First-Ever Conception Assistance Device FDA-Cleared for Home Use Launches U.S. OTC Sales -- The Stork® OTC Delivers Hope to Millions Struggling to Conceive A Child

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The Stork® OTC—the first-ever FDA-cleared home-use conception assistance device—launched today for over-the-counter sales in the U.S. For the one in six couples and others whose dream of having a baby is delayed by infertility or other issues, The Stork OTC delivers hope; it provides a safe, easy-to-use, cost-effective way to perform an established conception technique—cervical cap insemination—without drugs or invasive procedures, in the privacy of home.

The Stork OTC package exterior and device.

“The Stork OTC is an easy-to-use, drug-free, cost-effective way to take control and optimize your chances to conceive, at home, this month.” Steven Bollinger, Rinovum President & CEO

Rinovum Women’s Health announced today that The Stork® OTC—the only home-use conception assistance device on the market cleared by the FDA for over-the-counter sales—is available without a prescription in stores and online at http://www.storkotc.com.

For the one in six couples and others whose dream of having a baby is delayed by infertility1 or other issues, The Stork OTC offers a new first step to optimize their chances to conceive. It is the only FDA-cleared product that provides consumers a safe, easy way to perform cervical cap insemination—an established, effective conception technique previously available only by prescription—by themselves, at home.

“The Stork OTC is a new option for men and women who face challenges conceiving a child,” says Stephen Bollinger, Rinovum President & CEO. “It’s an easy-to-use, drug-free, cost-effective way to take control and optimize your chances to conceive, at home, this month.”

Who Can Use The Stork OTC?

The Stork OTC can help people optimize their chances of conceiving. This includes:

  •     Couples trying to become pregnant, whether just starting out or trying for a while.
  •     The Stork OTC is also suitable for those seeking to conceive without intercourse, such as individuals with certain disabilities, LGBT couples and single women.

How It Works

The Stork OTC includes two innovative parts: an updated cervical cap (similar to a condom) and an applicator device used to place the cap (similar to the delivery of a tampon). After collecting semen in the cap during natural intercourse, the applicator efficiently and easily places it near the woman’s cervix. The cap stays in place, keeping the sperm where it needs to be, for up to six hours, while the woman continues her normal routine, then is easily removed with the attached cord, similar to tampon removal.

Cervical cap insemination has documented success rates between 10 and 20%,2, 3 similar to IUI.4 FDA-cleared applications for The Stork OTC include common fertility difficulties:

  •     Low sperm count
  •     Low sperm motility
  •     Unfavorable vaginal environment
  •     Unexplained infertility

Recommended use of The Stork OTC is 1-3 times per month, on the woman’s most fertile days. Cost is $79.99 per single-use device. By comparison, IUI averages $865/cycle and IVF $12,400/cycle.5 Visit http://www.storkotc.com for online sales and store locations.

Barbara Collura, President/CEO of RESOLVE: The National Infertility Association says, “RESOLVE encourages women and men living with infertility to take charge of their family building. It’s empowering to have tools and products to use at home today. It’s important to discuss your options with your doctor. And it’s critical to receive emotional support and take care of yourself – you are not alone.”

“Many couples having difficulty conceiving don’t want to wait 12 months for an infertility diagnosis,” explains Dr. Michael Pelekanos, M.D., a Pittsburgh-based obstetrics and gynecology specialist. “They want to take action, now, and The Stork OTC gives them that option.”

FDA Clearances

The Stork OTC was cleared by the FDA for over-the-counter sales in July 2014. The Rx version of The Stork was launched in the U.S. in late summer 2013. Over-the-counter sales began in the United Kingdom May 2014 and in Canada September 2014.

1National Institutes of Health, National Institute of Child Health and Human Development; http://www.nichd.nih.gov/health/topics/infertility/conditioninfo/Pages/common.aspx

2”Therapeutic donor insemination: A prospective randomized trial of fresh versus frozen sperm.” Leslee L. Subak, MD, G. David Adamson, MD, Nancy L. Boltz, RNC. American Journal of Obstetrics & Gynecology, Volume 166, Issue 6, Part 1, June 1992. http://www.ncbi.nlm.nih.gov/m/pubmed/1615966/

3”The cervical cap for home artificial insemination.” Corson SL, Batzer FR, Otis C, Fee, D. Journal of Reproductive Medicine, May 1986; 31(5)349-52. http://www.ncbi.nlm.nih.gov/m/pubmed/3746786/

4American Society for Reproductive Medicine: http://www.reproductivefacts.org/FACTSHEET_Intrauterine_Insemination_IUI/

5“The Costs of Infertility Treatment,” Resolve: The National Infertility Association, http://www.resolve.org/family-building-options/making-treatment-affordable/the-costs-of-infertility-treatment.html

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About Rinovum Women's Health
Rinovum Women's Health is a privately held women's health company dedicated to bringing products into the market that will enhance women's lives and empower them to take charge of their health. The Stork Ib2C, Inc., A Rinovum Women’s Health Company, launches its flagship product, The Stork® OTC, which is a conception aid for reproductive health to assist in natural fertility and conception in the privacy of the patient’s home. Rinovum Women's Health aims to support the development of products that are easy-to-use and safe, as well as a more economical way for a couple to address some of these issues. For more information about Rinovum Women's Health, The Stork Ib2C, Inc., and The Stork OTC, visit http://www.rinovum.com and http://www.storkotc.com.

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Karen Lightell
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