Synvista Therapeutics Announces 510(k) Submission for Its HAPTOCHEK(TM) Test Kit
2008年11月19日 - 11:43PM
PRニュース・ワイアー (英語)
MONTVALE, N.J., Nov. 19 /PRNewswire-FirstCall/ -- 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
http://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. DATASOURCE: Synvista
Therapeutics, Inc. CONTACT: Synvista Therapeutics, Inc.,
+1-201-934-5000, ; or Investor Contact: Kim Sutton Golodetz, ; or
Media Contact: Jules Abraham, , both of Lippert/Heilshorn &
Associates Web Site: http://www.synvista.com/
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