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Biocompatibility:

Nanoparticle aggregates are composed of a polymer that has been used in FDA approved devices for over 30 years.

In vivo biocompatibility studies conducted in mice have produced the following results:

• Excellent long-term stability and no degradation of the pHEMA particles or breakup of the bulk aggregates.

• Aggregates exhibit a minimum immune response and fibrous capsule formation over periods up to 90 days.

• A 5-6 cell layer of fibroblasts form on the surface. No particles are found in the draining lymph nodes, lung, liver or spleen.

• With semi-degradable material cellular infiltration occurs and the rate can be controlled.

In vivo biocompatibility studies conducted in pigs have produced the following results:

• Short-term implant studies show limited acute immune response with TNFa levels statistically at background levels.

• Film immediately formed on application to wound site.

• 14 day burn and wound studies show no incidence or rejection of material.

Aggregates implanted in mice show excellent long-term stability and no degradation of the pHEMA particles or breakup of the bulk aggregate over time. In vivo biocompatibility studies show that aggregates exhibit a minimum immune response and fibrous capsule over periods up to 90 days.

Histology slides from Aggregates implanted in mice. The green shows the Nanoparticle Aggregate which contains a fluorescent tag. The blue is a 5-6 cell layer of fibroblasts which form on the surface. This type of Aggregate is dense and does not allow cellular infiltration.

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