Upstart gets $6M to back the first FDA-cleared OTC conception assistance device

Components of the Stork OTC--Courtesy of Rinovum Women's Health

Women trying alternative methods to conceive a child at home can dispense with the turkey baster. Monroeville, PA-based startup Rinovum Women's Health has gained $6 million to back its commercialization efforts for its home-use conception assistance device that was cleared by the FDA last fall. That's according to an SEC filing; the financing is an expansion of an infusion of just $700,000 it reported earlier this year .

The device is already available in drug-store chain CVS ($CVS) and in multiple online retailers for $79.99. The device, known as Stork OTC, includes a cervical cap inside of a condom-like sheath--wittily dubbed the Conceptacle--as well as an applicator device used to place the cap that its maker likens to the delivery method typically used for a tampon.

After semen is collected in the cap, it is placed near the woman's cervix for up to 6 hours while the woman is able to then go about her normal routine. It is then removed with an attached cord, also similar to a tampon.

"The Stork OTC is a new option for men and women who face challenges conceiving a child," said Rinovum President and CEO Stephen Bollinger in a statement when the device was cleared by FDA in September. "It's an easy-to-use, drug-free, cost-effective way to take control and optimize your chances to conceive, at home, this month."

The device is cleared for use in cases of common causes of fertility problems including low sperm count, low sperm motility, unfavorable vaginal environment as well as any unexplained fertility. It is intended to be used one to three times monthly during a woman's ovulation.

Rinovum notes that about one in 6 couples have trouble conceiving. It adds that cervical cap insemination has a monthly pregnancy success rate of about 10% to 20% when used properly. The cost of the device is much cheaper than intrauterine insemination (IUI) by a healthcare provider, often one of the first approaches to infertility. IUI averages about $865 per cycle, while in vitro fertilization (IVF), which is often the next step, costs about $12,400 per cycle.

"Many couples having difficulty conceiving don't want to wait 12 months for an infertility diagnosis," said Dr. Michael Pelekanos in the same statement. "They want to take action, now, and The Stork OTC gives them that option."

- here is the SEC filing

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