Cryogenic Approach to Treat Excessive Menstrual Bleeding Approved by FDA:

Her Option(TM) Provides Safe Alternative to Hysterectomy



Apr 20, 2001, 01:00 ET from CryoGen, Inc.

    SAN DIEGO, April 23 /PRNewswire Interactive News Release/ -- CryoGen, Inc.
 announced today that the U.S. Food and Drug Administration has approved its
 Her Option(TM) Uterine Cryoblation Therapy(TM) System for marketing. Her
 Option is a cryosurgical device for endometrial ablation in pre-menopausal
 women with menorrhagia (excessive menstrual bleeding) due to benign causes.
 Menorrhagia affects as many as one in five American women.
     "The Her Option procedure offers a safe and effective, less invasive
 alternative to hysterectomy for women who have completed childbearing,"
 explained Seth J. Herbst, M.D., F.A.C.O.G., of the Institute for Women's
 Health in West Palm Beach, Florida.  "It can be performed with a local
 anesthetic in a hospital, surgery center or physician's office in
 approximately 20 minutes."
 
     The Her Option Solution
     Her Option allows cryogenic technology to be applied in a safe and
 controlled way.  The Uterine Cryoblation Therapy System works via a slender
 probe attached to a cooling unit that is inserted through the cervix into the
 uterus. The tip of the probe is brought to a very low temperature to freeze
 and eliminate the uterine lining (endometrium), the tissue responsible for
 excessive bleeding.
     Her Option uses a unique closed-cycle cryogenic gas cooling unit the size
 of a desktop computer to cool the tip of the probe. The procedure is guided
 and monitored on a real-time basis using ultrasound. No serious adverse events
 due to the Her Option procedure were documented during the clinical trial.
     "Cryogenics has been in use in women's health for 25 years," explained
 Duane E. Townsend, M.D., F.A.C.O.G., clinical professor in the Department of
 OB/GYN at the University of Utah School of Medicine and a pioneer in the
 development of minimally invasive surgical techniques. "Her Option is the
 first and only FDA-approved technique that uses hypothermia, in contrast to
 other available uterine ablation technologies that use extreme heat or
 electricity to destroy the endometrium. The controllability of the procedure
 through the use of ultrasound guidance permits one to achieve a thorough level
 of ablation with safety."
 
     The Impact of Menorrhagia
     Women with menorrhagia experience protracted or unmanageable bleeding and
 a need to change sanitary products frequently. Many suffer in silence due to
 lack of awareness of treatments or reluctance to discuss the problem.
 Excessive bleeding often limits a woman's activities, impairs quality of life
 and can strain marital and family relationships.
     "I always had to count the weeks before and after my period and plan my
 life around it," reported Kimberly P., a teacher in her thirties who lived
 with menorrhagia for years. "I often felt exhausted and I couldn't go places
 for fear of an accident. It interfered with my job and my relationship with my
 husband and kids."
     Benign factors that can cause excessive bleeding include hormone
 imbalance, polyps or fibroids. The problem also frequently impacts a woman's
 general health and well-being.
     "More than two thirds of women who bleed excessively are anemic as a
 result," pointed out Dr. Herbst. "Standard treatments like hormone therapy
 work with some women but are not tolerated well by others. Another frequent
 solution, hysterectomy, is a major surgery with a four to six week recovery
 period and long-term implications."
     Traditionally, many menorrhagia patients who did not respond to hormone
 therapy or were unable to tolerate its side effects would undergo
 hysterectomy, accounting for as many as 45% of hysterectomies performed.
 During hysterectomy, the ovaries may also be removed, resulting in menopause.
 Other long-term effects of hysterectomy include weight gain, chronic pain,
 urinary incontinence and heart disease.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X28065235
 
 

SOURCE CryoGen, Inc.
    SAN DIEGO, April 23 /PRNewswire Interactive News Release/ -- CryoGen, Inc.
 announced today that the U.S. Food and Drug Administration has approved its
 Her Option(TM) Uterine Cryoblation Therapy(TM) System for marketing. Her
 Option is a cryosurgical device for endometrial ablation in pre-menopausal
 women with menorrhagia (excessive menstrual bleeding) due to benign causes.
 Menorrhagia affects as many as one in five American women.
     "The Her Option procedure offers a safe and effective, less invasive
 alternative to hysterectomy for women who have completed childbearing,"
 explained Seth J. Herbst, M.D., F.A.C.O.G., of the Institute for Women's
 Health in West Palm Beach, Florida.  "It can be performed with a local
 anesthetic in a hospital, surgery center or physician's office in
 approximately 20 minutes."
 
     The Her Option Solution
     Her Option allows cryogenic technology to be applied in a safe and
 controlled way.  The Uterine Cryoblation Therapy System works via a slender
 probe attached to a cooling unit that is inserted through the cervix into the
 uterus. The tip of the probe is brought to a very low temperature to freeze
 and eliminate the uterine lining (endometrium), the tissue responsible for
 excessive bleeding.
     Her Option uses a unique closed-cycle cryogenic gas cooling unit the size
 of a desktop computer to cool the tip of the probe. The procedure is guided
 and monitored on a real-time basis using ultrasound. No serious adverse events
 due to the Her Option procedure were documented during the clinical trial.
     "Cryogenics has been in use in women's health for 25 years," explained
 Duane E. Townsend, M.D., F.A.C.O.G., clinical professor in the Department of
 OB/GYN at the University of Utah School of Medicine and a pioneer in the
 development of minimally invasive surgical techniques. "Her Option is the
 first and only FDA-approved technique that uses hypothermia, in contrast to
 other available uterine ablation technologies that use extreme heat or
 electricity to destroy the endometrium. The controllability of the procedure
 through the use of ultrasound guidance permits one to achieve a thorough level
 of ablation with safety."
 
     The Impact of Menorrhagia
     Women with menorrhagia experience protracted or unmanageable bleeding and
 a need to change sanitary products frequently. Many suffer in silence due to
 lack of awareness of treatments or reluctance to discuss the problem.
 Excessive bleeding often limits a woman's activities, impairs quality of life
 and can strain marital and family relationships.
     "I always had to count the weeks before and after my period and plan my
 life around it," reported Kimberly P., a teacher in her thirties who lived
 with menorrhagia for years. "I often felt exhausted and I couldn't go places
 for fear of an accident. It interfered with my job and my relationship with my
 husband and kids."
     Benign factors that can cause excessive bleeding include hormone
 imbalance, polyps or fibroids. The problem also frequently impacts a woman's
 general health and well-being.
     "More than two thirds of women who bleed excessively are anemic as a
 result," pointed out Dr. Herbst. "Standard treatments like hormone therapy
 work with some women but are not tolerated well by others. Another frequent
 solution, hysterectomy, is a major surgery with a four to six week recovery
 period and long-term implications."
     Traditionally, many menorrhagia patients who did not respond to hormone
 therapy or were unable to tolerate its side effects would undergo
 hysterectomy, accounting for as many as 45% of hysterectomies performed.
 During hysterectomy, the ovaries may also be removed, resulting in menopause.
 Other long-term effects of hysterectomy include weight gain, chronic pain,
 urinary incontinence and heart disease.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X28065235
 
 SOURCE  CryoGen, Inc.