Stephen Bollinger had a simple idea for a company: Make it easier and less costly for couples struggling with infertility to conceive at home.
The concept has spawned a growing business, Rinovum Women’s Health. The Monroeville company’s first product, the Stork, received clearance from the Food and Drug Administration last year for over-the-counter sales and is available in about 3,000 CVS pharmacies.
The device, which helps women increase the odds of pregnancy by delivering sperm to the cervix, should be on the shelves of an additional 2,000 CVS stores by early next year, and could be in another national pharmacy chain next year, Bollinger said.
“The whole idea is to simplify medical technology so it can be used in a couple’s home,” he said. “Privacy, that’s where the Stork really adds value.”
The device, which retails for $79, mimics a type of artificial insemination performed in a doctor’s office or other clinical setting that can cost hundreds of dollars.
“This is a good first step, a bridge for the patients who are having trouble getting pregnant,” said Dr. Michael Pelekanos, an obstetrician and gynecologist with East Suburban OB/GYN Associates in Monroeville.
Pelekanos is a consultant and adviser to Rinovum who is organizing clinical studies of the Stork.
“This is a stop-gap measure between a major medical investigation and just standard intercourse,” he said. “I believe this will enhance fertility.”
Infertility in the United States has nearly doubled in the past 35 years, from one-in-10 couples in 1980 having difficulty conceiving to one-in-six, or an estimated 7.3 million couples, today.
The increase, driven up by women waiting longer to have children and lower sperm counts in men, has spawned a huge industry.
The market for infertility services and devices is more than $3.5 billion and expected to reach $4.3 billion by 2018, according to research firm Marketdata. About $1.9 billion of that is spent on in vitro fertilization, a lab procedure with an average cost of $12,000.
Rinovum positions the Stork as a significantly less costly alternative, which should be tried before going to a doctor.
“But it’s not a silver bullet,” Bollinger said. “If there’s a medical problem (that prevents pregnancy), we can’t help.”
Bollinger, a Delmont native, attended the Military Academy at West Point, fought in the first Gulf War and had a career in the life sciences industry. He started and sold two companies in Massachusetts before returning to the region in 2008 to help coach startup companies at the Pittsburgh Life Sciences Greenhouse.
A year later, the itch to run his own company returned, he said. “At some point, I got sick of coaching and wanted to get back to doing.”
He knew he wanted to pursue a solution to a health care problem that he could market directly to consumers and remembered the difficulty that he and his wife had trying to conceive their first child in the early 1990s. Bollinger was aware that it was an increasingly common problem.He formed Rinovum in 2009 and started developing early versions of the Stork. In 2013, it received approval from the FDA for prescription-only sales, which led to sales of “a couple thousand dollars a week,” he said.
A major turning point happened in September when the FDA cleared the Stork for over-the-counter sales. Rinovum also started selling the device in Canada and the United Kingdom.
With the addition of more pharmacies selling the Stork, Bollinger said he expects Rinovum’s revenue to grow to at least $12 million by the end of 2016, up from $800,000 in 2014 and an expected $2.4 million this year.
Rinovum is exploring how to expand sales to more countries in Europe and to Asia.
“Infertility in China is even bigger than in the U.S.,” Bollinger said.
Alex Nixon is a staff writer for Trib Total Media. He can be reached at 412-320-7928 or [email protected].