Pending regulatory approval of a progesterone drug could open up a new, lucrative market in helping prevent premature births for medical device maker CerviLenz.
The drug, Prochieve 8%, is a gel that was associated in a Phase 3 clinical trial with a 45 percent reduction in preterm births in pregnant women with a short cervix, and it could be approved by the FDA for that indication by the end of the year. Chagrin Falls, Ohio-based CerviLenz’s device, which provides a means of accurately and inexpensively measuring a pregnant woman’s cervix, can be used as a screening tool to identify candidates for the drug. A short cervix is the best predictor of preterm birth risk.
The cost and number of preterm births are significant. There are more than 500,000 preterm births (defined as birth prior to 37 weeks of gestation) every year in the U.S. In a 2006 report, the Institute of Medicine put the cost at $26 billion a year, which “constitutes a public health concern that costs society” in hardship and grief, not to mention dollars.
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“Looking for this problem and being able to do something about it is the biggest advance in obstetrics in 30 years,” said Dean Koch, CerviLenz’s CEO.
“But the full impact of this preventive treatment can only be realized if all pregnant women who will benefit from it get it,” he continued. “CerviLenz can make that happen quickly and easily.”
The CerviLenz device is already on the market, though Koch stressed the company hasn’t yet entered “full-scale commercialization mode.” The device has been introduced in “a couple hundred” physician offices and “a couple dozen” hospitals, Koch said.
Koch imagines the CerviLenz device being used for multiple measurements during a woman’s pregnancy. With more than 4 million American women getting pregnant each year, and the device costing about $50, that’s a lot of potential sales for the company.
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The other method for measuring cervical length, vaginal ultrasound, isn’t used for all pregnant women, in part because it’s generally too expensive and time-consuming to be done multiple times for one pregnancy.
Ideally, cervical length would be measured at least three times in all pregnant women. The first measurement is best done with transvaginal ultrasound, and then CerviLenz can be used during routine office visits, Koch said.
Twelve-employee CerviLenz has raised about $7.5 million so far, from investors including venture firms Arboretum Ventures in Ann Arbor, Michigan, and Chrysalis Ventures in Louisville, Kentucky, plus Cleveland’s North Coast Angel Fund and JumpStart.
The company is targeting a Series B round of between $5 million and $10 million in the next year to help it commercialize the device, Koch said. CerviLenz also hopes to earn the CE Mark, which would allow it to begin sales in the European Union, by the end of the year.
