Diabetes Care Study Shows Positive Results for Detecting Hypoglycemia With The Cygnus GlucoWatch(R) Biographer

Frequent, Non-Invasive and Automatic Nature of the New Device Allows for More

Effective Detection of Hypoglycemia Than That Achieved With Current Testing

Practice



Apr 26, 2001, 01:00 ET from Cygnus, Inc.

    REDWOOD CITY, Calif., April 26 /PRNewswire/ -- The May 2001 issue of
 Diabetes Care, a prestigious, peer-reviewed journal of clinical and applied
 research, includes the research paper entitled "Detection of Hypoglycemia with
 the GlucoWatch(R) Biographer."  The data presented confirms that the
 GlucoWatch Biographer provides an important improvement over current medical
 practice in detecting hypoglycemic (low blood sugar) events.  The GlucoWatch
 Biographer is the first and only monitoring system that provides glucose
 readings automatically and non-invasively, up to three times an hour, day or
 night, and it received FDA approval in March.
     Authors of the article were Kenneth R. Pitzer D.V.M., Shashi Desai B.S.,
 Tim Dunn B.S., Steve Edelman M.D., Yalia Jayalakshmi Ph.D., John Kennedy B.S.,
 Janet A. Tamada Ph.D., and Russell O. Potts Ph.D.  They presented results
 demonstrating that the GlucoWatch Biographer, with an alarm that is sounded in
 response to glucose readings below user-selected alert levels, can improve
 detection of hypoglycemia over existing medical practice.  This could
 potentially make intensive therapy safer and more acceptable for people with
 diabetes.
     "These results may represent a major step forward in the management of
 diabetes," notes Gerard Reach, M.D., a leading French diabetes researcher and
 author of an editorial article in the same issue of Diabetes Care.  "The
 landmark Diabetes Control and Complications Trial (DCCT) showed that
 improvement of glycemic control by intensive insulin therapy drastically
 reduced many complications of diabetes, but increased the risk of severe
 hypoglycemia.  Therefore, an optimal monitoring system would provide
 continuous glucose level information to people with diabetes, plus be able to
 detect and provide a clear warning of hypoglycemia.  The impact of this new
 technology must be estimated in terms of the metabolic control opportunities
 it provides, along with the ability to detect severe hypoglycemia, and
 ultimately the improved quality of life of people with diabetes."
     Hypoglycemia causes the body to release adrenaline to restore and maintain
 blood glucose levels by converting glycogen and fat into glucose.  The
 conversion process may cause symptoms of nervous system stimulation, such as
 anxiety, sweating, tremor, palpitations, nausea, and pallor.  Hypoglycemia can
 be brought on by taking too much medication, missing or delaying a meal,
 eating too little food for the amount of insulin taken, drinking too much
 alcohol, exercising too strenuously, or any combination of these factors.
 Hypoglycemia starves the brain of glucose energy and this lack of energy can
 cause symptoms ranging from headache and mild confusion to loss of
 consciousness, seizure, and coma.  Because many people with diabetes are
 familiar with the symptoms, they can often recognize them and treat
 hypoglycemia quickly by eating or drinking something with sugar in it.  But a
 person suffering a severe hypoglycemic episode may need emergency medical
 attention or have to be admitted to a hospital to stabilize their blood sugar
 level.  In its most extreme circumstance, hypoglycemia can cause death.
     Over time, many people with diabetes become insensitive to the warning
 signs of hypoglycemia and develop what is known as "hypoglycemia unawareness."
 When this occurs they have difficulty recognizing the symptoms of low blood
 sugar.  This can create potentially dangerous situations, as the person may
 become disoriented, lose consciousness or have a seizure while driving or
 operating machinery.  People with diabetes may also suffer from "nocturnal
 hypoglycemia," a condition where they experience a severe hypoglycemic episode
 while sleeping and lapse into a coma if treatment is not administered quickly.
 Ironically, people who have tight control of their diabetes are more at risk
 for hypoglycemia.
     "For some people with diabetes, particularly those on intensive insulin
 regimens or prone to hypoglycemia unawareness, it may be appropriate to use
 the GlucoWatch Biographer on a routine daily basis," advises study co-author
 Steven Edelman, M.D., Associate Professor of Medicine, Division of Diabetes
 and Metabolism, University of California San Diego School of Medicine and
 Veterans Affairs Medical Center, and founder of the non-profit organization
 Taking Control of Your Diabetes(TM).  "In other situations, the GlucoWatch
 Biographer may be most useful on particularly busy days when a normal routine
 is disrupted.  This type of periodic use may be especially appropriate during
 travel or changes in work shift, which can result in unpredictable glucose
 patterns."  The GlucoWatch Biographer can also be used frequently during
 transitions in therapy, such as a new insulin regimen and then periodically
 for detailed profiles.
