CONTACT:
For Immediate ReleaseRoderick L. Mackenzie
Gynétics Inc.
Tel: 908-359-2429
Lori Agin
Medisphere Communications
Tel: 212-213-4211
Fax: 212-696-5205

PREVENTM EMERGENCY CONTRACEPTIVE KIT — THE FIRST AND ONLY EMERGENCY CONTRACEPTIVEPRODUCT — APPROVED BY THE FDA

— Important Contraceptive Option Could Potentially ReduceAbortions and Unintended Pregnancies By Half

SOMERVILLE, NJ, September 2, 2022 — Gynétics Inc. announced today thatthe Food and Drug Administration (FDA) has approved the PREVENTM EmergencyContraceptive Kit. This is the first FDA-approved product for emergencycontraception that can prevent pregnancy when used within 72 hours (threedays) after sex. The PREVENTM Emergency Contraceptive Kit, which will beavailable by prescription from doctors and other healthcare professionalsbefore the end of September, is made in the United States.

The PREVENTM Emergency Contraceptive Kit pill regimen is the most widelystudied and used emergency contraceptive. The regimen utilizes special dosesof regular birth control pills, which act before pregnancy begins and willnot affect an existing pregnancy. Used correctly, the pills in the PREVENTMKit may result in only about two out of 100 women becoming pregnant after anact of sex.

“It is estimated that nearly 50 percent of all abortions and unintendedpregnancies in this country could be avoided if women had access toemergency contraception”,” said Anita Nelson, MD, Associate Professor in theDepartment of Obstetrics and Gynecology at the University of California atLos Angeles. “The availability of an effective emergency contraceptiveoption with a good safety profile is a major milestone in women’sreproductive health. Women may want to discuss keeping the PREVENTM Kit onhand with their doctors or other healthcare professionals in case emergencycontraception becomes necessary.”

There are over 2.7 million unintended pregnancies per year in the UnitedStates; nearly half are due to contraceptive failure. According to theCenters for Disease Control and Prevention (CDC), more than 11 millionAmerican women report using contraceptive methods associated with highfailure rates, including condoms, withdrawal, periodic abstinence anddiaphragms. These facts led the FDA to request that Gynétics make anemergency contraceptive product available in the United States.

The PREVENTM Kit Components

The PREVENTM EmergencyContraceptive Kit has three easy steps that set a new standard of care inemergency contraceptive therapy: a step-by-step “Patient Information Book”with detailed patient information, a pregnancy test and four light bluebirth control pills. The pills in the PREVENTM EmergencyContraceptive Kit contain progestin(0.25mg levonorgestrel) and estrogen (0.05mg ethinyl estradiol).

“Taking the pregnancy test is an important step when using emergencycontraceptive pills”, said Dr. Nelson. “Determining that a pregnancy has nottaken place from sex earlier in the month or in previous months helps ensurethat the pills in the PREVENTM Kithave an opportunity to work.* If a woman learns she is pregnant,she should visit a doctor or other healthcare professional as soon aspossible.”

“The only definitive scientific evidence indicates that the birth controlpills in the PREVENTM Emergency Contraceptive Kit work by preventing ordelaying ovulation. It has been theorized that birth control pills may alsoprevent fertilization of an egg, if one has been released from the ovary, orthat they may produce changes in the lining of the uterus that could preventimplantation of a fertilized egg”, said Carolyn Westhoff, MD, AssociateProfessor of Clinical Obstetrics and Gynecology and Public Health atColumbia University. “The pills will not work if a woman is already pregnantand will not affect a pregnancy.”

Emergency contraceptive pills have sometimes been referred to as “morningafter” pills. This is misleading since they can, in fact, be taken up to72 hours (three days) after sex, not just the morning after. The pillsin the PREVENTM Emergency Contraceptive Kit work before pregnancy orconception begins and should not be confused with RU486, the “abortionpill”.

How the Pills in the PREVENTM KitAre Used

After a woman determines that she is not pregnant by using the pregnancytest included in the PREVENTM Kit, the first dose of two light blue emergencycontraceptive pills is taken, as soon as possible, within 72 hours (threedays) after sex with a known or suspected birth control failure or after sexwithout birth control. The second dose is taken 12 hours later.

“We are pleased to meet an important contraceptive need”, said RoderickL. Mackenzie, Gynétics’ Chairman and Founder.“The PREVENTM EmergencyContraceptive Kit demonstrates Gynétics’ leadership and commitment towomen’s reproductive health”, added Mackenzie, who is also a past Presidentof Ortho Pharmaceutical Corporation and the founder of GynoPharma Inc., awomen’s healthcare company. The product is made in the United Statesexclusively for Gynétics.

Recognizing the need for emergency contraception, the FDA, on February25, 1997, issued a statement in the Federal Register that emergencycontraceptive pills were “safe and effective” in preventing pregnancy aftersex.

The FDA based its support of emergency contraception on a meta-analysisof 10 emergency contraceptive pill studies with special doses of regularbirth control pills. These studies, conducted since 1977, showed a goodsafety profile. The most commonly reported side effects were nausea and/orvomiting that may last a few hours or up to one to two days.

Other side effects may occur, some of which can be serious. To find outif emergency contraceptive pills are right for them, women should discussthe use of emergency contraception with their doctors or nursepractitioners, or with other healthcare professionals at family planningclinics. Like all birth control pills, emergency contraceptive pills do notprotect against infection with HIV (the virus that causes AIDS) and othersexually transmitted diseases.

Gynétics Inc.

Gynétics Inc. is a privately-held women’s healthcare company basedin New Jersey. Gynétics was founded in 1995 to develop and marketpharmaceutical products and medical devices to advance the healthcare ofwomen. Gynétics also markets the GynoSampler(r) Endometrial Curette, anendometrial sampling device used by physicians.

To help address questions about the PREVENTM Emergency Contraceptive Kit and emergencycontraception, Gynétics has established a toll-free number(1-888-PREVEN2) and web site (www.PREVEN.com) for women and healthcare professionals.

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