INGfertility Receives FDA Clearance for Pre' Vaginal Lubricant for Use During Fertility Interventions

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INGfertility, LLC received FDA clearance to market Pre' Vaginal Lubricant as the first lubricant specifically indicated for use to facilitate the entrance of diagnostic or therapeutic devices during fertility interventions (such as intrauterine insemination, embryo transfer etc..). "Many couples, and even some physicians are not aware of the damage to sperm caused by available lubricants . Pre' offers a safe lubricant for use in clinical procedures at fertility clinics" according to CEO Dr. JE Ellington. At least 15% of all couples will not become pregnant after a year of unprotected intercourse, and are diagnosed as infertile, resulting in a $1.5 B/yr industry. In order to receive clearance, Pre' underwent substantial testing regarding its effect on sperm function, including sperm's ability to fertilize eggs (in an animal model) and support normal embryo development. Pre' is a companion product to Pre~Seed Intimate Moisturizer. Many couples have found Pre~Seed to be the right solution for their vaginal dryness while actively trying to conceive.

We are very excited about this breakthrough product for trying-to-conceive couples

INGfertility, LLC recently received clearance from the FDA to market Pre' Vaginal Lubricant. Pre' is a personal lubricant for couples to enhance the comfort of intimacy. It is also the first lubricant specifically indicated for use to facilitate the entrance of diagnostic or therapeutic devices during fertility interventions (such as intrauterine insemination, embryo transfer etc..). Pre' is also compatible with condoms, including the polyurethane condoms used for semen sample collection by intercourse.

"We are very excited about this breakthrough product for trying-to-conceive couples" states Dr. JE Ellington, Founder of INGfertility. "Many couples, and even some physicians are not aware of the damage to sperm caused by most currently available lubricants . Pre' offers a safe lubricant for use in clinical procedures at fertility clinics".

At least 15% of all couples will not become pregnant after a year of unprotected intercourse, and are diagnosed as infertile. With only a 20% chance of becoming pregnant each cycle, many more couples seek medical advice before a diagnosis of infertility is applicable. Fertility interventions in the US represent at least a $1.5B/ yr industry with many couples using invasive, costly interventions. Pre' offers a lubricant which does not interfere with sperm function or embryo development during these procedures.

In order to receive clearance, Pre' underwent substantial testing regarding its effect on sperm function including sperm's ability to fertilize eggs (in an animal model) and support normal embryo development. In addition, each lot of product is required to undergo and report test results on human sperm and mouse embryos, similar to testing required for media used during assisted reproduction (such as in vitro fertilization).

In studies at Ghent University in Belgium, Pre' was found to more mild and less irritating than other leading lubricants (such as KY® , Astroglide®, and Replens®), making it an ideal Vaginal Lubricant for women at any time in their life.

Pre' is a companion product to Pre~Seed Intimate Moisturizer. Pre~Seed is sold in intravaginal applicators to deposit moisture in the vagina, near the cervix . Pre~Seed's unique formula does not harm sperm because it is pH and ion concentration matched to semen and fertile cervical mucus. Many couples have found Pre~Seed to be the right solution for their vaginal dryness while actively trying to conceive.

SOURCE: INGfertility, LLC 10/26/06

CONTACT: Dr. GD Clifton, VP Business Development 509.443.0149, fax 509.448.0601, info @ ingfertility.com.

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Dennis Clifton
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