WHY NOT ?

NO CHANGE IN SURGICAL TECHNIQUE NO CHANGE IN COST NO CHANGE IN CARE SIMPLY PROVIDING OPTIONS AIMED TO REDUCE REVISION RATES

INTEGR

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INTEGR

Solution

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INTEGR

Solution

IMAGINE IF ALL ORTHO/SPINE PRODUCTS COULD HARNESS THE BENEFITS OF STEM CELLS?

Study: Can the Integr8 draw in bone marrow cells? Bill Walsh University of New South Wales Australia 5/24/23

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Opportunity for

Ingrowth

Paracrine effect of Mesenchymal Stem Cells has proven capability to promote angiogenesis of endothelial cells to accelerate neovascularization for faster bone regeneration [18]

G6 - most complex Gaussian pattern demonstrated: (A) Superior new bone formation (B) Better tissue ingrowth facilitating neotissue infiltration & increase of newly formed bone (C) New bone tissue was higher in density & filled all the space in the scaffolds after 8 weeks (D and E) Higher bone volume/total volume value (F) Optimal potential in supporting the new bone formation Note: all scaffolds were found enveloped in soft tissue without obvious inflammation

Dr Wilson Zack Ray Washington University St. Louis

Dr Khoi Than Duke University

Alekos Theologis University of California San Francisco

Dr Mayur Jayarao Cox Health University of Missouri

Key Opinion Leaders

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Lisa Ferrara, PhD Leading Regulatory Expert

Dr Ralph Rashbaum Spine Surgeon

Advisors

Gunjan Bagla Global Commercialization

Carla Newman Finance & Operations

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Alyssa Huffman, MBA CEO/Founder/Inventor

Paul Orofino VP of Sales

Matthew Shomper Lattice Design Expert

Tarak Buch Global Commercialization

C.A. Schlect CLO - IP Expert

Leadership Team

Tim Rinks COO

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Call: 417.689.2424 Email: info@allumin8.com https://www.linkedin.com/company/allumin8

