Medicine:Ovine forestomach matrix

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Short description: Regenerative medical device platform
A scanning electron microscopy (SEM) image highlighting the complex collagenous microarchitecture underlying the luminal surface of OFM.

Ovine forestomach matrix (OFM) (marketed as AROA ECM) is a layer of decellularized extracellular matrix (ECM) biomaterial isolated from the propria submucosa of the rumen of sheep.[1][2] OFM is used in tissue engineering and as a tissue scaffold for wound healing and surgical applications[3][4]

History

OFM was developed and is manufactured by Aroa Biosurgery Limited (New Zealand, formerly Mesynthes Limited, New Zealand)[5] and was first patented in 2008[6] and described in the scientific literature in 2010.[7] OFM is manufactured from sheep rumen tissue, using a process of decellularization to selectively remove the unwanted sheep cells and cell components to leave an intact and functional extracellular matrix.[8] OFM comprises a special layer of tissue found in rumen, the propria submucosa, which is structurally and functionally distinct from the submucosa of other gastrointestinal tissues.[9][10]

OFM was first cleared by the FDA in 2009 for the treatment of wounds.[11][12] Since 2008 there have been >70 publications describing OFM and its clinical applications, and over 6 million clinical applications of OFM-based devices.[13][14]

Composition

OFM comprises more than 24 collagens (most notably types I and III), but also contains many growth factors, polysaccharides and proteoglycans that naturally exist as part of the extracellular matrix and play important roles in wound healing and soft tissue repair.[15][16] The composition includes more than 150 different proteins,[17] including elastin, fibronectin, glycosaminoglycans, basement membrane components, and various growth factors, such as vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF) and platelet derived growth factor (PDGF).[18] OFM has been shown to recruit mesenchymal stem cells,[19][20] stimulate cell proliferation, angiogenesis and vascularogenesis,[21] and modulate matrix metalloproteinase and neutrophil elastase.[22] The porous structure of OFM has been characterized by differential scanning calorimetry (DSC),[23] scanning electron microscopy (SEM),[24][25] atomic force microscopy (AFM),[26] histology,[27] Sirius Red staining,[28] small-angle x-ray scattering (SAXS),[29][30] and micro computerized topography (MicroCT).[31][32] OFM has been shown to contain residual vascular channels that facilitate blood vessel formation through angioconduction.[33][34]

Tissue engineering

OFM can be fabricated into a range of different product presentations for tissue engineering applications, and can be functionalized with therapeutic agents including silver,[35] doxycycline[36] and hyaluronic acid.[37] OFM has been commercialized as single and multi-layered sheets, reinforced biologics and powders.[38][39]

When placed in the body OFM does not elicit a negative inflammatory response and is absorbed into the regenerating tissues via a process called tissue remodeling.[40][41][42]

Clinical significance

Wound healing

Aroa Biosurgery Limited first distributed OFM commercially in 2012 as Endoform™ Dermal Template (later Endoform™ Natural) through a distribution partnership with Hollister Incorporated (IL, USA).[43] Endoform™ Natural and Endoform™ Antimicrobial (0.3% ionic silver w/w), are single layers of OFM is used in the treatment of acute and chronic wounds, including diabetic foot ulcers (DFU)[44] and venous leg ulcers (VLU).[45] Endoform™ Natural has been shown to accelerate wound healing of DFU.[46][47] The wound product Symphony™ combines OFM and hyaluronic acid and is designed to support healing during the proliferative phase particularly in patients whose healing is severely impaired or compromised due to disease[48][49]

Complex plastics and reconstructive surgery

OFM was cleared by the FDA in 2016 and 2021 for surgical applications in plastics and reconstructive surgery as a multi-layered product (Myriad Matrix™)[50][51][52] and powdered format (Myriad Morcells™).[53][54] OFM-based surgical devices are routinely used in complex lower extremity reconstruction,[55] pilonidal sinus reconstruction,[56] hidradenitis suppurativa[57] and complex traumatic wounds.

