With the timing right and new capital in its hands, CerviLenz is forging ahead with the commercialization of its device to aid in the prevention of preterm birth.
The Cleveland-area company has raised at least $2 million, as disclosed in U.S. Securities and Exchange Commission documents, and hired new sales representatives to help drive adoption of its device among OBGYNs in the U.S. The disposable device is designed to make it simple for OBGYNs to measure the length of a pregnant woman’s cervix, which helps identify women at risk for preterm birth.
One in eight babies in the U.S. is born preterm, which increases the risk of death and short-term and long-term complications. The OBGYN community has known for a long time that a short cervix length at mid-pregnancy is the best predictor of preterm birth. Although pregnant women who have previously experienced preterm births are routinely screened for cervical length with a transvaginal ultrasound probe, low-risk women usually are not. That’s a problem since about half of preterm births occur in pregnancies considered to be low-risk. A 2010 Yale study found that screening low-risk women was actually cost-effective when compared to routine care.
CerviLenz hopes its device will make that cost-effective, regular screening a possibility. This is all especially important because of Columbia Labs/Watson’s efforts to seek U.S. Food and Drug Administration approval of their progesterone vaginal gel called Prochieve 8%. In a collaborative study among several institutions, the gel was associated with 45 percent reduction in the rate of preterm birth before 33 weeks of gestation in women with a short cervix (PDF).
The FDA determined last year that the clinical trial did not yield results that were significant enough to support the approval of the product. But the Society for Maternal-Fetal Medicine (PDF) and American College of Obstetricians and Gynecologists (PDF) have recommended its use under certain conditions.
“We founded the company in anticipation of this new intervention to prevent preterm birth,” CEO Dean Koch said. “That really creates the market need for us. That takes us from being a more niche product to making it a really large screening market.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The CerviLenz device is already FDA-cleared but is now ready for full-scale commercialization. Koch declined to provide details on the recent round of financing, but said that the company plans to work later this year with a larger company on commercialization efforts.
CerviLenz was founded in 2008. Investors include Chrysalis Ventures, Arboretum Ventures, JumpStart and North Coast Angel Fund
[Photo from CerviLenz]
