A dancer walks into a doctor’s office.
It’s not the start of a bad joke. Rather, it’s the genesis of a simple device that could prevent thousands of preterm births — at least that’s the hope of a Chagrin Falls-based company that’s banking on CerviLenz being a success when it comes to market this spring.
Back to the dancer for a moment: When she came to Dr. Rosalyn Baxter-Jones’ San Diego-based obstetrics and gynecology practice, she was five months pregnant and having contractions. She wanted to stop them and get back to teaching dance lessons as soon as possible. Baxter-Jones first needed to determine whether the dancer was experiencing false contractions or if she was at risk of delivering early.
The key to that puzzle is the cervix: It naturally shortens just before a woman gives birth. A woman with a short cervix is more likely to deliver her baby preterm than a woman with a longer cervix.
“At the time, I determined how active I’d let my patients be depending on the length of their cervix,” Baxter-Jones says. But all she could do was estimate by touch, or a specialized transvaginal ultrasound.
“I thought it would be great if I could measure her cervix right here in the office instead,” Baxter-Jones says. That was when she had her aha moment: She could create a disposable measuring device that could be used in the examining room to give an instant, accurate read of cervix length.
Nine years later, CerviLenz is in the final stages of developing Baxter-Jones’ idea. Led by Dean Koch, a Cleveland native with a long history in ob-gyn device sales, CerviLenz has raised about $5 million in capital since 2007 from a number of institutional and private investors. The company plans to raise additional capital in 2011 to help expand its sales and marketing efforts.
The key to the success of CerviLenz will be progesterone, Koch suspects. The company is banking on the emerging treatment of preterm birth with progesterone, a steroid hormone that a woman’s body produces naturally to get pregnant and stay pregnant. If a short cervix is detected early, additional progesterone can be prescribed to reduce the risk of preterm birth.
In the past, doctors could prescribe bed rest for a short cervix, but nothing was proven to prevent preterm birth — an event that has increased overall in the U.S. since 1990, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.
Progesterone treatments weren’t available when Baxter-Jones first developed her product and launched a company around it, which eventually failed. “I think the first venture failed because of timing,” she says.
Michael Ross, the chairman of the department of obstetrics and gynecology at Harbor-UCLA Medical Center in Los Angeles, had been involved in clinically testing the device after getting FDA approved and saw its potential. He purchased the device from Baxter-Jones. “I thought it was remarkably creative,” Ross says. “It’s a very simple technology solution.”
CerviLenz was formed in 2007 when Ross met Koch, who had been working as the vice president of marketing at Adeza BioMedical, a maker of ob-gyn products. Koch was already familiar with the product because
Adeza had considered buying it before the company was sold in 2007.
Shortly after Adeza’s sale, Ross and Koch met at a health care meeting. “Within an hour or two, he had asked me to become the CEO and help him start this company,” Koch says. This time around, with Koch as CEO and Ross and Baxter-Jones as partners, the product has been streamlined and patented.
Currently, the best way to look at the length of a cervix is with a transvaginal ultrasound, which is not portable and requires specialized technicians to operate. It also costs anywhere from $150 to $350.
“Because ultrasounds are expensive, we don’t use them very often,” says Dr. James Liu, chairman of the department of obstetrics and gynecology at University Hospitals MacDonald Women’s Hospital.
His staff has been using the CerviLenz in a clinical study that compares the accuracy of the new device to that of a traditional ultrasound.
CerviLenz wants to sell the device, which Liu described as a “disposable Popsicle stick” with a light on one end and a measuring tool on the other, for $35 to $40 to hospitals.
“The CerviLenz allows clinicians to measure the cervix of a woman at risk at every visit,” Liu explains. “If the cervix is shortening, we can institute treatment.”
CerviLenz will initially sell its product to larger hospitals. Liu expects that at first it will only be used for women with a prior history of early delivery. “We’ll use it sparingly because insurance companies don’t compensate us for it yet,” he says. But as time goes on, Liu sees it becoming used in the everyday treatment of pregnant women.
Koch plans a larger rollout of the product to coincide with the introduction of new progesterone treatments from pharmaceutical companies in 2011 or 2012.
“The center of the pregnancy universe is really the cervix. What does the cervix look like? How is the cervix doing? What does the cervix feel like? How long is it? How soft is it? Is it dilating?” says Koch, who has three children of his own. “How professionals view the CerviLenz is very expansive. There are really broad uses.”
CerviLenz has been ramping up for its launch this year with a $4 million infusion of capital in May 2009 from Chrysalis and Arboretum. It’s also received money from JumpStart and the North Coast Angel Fund. The company has gone from one employee (Koch) in its Cleveland offices to five, plus an additional three salespeople in the field. The company has also moved into the Step North building in Chagrin Falls.
Early on, raising capital was CerviLenz’s biggest challenge, especially in the midst of the economic crisis.
“I would say there were some scary times,” Koch says. “You are trying to follow a business plan. And when that funding window is only a few months ahead of you, when you only have a few months of capital, that is a very tricky environment.”
On a recent Friday afternoon, the small CerviLenz staff scuttled around the office holding meetings and making phone calls. Employees wear jeans to the office, make Starbucks runs and recently went on a cross country skiing excursion together through the Cuyahoga Valley.
“I always say, don’t go through the bother of starting a company unless it’s the kind of company you want to work for,” says Koch, who was an employee at several Silicon Valley companies before returning to his hometown of Cleveland about 10 years ago to be closer to family.
But behind the casual demeanor, CerviLenz staff members understand the serious difference their product can make in the lives of women.
The dancer that originally helped Baxter-Jones conceive the idea for CerviLenz made it to full term before having her baby, but too many women don’t, Koch says.
“Prematurity is a big problem in the U.S., which has a huge emotional impact on women and a lot of cost at a hospital.”