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Funded Research/Products Under Development
1. Control of Microbial Biofilms in Dental Waterlines.
FUNDING INSTITUTION: National Institutes of Health - May, 1999 - April, 2001 - Phase II
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United States Air Force - 1997 - 1998 - Phase I
Commission on Science & Technology of New Jersey - 2000 |
DESCRIPTION: The turbulent two-phase flow method developed by Novaflux was used to efficiently remove biofilm from dental unit waterlines.
A cleaning device was designed, manufactured and installed in dental chairs at the University of Maryland at Baltimore Dental School.
A baseline microbial count of all the units showed a high level of contamination, near 10 million CFU/ml. After installing the device
in the dental units, the microbial count decreased to below the ADA recommended level of 200 CFU/ml. Examination of dental tubing from
the dental chairs used in the study revealed the absence of biofilm in the lumen of such tubing. The Novaflux device is fully automated
and simple to operate and requires about 10 minutes to clean all the waterlines in a typical dental chair.
STATUS: Phase I of this development was funded by the U. S. Air Force to prove the effectiveness of using the two-phase flow in
removing biofilm from dental tubing. The Phase II program (funded by NIH) was completed in June 2001. We are in the process of preparing 510(k)
application to FDA for the device. This technology is ready for commercialization.
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2. Improved Technology for Reprocessing Hemodialyzers.
FUNDING INSTITUTION: National Institutes of Health - May, 1999 - May, 2003.
DESCRIPTION: The two-phase flow process developed by Novaflux generates shear stresses inside the hollow fibers that are
orders of magnitude higher than can be obtained with current dialyzer reprocessing methods. The two-phase fluid mixture is
delivered by a novel means that achieves efficient cleaning of the dialyzer pore structure, fiber lumen surface and under-the-cap area.
The Novaflux process efficiently removes clots and proteins from the dialyzer and significantly increase the number of reuses to >40 without
compromising the clearance of small and middle solutes of the dialyzer. The technology should benefit ESRD (end stage renal disease) patients
by improving dialyzer performance and the dialysis operator by lowering the cost of dialysis.
STATUS: Phase I study is completed. The Phase I results have successfully demonstrated the advantages of the process by significantly
improving dialyzer performance, increasing reuse number and enhancing the clearance of B(2)-microglobulin. In the Phase II program,
we developed prototype devices to perform in-vitro work needed to complete protocol for clinical study. A system for measuring TCV and
pressure leak has been developed and will be incorporated into the final prototype hemodialyzer reprocessing device. We are in the process of
measuring the solute clearances and finalizing the protocol for two clinical studies. Application for 510(k) to FDA is being prepared during the
execution of the Phase II program. A commercial product is expected to be available in about 2 years.
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3. Novel Technology for Reprocessing Flexible Endoscopes.
FUNDING INSTITUTION: National Institutes of Health - Sept, 2000 - April, 2004.
DESCRIPTION: Current reprocessing technologies are deficient in achieving effective cleaning of internal channels of flexible
endoscopes due to limitations in fluid dynamics in such narrow channels. The turbulent two-phase flow developed by Novaflux overcomes
these limitations and is effective in cleaning narrow lumens of flexible endoscopes with high reliability. An optimized device and protocol
should reduce the need for manual cleaning, shorten the reprocessing cycle, reduce the exposure of endoscopes to corrosive sterilants and
ultimately minimize patients’ risk of infection. The goals of the Phase II program are to systematically study and validate the two-phase cleaning
method for endoscope internal channels, develop an appropriate prototype device and finalize protocols (both in-vitro and in clinical setting) to
achieve effective reprocessing of flexible endoscope.
STATUS: Phase I is completed. In Phase I, an automated device to clean the internal surfaces of endoscopes with two-phase flow was designed,
constructed and tested. We are in the process of finalizing the design of the endoscope reprocessing device and performing in-vitro and clinical testing.
Application for 510(k) to FDA will be prepared during the Phase II study.
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4. Low Temperature Decontamination of Dental Handpieces.
FUNDING INSTITUTION: National Institutes of Health - Sept, 2000 - April, 2001.
DESCRIPTION: We are in the process of developing a novel washer chemical sterilizer technology to sterilize dental
handpieces at low temperatures using our patented turbulent two-phase flow method. This technology combines elements of two
accepted technologies, namely washer disinfector and liquid chemical sterilant into a single system. The technology is expected to
minimize catastrophic rotor failure, prevent deterioration of fiberoptic light transmission and maintain the speed and power at a high
performance level.
STATUS: Phase I is completed. Phase I results showed that dental handpieces can be successfully sterilized at
<50C in <10-minute cycle. Phase II proposal with the goal of maturing this technology to commercial status is under review by NIH.
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5. Removal of Biofilm and other Foulants from Spiral-Wound Reverse Osmosis Membranes used in Water Treatment.
FUNDING INSTITUTION: U.S. Department of Interior - Bureau of Reclamation - Sept, 2001 - June, 2002.
DESCRIPTION: A major application of the two-phase flow technology developed by Novaflux is in the area of
cleaning membranes used in water treatment. We are now developing a new and innovative process for cleaning spiral wound
reverse osmosis membrane elements used in water treatment. The technology relies on the use of turbulent two-phase flow to remove foulant,
particularly biofilm, from the surface of membranes. The process takes only 10-30 minutes and uses only a small quantity of cleaning agent.
This is a major advantage over conventional membrane cleaning processes that require long processing time (about 8 hrs.) and very large amounts of
corrosive cleaning liquids.
STATUS: Protocol is under development to clean several spiral wound elements in series with the two-phase process. The hardware
needed to clean spiral-wound membranes with the two-phase flow technology has been largely developed.
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6. Novel Process for Cleaning Ultrafiltration Membranes used in Water Treatment.
FUNDING INSTITUTION: U.S. Navy - 1998 - 1999.
DESCRIPTION: We applied the turbulent two-phase flow technology developed by Novaflux to clean ultrafiltration tubular
membranes used in wastewater treatment on board Navy surface ships. The technology proved to be effective at maintaining membrane
flux at optimal levels during treatment of gray water using the bioreactor process. The cleaning requires only few minutes to accomplish.
Only a very small amount of cleaning liquid is needed to achieve effective membrane cleaning by this process.
STATUS: Concluded. A process and protocol to clean tubular membranes with the two-phase flow
process was developed, tested and validated. The technology is being extended to include the cleaning of piping systems
in food, beverage and pharmaceutical industries.
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7. Cleaning Methods for Submersible Filtration Modules.
FUNDING INSTITUTION: U.S. Navy - Sept, 2000 - Aug, 2001.
DESCRIPTION: Several methods have been systematically developed and tested to clean commercial submersible membrane filters manufactured by Zenon,
Kubota and Mitsubishi. The main objective of the program was to develop in-situ cleaning methods for the various module designs without
removing them from the tank (bioreactor).
STATUS: Concluded February 2002. New process to clean submersible membranes in-situ inside the tank
was developed and tested. Further testing will be done by the United States Navy personnel.
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8. Environmentally Safe Polymeric Wood Preservatives.
FUNDING INSTITUTION: United States Department of Agriculture - May, 2002 - Nov, 2002.
DESCRIPTION: We are developing environmentally safe wood preservatives based on a new class of biocides. A total of 18 compounds will
be synthesized and tested using the standard soil-block method. These compounds possess multiple functions (anti-fungal, insecticidal,
ion-chelating and hydrophobicity) to perform as broad-spectrum wood preservative.
STATUS: All the 18 compounds have been made and formulated and are in the process of being tested as wood
preservatives at Oregon State University.
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