OFM-based surgical devices are routinely used in plastics and reconstructive surgery for the regeneration of soft tissues when used as an artificial skin[58][59][60]

Hernia repair

Multi-layered OFM devices, reinforced with synthetic polymer were first described in 2008[61] and in the scientific literature in 2010.[62] These devices, termed ‘reinforced biologics’ have been designed for applications in the surgical repair of hernia as an alternative to synthetic surgical mesh (a mesh prosthesis). OFM reinforced biologics are distributed in the US by Tela Bio Inc.[63][64] Clinical studies have shown that OFM reinforced biologics have lower hernia recurrence rates versus synthetic hernia meshes[65][66][67] or biologics[68] such as acellular dermis.

References

  1. ↑ Lun, S., et al., A functional extracellular matrix biomaterial derived from ovine forestomach. Biomaterials, 2010. 31(16): p. 4517-29.
  2. ↑ High Tech Wound Care Company Aroa Releases First Product in Own Backyard. 2020. [Retrieved 25 Sep 23]. Available from: https://www.nzherald.co.nz/business/high-tech-wound-care-company-aroa-releases-first-product-in-own-backyard/JDMEGIPXYMBLIVGHVBNAROMRTU/
  3. ↑ 'Sounds like science fiction': Aroa Biosurgery uses sheep to help humans heal. 2022. [Retrieved 25 Sep 2023]. Available from: https://www.stuff.co.nz/business/industries/127888238/sounds-like-science-fiction-aroa-biosurgery-uses-sheep-to-help-humans-heal
  4. ↑ Sheep guts powering Kiwi firm to ASX float. 2020. [Retrieved 7 Nov 23]. Available from: https://7news.com.au/business/ipos/sheep-guts-powering-kiwi-firm-to-asx-float-c-1122610
  5. ↑ Clever Kiwi Companies Out to Prove that Technology can Save Money as well as Many Peoples Lives. 2010. [Retrieved 25 Sep 2023]. Available from: https://www.nzherald.co.nz/business/clever-kiwi-companies-out-to-prove-that-technology-can-save-money-as-well-as-many-peoples-lives/TVVQSE7OCZOPTRM3EJ2U3FCYXY/
  6. ↑ Ward, B.R., K.D. Johnson, and B.C.H. May, Tissue scaffolds derived from forestomach extracellular matrix, USPTO, Editor. 2008, Mesynthes Ltd.: US.
  7. ↑ Lun, S., et al., A functional extracellular matrix biomaterial derived from ovine forestomach. Biomaterials, 2010. 31(16): p. 4517-29.
  8. ↑ From Tripe, a Kiwi Medical Innovation. 2019. [Retrieved 25 Sep 2023]. Available from: https://www.stuff.co.nz/science/117957242/from-tripe-a-kiwi-medical-innovation
  9. ↑ Well healed. 2023. [Retrieved 7 Nov 23]. Available from: https://www.callaghaninnovation.govt.nz/customer-stories/well-healed
  10. ↑ Franco, A.J., et al., Morphometric and immunohistochemical study of the rumen of red deer during prenatal development. J Anat, 2004. 204(6): p. 501-13
  11. ↑ FDA approves biologic template for tissue regeneration. 2010. [Retrieved 7 Nov 23]. Available from: https://www.dermatologytimes.com/view/fda-approves-biologic-template-tissue-regeneration.
  12. ↑ Premarket notification, 510(k) : K092096. 2010; Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092096.
  13. ↑ Aroa Biosurgery December 2022 4C - Commentary.
  14. ↑ Auckland High Tech Wound Care Company Makes Maiden Profit as Sales Double to 24m. 2020. [Retrieved 25 Sep 2023]. Available from: https://www.nzherald.co.nz/business/auckland-high-tech-wound-care-company-makes-maiden-profit-as-sales-double-to-24m/TRELCVONB6OZ5IXIOI7UVD26YY/
