Yet the device that quickly, accurately and inexpensively measures a pregnant
woman’s cervix could help answer the $26 billion-a-year problem of preterm
births in the United States.
And CerviLenz, the Chagrin Falls, Ohio, company commercializing
the device, is aiming at a yet-to-emerge market that would use its product as a
screening tool during all pregnancies to work with a progesterone
drug to halve the risk of that problem.
While that market develops, CerviLenz is targeting the obstetricians,
nurse-midwives, and labor and delivery nurses who need to know now whether a
patient is in preterm labor.
The cost of preterm birth is staggering. In a 2006 report, the National Academies put the cost at $26 billion a year in
the United States alone, which “constitutes a public health concern that costs
society” in hardship and grief, not to mention dollars.
And the problem is getting worse. “The preterm birth problem has been growing
over the last decade,” said Dr. Michael Ross, a maternal fetal medicine
specialist in Torrance, Calif., and medical director for CerviLenz. “Prematurity
accounts for 70 percent of prenatal morbidity. So it’s probably the most
significant factor in obstetrics, in terms of numbers.”
That’s why the National Institutes of Health (NIH) has been researching
preterm birth for decades. In the 1980s, the institutes studied 3,000 pregnant
women during its landmark Preterm Prediction Study. One of the conclusions of
the study: A short cervical length is the best predictor of preterm
birth.”That’s been replicated hundreds of times around the world,” said Dean
Koch, president and chief executive of CerviLenz.
Dr. Rosalyn Baxter-Jones, an obstetrician and gynecologist in San Diego,
Calif. knew the predictive value of cervical length, but she was aggravated by
the inability to accurately measure a patient’s cervix. The only test available
— vaginal ultrasound — was expensive and took a couple days to complete.
Patients who were in premature labor couldn’t wait.
“This is ridiculous,” Baxter-Jones remembers saying to herself. So she sat
down and sketched a device that could instantly measure the cervix. Within six
months, Baxter-Jones was testing a prototype.
Ross, chairman of the obstetrics and gynecology department at Harbor/UCLA Medical Center where
the device was being tested, thought it had “great potential as a screening
tool.” Eventually, Ross bought the device assets, hired Koch and helped start
CerviLenz to commercialize it.