Sanguine Corp. (fka SGUI)

[manny21]

Sanguine Receives FDA Meeting Minutes to Define PHER-O2 Regulatory Path
TUESDAY, JANUARY 23, 2007 6:00 AM

PASADENA, Calif., Jan 23, 2007 (BUSINESS WIRE) -- Sanguine Corporation (SGNC) , a bio-pharmaceutical company focused on the development of an oxygen-carrying synthetic substitute for human red blood cells and numerous other areas requiring oxygen profusion, in collaboration with its FDA testing contractors and development team, received its meeting minutes letter from the FDA related to the Company's regulatory approval path. The Company is pleased to announce that it is complete with its animal testing program and is preparing to complete the manufacturing process to support PHER-O2's Master Drug File (MDF) submission to the FDA. Information related to Drug Master Files may be found at: http://www.fda.gov/cder/guidance/dmf.htm.

Furthermore, the Sanguine team is preparing its protocol for the use of PHER-O2 in human whole organ transplant tissue (Liver, Kidneys, Heart, Lung, etc...) as detailed by the Company's meeting minutes. Following the development of the transport protocol and the submission of PHER-O2's MDF, the Company plans to file a Medical Device 510(k) application. Once complete for each organ, this designation will enable the sale of PHER-O2 as indicated for the transport of whole organs used in the 12 billion-dollar annual organ and tissue transplantation market in the U.S.

Dr. Thomas C. Drees, Ph.D. - President and CEO added, "Our medical advisory team is to be commended related to the effort necessary to support the FDA meeting. We are excited to finally have a clear path toward our 510(k) application and potential approval for product sales. Although we will not know the final time-line for the submission until we have completed the manufacturing study and the human protocol, our team is in agreement that the total process should be substantially shorter than originally planned when considering intravenous use of PHER-O2. We look forward to announcing further updates, as they become available."

For information related to the Sanguine Corporation, contact Investor Relations: Michael Dancy, 801-746-3570, email: [e-mail], or visit: www.sanguine-corp.com.

Forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties, including without limitation, continued acceptance of the Company's products, increased levels of competition for the Company, new products and technological changes, the Company's dependence on third-party suppliers, and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission.

SOURCE: Sanguine Corporation

For Sanguine Corporation
Michael Dancy, 801-746-3570 (Investor Relations)
e-mail: [e-mail]
www.sanguine-corp.com


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