  15. ↑ 'Sounds like science fiction': Aroa Biosurgery uses sheep to help humans heal. 2022. [Retrieved 25 Sep 2023]. Available from: https://www.stuff.co.nz/business/industries/127888238/sounds-like-science-fiction-aroa-biosurgery-uses-sheep-to-help-humans-heal
  16. ↑ Badylak, S.F., The extracellular matrix as a biologic scaffold material. Biomaterials, 2007. 28(25): p. 3587-93
  17. ↑ Using agricultural byproducts to heal complex wounds. 2023. [Retrieved 7 Nov 23]. Available from: https://www.seetomorrowfirst.nz/domestic/news/aroa-using-agricultural-byproducts-to-heal-complex-wounds
  18. ↑ Dempsey, S.G., et al., Functional Insights from the Proteomic Inventory of Ovine Forestomach Matrix. J Proteome Res, 2019. 18(4): p. 1657-1668
  19. ↑ Aroa’s Endoform gains validation to recruit stem cells. 2020. [Retrieved 7 Nov 23]. Available from: https://www.biospectrumasia.com/news/36/16555/aroas-endoform-gains-validation-to-recruit-stem-cells.html
  20. ↑ Dempsey, S.G., et al., A novel chemotactic factor derived from the extracellular matrix protein decorin recruits mesenchymal stromal cells in vitro and in vivo. PLoS One, 2020. 15(7): p. e0235784.
  21. ↑ Irvine, S.M., et al., Quantification of in vitro and in vivo angiogenesis stimulated by ovine forestomach matrix biomaterial. Biomaterials, 2011. 32(27): p. 6351-61
  22. ↑ Negron, L., S. Lun, and B.C.H. May, Ovine forestomach matrix biomaterial is a broad spectrum inhibitor of matrix metalloproteinases and neutrophil elastase. Int Wound J, 2012. 11(4): p. 392-397
  23. ↑ Sizeland, K.H., et al., Collagen Fibril Response to Strain in Scaffolds from Ovine Forestomach for Tissue Engineering. ACS Biomater. Sci. Eng., 2017. 3(10): p. 2550–2558.
  24. ↑ Lun, S., et al., A functional extracellular matrix biomaterial derived from ovine forestomach. Biomaterials, 2010. 31(16): p. 4517-29.
  25. ↑ Sizeland, K.H., et al., Collagen Fibril Response to Strain in Scaffolds from Ovine Forestomach for Tissue Engineering. ACS Biomater. Sci. Eng., 2017. 3(10): p. 2550–2558.
  26. ↑ Smith, M.J., et al., Further structural characterization of ovine forestomach matrix and multi-layered extracellular matrix composites for soft tissue repair. J Biomater Appl, 2021. 36(6): p. 996-1010
  27. ↑ Lun, S., et al., A functional extracellular matrix biomaterial derived from ovine forestomach. Biomaterials, 2010. 31(16): p. 4517-29.
  28. ↑ Sizeland, K.H., et al., Collagen Fibril Response to Strain in Scaffolds from Ovine Forestomach for Tissue Engineering. ACS Biomater. Sci. Eng., 2017. 3(10): p. 2550–2558.
  29. ↑ Sizeland, K.H., et al., Collagen Fibril Response to Strain in Scaffolds from Ovine Forestomach for Tissue Engineering. ACS Biomater. Sci. Eng., 2017. 3(10): p. 2550–2558.
  30. ↑ Floden, E.W., et al., Biophysical characterization of ovine forestomach extracellular matrix biomaterials. J Biomed Mater Res B Appl Biomater, 2010. 96(1): p. 67-75.
  31. ↑ Smith, M.J., et al., Further structural characterization of ovine forestomach matrix and multi-layered extracellular matrix composites for soft tissue repair. J Biomater Appl, 2021. 36(6): p. 996-1010
  32. ↑ Remond, D., F. Meschy, and F. Boivin, Metabolites, water and mineral exchanges across the rumen wall: Mechanisms and regulation. Annales de Zootechnie, 1996. 45(2): p. 97-119.
  33. ↑ Smith, M.J., et al., Further structural characterization of ovine forestomach matrix and multi-layered extracellular matrix composites for soft tissue repair. J Biomater Appl, 2021. 36(6): p. 996-1010.
