PITTSBURGH--(BUSINESS WIRE)--Rinovum Women's Health, Inc., a Pittsburgh-based medical device company focused on reproductive health, announced today that it has received CE mark (European Conformance) for The Stork®. The CE mark will allow for Rinovum to bring The Stork to Europe and other markets that recognize the CE mark. The Stork is a take-home conception aid designed to assist couples with becoming pregnant from the privacy of home.
"As Rinovum delivers The Stork under a prescription today in the U.S., we are excited to expand the technology's reach outside the U.S.," says CEO and Founder, Stephen Bollinger.
Today, approximately 10 million couples in the EU are struggling with fertility issues.1 The Stork was designed to assist those struggling with common fertility difficulties such as: low sperm count, low sperm motility, hostile vaginal environment, ovulation timing and unexplained infertility.
It is a drug-free product that uses a condom-like sheath for collection and a tampon-like applicator for delivery of semen to the cervical opening by way of cervical cap. It is an easy way to "bridge the gap" between natural intercourse and more aggressive assisted reproductive treatments.
The Stork is indicated for home use assisted insemination by couples who are trying to become pregnant. The Stork contains a cervical cap inside a condom-like silicone sheath and an applicator. It is used to collect semen into a cervical cap then deliver it to the outside of the cervix as an aid to conception. The Stork cervical cap should not be left in place for longer than 6 hours.
"Our recent achievement of the CE mark for The Stork is a significant milestone for Rinovum. The Stork can now reach couples trying to conceive in both the EU and Canada. The great news is that The Stork will be available to them without a prescription from a physician. As couples attempt to nudge the stork with ovulation predictor kits, they can now go beyond simple diagnostic support, and get one step close to their goals of building a family naturally," says Mr. Bollinger.
Rinovum Women's Health, Inc. 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. Our first focus is an Rx device, driving towards a direct-to-consumer device, for reproductive health to aid in natural fertility and conception in the privacy of the patients' home. We aim to provide products that are easy-to-use and safe, as well a more economical way for a couple to address some of these issues.
1 Form 8-K/A U.S.S. and Exchange Comm., INVO Biosciences, Dec 2008. Pg. 8