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Lizhen Wang, Huiwen Huang, Hao Yuan, Yan Yao, Jeong Hun Park, Jinglong Liu, Xuezheng Geng, Kuo Zhang, Scott J Hollister, Yubo Fan, In vitro fatigue behavior and in vivo osseointegration of the auxetic porous bone screw, Acta Biomaterialia, Volume 170, 2023, Pages 185-201, ISSN 1742-7061, Y. Xiong, W. Wang, R. Gao, H. Zhang, L. Dong, J. Qin, B. Wang, W. Jia, X. Li, Fatigue behavior and osseointegration of porous Ti-6Al-4V scaffolds with dense core for dental application, Mater. Des., 195 (2020), Article 108994 R. Dhandapani, P.D. Krishnan, A. Zennifer, V. Kannan, A. Manigandan, M.R. Arul, D. Jaiswal, A. Subramanian, S.G. Kumbar, S. Sethuraman, Additive manufacturing of biodegradable porous orthopaedic screw, Bioact. Mater., 5 (3) (2020), pp. 458-467 Y. Wang, X. Chen, C. Zhang, W. Feng, P. Zhang, Y. Chen, J. Huang, Y. Luo, J. Chen, Studies on the performance of selective laser melting porous dental implant by finite element model simulation, fatigue testing and in vivo experiments, Proc. Inst. Mech. Eng. Part H J. Eng. Med., 233 (2) (2019), pp. 170-180 Sebastien J.P. Callens, Duncan C. Tourolle né Betts, Ralph Müller, Amir A. Zadpoor, The local and global geometry of trabecular bone, Acta Biomaterialia, Volume 130, 2021, Pages 343-361, SSN 1742-7061, https://doi.org/10.1016/j.actbio.2021.06.013. Zou, D., Muheremu, A., Sun, Z., Zhong, W., Jiang, S., & Li, W. (2020). Computed tomography Hounsfield unit–based prediction of pedicle screw loosening after surgery for degenerative lumbar spine disease. Journal of Neurosurgery: Spine SPI, 32(5), 716-721. https://doi.org/10.3171/2019.11.SPINE19868 D.G. Kim, S.S. Huja, B.C. Tee, P.E. Larsen, K.S. Kennedy, H.H. Chien, J.W. Lee, H.B. Wen, Bone ingrowth and initial stability of titanium and porous tantalum dental implants: a pilot canine study, Implant Dent., 22 (4) (2013), pp. 399-405 F. Yang, C. Chen, Q. Zhou, Y. Gong, R. Li, C. Li, F. Klaempfl, S. Freund, X. Wu, Y. Sun, X. Li, M. Schmidt, D. Ma, Y. Yu, Laser beam melting 3D printing of Ti6Al4V based porous structured dental implants: fabrication, biocompatibility analysis and photoelastic study, Sci. Rep., 7 (2017) R. Agarwal, V. Gupta, J. Singh, Mechanical and biological behaviour of additive manufactured biomimetic biodegradable orthopaedic cortical screws, Rapid Prototyp. J., 28 (9) (2022), pp. 1690-1705 P. Trueba, C. Navarro, M. Giner, J.A. Rodriguez-Ortiz, M.Jose Montoya-Garcia, E.J. Delgado-Pujol, L.M. Rodriguez-Albelo, Y. Torres, Approach to the fatigue and cellular behavior of superficially modified porous titanium dental implants, Materials, 15 (11) (2022) The hydroxyapatite modified 3D printed poly L-lactic acid porous screw in reconstruction of anterior cruciate ligament of rabbit knee joint: a histological and biomechanical study, BMC Musculoskelet. Disord., 24 (1) (2023) S. Van Bael, Y.C. Chai, S. Truscello, M. Moesen, G. Kerckhofs, H. Van Oosterwyck, I.P. Kruth, J. Schrooten, The effect of pore geometry on the in vitro biological behavior of human periosteum-derived cells seeded on selective laser-melted Ti6Al4V bone scaffolds, Acta Biomater., 8 (7) (2012), pp. 2824-2834 S.J.P. Callens, D. Fan, I.A.J. van Hengel, M. Minneboo, P.J. Diaz-Payno, M.M. Stevens, L.E. Fratila-Apachitei, A.A. Zadpoor, Emergent collective organization of bone cells in complex curvature fields, Nat. Commun., 14 (1) (2023), p. 855 Anmol Gupta, Thomas Cha, Joseph Schwab, Harold Fogel, Daniel Tobert, Afshin E. Razi, Andrew Hecht, Christopher M. Bono, Stuart Hershman,, Osteoporosis increases the likelihood of revision surgery following a long spinal fusion for adult spinal deformity, The Spine Journal,, Volume 21, Issue 1,, 2021,, Pages 134-140, ISSN 1529-9430, https://doi.org/10.1016/j.spinee.2020.08.002. Rollinghoff M, Schluter-Brust K, Groos D, Sobottke R, Michael JW, Eysel P, Delank KS. Mid-range outcomes in 64 consecutive cases of multilevel fusion for degenerative diseases of the lumbar spine. Orthop Rev. 2010;2(1):e3. Mahesh B, Upendra B, Vijay S, Kumar GA, Reddy S. Complication rate during multilevel lumbar fusion in patients above 60 years. Indian J Orthop. 2017 Mar-Apr;51(2):139-146. doi: 10.4103/0019-5413.201704. PMID: 28400658; PMCID: PMC5361463. Writer, Staff. “Pedicle Screw Systems Market Set to Hit $3.4 Billion in 2027.” Spinal Surgery News, 21 Apr. 2022, www.spinalsurgerynews.com/2022/04/pedicle-screw-systems-market-set-to-hit-3-4-billion-in-2027/91010. Yang, Y., Xu, T., Bei, H., Zhang, L., Tang, C. Y., Zhang, M., … & Zhao, X. (2022). Gaussian curvature–driven direction of cell fate toward osteogenesis with triply periodic minimal surface scaffolds. Proceedings of the National Academy of Sciences, 119(41). https://doi.org/10.1073/pnas.2206684119 Chris Centeno, MD. “How Much Does Low Back Fusion Cost?” Regenexx, 27 Feb. 2022, regenexx.com/blog/how-much-does-low-back-fusion-cost/. Spine Surgery: Global Trends & Opportunities.” Spine Surgery | Global Trends & Opportunities 2018 - Life Science Intelligence, www.lifesciencemarketresearch.com/market-reports/spine-surgery-global-trends-opportunities-procedure-volumes-analysis-2018. Accessed 8 Dec. 2023. Daniell, James R, and Orso L Osti. “Failed Back Surgery Syndrome: A Review Article.” Asian Spine Journal, U.S. National Library of Medicine, Apr. 2018, www.ncbi.nlm.nih.gov/pmc/articles/PMC5913031/. SPINEMarketGroup. “What Is Our Estimate of Spine’s Market Shares by the End of 2022?” SPINEMarketGroup, 6 Jan. 2023, thespinemarketgroup.com/what-is-our-estimate-of-spines-market-shares-by-the-end-of-2022/.