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USPTO Notice of Allowance

AMxTek LLC is pleased to ring in the New Year by inaugurating its weblog with the following posting:

AMxTek LLC has received USPTO Notice of Allowance regarding its Patent Publication No. US2011/0196502, filed Feb. 1, 2011, with a Provisional Patent Application priority date of Feb. 5, 2010, entitled: Methods of Using Water-Soluble Inorganic Compounds for Implants. A USPTO Patent Publication can be found at: http://www.amxtek.com/services.html

The focus of this USPTO Notice of Allowance pertains to methods of seeding and fixating inorganic compounds, and more specifically water-soluble bioactive glass particles, within the interstices of porous-coated implants, which upon dissolution provide for: i) osteostimulation – i.e. the up-regulation of osteoblast growth factor gene expression [BMPs], enhancing bone matrix deposition and implant fixation; and/or ii) antimicrobial implant prophylaxis – via ionic silver [Ag+] release.

Bioglass® [45S5], first developed by L.L. Hench, PhD1, in the early 1970’s, is a well studied and often cited example of such bioactive glass.  Calcium ions have been shown to up-regulate osteoblast growth factor gene expression2 [i.e. Bone Morphogenic Proteins – BMP], accelerating bone matrix deposition. The osteogenic attributes of Bioglass® 3-9 and/or similar bioactive glassy inorganic compounds, has been exploited in several U.S. FDA 510(k)-concurred orthopedic bone void fillers and putties10-15.

The in-vitro antimicrobial effectiveness16-17 and clinical antimicrobial prophylaxis from the in-situ dissolution of water-soluble phosphate glass particles containing various silver-oxide compounds, has also been clinically demonstrated18. Such water-soluble, bioactive glassy particles have been exploited in several antimicrobial U.S. FDA 510(k)-concurred medical devices in wound care19-21, urology22 and hemodialysis23-24.

AMxTek LLC IP provides for the use of such bioactive glassy particles in porous-coated [orthopedic and spinal] implants, affording the device both antimicrobial and osteogenic attributes concurrently, while maintaining the ability to terminally sterilize or autoclave the implant without loss of bioactive effectiveness.

AMxTek LLC is seeking business development partners in the orthopedic and/or spinal implant market interested in commercializing the technology via IP license or co-development. Inquiries should be addressed to:

Jim Walls
President
AMxTek LLC

Email: jim.walls@amxtek.com
Office Phone:  (203) 393-1387
Mobile Phone: (203) 859-2997

Cited References:

  1. Hench LL; The Story of Bioglass®; J Mater Sci: Mater Med (2006) 17: 967-978
  2. Barradas A: Molecular analysis of biomaterial-driven osteogenic differentiation of human mesenchymal stem cells; BioInterface 2011
  3. Xynos ID, Hukkanen MV, Batten JJ, Buttery LD, Hench LL, Polak JM: Bioglass 45S5 stimulates osteoblast turnover and enhances bone formation In vitro: implications and applications for bone tissue engineering; Calcif. Tissue Int., 2000 Oct; 67(4): 321-9
  4. Price N, Bendall SP, Frondoza C, Jinnah RH, Hungerford, DS: Human osteoblast-like cells (MG63) proliferate on a bioactive glass surface; J of Biomaterials Research, 1997; 37(3): 394–400
  5. Qui Z, Yang H, Wu J, Li. J: Ionic dissolution products of NovaBone promote osteoblastic proliferation via influences on the cell cycle; J of International Medical Research, 2009; 37(3): 737-45
  6. Tsigkou O, Jones JR, Polak JM, Stevens MM: Differentiation of fetal osteoblasts and formation of mineralized bone nodules by 45S5 Bioglass conditioned medium in the absence of osteogenic supplements; Biomaterials, 2009; 30(21): 3542-50
  7. Saino E, Maliardi V, Quartarone E, Fassina L, Benedetti L, Cusella De Angelis MG, Mustarelli P, Facchini A, Visal L: In-vitro enhancement of SAO-2 cell calcified matrix deposition onto radio frequency magnetron sputtered Bioglass-coated titanium scaffold; Tissue Engineering Part A, 2010 Mar; 16(3): 995-1008
  8. Huang W, Rahaman N, Day DE: Conversion of Silicate 45S5, Borosilicate Glasses Hydroxyapatite in Dilute Phosphate Solution; 30th International Conf. on Advanced Ceramics and Composites
  9. Jung SB, Day DE: Conversion Kinetics of Silicate, borosilicate and borate bioactive glass to hydroxyapatite; Physics and Chemistry of Glasses, European Journal of Glass Science and Technology B, April 2009; 50(2): 85-88
  10. Orthovita, Inc.: Vitross BA Bimodal bioactive Bone Graft Substitute; K103173
  11. Novabone Products, LLC: Perioglas – Bioglass Bone Graft Substitute; K040278
  12. Novabone Products, LLC: MacroPor-Si – Bioactive Synthetic Bone Graft; K110925
  13. Nanotherapeutics, Inc.: Origen DBM with Bioactive Glass; K062459
  14. Nanotherapeutics, Inc.: Origen DBM with Bioactive Glass, NanoFuse® DBM; K110976
  15. Inion Oy: Inion Biorestore Biodegradable Bone Graft Substitute; K090177
  16. Cook1 GS, Costerton2 JW; 1Bacterin. Inc., 2Center for Biofilm Engineering, Montana State Univ.; Foley Catheter Biofilm Formation Comparison Study in an In-vitro Assay; http://www.amxtek.com/about.html; hyperlink: Dover® Silver
  17. Case Study: Corglaes® Ag; www.giltech.biz
  18. Gonzalez VR, et al.; Changing Clinical Practice to Reduce Sternal Surgical Site Infections (S-SSI) in Open Bypass Surgery; APIC, June 2001
  19. Maersk Medical Ltd.: Arglaes Film Dressing; K970566
  20. Maersk Medical Ltd.: Arglaes-Ab Antimicrobial Barrier Island; K990810
  21. Maersk Medical Ltd.: Arglaes-Ab Antimicrobial Barrier Powder; K04028
  22. The Kendall Co., Div. of Tyco Healthcare Group: Dover Silver Hydrogel Coated Silicone Foley Catheter; K024010
  23. The Kendall Co., Div. of Tyco Healthcare Group: 14.5 Fr. Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve [Palindrome™ Sapphire™]; K062671
  24. Covidien plc; Palindrome Precision SI Chronic Catheter, and Palindrome Precision HSI Chronic Catheter; K123196