Obstetricians, nurse-midwives and labor and delivery nurses now have a powerful — and inexpensive — tool for assessing a woman’s risk of delivering a baby too early. CerviLenz.
The disposable device made by CerviLenz Inc. — a Chagrin Falls, Ohio, startup — was introduced today at the American Academy of Obstetricians and Gynecologists annual meeting in San Francisco.
Clinicians see many cases of preterm labor each year, but a majority of those cases do not end in preterm birth, according to CerviLenz Medical Director Dr. Michael Ross. Because research has shown the length of a woman’s cervix is a good indicator of imminent birth, clinicians use the CerviLenz device to measure a woman’s cervix as part of an exam to asses preterm birth risk.
“Evaluating cervical length and any cervical change over time is well established as critical in determining preterm birth risk,” said Ross, a maternal-fetal medicine specialist, in a written statement. “A CerviLenz measurement adds significant clinical value to preterm labor triage.”
The cost of preterm births is staggering. In a 2006 report, the National Academies put the cost at $26 billion a year in the United States, which “constitutes a public health concern that costs society.”
Until CerviLenz, clinicians estimated cervical length with a physical exam when a patient has premature contractions. “CerviLenz gives clinicians an objective evaluation right away,” Ross said. That evaluation could indicate no preterm labor, so a doctor could send a patient home. However, the evaluation could speed a doctor’s decision to admit a patient or use other tests, such as transvaginal ultrasound or fetal fibronectin, to complete a diagnosis of preterm labor.
On Monday, Dr. Richard Burwick of Harbor-UCLA Medical Center in Los Angeles presented data from a new study that indicates a CerviLenz measurement of 30 millimeters is equivalent to Hologic Inc.’s fetal fibronectin test in predicting preterm birth.
CerviLenz was invented by Dr. Rosalyn Baxter-Jones, an obstetrician and gynecologist in San Diego, Calif., who needed a simple, low-cost way to identify patients who were at risk for preterm births. Ross, chairman of the Harbor-UCLA Medical Center’s department of obstetrics and gynecology, and Dean Koch, president and chief executive of CerviLenz, bought a majority interest in the device in 2006.
In May 2008, CerviLenz — the company — received a $350,000 investment commitment from Northeast Ohio venture developer JumpStart Inc. The investment launched commercialization of the device that already had Food and Drug Administration approval to be sold.
A year ago, CerviLenz landed $4 million from venture firms Arboretum Ventures in Ann Arbor, Mich. and Chrysalis Ventures in Louisville, Ky. to take its device through clinical trials and into the market. At that time, the company thought its $30 device could make cervical checks common during pregnancy — particularly since physicians can use the information to administer progesterone, which can drastically cut the risk of many preterm births.