     "Medical experts have always told Cygnus that the value of frequent,
 automatic glucose monitoring is compromised without an effective way to detect
 and warn of hypoglycemia," noted John C Hodgman, Chairman, CEO and President
 of Cygnus, Inc (Nasdaq:   CYGN).  "This key capability of the GlucoWatch
 Biographer may encourage more patients to work with their caregivers to embark
 upon the intensive treatment regimens that have been proven to reduce the
 debilitating and expensive consequences of diabetes.  We look forward to
 continuing our pilot marketing program and finalizing our high capacity
 manufacturing capabilities that will ultimately lead to the product's
 availability here in the U.S."
     The published article reports that results from four clinical trials were
 assessed to determine the effectiveness of the GlucoWatch Biographer in
 detecting hypoglycemic events.  The researchers analyzed the performance of
 the GlucoWatch Biographer low glucose alarm relative to hypoglycemia as
 defined by blood glucose (BG) of less than or equal to 3.9 mmol/L (70 mg/dL).
 The analysis was based on 1,091 total GlucoWatch Biographer uses, which
 generated 14,487 paired (GlucoWatch Biographer and BG) readings.  Results
 showed that the number of true positive (alarm sounds and BG less than or
 equal to 3.9 mmol/L) and false positive (alarm sounds but BG greater than
 3.9 mmol/L) increased as the low-glucose alert level of the GlucoWatch
 Biographer was increased.  However, setting the alert level from 1.1 to
 1.7 mmol/L (20 to 30 mg/dL) above the level of concern helped to optimize the
 trade-off between true positives and false positives for the user.
 Researchers found that the same BG data analyzed for typical monitoring
 practices detected fewer hypoglycemic events than with the GlucoWatch
 Biographer.  The results show that with the alert threshold set at 1.1 mmol/L
 (20 mg/dL) above the target level (3.9 mmol/L or 70 mg/dL), 62% of all
 hypoglycemic events were detected, with only 6% fault alerts.  By contrast,
 only 14% of hypoglycemic events were detected with the standard practice of
 two finger stick measurements per day.  They concluded that the GlucoWatch
 Biographer's frequent and automatic readings allow for more effective
 detection of hypoglycemia that that achieved with current medical practice.
     The innovative GlucoWatch Biographer differs from conventional blood
 glucose testing devices in several ways.  Worn like a watch, it calculates,
 displays and stores glucose readings.  It automatically and non-invasively
 measures glucose collected through the skin, not from blood, and displays
 glucose levels as often as every twenty minutes, for up to twelve hours.  It
 also creates an "electronic diary," storing up to 4,000 values that can be
 reviewed at the touch of a button, helping to detect trends and track patterns
 in glucose levels.  In addition, users can set personal glucose alert levels
 so that an alarm sounds if readings are too high or too low, or if readings
 decline rapidly.  The system consists of two integrated parts, the Biographer
 and the AutoSensor.  The Biographer is worn like a watch and calculates,
 displays and stores glucose readings.  The AutoSensor is a single-use
 component that first collects and then measures the glucose sample.  The
 AutoSensor snaps into the back of the Biographer and adheres to the skin,
 providing up to twelve hours of automatic readings.
     Experts agree that many people with diabetes should test their glucose
 levels as often as four to seven times a day.  However, due to the pain and
 inconvenience of current testing methods, many perform just a few tests each
 day; for example, right before meals, possibly missing revealing information
 about glucose levels at other important times, such as after meals or during
 sleep.  The GlucoWatch Biographer allows people with diabetes access to
 information for potentially better-informed decisions about diet, medication
 and physical activities, possibly leading to a better quality of life and
 lower health care costs.  The GlucoWatch Biographer is not intended to replace
 the common "finger-stick" testing method, but rather is designed to be used
 together with blood glucose testing to provide more complete, ongoing
 information about glucose levels.
     Diabetes is a chronic disease characterized by the body's inability to
 produce or properly use insulin, a hormone that is needed to convert sugar,
 starches and other food into the energy needed for daily life.  When left
 untreated, diabetes can lead to heart disease, blindness, amputation, kidney
 disease, dental disease, nerve damage, sexual dysfunction and pregnancy
 complications.
