ExEm® Foam, the only FDA-approved contrast agent for ultrasound tubal patency testing, now available in the U.S.

NASHVILLE, Tenn., Feb. 17, 2021 /PRNewswire/ -- ExEm® Foam Inc announced today that ExEm® Foam ((air polymer-type A) intrauterine foam), the only FDA-approved contrast agent for ultrasound tubal patency testing, is now available at select fertility clinics nationwide. The Foam procedure, a new ultrasound technique of hysterosalpingo foam sonography (HyFoSy), uses ExEm® Foam to assess whether there may be a blockage in the fallopian tubes in women with known or suspected infertility. The innovative imaging technique offers a less complicated and less invasive alternative to laparoscopy and dye, the gold standard for diagnosing tubal patency. The outpatient tubal assessment is also associated with significantly lower pain scores as compared to the standard of care, X-ray hysterosalpingography (HSG), and does not require the use of radiation and iodine.ⁱ

"For couples experiencing infertility, we must evaluate a number of different aspects of the reproductive system to determine the root cause. Unfortunately, this evaluation can involve a lengthy process and several uncomfortable procedures," said Professor Mark Hans Emanuel, M.D., Ph.D., Department Gynecology and Reproductive Medicine, University Medical Center Utrecht, The Netherlands, and co-inventor of the Foam procedure. "Cutting-edge, safe and effective diagnostic procedures, like the Foam procedure, allow us to quickly and as comfortably as possible identify fertility issues and plan the next step in a patient's fertility journey."

Blockage of the fallopian tubes accounts for infertility in approximately 20% of couples who are having difficulty conceiving.ⁱ HSG using iodine and X-ray, laparoscopy or saline/air hysterosalpingo contrast sonography (HyCoSy) are commonly used to determine tubal patency but have several limitations. For example, X-Ray HSG is generally a more painful and time-consuming procedure, and HyCoSy uses an unapproved air-saline mixture that can produce lower image quality and accuracy.

"With a growing demand for assisted reproductive technologies and a downward trend for using radiation in women trying to conceive, there is a huge need for a gentler and more patient-friendly tubal patency test," said Johan Remmerswaal, President, ExEm Foam Inc. "We are proud to be able to fulfill this need with the Foam procedure by quickly, safely and accurately assessing the patency of the fallopian tubes in the comfort of a patient's gynecologist office."

ExEm Foam, approved by the U.S. Food and Drug Administration in 2019, has been used in more than 500,000 tubal patency procedures worldwide since it first launched in Europe in 2011. For more information, please visit www.ExEmFoam.com.

About ExEm® Foam (air polymer-type A) intrauterine foam
ExEm® Foam ((air polymer-type A) intrauterine foam) is an innovative, FDA-approved product that offers a less invasive ultrasound procedure, a highly accurate alternative to other tubal patency assessment procedures, like laparoscopy or X-ray HSG. The contrast agent allows for easy recognition of tubal patency using the Foam procedure. During the tubal patency procedure, the foam is infused into the uterus by a healthcare professional to allow for visual assessment of fallopian tubes. If the tubes are patent the foam will appear as a thin, bright white line within the fallopian tubes and spill over the ovaries and into the peritoneal cavity when visualized with ultrasound. If the white line does not appear, the fallopian tubes might be occluded or blocked.

IMPORTANT SAFETY INFORMATION
ExEm® Foam should not be used on patients who are pregnant, have known or suspected lower genital tract inflammation or infection, have had a gynecologic procedure within the last 30 days, have vaginal bleeding, or have known or suspected reproductive tract neoplasia. Common side effects include pelvic and abdominal pain, vasovagal reactions (and associated symptoms such as nausea and faintness), and post-procedure spotting.

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About ExEm® Foam Inc
ExEm® Foam Inc is focused on providing solutions to simplify infertility diagnosis and enhance the fertility journey. Drawing on its years of experience, the team develops innovative products that better meet the needs of today's patient and healthcare professional. ExEm® Foam, the company's first FDA-approved product, is indicated as a contrast drug for hysterosalpingo foam sonography, also known as HyFoSy, to assess whether there may be a blockage in the fallopian tubes in women with known or suspected infertility. ExEm Foam has been used in more than 500,000 tubal patency procedures worldwide since it first launched in Europe in 2011. ExEm Foam Inc is headquartered in Nashville, TN. For more information, please visit www.ExEmFoam.com.

ⁱ van Rijswijk, J., van Welie, N., Dreyer, K. et al. The FOAM study: Is Hysterosalpingo foam sonography (HyFoSy) a cost-effective alternative for hysterosalpingography (HSG) in assessing tubal patency in subfertile women? Study protocol for a randomized controlled trial. BMC Women's Health 18, 64 (2018). https://doi.org/10.1186/s12905-018-0556-6

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SOURCE ExEm Foam Inc.