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A New High-Level Disinfectant for Medical Instruments

Award Information
Agency: Department of Health and Human Services
Branch: Centers for Disease Control and Prevention
Contract: 2R44CI000078-02
Agency Tracking Number: CI000078
Amount: $750,000.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Solicitation Year: N/A
Award Year: 2005
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
7795 Mainland, Suite 103
United States
DUNS: 611002614
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (210) 681-3211
Business Contact
Phone: () -
Research Institution

DESCRIPTION (provided by applicant): We have developed a new dialdehyde based cold high-level disinfection/sterilization product for treatment of medical instruments specially heat sensitive fiberoptic endoscopes and have demonstrated that it is 100% e
ffective against Mycobacterium tuberculosis in less than 30 minutes at 20 degree Celcius at a concentration of as low as 0.5%. Our formulations at 2%, 1% and 0.5% dilutions, also exhibited sporicidal activity against B. subtilis and C. sporogenes at 20 deg
ree Celcius. The formulations were stable enough at the pH of activity. This Phase-II proposal aims to elevate our product from the level of feasibility demonstration to that of marketable high level disinfection product that has acceptable use life and s
torage stability, will not damage or alter the functionality of medical equipment, is sporicidal and rapidly tuberculocidal at 20 degree Celcius to assure fast turn around time, and will meet the safety and efficacy requirements for federal (510k) approval
. It is proposed that a large scale and cheaper synthesis of active ingredient of our product and its analyses will be optimized into a set for standard operating procedure under GMP and GLP licenses from FDA. An optimized formulation will be designed for
stability, materials compatibility, user friendliness, and disinfection/ sterilization capabilities to fulfill the federal efficacy and safety requirements for 510(k) notification for marketability. This will be achieved through a research done in 5 speci
fic aims, proposed here. Based on the promising data exhibited by the active ingredient of our product in Phase I study, a US patent application has been filed. The same data also indicate that the success our product through this proposed Phase-ll study,
which leads to the FDA approval against 510(k) notification, is clearly foreseen, too. This product can help contain many nosocomial infections, which affect as many as 2 million citizens and cost more than 4.5 millions to economy annually. Our product
has a potential to eradicate the problems associated with HLD agents of today, and to capture their almost entire market.

* Information listed above is at the time of submission. *

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