The production of large amounts of sterile, pyrogen-free water on-line at low cost has been hampered by the lack of technology. We have demonstrated the feasibility of developing such technology by our Phase I. Research. We are proposing to apply this technology for dialysis treatments. The following areas are targeted: preparing dialysate, water for reuse procedures, and substitution fluids. All the above can be improved by the availability of ultrapure water for low cost. Our goal is to demonstrate that the device-treated water and dialysate are at least as safe as traditional, and that endotoxin free solutes decrease side effects of dialysis. We propose to develop prototypes of water and dialysate treating devices: a.) meeting regulatory requirements b.) demonstrating the benefits, c.) the safety of this technology, d.) and reduced side effects. This technology has broader range of applications that we have outlined, including peritoneal dialysis, home hemodialysis, production of WFI grade solutions in hospitals, pharmacies, and pharmaceutical companies. The market potential for the prospective products is in excess of 100 million dollars over a period of five year. The commercial potential of the proposed devices lies in addressing the needs of large patient populations.

Proposed Commercial Applications

Commercial application include removal of endotoxin from water, dialysate, and different solutions. The use of endotoxin free wate is important in preparation of clinical grade solutions. This technology also provides the users with the opportunity to purge ready solutions from endotoxin, without altering the original ion composition.

Agency
National Institute of Health (NIH)
Institute
National Institute of Environmental Health Sciences (NIEHS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44ES007473-02
Application #
2539775
Study Section
Special Emphasis Panel (ZRG5-BM-2 (04))
Project Start
1995-09-30
Project End
2000-03-14
Budget Start
1998-03-15
Budget End
1999-03-14
Support Year
2
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Clarigen, Inc.
Department
Type
DUNS #
City
Carlsbad
State
CA
Country
United States
Zip Code
92008