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100 N. Main St., Suite 300
Chagrin Falls, OH 44022 USA
phone:440.337.4260
fax:866-397-1833
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| Symbol |
Private |
| Founded |
2008 |
| Employees |
9 |
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| www.cervilenz.com
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| Research Sector |
Medical Devices & Tech |
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| Summary Description |
| Cervical length measurement to determine risk of preterm birth |
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| Management |
| Dean Koch, President and Chief Executive Officer;
Federica O'Brien, Chief Financial Officer/Chief Operating Officer; Melanie Sweeney, Vice President, Marketing; Michael Ross, MD, MPH, Medical Director; Rosalyn Baxter-Jones, MD, inventor |
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| Keywords |
| Women's health, Ob-Gyn, short cervix, PTB, preterm birth, cervical length, device, diagnostics, obstetricians, maternal fetal medicine |
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| Description |
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CerviLenz has developed a device that measures cervical length in pregnant women and thereby helps health practitioners determine risk of preterm birth. The CerviLenz® device can be used by health care practitioners to generate valuable clinical data in any office, clinic, or hospital by inserting the device with its measurement probe extended, advancing it along the lateral wall of the cervix, locking the measurement probe, and reading the scale. Practitioners may use the device however often is indicated for preterm risk factors so that appropriate preventive therapy may be enacted if needed. This later-stage medical device company’s product is FDA-cleared. |
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| Products / Services |
CerviLenz is a disposable medical device that measures cervical length. Pregnant women with a short cervix are at high risk of preterm birth. Diagnosing and managing high risk patients are among the most critical daily tasks in obstetrics. CerviLenz gives physicians and midwives an immediate, reliable method for measuring the cervix in any healthcare setting, yielding actionable results that can influence treatment.
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| Technology / Differentiation |
| CerviLenz is readily available and provides a significant enhancement to current technology. There is no direct competition to CerviLenz. Other technologies have limitations which preclude widespread use, such as expensive capital equipment or specialized laboratory equipment. CerviLenz is covered by multiple U.S. and international patents. |
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| Market / Customers |
The total market opportunity annually for cervical length evaluation in the U.S. exceeds 13 million measurements across three key segments. 1) Preterm birth risk assessment: baseline cervical length measurements will be the fastest growing and largest market potential for CerviLenz, driven by advances in progesterone therapy to prevent preterm birth in women with a short cervix. New progesterone drugs are expected to receive extensive promotion in late 2011. 2) High risk patient management: the current standard of care already includes measurements every one to two weeks to monitor for cervical shortening. 3) Preterm labor management: cervical length measurement is central to the assessment of pregnant women with signs or symptoms of preterm labor and guides decisions about further testing and treatment. In the U.S., customers include physicians' and midwives' offices and clinics as well as hospitals. Worldwide, CerviLenz will be especially valuable in countries that do not have access to laboratory and ultrasound equipment.
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| Competitors / Substitutes / Alternatives |
Currently, cervical length is measured using a specialized ultrasound technique with a transvaginal probe (TVU). This cervical length exam is done primarily in high risk pregnancies, such as women pregnant with twins or a history of adverse outcomes, and is most often performed by Maternal-Fetal Medicine physicians. CerviLenz will be marketed for use by Obstetricians and Certified Nurse Midwives, who will perform the large majority of cervical length measurements with the growing need to identify high risk patients for appropriate care and treatment. A short cervical length by CerviLenz may lead to referral for a TVU or Maternal-Fetal Medicine consult. In hospital management of suspected preterm labor, CerviLenz may compete with a laboratory test for fetal fibronectin (fFN). CerviLenz is a very cost effective alternative to fFN because it has comparable statistical predictive power.
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| Strategy |
Marketing is focused on increasing awareness of CerviLenz as a new device that aids preterm birth prediction and influences treatment. A controlled commercial launch of CerviLenz in target markets is driving adoption and supporting efforts to achieve reliable reimbursement. There are already five peer reviewed publications on CerviLenz, and three sponsored studies are underway.
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| Funding |
| Series A funding by Arboretum Ventures, Chrysalis Ventures, JumpStart Ventures, and North Cost Angel Fund. |
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| Status |
| Early stages of controlled commercial launch. |
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Biotech & Specialty Pharma
Healthcare Services
Medical Devices & Tech
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