ADZA Adeza Biomedical (MM)

Adeza (NASDAQ:ADZA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's New Drug Application (NDA) for Gestiva(TM), a long-acting form of a naturally occurring progesterone to prevent preterm birth in women with a history of preterm delivery. In May 2006, Adeza announced its submission of the Gestiva NDA, which includes data from a clinical study conducted by the National Institutes of Health (NIH). The NDA for Gestiva was granted Priority Review status by the FDA in June 2006. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the FDA has set a priority review goal to respond to the Gestiva NDA by October 20, 2006. "We are pleased that the Gestiva NDA is moving forward in the regulatory process," said Emory V. Anderson, president and chief executive officer. "Gestiva has the potential to significantly reduce the risk of preterm birth in one of the highest risk groups, women with a history of preterm delivery." The use of this form of progesterone is recommended by the American College of Obstetricians and Gynecologists (ACOG) in the treatment of women for recurrent preterm birth. If Gestiva receives FDA approval, Adeza will have the only NIH-studied, ACOG-recommended and FDA-approved therapeutic for the prevention of recurrent preterm birth. Adeza designs, manufactures and markets innovative products for women's health. Adeza's initial focus is on reproductive healthcare using its proprietary technologies to predict preterm birth and assess infertility. Adeza's principal product is a patented diagnostic test, FullTerm(TM), The Fetal Fibronectin Test, which utilizes a single-use, disposable cassette and is analyzed on Adeza's patented TLiIQ(R) System. This product is approved by the U.S. Food and Drug Administration (FDA) for use in assessing the risk of preterm birth. Adeza also markets and sells the E-tegrity(R) Test, an infertility-related test to assess receptivity of the uterus to embryo implantation in women with unexplained infertility. In May 2006, Adeza announced the submission of its New Drug Application (NDA) to the FDA for Gestiva, a long-acting form of a naturally occurring progesterone to prevent preterm birth in women with a history of preterm delivery. Adeza's NDA submission includes data from a clinical study conducted by the National Institutes of Health. In June 2006, the NDA for Gestiva was granted Priority Review status. More information is available at www.adeza.com. Adeza cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements, including for example, statements related to Gestiva's regulatory status and medical potential. The inclusion of forward-looking statements should not be regarded as a representation by Adeza that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Adeza's business including, without limitation, risks related to the anticipated regulatory or commercial path for its product candidates. Further information about these and other risks is included in Adeza's Annual Report on Form 10-K and other periodic and current reports filed by Adeza with the Securities Exchange Commission, which are available from the SEC's Web site (www.sec.gov), and also available on the Investor Relations section of Adeza's Web site. All forward-looking statements are qualified in their entirety by this cautionary statement and Adeza undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.