Our technology platform
The company’s technology platform leverages the self-assembly of biocompatible components to create medical implants that mimic and recreate the structure and composition of tissue. Our implant devices allow cells to integrate with them, which leads to blood vessel formation and the regeneration of new healthy tissue.
We produce our implant devices by isolating and then purifying proteins and carbohydrates from tissues. When placed under the correct conditions and in solution these proteins and carbohydrates join together and self-assemble into nano-sized spheres. These spheres, the building blocks of mammalian tissue, then aggregate together and fall out of solution to form our proprietary insoluble, non-fibrous biomatrix that is shown below in the SEM image.
The biomatrix we manufacture mirrors the protein-carbohydrate-water format of the non-cellular component present within all tissues and organs. This non-cellular tissue is often called the extracellular matrix (ECM). Our biomatrix is a scaffold for the functional regeneration and replacement of vascular, skeletal, dermal and other tissue types.
A good example of how our manufactured biomatrix matches the naturally occurring extracellular matrix is demonstrated below in the two transmission electron micrographs (TEM); both samples were stained with osmium tetroxide. On the left is our manufactured biomatrix and to the right is the extracellular matrix naturally produced by the coronary artery following stenting.
After the matrix is self-assembled it is separated from solution and melted into pellets to simplify commercial production. The pelletized matrix is then further processed into its final form, using the material’s inherent thermoplastic and polymeric properties. Once the products are in their final form they are covalently cross-linked, packaged and sterilized.
Our biomatrix devices have been tested in vascular, orthopedic, urologic and tissue filler replacement-regeneration applications. We have validated manufacturing for use in a clinical trial and successfully completed a FDA-IDE pivotal clinical trial that demonstrated the safety and efficacy of our biomatrix in 150 patients at six sites around the United States.
The biomatrix production processes are easily reproducible and extremely consistent from lot-to-lot. All of the manufacturing steps, including the self-assembly process, have been commercially scaled with minimal infrastructure. The products are shelf-stable with demonstrated stability beyond two years.
We have secured extensive intellectual property covering our biomatrix materials, manufacturing processes and a wide variety of therapeutic applications.