     The World Health Organization estimates there are 125 million people
 worldwide with diabetes.  This number has increased 15% in the last ten years
 and is expected to double by 2005.  In the U.S., approximately ten million
 Americans have been diagnosed with diabetes.  Diabetes is a leading cause of
 death in the U.S., and the complications of uncontrolled diabetes result in an
 estimated $100 billion in medical costs annually.  The current worldwide
 market for glucose measuring products is estimated at between $3 and
 $4 billion, and it is expected to exceed $4.7 billion by 2002.  The U.S. is
 estimated to account for 50-60% of all sales, while Western Europe accounts
 for approximately 30%.
     Cygnus, Inc., headquartered in Redwood City, California, develops and
 manufactures non-invasive diagnostic medical devices, utilizing proprietary
 biosensor technologies to satisfy unmet medical needs cost-effectively.  The
 Company's current efforts are focused on the GlucoWatch Biographer and
 enhancements thereto.
     More information about Cygnus can be found at the corporate web site:
 www.cygn.com.  Additional information about the GlucoWatch Biographer can be
 obtained by calling the Company's toll free number, 866-GLWATCH, or by
 visiting www.glucowatch.com.
     This news release contains forward-looking statements regarding future
 events and the future performance of the Company that involve risks and
 uncertainties that may cause the Company's actual results to differ
 materially.  There can be no assurance that unforeseen problems will not occur
 in product manufacturing and commercial scale-up or marketing or product
 distribution of the GlucoWatch Biographer or that regulatory approval will be
 received for large-scale manufacturing processes.  Any such occurrence could
 significantly delay the commercialization of the GlucoWatch Biographer system
 or prevent its market introduction entirely.  Further, there can be no
 assurance that the Company will be able to enter into a commercialization
 alliance or alliances or that the Company will be able to outsource certain
 commercialization capabilities for launch without a worldwide
 commercialization alliance in place.  There also can be no assurance that the
 product can be successfully manufactured in commercial quantities at a
 reasonable cost, be marketed successfully or achieve market acceptance.
 Furthermore, as the Company seeks regulatory approval for enhancements and
 possible manufacturing changes through the pre-market approval (PMA)
 supplement process, there can be no assurance that such supplements will be
 approved or that one or more new PMAs will not need to be filed.  The Company
 refers you to the documents the Company files from time to time with the
 Securities and Exchange Commission, including the Company's Annual Report on
 Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K,
 which contain descriptions of certain factors that could cause the Company's
 actual results to differ from the Company's current expectations and any
 forward-looking statements contained in this news release.  "GlucoWatch" is a
 registered trademark of Cygnus, Inc.
 
 

SOURCE Cygnus, Inc.
    REDWOOD CITY, Calif., April 26 /PRNewswire/ -- The May 2001 issue of
 Diabetes Care, a prestigious, peer-reviewed journal of clinical and applied
 research, includes the research paper entitled "Detection of Hypoglycemia with
 the GlucoWatch(R) Biographer."  The data presented confirms that the
 GlucoWatch Biographer provides an important improvement over current medical
 practice in detecting hypoglycemic (low blood sugar) events.  The GlucoWatch
 Biographer is the first and only monitoring system that provides glucose
 readings automatically and non-invasively, up to three times an hour, day or
 night, and it received FDA approval in March.
     Authors of the article were Kenneth R. Pitzer D.V.M., Shashi Desai B.S.,
 Tim Dunn B.S., Steve Edelman M.D., Yalia Jayalakshmi Ph.D., John Kennedy B.S.,
 Janet A. Tamada Ph.D., and Russell O. Potts Ph.D.  They presented results
 demonstrating that the GlucoWatch Biographer, with an alarm that is sounded in
 response to glucose readings below user-selected alert levels, can improve
 detection of hypoglycemia over existing medical practice.  This could
 potentially make intensive therapy safer and more acceptable for people with
 diabetes.
     "These results may represent a major step forward in the management of
 diabetes," notes Gerard Reach, M.D., a leading French diabetes researcher and
 author of an editorial article in the same issue of Diabetes Care.  "The
 landmark Diabetes Control and Complications Trial (DCCT) showed that
 improvement of glycemic control by intensive insulin therapy drastically
 reduced many complications of diabetes, but increased the risk of severe
 hypoglycemia.  Therefore, an optimal monitoring system would provide
 continuous glucose level information to people with diabetes, plus be able to
 detect and provide a clear warning of hypoglycemia.  The impact of this new
 technology must be estimated in terms of the metabolic control opportunities
 it provides, along with the ability to detect severe hypoglycemia, and
 ultimately the improved quality of life of people with diabetes."
