Eros™ Therapy Tested with Diabetic Women, Preliminary Results Released at Boston University Conference on Female Sexual Dysfunction

BOSTON/ST. PAUL—October 26, 2000—Nugyn, Inc. released today at the third international Female Sexual Function Forum preliminary results of a study on the effectiveness of the EROS-Clitoral Therapy Device (CTD) Treatment on women suffering from diabetes-induced Female Sexual Dysfunction (FSD). Lead investigator Dr. Kevin Billups of the Billups Institute of Sexual Health reported that early results indicate the Eros therapy device is effective and safe in women with diabetes-induced FSD.

The American Diabetes Association reports that approximately 8.1 million U.S. women have diabetes, and women with diabetes are 7.6 times as likely to suffer peripheral vascular disease (PVD) than non-diabetic women. PVD is a disorder resulting in reduced flow of blood and oxygen to tissues to the feet and legs; this reduced blood flow can also affect the genital area. Just as the reduced blood flow can result in numbness in the feet and legs, for women it can result in loss of sensation in the clitoris. The Eros therapy device, developed and manufactured by Nugyn, Inc., can treat this situation by using a gentle vacuum to draw blood back into the clitoral region.

In Dr. Billups’ clinical trial in Minneapolis, preliminary results show that after using the device, 80% of women with diabetes said Eros therapy improved their sexual sensation. 80% noted increased overall sexual satisfaction, 100% experienced improved lubrication, and 80% reported increased orgasm. In November, Dr. Irwin Goldstein of Boston University will begin trials in Boston as part of the same study, increasing the total number of participants to 40. The multi-facility study is expected to be completed in early spring 2001.

Other studies on the effectiveness of Eros therapy for other groups of women are also underway. In the coming six months, Nugyn, Inc. expects to release results of clinical trials of women with cervical cancer and multiple sclerosis as well as a study focusing solely on post-menopausal women.

Insurance Coverage for Eros therapy Increases

An increasing number of women will be reimbursed by their health insurance companies as more companies commit to covering part or all of the device’s cost. The companies that have chosen to cover the cost of the device are generally doing so because they categorize it with its male counterpart, the vacuum for treating erectile dysfunction, introduced in the early 1980s. States with one or more insurance companies that now cover Eros therapy are: California, Connecticut, Florida, Illinois, Louisiana, Michigan, Nebraska, New York, Ohio, Tennessee and Texas.

Physician Survey on FSD

A recently completed survey of gynecologists, primary care physicians, internal medicine specialists and urologists indicates that contrary to common belief, FSD may not be restricted primarily to older women and may affect younger women more than previously thought. According to an independent market research study conducted by McKesson HBOC, the world's largest pharmaceutical supply management and healthcare information technology company, women with FSD are spread more evenly across the generations: 36% are pre-menopausal, 32% are peri-menopausal (going through menopause), and 31% are post-menopausal.

Of the healthcare providers surveyed, 67% said the number of new FSD cases they have seen has increased in the past year. The most-mentioned (69%) barrier to treatment of FSD is a lack of communication in discussing sexual matters.

Requests from Spanish-Speakers

Responding to numerous requests from people whose primary language is Spanish, Nugyn, Inc. is investing in translating not only its informational brochure on Eros therapy into that language, but also the educational FSD Web site it sponsors, www.womenssexualhealth.com. Requests for this bilingual information have come from physicians and women with FSD from regions including San Diego, Los Angeles, Florida, Mexico and Spain. Nugyn, Inc. hopes to have these materials available by the end of 2000.

More Information

November is American Diabetes Month, during which time the American Diabetes Association focuses on raising awareness of the disease and the important annual exams that can prevent serious complications of the disease.

FSD, a disease recognized by the National Institutes of Health, affects more than 43 percent of women to some degree. Women with diabetes, spinal cord injuries, or cardiovascular problems such as hypertension or high cholesterol are at a higher risk of experiencing FSD. Women who take certain prescription medications, including anti-depressants or blood pressure medications, such as beta blockers, may experience FSD as a side effect of these medications.

In April 2000, the U.S. Food and Drug Administration (FDA) granted market clearance for the Eros therapy device. Designed to treat forms of FSD caused by inadequate blood flow to the genitalia, Eros therapy safely and non-invasively provides gentle vacuum directly to the clitoris, causing engorgement. The FDA-cleared indications for the Eros therapy device are that it improves sensation, lubrication, orgasm and overall satisfaction. Clinical studies have shown no adverse side effects from its use. The Eros therapy device is available by prescription in the United States and Canada. It is also CE marked and available internationally in Australia, France, Spain, Italy, Belgium and the United Kingdom.