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Technology: Biocompatibility

Since biocompatibility is determined by the final device configuration, different configurations can be pursued based on the intended exposure time of the medical device (for example, acute use versus chronic use) and ISSYS has investigated several pathways to biocompatibility.

The biocompatibility of ISSYS' devices is based on a solid foundation of academic research. ISSYS' founders, Dr. Ken Wise and Dr. Khalil Najafi, are world-renowned for biologic MEMS applications and lead the largest, longest NIH program for invasive MEMS. Studies have demonstrated biocompatibility for up to one year in animal implantation and show great potential for long-term biocompatibility for ISSYS core technology. These studies have also suggested the superior biocompatibility of ISSYS materials, making ISSYS' systems an ideal choice for use in the body.

To build on the academic research foundation and document proof that will be acceptable to the medical community, ISSYS has performed and is continuing to perform biocompatibility evaluations with several partners, including ViroMed, the Cleveland Clinic Foundation, and Kellogg Eye Center, as well as others. Initial results are positive at the materials level. In addition, capacitive sensors in particular offer low operating power and are compatible with protective coatings that provide additional opportunities to enhance biocompatibility.

Preliminary screening for FDA tests
Animal study of implantable intraocular pressure sensors in 2002
Tissue Compatibility Study

Animal study of implantable pressure sensors in 2002



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