This post is sponsored by Cervilenz Inc.

12.9 million babies are born too soon every year around the world, and 1 million of those babies die. The United States has the second-highest rate of prematurity in the world.  Here, 1 of 8 babies is born prematurely, and these early deliveries are the leading cause of infant death and many long-term disability and health complications. It’s time to do more.

For more than a decade, researchers have been talking about cervical length as the best predictor of preterm birth risk. The shorter the cervix, the higher the risk. A big problem without a solution. Until now.

This year, researchers are talking about an evidence-based intervention for prematurely short cervix. There is now conclusive data that vaginal progesterone treatment for women diagnosed with a short cervix mid-pregnancy reduces the rate of prematurity by 45% and improves infant outcomes. Diagnose a short cervix, and now we can treat it.

Today, leading Maternal-Fetal Medicine experts are calling for a fundamental shift in obstetrics practice to start measuring cervical length for all pregnant women to find high-risk patients for treatment.

Cervilenz Inc. – a small, venture capital-backed company – is poised to play a vital role. The company’s new CerviLenz® device gives doctors an immediate cervical length measurement during any prenatal visit.
While Americans are prone to look for high-tech solutions, sometimes the best answer is something simple. That’s what CerviLenz is  – a simple, low-cost device that identifies pregnant women with a prematurely short cervix.
Prematurity is a $26.2 billion problem in the U.S. annually. When more moms have healthier babies, we save millions of dollars. Improving care while reducing cost. Today is a new day in the world of prematurity.
Learn more at www.measure2besure.com.

Melanie Sweeney

This post is sponsored by Cervilenz Inc.

November is a time for thanks.  Every day, I am thankful for my husband, Jim, and our three healthy children – Emmett, Riley, and Allie. But, this time of year is a mixed blessing for me.

November is Prematurity Awareness Month.   Every minute of every day, a baby is born prematurely.   That’s 1 of 8 babies, and it’s the leading cause of infant death.   On October 29th, 1993, my twin daughters were born three months too soon.  Annabelle died at birth.  Isabelle lived for only 10 months. I’m grateful for all the time and effort of so many people to bring attention to this huge problem of prematurity.

I’ve dedicated endless hours to spreading hope, supporting other families like ours, and helping raise money for research.  This year is different because there’s a new message  — and it’s great news.  Researchers have found a way to prevent prematurity for some pregnant women.   A study sponsored by the NIH showed that daily vaginal progesterone started mid-pregnancy for women diagnosed with a short cervix reduced their rate of prematurity by 45%.

For such a complex, multi-factorial disease, this research offers a simple solution.  Measure cervical length to identify high-risk patients.  Treat those high-risk patients with vaginal progesterone.  The result:  fewer premature births and healthier babies.

When I met Dean Koch in 2008, just after he founded Cervilenz Inc., he told me this day would come as he showed me the CerviLenz® device.   This low-tech yet sophisticated device makes it easy to measure cervical length during any prenatal visit.  CerviLenz is going to be part of the solution to the worldwide epidemic of prematurity.   That’s why I’m proud to help bring this novel device to market.

The stakes are too high to rely on someone’s finger to estimate cervical length.  There’s plenty of evidence that abdominal ultrasound isn’t reliable either.  Transvaginal ultrasound can provide an accurate cervical length measurement, but this high-tech exam is not available for all pregnant women in the United States, much less abroad.  CerviLenz is cost-effective innovation.

The annual economic toll of prematurity in the U.S. is $26.2 billion.  Preventive medicine saves money.   One cost analysis showed a savings of $19.5 million for every 100,000 pregnant women evaluated for short cervix with transvaginal ultrasound and treated with vaginal progesterone as appropriate.  CerviLenz can help save even more.

This November, I’m thankful for Dr. Rosalyn Baxter-Jones who invented CerviLenz, my colleagues at Cervilenz Inc. who all share my passion for fighting prematurity, and the company’s investors (Arboretum Ventures, Chrysalis Ventures, JumpStart Ventures, and North Coast Angel Fund) who give hope to moms like me.

Medical professionals, learn more at cervilenz.com.

Moms-to-be, learn more at measure2besure.com.

Simulation of how CerviLenz is used to measure the length of the cervix

Women’s health medical device company Cervilenz has increased its series A round of investment to $8.35 million, thanks to a recent tranche of funding from existing investors.

Cleveland-area Cervilenz plans to use the funding to continue commercialization of its device, which provides a means of accurately and inexpensively measuring a pregnant woman’s cervix. A short cervix is the best predictor of preterm birth risk.

“We’re focused on early adoption of the device and introducing it to the market,” said CEO Dean Koch, who was hesitant to reveal much about the company’s commercialization strategy for competitive reasons.

The company recently hit a significant milestone when it received the European Union’s CE Mark, giving the company the right to sell the device in the EU, Koch said.

Cervilenz could be poised for big things next year, when a progesterone drug to reduce the rates of preterm birth in pregnant women with a short cervix is expected to hit the market. Cervilenz’s device could be used as a screening tool to identify candidates for the drug, opening up a large and potentially lucrative market for the low-cost device.

The device “is primed for commercial use just at a time when there’s a therapy available to help these women who Cervilenz helps determine are at risk,” said Koleman Karleski, managing director with Chrysalis Ventures, one of Cervilenz’s investors.

The CerviLenz device is already on the U.S. market, though Koch stressed in a previous interview that the company hasn’t yet entered “full-scale commercialization mode.”  For those given to speculation, it seems reasonable to infer that Cervilenz is awaiting U.S. Food and Drug Administration approval of a progesterone drug before ramping up significant commercialization of its device.

In addition to Louisville, Kentucky-based Chrysalis, Cervilenz’s investors include Arboretum Ventures in Ann Arbor, Michigan, plus Cleveland’s North Coast Angel Fund and JumpStart.

