Healthcare Industry News: organ transplant
News Release - May 8, 2007
Sanguine Continues Work Toward FDA 510(k) ApplicationPASADENA, Calif.--(HSMN NewsFeed)--Sanguine Corporation (OTC Bulletin Board: 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, recently added additional management contractors to aid in moving the Company through the 510(k) device application process. The new contractors are intended to aid in managing the 510(k) approval and capitalization path.
The Company's product manufacturer, a well known pharmaceutical development company located in Europe, is completing the chemistry, manufacturing and controls (known as CMC) effort necessary to move PHER-O2 into a position where large manufactured quantities are possible. This effort is also planned to support the previously announced FDA requested task of preparing a Master Drug File submission. According to a Company spokesperson, the Company has had PHER-O2 prepared in small test-only quantities; however, it is now time to be able to prepare PHER-O2 in large quantities.
Also as previously announced, the Sanguine team continues its effort in preparing its protocol for the use of PHER-O2 in human whole organ transplant tissue (Liver, Kidneys, Heart, Lung, etc.). Following the development of the transport protocol and the submission of PHER-O2's Master Drug File submission, the Company plans to file a Medical Device (510-K) application with the FDA. 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 annual organ and tissue transplantation market in the U.S.
Dr. Thomas C. Drees, Ph.D., President and CEO, commented, "We have been at the forefront of synthetic blood innovation for the past decade, and continue to make significant progress in the area. Recently, we received notification from the FDA that PHER-O2 is (to be) classified as a medical device and not a drug, which now avails us to apply for approval as such under a 510(k) filing instead of a full Pre-Market Approval (PMA). We believe that this represents a great opportunity for the Company inasmuch that we can look forward to a potentially much shorter path to market."
Drees added, "During our development of PHER-O2 as a blood alternative, we realized its incredible oxygen carrying capabilities. This led us to determine that PHER-O2 has multiple prospective additional applications including: transfusion recipients, heart attack and stroke victims and other applications, with the intent of seeing that PHER-O2 is in every emergency room (ER) and ambulance across the U.S. The total market potential for PHER-O2 is estimated at more than $7 billion in the U.S. alone. We believe that our product is far superior to any other product currently in the industry and represents a major breakthrough. We are looking forward to making our FDA application and working to take Sanguine to the next level."
For information related to the Sanguine Corporation, contact Investor Relations: Michael Dancy, 801-746-3570, email: firstname.lastname@example.org, 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.
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