FortaFlex^® Technology

Organogenesis has been developing and commercializing bioengineered collagen products for the past 20 years. Engineering biomaterials that incorporate ideal design characteristics is a major challenge driven by rapid advances in surgical procedures. These biomaterials have uses in many surgical fields including urologic, gynecologic, plastic, neurological and orthopedic surgery. Long term persistence of a biomaterial may be required in certain cases, while other applications need a durable, but not permanent biomaterial that allows for host-tissue integration and tissue regeneration. By controlling the chemical and physical configuration and biocompatibility, FortaFlex^® Technology allows for the creation of biomaterial products for specific applications.  There are three key components to this process:

• Purifying with a proprietary process to ensure biocompatibility.
• Laminating the material to achieve desired physical characteristics.
• Matrix bonding of collagen with a propriety process to control in situ tissue reaction.

The FortaFlex^® Technology process starts with a porcine-derived tissue that has inherent strength and biocompatibility. In summary, the chemical cleaning process consists of:

• Purifying the porcine tissue by treating with chemicals to remove cells and other non-collagenous materials.
• Removing materials that can cause an inflammatory or immunologic response.
• Inactivating viruses and bacteria and decreasing bio-burden.

This cleaning process results in a very pure sheet of Type I collagen in a natural three dimensional matrix structure.

	Before Purification		After Purification

Lamination of FortaFlex^® Technology is engineered to obtain the required physical strength for a wide range of surgical applications.

Collagen Matrix Bonding is the last step in the manufacturing of FortaFlex^® Technology.  Xenogeneic biomaterials are typically crosslinked with glutaralde-hyde to reduce antigenicity and immunogenicity.  However, glutaraldehyde has been shown to accelerate calcification in collagenous materials.  FortaFlex^® Technology does not use glutaraldehyde for this reason; therefore, a proprietary process has been developed.  Collagen matrix bonding is a bioengineered process that modifies the structure of a collagen matrix to control the rate of remodeling in situ.  For remodeling tissue repair, such as that required for hernia repair, a low level of collagen matrix bonding is advantageous. When a lack of cell infiltration is required to resist degradation and remodeling, as in tissue support applications, a higher level of collagen matrix bonding is used.  Collagen matrix bonding increases the biomechanical strength, decreases antigenicity, controls cellular infiltration, remodeling, and enzymatic degradation of collagen.

Organogenesis has five products developed from this technology: FortaGen^®,  bioengineered tissue repair; FortaPerm^®,  bioengineered tissue support; CuffPatch^®,   for rotator cuff repair and all tendons of the body (jointly developed and fully marketed by Biomet Inc.); BioSTAR^®,  for patent foramen ovale (jointly developed and fully marketed by NMT Medical); and FortaDerm^™ Antimicrobial, a wound dressing.  Licensing opportunities are available in various indications.