Chosen from a field of nearly 250 entrants, Michael House, MD Director of Perinatal Research at Tufts Medical Center and his faculty start-up company Cx Therapeutics have received the first ever Grand Prize award from the Massachusetts Medical Device Development Center & Biotech Incubator (M2D2) for a novel medical device designed to prevent preterm birth and improve outcomes for pregnant women due to cervical insufficiency.
“Cervical insufficiency affects more than 15,000 pregnant women in the United States each year, but the treatment for these women hasn’t changed in decades,” said Dr. House, a Maternal-Fetal Medicine physician and researcher in Tufts MC’s Mother Infant Research Institute (MIRI). “Our innovation is a cervical support device that we believe will prove safer and more effective than the treatment options that are currently available.
Cervical insufficiency (also known as incompetent cervix) typically occurs mid-pregnancy. For most women, the cervix remains closed until term and then opens in response to uterine contractions. In women who experience cervical insufficiency, however, the cervix opens early, without contractions, putting the pregnancy at significant risk. The cause of cervical insufficiency relates to mechanical weakness of cervical tissue. And for reasons that are unclear, Black women appear to be at higher risk of developing the condition.
The current treatment for cervical insufficiency is cerclage, a surgical procedure where clinicians suture or stitch the cervix closed. The stitch acts to compress the cervix and protect the fetal membranes from the vaginal environment. The cerclage suture is then removed at term before the baby is delivered.
“We know that even with the sutures, 22 percent of patients still suffer a miscarriage or a preterm birth before 28 weeks. A contributing factor is that cerclage doesn’t adapt to changes as the baby grows,” said Dr. House. “We have developed a personalized approach to treatment that can be adjusted during pregnancy to keep the cervix closed.”
With the device, cervical compression is achieved with polymer components that act to spread out the cervical compression and reduce adverse effects. The device is adjustable, to permit increased compression over time.
“Our device not only has the potential to improve the health of women and their babies, it may also reduce medical costs associated with birth complications and the care of preterm infants,” said Dr. House.
Tufts MC has submitted a provisional patent application for the device. Cx Therapeutics also received a phase 1 Small Business Technology Transfer (STTR) grant from the NIH to permit prototype development and device design. Dr. House and his team will partner with Sabrina Craigo, MD, Interim Chair of Obstetrics and Gynecology to further study the effectiveness of the device.
M2D2 is a program based out of UMASS Lowell that offers Massachusetts-based small companies connections to resources to enhance their commercialization and development efforts. The M2D2 Grand Prize is sponsored by the Massachusetts Life Sciences Center and comes with a $50,000 award that will be used to accelerate efforts to bring the device to the bedside.
“On behalf of Tufts Medical Center, we proudly applaud Dr. House’s clinical translational research in identifying an unmet need and developing an innovative solution, and we thank M2D2 for their recognition of its potential benefit, especially in Black women at higher risk,” said John Wong, MD Interim Chief Scientific Officer at Tufts Medical Center.
