 2025 Nov;25(11):2382-2390.
A prospective multicenter randomized controlled trial on safety and procedural competency in SI joint fusion performed by interventional pain physicians trained by a spine surgeon
| Kingsley R Chin 1, Erik Spayde, William M Costigan, Soubrata V Raikar, Yeshvant A Navalgund, Paul Pannozzo, Jessen J Mukalel, Steven Siwek, Sachin Narain, Luis Fandos, Paul Ky, Shaun Jackson, Ajay Yeddu, Michael Rock, Randolph Chang 15, Tian Xia, Abdul Shahid, Vasilios Kountis, Mark H Coleman, Azhar Pasha, Boleslav Kosharskyy, Christine Haddad, Faris Abusharif, Matthew McCarty, Michael D Danko, Justice Otchere, Michael Hunter, Matthias Wiederholz, Abram Burgher, Vito Lore, Angel Walker 2nd, Hope Estevez, Chukwunonso C Ilogu, Jason A Seale
Evaluated training, procedural competency, and safety in sacroiliac joint fusion using threaded fixation and biologics. This study was not designed to isolate NanoFUSE graft effectiveness.
2023. Sacrix
J Spine Surg . 2023 Sep 22;9(3):348-356.
Salvage of failed direct lateral sacroiliac joint fixation using a new percutaneous lateral-oblique transfixation technique with two variable-threaded screws: a multicenter case report of three cases
| Kingsley R Chin 1, Richard R Francis, William M Costigan, Erik Spayde, Chidubem Ike, Yujin Jeong, Deepak K Pandey, Jason A Seale
Described revision sacroiliac joint procedures using threaded implants with NanoFUSE biologics. Outcomes reflect the complete technique rather than the graft in isolation.
04 | SCIENTIFIC BACKGROUND
45S5 Bioactive Glass Research
Supporting scientific literature on bioactive glass in tissue engineering, bone regeneration, spinal fusion, and antimicrobial applications.
Nanomaterials (Basel). 2024 Jul 13;14(14):1196.
Kevin G Liu 1, Elan Karlin, Henry Avetisian, Ishan Shah, Andy T Ton, William Karakash, Marc A Abdou, Jeffrey C Wang, Raymond J Hah, Ram K Alluri
Nanomaterials (Basel). 2024 Jul 13;14(14):1196.
Andreea-Luiza Mîrț, Denisa Ficai, Ovidiu-Cristian Oprea, Gabriel Vasilievici, Anton Ficai
Acta Biomater. 2011 Jun;7(6)
Mohamed N Rahaman 1, Delbert E Day, B Sonny Bal, Qiang Fu, Steven B Jung, Lynda F Bonewald, Antoni P Tomsia
Pathogens. 2025 Aug 1;14(8):760.
Humera Sarwar, Richard A Martin, Heather M Coleman, Aaron Courtenay, Deborah Lowry
Mater Sci Eng C Mater Biol Appl. 2021 Dec:131:112453.
B R Spirandeli 1, R G Ribas 2, S S Amaral 3, E F Martins 1, E Esposito 1, L M R Vasconcellos 3, T M B Campos 2, G P Thim 2, E S Trichês 4
BMC Microbiol. 2022 Sep 2;22(1):212.
Peng Zhou 1 2, Brittny L Garcia 2, Georgios A Kotsakis 3 4
Pending Studies
Pending Publication
Efficacy of an FDA Approved Synthetic Nano-Bioactive Glass Plus Demineralized Bone Matrix (DBM) Combination versus DBM Alone in Instrumented Lumbar Fusion for Low-Grade Degenerative Spondylolisthesis: A Prospective Randomized Controlled Trial Pilot Study
Pending Publication
A Prospective Randomized Controlled Trial Comparing Nano-Bioactive Glass plus Demineralized Bone Matrix (DBM) vs. DBM Alone in Single-Level ACDF with Standalone PEEK Cages
Pending Publication
Safety and efficacy of a nano-bioactive glass combined with demineralized bone matrix (DBM) versus DBM alone with standalone PEEK cages in two-level ACDF: A prospective randomized controlled trial pilot study
Pending Publication
An In Vitro Study of Alkaline Phosphatase Induction as a Quantitative Measure of the Osteoinductive Potential of FDA-Approved Nano-Bioactive Glass Combined with Demineralized Bone Matrix (DBM) vs Bioactive Glass Alone and DBM Alone