  34. ↑ Kiwi biotech makes its mark in asx debut. 2021. [Retrieved 7 Nov 23]. Available from: https://www.investsmart.com.au/investment-news/kiwi-biotech-makes-its-mark-in-asx-debut/148404
  35. ↑ Karnik, T., et al., Ionic silver functionalized ovine forestomach matrix - a non-cytotoxic antimicrobial biomaterial for tissue regeneration applications. Biomater Res, 2019. 23(6): p. 17.
  36. ↑ May, B.C.H., C.H. Miller, and B.R. Ward, Collagen-Based Device Having Antifungal Properties, USPTO, Editor. 2016, Aroa Biosurgery Ltd.: US.
  37. ↑ Smith, M.J., et al., Further structural characterization of ovine forestomach matrix and multi-layered extracellular matrix composites for soft tissue repair. J Biomater Appl, 2021. 36(6): p. 996-1010.
  38. ↑ Aroa Biosurgery Web Page. 2023 [cited 2023 27 February 2023]; Available from: https://aroa.com/.
  39. ↑ TELA Bio rolls out new OviTex resorbable for implantation. 2023. [Retrieved 7 Nov 2023]. Available from: https://www.medicaldevice-network.com/news/tela-bio-ovitex-resorbable-implantation/?cf-view
  40. ↑ TELA Bio starts commercialization for large size OviTex reinforced bioscaffolds. 2019. [Retrieved 7 Nov 23]. Available from: https://www.nsmedicaldevices.com/news/tela-bio-aroa-biosurgery-ovitex-rbss/
  41. ↑ Auckland High Tech Wound Care Company Makes Maiden Profit as Sales Double to 24m. 2020. [Retrieved 25 Sep 2023]. Available from: https://www.nzherald.co.nz/business/auckland-high-tech-wound-care-company-makes-maiden-profit-as-sales-double-to-24m/TRELCVONB6OZ5IXIOI7UVD26YY/
  42. ↑ TELA Bio rolls out new OviTex resorbable for implantation. 2023. [Retrieved 7 Nov 2023]. Available from: https://www.medicaldevice-network.com/news/tela-bio-ovitex-resorbable-implantation/?cf-view
  43. ↑ Aroa Biosurgery tipped for IPO at $300m valuation. 2020. [Retrieved 25 Sep 2023]. Available from: https://www.nzherald.co.nz/business/aroa-biosurgery-tipped-for-ipo-at-300m-valuation/HVHFJ24MYSELY6A62WSADNNCTQ/
  44. ↑ Bosque, B.A., et al., Retrospective real-world comparative effectiveness of ovine forestomach matrix and collagen/ORC in the treatment of diabetic foot ulcers. Int Wound J, 2022. 19(4): p. 741-753.
  45. ↑ Bohn, G.A. and K. Gass, Leg ulcer treatment outcomes with new ovine collagen extracellular matrix dressing: a retrospective case series. Adv Skin Wound Care, 2014. 27(10): p. 448-54.
  46. ↑ Aroa launches large format extracellular matrix to treat larger and more complex wounds. 2020. [Retrieved 7 Nov 23]. Available from: https://vascularnews.com/aroa-large-format-extracellular-matrix-larger-complex-wounds-endoform/
  47. ↑ Bosque, B.A., et al., Retrospective real-world comparative effectiveness of ovine forestomach matrix and collagen/ORC in the treatment of diabetic foot ulcers. Int Wound J, 2022. 19(4): p. 741-753.
  48. ↑ Win puts Lower Hutt company on US fast-track. 2010. [Retrieved 7 Nov 23]. Available from: https://www.beehive.govt.nz/release/win-puts-lower-hutt-company-us-fast-track
  49. ↑ Smith, M.J., et al., Further structural characterization of ovine forestomach matrix and multi-layered extracellular matrix composites for soft tissue repair. J Biomater Appl, 2021. 36(6): p. 996-1010.
  50. ↑ Aroa Biosurgery Expands Options for Soft Tissue Repair with Launch of Myriad. 2020. [Retrieved 25 Sep 23]. Available from: https://www.scoop.co.nz/stories/SC2002/S00048/aroa-biosurgery-expands-options-for-soft-tissue-repair-with-launch-of-myriad.htm