     Hypoglycemia causes the body to release adrenaline to restore and maintain
 blood glucose levels by converting glycogen and fat into glucose.  The
 conversion process may cause symptoms of nervous system stimulation, such as
 anxiety, sweating, tremor, palpitations, nausea, and pallor.  Hypoglycemia can
 be brought on by taking too much medication, missing or delaying a meal,
 eating too little food for the amount of insulin taken, drinking too much
 alcohol, exercising too strenuously, or any combination of these factors.
 Hypoglycemia starves the brain of glucose energy and this lack of energy can
 cause symptoms ranging from headache and mild confusion to loss of
 consciousness, seizure, and coma.  Because many people with diabetes are
 familiar with the symptoms, they can often recognize them and treat
 hypoglycemia quickly by eating or drinking something with sugar in it.  But a
 person suffering a severe hypoglycemic episode may need emergency medical
 attention or have to be admitted to a hospital to stabilize their blood sugar
 level.  In its most extreme circumstance, hypoglycemia can cause death.
     Over time, many people with diabetes become insensitive to the warning
 signs of hypoglycemia and develop what is known as "hypoglycemia unawareness."
 When this occurs they have difficulty recognizing the symptoms of low blood
 sugar.  This can create potentially dangerous situations, as the person may
 become disoriented, lose consciousness or have a seizure while driving or
 operating machinery.  People with diabetes may also suffer from "nocturnal
 hypoglycemia," a condition where they experience a severe hypoglycemic episode
 while sleeping and lapse into a coma if treatment is not administered quickly.
 Ironically, people who have tight control of their diabetes are more at risk
 for hypoglycemia.
     "For some people with diabetes, particularly those on intensive insulin
 regimens or prone to hypoglycemia unawareness, it may be appropriate to use
 the GlucoWatch Biographer on a routine daily basis," advises study co-author
 Steven Edelman, M.D., Associate Professor of Medicine, Division of Diabetes
 and Metabolism, University of California San Diego School of Medicine and
 Veterans Affairs Medical Center, and founder of the non-profit organization
 Taking Control of Your Diabetes(TM).  "In other situations, the GlucoWatch
 Biographer may be most useful on particularly busy days when a normal routine
 is disrupted.  This type of periodic use may be especially appropriate during
 travel or changes in work shift, which can result in unpredictable glucose
 patterns."  The GlucoWatch Biographer can also be used frequently during
 transitions in therapy, such as a new insulin regimen and then periodically
 for detailed profiles.
     "Medical experts have always told Cygnus that the value of frequent,
 automatic glucose monitoring is compromised without an effective way to detect
 and warn of hypoglycemia," noted John C Hodgman, Chairman, CEO and President
 of Cygnus, Inc (Nasdaq:   CYGN).  "This key capability of the GlucoWatch
 Biographer may encourage more patients to work with their caregivers to embark
 upon the intensive treatment regimens that have been proven to reduce the
 debilitating and expensive consequences of diabetes.  We look forward to
 continuing our pilot marketing program and finalizing our high capacity
 manufacturing capabilities that will ultimately lead to the product's
 availability here in the U.S."
     The published article reports that results from four clinical trials were
 assessed to determine the effectiveness of the GlucoWatch Biographer in
 detecting hypoglycemic events.  The researchers analyzed the performance of
 the GlucoWatch Biographer low glucose alarm relative to hypoglycemia as
 defined by blood glucose (BG) of less than or equal to 3.9 mmol/L (70 mg/dL).
 The analysis was based on 1,091 total GlucoWatch Biographer uses, which
 generated 14,487 paired (GlucoWatch Biographer and BG) readings.  Results
 showed that the number of true positive (alarm sounds and BG less than or
 equal to 3.9 mmol/L) and false positive (alarm sounds but BG greater than
 3.9 mmol/L) increased as the low-glucose alert level of the GlucoWatch
 Biographer was increased.  However, setting the alert level from 1.1 to
 1.7 mmol/L (20 to 30 mg/dL) above the level of concern helped to optimize the
 trade-off between true positives and false positives for the user.
 Researchers found that the same BG data analyzed for typical monitoring
 practices detected fewer hypoglycemic events than with the GlucoWatch
 Biographer.  The results show that with the alert threshold set at 1.1 mmol/L
 (20 mg/dL) above the target level (3.9 mmol/L or 70 mg/dL), 62% of all
 hypoglycemic events were detected, with only 6% fault alerts.  By contrast,
 only 14% of hypoglycemic events were detected with the standard practice of
 two finger stick measurements per day.  They concluded that the GlucoWatch
 Biographer's frequent and automatic readings allow for more effective
 detection of hypoglycemia that that achieved with current medical practice.
