Cervilenz

CerviLenz Inc. is a medical device company focused on addressing the significant challenge of preterm birth. The company was established in Chagrin Falls, Ohio, after Dean Koch, President and CEO, and Dr. Michael Ross, a maternal-fetal medicine specialist and the company's medical director, acquired a majority interest in the device in 2006. The initial invention came from Dr. Rosalyn Baxter-Jones, an obstetrician and gynecologist who sought a simpler, low-cost method for identifying patients at risk for preterm labor. Koch, a former vice president at women's health manufacturer Adeza, brought his commercialization experience to the venture. He decided to base the company in Ohio to leverage the support of BioEnterprise, a local bioscience developer.

The company's core product is the CerviLenz® device, a disposable, wand-like instrument designed to quickly and objectively measure the length of the vaginal cervix. This measurement is a critical predictor of preterm birth risk, as a short cervix is a significant indicator. The device offers a less complex and more accessible alternative to transvaginal ultrasound, which is often reserved for high-risk pregnancies and may not be readily available in all healthcare settings. By providing an immediate and quantifiable measurement, the CerviLenz device aims to reduce the guesswork in diagnosing preterm labor, as many women who exhibit symptoms do not deliver prematurely. The product is sold to hospitals, targeting obstetricians, nurse-midwives, and labor and delivery nurses who need to triage patients with signs of preterm labor.

CerviLenz obtained its first FDA approval prior to its initial fundraising efforts, which included a $350,000 investment from JumpStart Inc. in May 2008, followed by $315,000 from the North Coast Angel Fund. These funds were used to redesign the device for more cost-effective manufacturing. A significant milestone was achieved in 2009 when the company secured a $4 million Series A funding round from Arboretum Ventures and Chrysalis Ventures to support clinical trials and market entry. The device was commercially launched in May 2010 at the American Academy of Obstetricians and Gynecologists annual meeting. The business model is based on the sale of the disposable, single-use device, which was priced modestly to encourage widespread adoption while maintaining high margins.

Keywords: medical device, preterm birth, obstetrics, cervical length measurement, women's health, labor and delivery, maternal-fetal medicine, diagnostic tool, single-use device, FDA approved, venture capital, medtech, pregnancy risk assessment, ObGyn, clinical diagnostics, healthcare technology, perinatal morbidity, hospital supplies, JumpStart Inc., Arboretum Ventures, Chrysalis Ventures