Re: FDA Submission
April 02 2001 - 3:00AM
UK Regulatory
RNS Number:3730B
Osmetech PLC
02 April 2001
OSMETECH SUBMITS E-NOSE TECHNOLOGY
FOR FDA APPROVAL
* Submission made to U.S. Food and Drug Administration
for regulatory approval of UTI sensor technology
* First for any e-nose company
* Remain on track to receive FDA approval by autumn 2001
Osmetech plc ("Osmetech" or "the Company"), the world's
leading electronic nose ("e-nose") company for healthcare
applications today announces that it has made a
submission to US Food and Drug Administration ("FDA") for
approval of its Urinary Tract Infection (UTI) sensor
technology.
In January, the Company announced that it had
successfully completed FDA clinical trials for the
detection of urinary tract infections. These performance
results, better than expected, have now been submitted to
the FDA. This FDA submission is a landmark achievement in
the e-nose industry.
FDA approval for the Company's first diagnostic test is
expected by autumn 2001, a major endorsement of
Osmetech's core technology.
Enquiries:
Osmetech plc 01270 216 444
James White, Chief Executive
Bell Pottinger Financial 020 7353 9203
Matthew Moth/Rebecca Fox
Notes to Editors
* Osmetech plc designs, develops and manufactures
electronic gas and odour sensors (electronic noses) for
use in the healthcare sector. Osmetech's multi-sensor
array based gas sensing technology screens patient
samples and tests for the presence of infection-causing
bacteria.
* The Company, which is based in Crewe, is currently
focusing its IP development on sensors that can detect
bacteria associated with urinary tract infections
(UTIs), bacterial vaginosis (BV) and pneumonia in ICU
patients.
* FDA approval of Osmetech's UTI sensor technology would
represent the strongest possible regulatory endorsement
of the Company's core technology. It would enable
Osmetech to market its product to licensing partners in
the United States, where the size of the healthcare
market provides enormous opportunities.
* Every year there are 50 million Urinary Tract
Infections (UTI) tests in the US. The average cost per
test is at least $5.
* In January 2000, Osmetech announced that its first set
of trials for its UTI product had been successful. The
trials, carried out at St Thomas', London, and the
Brigham & Women's Hospital, Harvard, USA, enabled the
company to obtain "proof of concept" status for its
technology.
* In October 2000, the Board of Osmetech announced that,
following a large proof of concept study at St George's
Hospital Medical School, London, Osmetech's Bacterial
Vaginosis (BV) Microbial Analyser matched the
diagnostic performance of the existing "gold standard"
diagnostic test.
Osmetech (LSE:OMH)
Historical Stock Chart
From Jun 2024 to Jul 2024
Osmetech (LSE:OMH)
Historical Stock Chart
From Jul 2023 to Jul 2024