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CELLSENSE - MICROENGINEERING CELL RESPONSE

The  CellSense  technology  is  designed  to  interfere  with  the  complex  biological response involved in the foreign body reaction and subsequent formation of fibrotic tissue around the implantable medical device. 

The foreign body response begins with adsorption of various proteins to the surface of  the  implant. This non-specific layer of proteins labels the device as foreign to the body and triggers  high  neutrophil  activity  and  release  of  soluble  factors.

 

Subsequently macrophages and monocyte precursor cells are recruited. Given the impossibility to kill the foreign object, the immune system starts the recruitment of fibroblasts, with the aim of encapsulating the foreign material in a newly deposited collagen matrix. The resulting fibrotic capsule creates a thick physical and physiological barrier between the implant and the host tissue, leading to several clinical problems.

The CellSense technology comprises surface microstructured biosynthesised cellulose which disrupts the process of cell adhesion and deposition of fibrous tissue, through a combination of ideal physiochemical and surface characteristics.

DEVELOPMENT TIMELINE

The CellSense technology is the foundation for the Hylomate range of products currently developed for a number of intended uses and indications.

An extensive development program has been undertaken to gather evidence on the safety and performance of the Hylomate range of products. In vitro studies have clearly shown the effectiveness of the technology to reduce cell adhesion to a minimum when compared to other materials and surfaces[2] and further long term in vivo studies have shown a significant reduction of fibrotic encapsulation when combined with a variety of soft tissue implantable medical devices.

MICROTOPOGRAPHY

Biosynthesized Cellulose

Ultra-pure cellulose produced by a biotech fermentation process comprising a network of cellulose nanofibres that strongly resembles the microstructure of human connective tissue.

​The hydrophilic nature of the biocellulose provides a physiological environment as the water layer is the first to interact with host tissue.

Rationally Designed Microtopography

The unique surface topography consisting of an isotropic distribution of micro-sized wells, disrupts adhesion and activation of immune cells through a process called mechano-transduction.

Specific surface topographies can be rationally designed promote different cell responses (e.g. stimulate cell differentiation or cell migration).

CellSense Platform

Hylomorph's patented production methods can manufacture the CellSense material in large volumes with an essentially unlimited variety of forms and dimensions [1].

The Hylomate range of products in development is based upon the CellSense technology, and are designed to be used with a variety of soft tissue implantable medical devices.

Development timeline for the Hylomate range of products incorporating the CellSense technology

References

[1] S. Bottan et al., “Surface-structured bacterial cellulose with guided assembly-based biolithography (GAB),” ACS Nano, vol. 9, no. 1, pp. 206–219, 2015.

[2] F. Robotti et al., “A micron-scale surface topography design reducing cell adhesion to implanted materials,” Sci. Rep., vol. 8, no. 1, p. 10887, Dec. 2018.

[3] F. Robotti et al, "Microengineered biosynthesized cellulose as anti-fibrotic in vivo protection for cardiac implantable electronic devices," Biomaterials, vol. 229, 2020.