Preterm birth risk could be halved with CerviLenz, progesterone

MedCity News, June 1, 2010, by Mary Vanac

CerviLenz is a simple, low-tech medical device that prompts a “why didn’t I think of that?” response from many obstetricians.

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.

Koch was the right leader for CerviLenz. He had been leading sales and marketing at Adeza Biomedical Corp., a Sunnyvale, Calif. developer of women’s health products, including FullTerm, a fetal fibronectin test to assess the risk of preterm birth, and Gestiva, a progesterone drug that could be used to prevent preterm birth.

Cytyc Corp. in Marlborough, Mass. bought Adeza for $450 million in March 2007. By May of that year, Cytyc was merging with Hologic Inc. in Bedford, Mass. in a $6.2 billion stock deal.

“We sold that company for a lot of money right before I met Michael [Ross],” Koch said. “I was in the process of evaluating what I was going to do next. Michael asked me to start this company with him.”

Though Adeza had developed a test for the breakdown of fetal fibronectin — the protein that connects a developing baby to the uterus — as a predictor of preterm birth, the NIH says a short cervical length is still the best predictor. Developing the CerviLenz device became the next step in Koch’s preterm birth career.

Ross wanted Koch to move to California to start their company. But Koch, who was born in Cleveland and lived near Columbus while working for Adeza, was impressed with how BioEnterprise, the bioscience company developer in Northeast Ohio, helped first-time CEOs. So in March 2008, he chose Chagrin Falls for his business home.

In May of that year, CerviLenz landed its first investment — $350,000 from JumpStart Inc., the venture development organization in Cleveland. A few months later, the company raised an additional $315,000 from North Coast Angel Fund in Cleveland and some of its members.

Koch used the money to redesign his device, which already had Food and Drug Administration approval to be sold. “So we knew while the device was clever and useful, it also was not optimal,” he said. “It also had too many parts to be manufactured at a low cost.” He chose Interplex Medical LLC in Millford, Ohio near Cincinnati to redesign and make the device.

A year later, CerviLenz raised $4 million from venture firms Arboretum Ventures in Ann Arbor, Mich. and Chrysalis Ventures in Louisville, Ky. to take its device through clinical testing and into the market. “We invested in CerviLenz in April of 2009,” said Koleman Karleski, Chrysalis Ventures’ managing partner. “It’s an exciting, young healthcare company.”

The company also used the investment to develop online materials to train professionals how to use its device and develop a “giving back” program through which it supports mother and child care worldwide.

In mid-May, CerviLenz did a staged launch of its device at the American Academy of Obstetricians and Gynecologists annual meeting in San Francisco. “It’s really at the stage of demonstrating commercial potential,” Koch said. “So, right now, we’re focusing on about 25 customers around the country who, over the next few weeks, are going to start their evaluations” of the disposable CerviLenz device to triage women in emergency rooms for premature labor.

Most of those women will be in false labor and will be sent home. But “if her cervix is very short and she’s premature, I would admit her and treat her with medications to stop the contractions,” Ross said.

In addition to demonstrating the clinical effectiveness of the device, Koch and his 11 employees want to show a limited number of hospital customers that they can sell, deliver and train people to use their $45 device before throwing wide the sales door.

“Although we are pricing our device modestly, we’ll be able to generate high margins,” he said. “We will likely need an additional round of capital about a year from now, probably in the $5 million range. That’ll be to accelerate our sales and marketing activities.”

In the meantime, the NIH will continue its studies of using progesterone as a prophylactic treatment to reduce the risk of preterm birth — not just as a way to stop premature labor. And the FDA could consider approving a drug for that use. Only then would doctors begin using CerviLenz as a routine screening tool during most pregnancies.

“We feel over the next year or two years as those studies are completed, the stance will change,” Koch said. “So we feel we’ll be demonstrating our usefulness in this preterm labor marketplace first. And as that market develops, we’ll be in a good position to play a role in helping to bring that drug to the right women at the right time.”

Mary Vanac is co-founder of MedCity News and serves as its vice president and Ohio bureau chief.