  51. ↑ Premarket notification, 510(k) : K153632. 2016; Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K153632.
  52. ↑ Premarket notification, 510(k) : K153633. 2016; Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K153633.
  53. ↑ New Zealand's Aroa Biosurgery Takes Wound Technology to the World. 2021. [Retrieved 25 Sep 2023]. Available from: https://www.asx.com.au/blog/listed-at-asx/new-zealands-aroa-biosurgery-takes-wound-technology-to-the-world
  54. ↑ Premarket notification, 510(k) : K200502. 2021; Available from: https://www.fda.gov/medical-devices/510k-clearances/march-2021-510k-clearances.
  55. ↑ Bosque, B.A., et al., Ovine Forestomach Matrix in the Surgical Management of Complex Lower-Extremity Soft-Tissue Defects. J Am Podiatr Med Assoc, 2023. 113(3).
  56. ↑ Chaffin, A.E., et al., Surgical reconstruction of pilonidal sinus disease with concomitant extracellular matrix graft placement: a case series. J Wound Care, 2021. 30(Sup7): p. S28-S34.
  57. ↑ Chaffin, A.E. and M.C. Buckley, Extracellular matrix graft for the surgical management of Hurley stage III hidradenitis suppurativa: a pilot case series. J Wound Care, 2020. 29(11): p. 624-630.
  58. ↑ Bohn, G.A. and A.E. Chaffin, Extracellular matrix graft for reconstruction over exposed structures: a pilot case series. J Wound Care, 2020. 29(12): p. 742-749.
  59. ↑ Chaffin, A.E. and M.C. Buckley, Extracellular matrix graft for the surgical management of Hurley stage III hidradenitis suppurativa: a pilot case series. J Wound Care, 2020. 29(11): p. 624-630.
  60. ↑ Desvigne, M.N., et al., Case Report: Surgical Closure of Chronic Soft Tissue Defects Using Extracellular Matrix Graft Augmented Tissue Flaps. Frontiers in Surgery, 2020. 7(173)
  61. ↑ Ward, B.R., K.D. Johnson, and B.C.H. May, Tissue scaffolds derived from forestomach extracellular matrix, USPTO, Editor. 2008, Mesynthes Ltd.: US.
  62. ↑ Floden, E.W., et al., Biophysical characterization of ovine forestomach extracellular matrix biomaterials. J Biomed Mater Res B Appl Biomater, 2011. 96(1): p. 67-75.
  63. ↑ Pacira to invest up to $25m in surgical reconstruction company. 2017. [Retrieved 7 Nov 23]. Available from:https://www.drugdeliverybusiness.com/pacira-invest-25m-surgical-reconstruction-company/
  64. ↑ Tela Bio Wins FDA Nod for Ovitex Hernia Repair Bioscaffold. 2016. [Retrieved 25 Sep 2023]. Available from: https://www.massdevice.com/tela-bio-wins-fda-nod-ovitex-hernia-repair-bioscaffold/?utm_source=TrendMD&utm_medium=cpc&utm_campaign=Mass_Device_TrendMD_0
  65. ↑ NextUp: The Malvern Medtech Company Working to Improve Surgical Mesh Options. 2021. [Retrieved 7 Nov 23]. Available from: https://www.phillymag.com/healthcare-news/2021/02/12/tela-bio-surgical-mesh-ovitex/
  66. ↑ Parker, M.J., et al., A novel biosynthetic scaffold mesh reinforcement affords the lowest hernia recurrence in the highest-risk patients. Surg Endosc, 2020. 35(9): p. 5173-5178.
  67. ↑ Sivaraj, D., et al., Outcomes of Biosynthetic and Synthetic Mesh in Ventral Hernia Repair. Plast Reconstr Surg Glob Open, 2022. 10(12): p. e4707.
  68. ↑ Sivaraj, D., et al., Reinforced Biologic Mesh Reduces Postoperative Complications Compared to Biologic Mesh after Ventral Hernia Repair. Plast Reconstr Surg Glob Open, 2022. 10(2): p. e4083.



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