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NanoFuse Research

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Featured Scientific Study

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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.

Featured Rabbit Study

International Journal of Biomedical Materials Research. 2015 July;3(3)

Radiographic, Histologic and Mechanical Comparison of NanoFUSE® DBM and a Bioactive Glass in a Rabbit Spinal Fusion Model

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

A Rabbit Model Study of NanoFuse® Combination of DBM and 45S5 Bioactive Glass Rabbit spinal fusion models remain a well-established preclinical method for evaluating bone graft materials and biologics. In a space often driven by clinical claims and marketing narratives, studies like this provide an opportunity to examine underlying biological performance in a controlled setting. Findings: The study demonstrated that the FDA-cleared NanoFuse® combination of DBM and 45S5 bioactive glass outperformed bioactive glass alone in a rabbit model. Complementary alkaline phosphatase data further showed enhanced biological activity compared to DBM alone, supporting a combined—or potentially synergistic—effect of the formulation. In addition, NanoFuse combined with autograft performed comparably to autograft alone, indicating its potential utility as an adjunct in grafting applications. Taken together, these findings suggest that NanoFuse may provide improved biological performance relative to DBM alone. As the only FDA-cleared combination of DBM and bioactive glass, these data offer validation of its design and proposed mechanism. At the 4-week timepoint, NanoFuse demonstrated lower early fusion rates compared to autograft, indicating a slower early radiographic response. The overall pattern is consistent with a more gradual, dose-dependent bone formation profile, distinct from the rapid inductive effect associated with BMP-2. From a practical perspective, NanoFuse is designed to build on the clinical utility of DBM by enhancing performance while potentially reducing the volume of DBM required. Its ability to be combined with autograft also provides flexibility for surgical use.

Scientific Studies

Int J Spine Surg . 2025 Dec 28;19(6)

Comparative Osteoinductive Potential of BMP-2, Bioactive Glass, and Demineralized Bone Matrix: An In Vitro Alkaline Phosphatase Assay Study

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

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

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

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Animal Studies

International Journal of Biomedical Materials Research. 2015 July;3(3)

Radiographic, Histologic and Mechanical Comparison of NanoFUSE® DBM and a Bioactive Glass in a Rabbit Spinal Fusion Model

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

Clinical Studies

Spine J . 2025 Nov;25(11):2382-2390.

| 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

J Spine Surg . 2023 Sep 22;9(3):348-356.

| Kingsley R Chin 1, Richard R Francis, William M Costigan, Erik Spayde, Chidubem Ike, Yujin Jeong, Deepak K Pandey, Jason A Seale

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

45S5 Bioglass Studies

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

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

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