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 of these births at $26 billion a year, which “constitutes a public health concern that costs society” in hardship and grief, not to mention dollars.

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, some simple math shows that Cervilenz stands to pull in substantial revenues if its device achieves the widespread adoption the company and its investors think it will — likely making Cervilenz an attractive acquisition target for a big device firm.

MedCity News’ Brandon Glenn discusses the opportunities a new progesterone drug could have for Ohio medical device company CerviLenz on this week’s edition of Health Journal on ONN.

CerviLenz’s device provides a means of accurately and inexpensively measuring a pregnant woman’s cervix. The new 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. It could be approved by the FDA for that indication by the end of the year.

CerviLenz’s device, which is already on the market, can be used as a screening tool to identify candidates for the drug.

A short cervix is the best predictor of preterm birth risk.

“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.

ONN broadcasts Health Journal featuring MedCity News throughout the week starting on Tuesdays.

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.

“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.

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.

Federica "Freddi" O'Brien

Medical device startup CerviLenz Inc. has appointed its first chief financial/operating officer: Federica “Freddi” O’Brien, a certified public accountant who spent the last decade working with bioscience companies.

“I have 30 years of experience working with middle-market, development-stage companies, as well as big pharma companies,” O’Brien said. “I had been tracking CerviLenz since I heard about it in the Fall. I’m pretty passionate about what we’re doing here. When there was a opportunity, I threw my hat in the ring.”

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,” Dean Koch, CerviLenz’ president and CEO, said early this month about his company’s device.

CerviLenz is an inexpensive, wand-like device that obstetricians, nurse-midwives and labor and delivery nurses can use to accurately measure a pregnant woman’s cervix. A short cervix is the best predictor of preterm birth — a $26 billion-a-year problem in the United States.

“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, Koch said.

Eventually, he hopes the device of his Chagrin Falls, Ohio, company will be used as a routine screening tool in most pregnancies, as well as with yet-to-be-approved progesterone drugs to treat preterm labor.

O’Brien comes to CerviLenz from the Philadelphia office of RSM McGladrey, the national assurance, tax and consulting firm based in Charlotte, N.C. As director of Life Sciences at that firm, she was vice president of finance and chief financial officer for Cardiokine Inc., a Phase 3 biotechnology company; and senior financial executive for Barrier Therapeutics, a late-stage biotech company.

Before that, O’Brien was vice president and chief financial officer of Infonautics Inc., an online service company. She practiced as a CPA for almost 15 years at Coopers and Lybrand and other national accounting firms, working primarily with life sciences and technology companies.

O’Brien believes her background is just right for CerviLenz. “Having been in public accounting for many years, I have helped companies build at different stages, whether they were early development stage or at the stage of going commercial,” she said. “I’ve raised over $300 million combined at all those companies.”

Fundraising will be important for the future of CerviLenz. “We will likely need an additional round of capital about a year from now, probably in the $5 million range,” Koch said. “That’ll be to accelerate our sales and marketing activities.”

Bottom line, O’Brien loves what CerviLenz is doing.

“I’m a mom. I love all babies,” she said. “We are able to provide a tool to help pregnancies succeed. That’s something I feel really good about.”

MedCity News President Chris Seper appeared on air of content partner WKYC-TV, discussing three Cleveland-area medical device companies: AxioMed Spine, CerviLenz and Neuros Medical.

Read the latest on each company below:

• AxioMed Spine Corp. raises $6.4 million to continue developing spinal disc replacements
• Preterm birth risk could be halved with CerviLenz, progesterone.
• Neuros Medical chooses Battelle to co-develop neurostimulation device for chronic pain.

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.”

Simulation of how CerviLenz measures the length of the cervix

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.

Sketch of the CerviLenz device

CHAGRIN FALLS, Ohio — Cleveland-area medical device maker CerviLenz Inc. has closed on a $4 million funding round that will take its product, which promises to help cut the number of preterm births, through clinical trials and into the market as early as next year.

The company is developing a disposable device that measures the length of a woman’s cervix to help predict risks of preterm birth. It is potentially easier, less costly and just as accurate as the transvaginal ultrasound device used in only high-risk pregnancies.

CerviLenz thinks 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. It has already received approval from the U.S. Food and Drug Administration and is in the midst of national and international clinical trials.

“What we’re trying to do is when we go to market have all the evidence for adoption,” said Dean Koch, a former vice president at the women’s health manufacturer Adeza who is now CerviLenz’s chief executive officer.

Arboretum Ventures and Chrysalis Ventures combined on the Series A funding. Tim Peterson and Koleman Karleski, managing directors at Arboretum and Chrysalis, respectively, will sit on CerviLenz’s five-member board of directors.

Karleski referred to preterm births as a “$30 billion problem” — roughly the annual cost of preterm births in the United States. But the problem is even greater than that. The increase in premature infants is considered the primary reason infant mortality has plateaued.

The number of preterm babies has increased by nearly one-third since the 1980s, though it dropped slightly in the most recent report by the Centers for Disease Control and Prevention’s National Center for Health Statistics. Preterm children also made up two-thirds of all infant deaths, according to the CDC.

“It’s an economic issue,” Karleski said. “And it’s a family issue and a health issue.”

Petersen stated in a press release that new treatments for preterm births “have created a huge need for an easy-to-use, inexpensive screening technology to identify women at risk for preterm birth.”

“The company is in the right place at the right time with the right product,” Petersen stated.

Koch said CerviLenz will hire five to 10 new employees over the next year to sell and market the device.

It raised $715,000 last May through investments from the North Coast Angel Fund, JumpStart and other private investors.

[Front-page photo courtesy of Flickr user zzzack]