Market Overview

New Clinical Study Demonstrates Stork OTC Home Conception Kit is More Effective at Delivering Sperm to the Cervix Than Natural Intercourse When Trying to Get Pregnant

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PITTSBURGH--(BUSINESS WIRE)--

A new clinical study demonstrates that The Stork® OTC is more effective at delivering sperm to the cervix than natural intercourse when trying to get pregnant. The peer-reviewed, post-coital sperm assessment study was performed over a ten-month period by study author Dr. Michael J. Pelekanos, and is published in the Surgical Technology International, Issue XXVII. The Stork OTC, the only FDA cleared, over-the-counter home conception kit using cervical cap insemination, is clinically shown to deliver a higher concentration of sperm directly to the cervix compared to natural intercourse1.

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Stork OTC Kit (Photo: Business Wire)

Stork OTC Kit (Photo: Business Wire)

The study was an efficacy study designed to compare the number of sperm in the cervical mucus both with the use of The Stork OTC home conception kit and natural intercourse. Post-coital test data was collected after participants used both the Stork OTC home conception kit and the natural intercourse method to evaluate concentrations of sperm in the cervical mucus.

The results are promising for the 1 in 6 US couples having difficulty conceiving with intercourse alone2. "We were very excited to see the study results confirm that The Stork OTC delivers a significantly higher sperm concentration to the cervix," said Stephen Bollinger, President and CEO of Rinovum® Women's Health, and Co-Creator of the device. "With the new data demonstrating the efficacy of the Stork OTC in aiding conception compared to natural intercourse, couples trying to get pregnant now have a safe, clinically validated option to optimize their chances with the Stork OTC."

The results:

  • In 85% of study subjects, the Stork OTC delivered a 3.23x higher value of sperm concentration at the cervix compared to the value of sperm concentration with natural intercourse.
  • The remaining 15% of study subjects saw no change in sperm concentration between The Stork OTC and natural intercourse.

"Three times the sperm value is quite significant for so many couples, especially with the growth of male factor infertility," says Harry Reich, MD, FACOG, FRCOG. "Understanding the growing value of semen for successful conception, and having a technology like The Stork® OTC that can deliver more sperm to the cervix than natural intercourse, this at-home conception kit may greatly impact many couples on their path to building a family. The Stork OTC makes sense."

The kit provides a way for the user to collect, insert and deliver the sperm directly at the opening of the cervix, and keeps it at the cervix for longer, giving sperm the opportunity to enter into the uterus. Considering most sperm never make it through the vaginal tract, the Stork OTC's applicator provides a simple and safe way for the user to bypass the normally unfavorable vaginal environment, to deliver the sperm. Cervical cap insemination has documented success rates between 10 and 20%3, similar to in-clinic intrauterine insemination (IUI) success rates (16-21%)4,5.

The Stork OTC is available for purchase at select retailers nationwide, and online. Visit www.storkotc.com for online sales and store locations. The device was cleared by the FDA for over-the-counter sales in July 2014, and made available to the market in September of 2014. The product is available for sale as The Stork in the United Kingdom, Australia, and Canada.

About Rinovum® Women's Health, LLC

Rinovum Women's Health, LLC 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, launched 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. For more information about Rinovum Women's Health, The Stork Ib2C, Inc., and The Stork OTC, visit www.rinovum.com and www.storkotc.com.

1 "Postcoital Sperm Assessment Comparative Study." Michael. J. Pelekanos, MD. Surgical Technology International, XXVII, November 2015.
2 National Institutes of Health, National Institute of Child Health and Human Development; http://www.nichd.nih.gov/health/topics/infertility/conditioninfo/Pages/common.aspx
3 "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/
4 "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/
5 American Society for Reproductive Medicine: http://www.reproductivefacts.org/FACTSHEET_Intrauterine_Insemination_IUI/

Rinovum Women's Health
Brianna Freeman, 724-241-8936
bfreeman@rinovum.com

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