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TM

Not Cleared for Sale in the US

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Black Gradient Background

TM

3D Porous Pedicle Screw

FEATURED

12/18/23

Problem

  • 21-62% of spine fusions have serious and debilitating complications [14,15,16]


  • Most common mechanical issue is screw loosening (30-54%) [1,15]


  • 5.2 million spine surgery procedures performed worldwide increasing at a 7.9% annual rate[20]


  • The rate of lumbar fusion complications continue to escalate despite more advanced technologies [21]


  • High cost burden and risk of serious complications [19]


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INTRAOPERATIVE X-RAY

1 MONTH POST-OP X-RAY

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3d red arrow down
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Red Long Right Arrow

Why Do Screws Loosen?

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Circle Shape Outline
Circle Shape Outline
Circle Shape Outline

Vertebral Bone

[5]

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Vertebral Bone is Unique

  • Thinner lattices
  • Larger macro pores
  • Smaller micro pores
  • More vascular
  • Large variances in shapes

[5]

WHY NOT ?

INTEGR

TM

  • NO CHANGE IN SURGICAL TECHNIQUE


  • NO CHANGE IN COST


  • NO CHANGE IN CARE


  • SIMPLY PROVIDING OPTIONS AIMED TO REDUCE REVISION RATES


INTEGR

TM

Solution

INTEGR

Solution

TM

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*Video speed enhanced 1.5X

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


Opportunity for

Ingrowth

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

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

TM

Key Opinion Leaders

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

TM

Advisors

Prof Bill Walsh


Leading Research Expert

Gunjan Bagla


Global Commercialization

Carla Newman


Finance & Operations

Dr Ralph Rashbaum


Spine Surgeon

TM

Alyssa Huffman, MBA


CEO/Founder/Inventor

Tarak Buch


Global Commercialization

Leadership Team

Matthew Shomper


Lattice Design Expert

C.A. Schlect


CLO - IP Expert

Paul Orofino


VP of Sales

TM

Get in

Touch

Call: 417.689.2424

Email: info@allumin8.com

https://www.linkedin.com/company/allumin8

Allumin8 is a registered trademark of Allumin8, Inc.

  1. 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,
  2. 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
  3. 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
  4. 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
  5. 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.
  6. 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
  7. 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
  8. 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)
  9. 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
  10. 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)
  11. 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)
  12. 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
  13. 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
  14. 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.
  15. 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.
  16. 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.
  17. 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.
  18. 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
  19. Chris Centeno, MD. “How Much Does Low Back Fusion Cost?” Regenexx, 27 Feb. 2022, regenexx.com/blog/how-much-does-low-back-fusion-cost/.
  20. 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.
  21. 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/.
  22. 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/.