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| |  Investigational Freezing Procedure May Reduce Abnormal Uterine Bleeding San Diego, CA -- November 3, 1999 -- Ninety-two percent of women treated for abnormal uterine bleeding (AUB) with cryoablation-a procedure that uses extreme cold to freeze and destroy uterine tissue-reported success (below normal bleeding levels) six months after treatment. According to CryoGen, Inc., a medical device company using cryoablation, the preliminary results of the clinical trial of its First Option™ Uterine Cryoblation Therapy™ offer promising findings for women suffering from AUB. The First Option clinical trial data will be presented at next week’s American Academy of Gynecologic Laparoscopists (AAGL) conference in Las Vegas, Nev. Affecting 22 percent of healthy women, abnormal uterine bleeding is one of the most common menstrual disorders. More than two-thirds of women who bleed excessively suffer from iron deficiency anemia and AUB can limit a woman’s ability to work, exercise or even leave the proximity of her home and. Ninety-four percent of women surveyed one year following treatment with First Option were satisfied with the results. In evaluating First Option, patients pointed to the treatment’s efficacy in reducing or eliminating menstrual bleeding and the ease of the procedure as benchmarks for their satisfaction. Fifty-three percent of patients reported, at most, minimal spotting and 36 percent reported bleeding levels well below normal six months after treatment. Forty-seven percent of First Option patients were treated under local anesthesia, while 92 percent of women treated with the clinical trial control therapy received general anesthesia. "I’m extremely satisfied with the outcome," said patient Linda Gibson, who had severe and sudden bleeding episodes before treatment. "Prior to First Option, I would worry about having an embarrassing accident as a result of my condition. Now, my heavy bleeding is gone, as well as the accompanying anxiety and stress, allowing me to go about my daily routine worry-free." First Option destroys the uterine lining by using extreme cold to freeze tissue and has already received U.S. Food and Drug Administration (FDA) clearance for intrauterine soft tissue ablation in the treatment of menstrual disorders. By conducting a clinical trial for the specific indication of endometrial ablation, CryoGen hopes to market the device to physicians who treat women suffering from AUB. Until recently, the only widely available and permanent solution to AUB was a hysterectomy, the second most frequently performed major surgical operation for U.S. women of reproductive age. Approximately 600,000 hysterectomies, or one-third of the world’s total, are performed annually in the United States and it is estimated that up to 45 percent of these surgeries are performed to treat severe dysfunctional bleeding. Unlike a hysterectomy, First Option is designed to be performed under local anesthesia in an outpatient or office environment. Additionally, this treatment has the flexibility to treat women with a large or irregularly shaped uterus, enabling physicians to treat a wide range of patients and achieve superior outcomes. "The patients I treated with First Option had very favorable results and experienced a significant, if not complete, reduction in their menstrual bleeding," said Dr. Keith Isaacson, associate professor of Obstetrics and Gynecology and director of Reproductive Endocrinology and Infertility at Massachusetts General Hospital. "The results of this study show that First Option is a clinically effective alternative to hysterectomy and, because of the procedure’s flexibility, may be appropriate for treating a wider range of women suffering from AUB." In the clinical trial, 266 women who recorded a menstrual diary score of 150 or more each month (compared to a normal score of 100) were treated at 11 medical centers across the country. Two-thirds of the patients were treated with First Option and one-third was treated with the control therapy, electrosurgical ablation using a rollerball. Current alternatives to hysterectomy for AUB include electrosurgical techniques using a rollerball or loop, and a recently introduced procedure, balloon ablation. This procedure uses heated liquid inside a latex balloon to ablate the endometrial lining. First Option results were found to be comparable to the rollerball technique, as both procedures significantly reduced menstrual blood flow. "CryoGen is very pleased with the results of our trial to assess First Option as a treatment for abnormal uterine bleeding and we are preparing this data for submission to the FDA," said David Murray, president and CEO of CryoGen, Inc. "We are committed to providing women with a minimally invasive alternative to hysterectomy for the treatment of AUB, and are enthusiastic about these findings as they help demonstrate the efficacy of cryoablation."
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