Ovine forestomach matrix
Ovine forestomach matrix, marketed as AROA ECM, is a layer of decellularized extracellular matrix biomaterial isolated from the propria submucosa of the rumen of sheep. OFM is used in tissue engineering and as a tissue scaffold for wound healing and surgical applications.
History
OFM was developed and is manufactured by Aroa Biosurgery Limited and was first patented in 2008 and described in the scientific literature in 2010. 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. 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.OFM was first cleared by the FDA in 2009 for the treatment of wounds. Since 2008 there have been >70 publications describing OFM and its clinical applications, and over 6 million clinical applications of OFM-based devices.
Composition
OFM comprises more than 24 collagens, 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. The composition includes more than 150 different proteins, including elastin, fibronectin, glycosaminoglycans, basement membrane components, and various growth factors, such as vascular endothelial growth factor, fibroblast growth factor and platelet derived growth factor. OFM has been shown to recruit mesenchymal stem cells, stimulate cell proliferation, angiogenesis and vascularogenesis, and modulate matrix metalloproteinase and neutrophil elastase. The porous structure of OFM has been characterized by differential scanning calorimetry, scanning electron microscopy, atomic force microscopy, histology, Sirius Red staining, small-angle x-ray scattering , and micro computerized topography. OFM has been shown to contain residual vascular channels that facilitate blood vessel formation through angioconduction.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, doxycycline and hyaluronic acid. OFM has been commercialized as single and multi-layered sheets, reinforced biologics and powders.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.
Clinical significance
Wound healing
Aroa Biosurgery Limited first distributed OFM commercially in 2012 as Endoform™ Dermal Template through a distribution partnership with Hollister Incorporated. Endoform™ Natural and Endoform™ Antimicrobial, are single layers of OFM used in the treatment of acute and chronic wounds, including diabetic foot ulcers and venous leg ulcers. Endoform™ Natural has been shown to accelerate wound healing of DFU. 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.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 and powdered format. OFM-based surgical devices are routinely used in complex lower extremity reconstruction, pilonidal sinus reconstruction, hidradenitis suppurativa 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.