PLEXimine™ polysaccharide technology is based on two processed polysaccharides in aqueous precursor solutions. When simultaneously mixed and applied, these solutions form a dynamic, structured and transparent matrix in situ. Key characteristics of the PLEXimine matrices can be greatly altered for different intended uses by altering the specifications of the starting materials, processing techniques, and application methods. PLEXimine can be applied as either a flowable liquid or a spray, and the matrices can also be provided in lyophilized formats. The matrix structure forms via a transient reversible Schiff base, which provides the cohesive strength of the matrix. The covalent bonds of the Schiff base also provide the adherent strength of the matrix. The matrix will form even when completely immersed, and the transient reversible characteristics of the Schiff base drive it to gently shrink or contract after formation at a predictable rate even when immersed. Though based on patented chemistry, PLEXimine matrices are regulated as medical devices as they do not achieve their primary intended purposes through chemical action within or on the body and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
When provided as a spray or flowable liquid to form structure devices in situ, key functional characteristics can be altered by design for specific indications. These characteristics include the following:
- Gelation time
- Size range, structure and function of matrix pores
- Rate of shrinkage
- Cohesive and adhesive strengths
- Rate of biodegradation and elimination
PLEXimine matrices are based on the processing and concentrations of two polysaccharides – dextran and chitosan, both of which have a history of use in regulated medical products. However, the composition of matter and methods of both processing and use of these two natural or biologically derived sugars are patented. The two processed materials react directly without the use of an external crosslinking agent to form the PLEXimine matrices, thus eliminating the crosslinking agents that are often the source of inflammation and cytotoxicity, swelling, and biodegradation complications.
Endomedix believes that PLEXimine will be the source of a new generation of biosurgery products designed for both established and evolving procedures.