Technology
Technology Overview
Since the company's inception, the founders sought to develop a new biomaterial specifically designed for medical applications. The Biomerix Biomaterial™ is constructed to mimic the nature and function of the extracellular matrix (ECM), a biological structure in the body capable of supporting tissue repair and regeneration. Constructed as an ideal biointegrative scaffold, the Biomerix Biomaterial™ is a cross-linked and reticulated polycarbonate polyurethane-urea. The Biomaterial consists of a three-dimensional, open-cell, macroporous structure that selectively adsorbs plasma and ECM proteins paving the way for cells to migrate, proliferate, attach and regenerate new tissue.
23x Magnified View of Biomerix Biomaterial™
Fundamental to Biomerix's research and development approach is its thorough understanding of the healing process and an appreciation for the key features essential to optimizing a biomaterial.
Ideal Scaffold Characteristics
- Attract and attach autologous (locally available) cells into the scaffold/repair site
- Define and maintain a three-dimensional construct for tissue regeneration
- Provide biomechanical support framework for remodeling of regenerated tissue
Among the essential features for a synthetic scaffold, are biocompatibility, biointegration, biostability, biodurability, and biomechanical properties. In addition it is also beneficial to have a scaffold material that can be customized to fit specific clinical and anatomical applications.
FEATURES
Biocompatibility
The Biomerix Biomaterial™ is derived from the base chemistry of a family of biomedical polyurethanes, with a long history of use in implantable medical device applications. Consisting of a biocompatible polycarbonate polyurethane-urea (PCPU), the Biomaterial represents classic segmented, elastomeric morphology typical of urethanes. It has passed a panel of ISO 10993 biocompatibility testing with outstanding results. Factors such as cellular toxicity, systemic toxicity (acute and chronic), and degradation are among just a few of the elements covered in the ISO 10993 panel.
Biointegration
Biointegration, as defined by robust fibrovascular ingrowth and remodeling into the Biomerix Biomaterial is a result of its unique structural features:
Fully-accessible interconnected macro porous morphology
- Over 90-95% accessible void content
- Cell sizes ranging from 250µ–500µ
- Pore sizes ranging from 100µ–250µ
High fluid permeability—a direct consequence of the interconnected porous structure, which allows for permeation and adsorption of plasma and ECM proteins
Large internal surface area—a product of the interconnected pore structure, allows for three-dimensional organization of cells to protein surfaces
Biostability & Biodurability
The superior biostability and biodurability of the Biomerix Biomaterial is the direct result of its base chemistry, polycarbonate polyurethanes (PCPU). Considered to be the best-in-class polymer chemistry for biostability, PCPUs are supported by a well-established body of peer-reviewed scientific evidence. The polycarbonate soft segment and the methyl-diisocyanate (MDI) hard segment structure, combined with urea crosslinks ensures that the Biomerix Biomaterial is highly resistant to the four major in vivo degradation pathways, i.e. oxidative, hydrolytic, enzymatic, and metal ion degradation. This ensures that the implanted scaffold is intact and acts as a long-term support framework for the maintenance and homeostasis of regenerated tissue.
Biomechanical Properties
The chemistry of the Biomerix Biomaterial can be manipulated to tailor various biomechanical properties (i.e., stiffness, strength, and resilience) of the scaffold. The cross-linked Biomaterial is elastomeric and demonstrates resilient recovery after being deformed in both compression and tensile modes. The elastic nature of the Biomaterial, especially in its recovery characteristics when subjected to dynamic loading, is extremely unique in an open-cell matrix and allows the Biomaterial to be used in surgical applications and in soft tissue implant applications involving dynamic biomechanical loading where resilience is critical.
Customizable
The Biomerix Biomaterial can be customized for site appropriate applications to provide conforming implants across a near infinite range of form factors. A broad range of physical properties, such as tensile strength, pore size and recovery profile can also be adapted to meet specific device requirements.