     The innovative GlucoWatch Biographer differs from conventional blood
 glucose testing devices in several ways.  Worn like a watch, it calculates,
 displays and stores glucose readings.  It automatically and non-invasively
 measures glucose collected through the skin, not from blood, and displays
 glucose levels as often as every twenty minutes, for up to twelve hours.  It
 also creates an "electronic diary," storing up to 4,000 values that can be
 reviewed at the touch of a button, helping to detect trends and track patterns
 in glucose levels.  In addition, users can set personal glucose alert levels
 so that an alarm sounds if readings are too high or too low, or if readings
 decline rapidly.  The system consists of two integrated parts, the Biographer
 and the AutoSensor.  The Biographer is worn like a watch and calculates,
 displays and stores glucose readings.  The AutoSensor is a single-use
 component that first collects and then measures the glucose sample.  The
 AutoSensor snaps into the back of the Biographer and adheres to the skin,
 providing up to twelve hours of automatic readings.
     Experts agree that many people with diabetes should test their glucose
 levels as often as four to seven times a day.  However, due to the pain and
 inconvenience of current testing methods, many perform just a few tests each
 day; for example, right before meals, possibly missing revealing information
 about glucose levels at other important times, such as after meals or during
 sleep.  The GlucoWatch Biographer allows people with diabetes access to
 information for potentially better-informed decisions about diet, medication
 and physical activities, possibly leading to a better quality of life and
 lower health care costs.  The GlucoWatch Biographer is not intended to replace
 the common "finger-stick" testing method, but rather is designed to be used
 together with blood glucose testing to provide more complete, ongoing
 information about glucose levels.
     Diabetes is a chronic disease characterized by the body's inability to
 produce or properly use insulin, a hormone that is needed to convert sugar,
 starches and other food into the energy needed for daily life.  When left
 untreated, diabetes can lead to heart disease, blindness, amputation, kidney
 disease, dental disease, nerve damage, sexual dysfunction and pregnancy
 complications.
     The World Health Organization estimates there are 125 million people
 worldwide with diabetes.  This number has increased 15% in the last ten years
 and is expected to double by 2005.  In the U.S., approximately ten million
 Americans have been diagnosed with diabetes.  Diabetes is a leading cause of
 death in the U.S., and the complications of uncontrolled diabetes result in an
 estimated $100 billion in medical costs annually.  The current worldwide
 market for glucose measuring products is estimated at between $3 and
 $4 billion, and it is expected to exceed $4.7 billion by 2002.  The U.S. is
 estimated to account for 50-60% of all sales, while Western Europe accounts
 for approximately 30%.
     Cygnus, Inc., headquartered in Redwood City, California, develops and
 manufactures non-invasive diagnostic medical devices, utilizing proprietary
 biosensor technologies to satisfy unmet medical needs cost-effectively.  The
 Company's current efforts are focused on the GlucoWatch Biographer and
 enhancements thereto.
     More information about Cygnus can be found at the corporate web site:
 www.cygn.com.  Additional information about the GlucoWatch Biographer can be
 obtained by calling the Company's toll free number, 866-GLWATCH, or by
 visiting www.glucowatch.com.
     This news release contains forward-looking statements regarding future
 events and the future performance of the Company that involve risks and
 uncertainties that may cause the Company's actual results to differ
 materially.  There can be no assurance that unforeseen problems will not occur
 in product manufacturing and commercial scale-up or marketing or product
 distribution of the GlucoWatch Biographer or that regulatory approval will be
 received for large-scale manufacturing processes.  Any such occurrence could
 significantly delay the commercialization of the GlucoWatch Biographer system
 or prevent its market introduction entirely.  Further, there can be no
 assurance that the Company will be able to enter into a commercialization
 alliance or alliances or that the Company will be able to outsource certain
 commercialization capabilities for launch without a worldwide
 commercialization alliance in place.  There also can be no assurance that the
 product can be successfully manufactured in commercial quantities at a
 reasonable cost, be marketed successfully or achieve market acceptance.
 Furthermore, as the Company seeks regulatory approval for enhancements and
 possible manufacturing changes through the pre-market approval (PMA)
 supplement process, there can be no assurance that such supplements will be
 approved or that one or more new PMAs will not need to be filed.  The Company
 refers you to the documents the Company files from time to time with the
 Securities and Exchange Commission, including the Company's Annual Report on
 Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K,
 which contain descriptions of certain factors that could cause the Company's
 actual results to differ from the Company's current expectations and any
 forward-looking statements contained in this news release.  "GlucoWatch" is a
 registered trademark of Cygnus, Inc.
 
 SOURCE  Cygnus, Inc.