MONTVALE, N.J., Nov. 19 Synvista Therapeutics, Inc. (AMEX: SYI) today announced that it has submitted, and that the FDA has received its application for 510(k) clearance for its HAPTOCHEK(TM) diagnostic test kit. The 510(k) submission begins a 90-day review process, during which the FDA will determine whether the kit can be distributed to labs throughout the country as an in vitro diagnostic.
"We are very pleased to announce the submission of a 510(k) application for our test kit to the FDA, as it demonstrates that we are continuing to execute on our business plan," said Noah Berkowitz, M.D., President and CEO of Synvista Therapeutics. "We believe that, once cleared by the FDA, our test will become an important facilitator of personalized medicine and may provide a standard by which physicians can influence clinical outcome."
About Synvista Therapeutics
Synvista Therapeutics is a biopharmaceutical company developing clinical diagnostic laboratory tests and drugs to diagnose, treat and prevent cardiovascular disease in people with diabetes. The Company has developed a protein-based clinical laboratory test to identify patients with Hp2-2 diabetes. Tests which identify patients with Hp2-2 diabetes may be useful in identifying diabetic patients at high risk for cardiovascular complications. These patients may benefit from a particular formulation of vitamin E. The Company is also developing a kit to measure CML (carboxy-methyllysine), another potential cardiovascular risk marker.
Synvista Therapeutics is developing oral antioxidant drugs to treat the HDL dysfunction seen in Hp2-2 diabetes, a disease affecting almost 7 million patients in the United States. The Company is also developing alagebrium, a proposed breaker of advanced glycation endproducts (AGEs) for the treatment of systolic and diastolic heart failure.
For more information, please visit the Company's Web site at www.synvista.com.
Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties including, but not limited to, the risks associated with the events described in this press release, future clinical development of Synvista Therapeutics' diagnostic tests and product candidates, and other risks identified in Synvista Therapeutics' filings with the Securities and Exchange Commission. Further information on risks faced by Synvista are detailed under the caption "Risk Factors" in Synvista Therapeutics' Annual Report on Form 10-K for the year ended December 31, 2007. These filings are available on a website maintained by the Securities and Exchange Commission at http://www.sec.gov. The information contained in this press release is accurate as of the date indicated. Actual results, events or performance may differ materially. Synvista Therapeutics undertakes no obligation to publicly release the result of any revision to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
SOURCE Synvista Therapeutics, Inc.