Cygnus Announces Results of Research Clinical Studies for
The GlucoWatch
REDWOOD CITY, Calif., Nov. 25 /PRNewswire/ -- Cygnus(R), Inc.
(Nasdaq: CYGN) announced the results from a series of research clinical
studies conducted in 1997 for its painless, bloodless and automatic
glucose monitor, The GlucoWatch(TM).
Based on the accuracy and precision data from these studies, Cygnus
believes that the GlucoWatch system performs comparably with currently
marketed glucose devices. Data from these studies demonstrate that the
GlucoWatch system is able to measure glucose levels with statistically
significant accuracy and precision across a variety of conditions. The
results indicated a correlation coefficient of 0.90, a mean absolute error of
0.20 and a mean bias of 5.0%. These studies have shown that differences
in physiological factors (age, race, ethnicity, gender, body mass index) and
environmental factors (temperature and moderate levels of perspiration)
do not affect the accuracy and precision of the GlucoWatch system's
glucose measurement. Certain commonly used drugs also did not
adversely affect the performance of the GlucoWatch system in those
studies. The accuracy and precision of the GlucoWatch system did not
vary significantly from the overall averages in the groups in which these
variables were tested. Another statistical measure of the data, known as
error grid analysis, supports the accuracy and precision of the
GlucoWatch (92% in the clinically desirable zones A and B). The
Company has recently initiated registration clinical studies for the
GlucoWatch. Cygnus anticipates filing an application for approval with the
FDA in the second quarter of 1998.
These research clinical studies were conducted on people with diabetes by
outside, independent clinical investigators using the commercial version of
the GlucoWatch. GlucoWatch measurements were compared to venous
blood glucose reference measurements every 20 or 30 minutes.
The Company believes the GlucoWatch system offers a combination of
features not available in currently marketed devices, such as: painless and
bloodless glucose extraction; automatic and frequent measurements; an
electronic memory to store and display glucose levels; the ability to
download stored information to personal computers to analyze glucose
data and trends; alarms indicating hypo- and hyperglycemic conditions;
and event markers which record factors that affect glucose levels, all in a
discreet watch format. The Company believes this unique combination of
features will result in better control of glucose levels, an improved quality
of life for people with diabetes and more cost-effective health care.
The forward looking statements regarding future events and the future
performance of the Company contained in this press release involve risks
and uncertainties which may cause the Company's actual results in future
periods to be materially different from any future performance suggested
herein. The Company believes that the submission to the FDA for the
GlucoWatch will be in the form of a premarket notification (a "510(k)
notification"), although the final determination of the type of submission will
not be made until FDA submission. There can be no assurance that a
510(k) notification will be accepted by the FDA. If a 510(k) notification is
not accepted by the FDA, the Company will be required to submit a
premarket approval application ("PMA") for this product. The FDA
approval process for a PMA is typically more involved and requires more
time than a 510(k) notification and could materially delay the introduction
of the GlucoWatch. There can be no assurance as to FDA acceptance or
approval of the form or timing of a 510(k) notification, a PMA or any
similar FDA submission, that the results of the registration clinical trials for
submission to the FDA will be approved by the FDA nor that the results
will be comparable to the results obtained in the research clinical studies
performed to date. Delays or failure to receive clearance following a
510(k) notification or approval of a PMA application could have a
significant adverse effect on the Company's business, financial condition
and results of operations. For more information, refer to Cygnus' filings
with the Securities and Exchange Commission, including its Form 10-K,
Form 10-Q and Form 8-K reports.
Cygnus is engaged in the development and manufacture of diagnostic and
drug delivery systems utilizing proprietary technologies to satisfy unmet
medical needs cost-effectively. The Company's current efforts are
primarily focused on two core areas: a painless, bloodless and automatic
glucose monitoring device (the GlucoWatch system) and transdermal drug
delivery systems.
Copyright 1997, PR Newswire
CONTACT: Craig Carlson |
