Clinical Innovations Helps Labor and Delivery Specialists Accurately Detect Premature Membrane Ruptures Using ROM Plus®

SALT LAKE CITY–(BUSINESS WIRE)–Clinical
Innovations is the largest medical device company exclusively
focused on labor and delivery, including the ROM Plus®, a rupture of
membranes (ROM) diagnostic test, which provides immediate results to
help minimize potential risks to expectant mothers and their babies. The
device’s accuracy and ease of use provides a less invasive and more
efficient alternative to traditional ROM detection methods used for more
than 60 years, according to two new peer-reviewed clinical research
papers recently published in Clinical Medicine
Insights: Reproductive Health and Medical
Devices: Evidence and Research.

Membrane rupture “can occur at any gestational age and presents a
particularly serious clinical problem if it occurs prior to 37 weeks’
gestation, where it is responsible for [up to 40 percent] of preterm
births,” according to new research from Clinical
Medicine Insights: Reproductive Health. The ROM Plus’ point-of-care
test uses a noninvasive approach to detect proteins found in significant
concentrations in amniotic fluid. The research shows that ROM Plus®
outperforms more traditional testing in terms of sensitivity,
specificity, and accuracy, allowing for more timely diagnosis and
gestational age-specific intervention.

Traditionally, other ROM tests can be invasive, requiring a speculum and
microscope, which often produces inaccurate results and can expose
mothers and babies to added risk. With 99 percent sensitivity, ROM Plus®
is a quick, painless, and effective solution. The test’s rapid results
support better “clinical decision making, improved patient care, and
greater patient satisfaction, all of which lead to better clinical
outcomes,” according to a new paper in Medical
Devices: Evidence and Research, describing the usage, procedures and
clinical characterization of the device.

“Our mission at Clinical Innovations is to develop safe, reliable and
innovative solutions to improve the lives of mothers and their babies,”
said Dr. Ross McQuivey, chief medical officer for Clinical Innovations.
“Rupture of membranes is one of the most common diagnostic dilemmas in
obstetrics, affecting up to 10 percent of pregnancies. By helping labor
and delivery providers accurately detect ruptured membranes, ROM Plus®
can help identify or minimize potential complications.”

As a market leader in medical devices for labor and delivery, Clinical
Innovations helps mothers and babies in more than 75 countries around
the world. ROM Plus® is a critical part of Clinical Innovations’ growing
product portfolio, including the Koala® Intrauterine Pressure Catheter,
Kiwi® Vacuum-Assisted Delivery System and other industry-changing
specialty devices.

Clinical Innovations is a member of Pritzker Group Private Capital’s
family of companies.

About Clinical Innovations

Clinical Innovations is the largest medical device company exclusively
focused on labor and delivery. Already a market leader in several
categories with products such as the Koala® Intrauterine Pressure
Catheter; Kiwi® Vacuum-Assisted Delivery System; ROM Plus® Rupture of
Membranes Test; traxi^® Panniculus Retractor and ClearView
Uterine Manipulator. Clinical Innovations is expanding its global
presence while directly researching and developing state-of-the-art
technologies and innovative medical devices that fulfill its mission of
improving the lives of mothers and their babies throughout the world.
Clinical Innovations is a Pritzker Group company. For more information,
visit clinicalinnovations.com.

About Pritzker Group

Pritzker Group, led by Tony and J.B. Pritzker, has three principal
investment teams: Private Capital, which acquires and operates leading
North America-based companies; Venture Capital, which provides
early-stage and growth venture funding to technology companies
throughout the United States; and Asset Management, which partners with
top-performing investment managers across global public markets.

Pritzker Group Private Capital acquires North America-based
middle-market companies with leading positions in the manufactured
products, services and healthcare sectors. The firm’s permanent,
proprietary capital base allows for efficient decision making, broad
flexibility with transaction structure and investment horizon, and
alignment with management teams focused on creating long-term value.
Pritzker Group brings significant resources, expertise and credibility
in building businesses and is an ideal partner for entrepreneur- and
family-owned companies. For more information, visit pritzkergroup.com.

Contacts

Aileron Communications
Martha Arendt, 312.629.9400
marendt@aileroninc.com