Utepreva Introduces FDA 510(k)-Cleared Endometrial Sampler Designed to Support Early Detection of Endometrial Cancer

The innovative device supports early diagnosis when survival outcomes are most favorable.

NEW YORK, April 22, 2026 /PRNewswire/ -- Utepreva LLC today announced the launch of the Utepreva Endometrial Sampler, a patented, FDA 510(k)-cleared, single-use endometrial sampling device engineered to enhance tissue capture and support early diagnostic evaluation of endometrial cancer. The proprietary design combines three complementary mechanisms to facilitate the comprehensive collection of tissue and fluid in a single sampling pass.

Uterine cancer is the most common gynecologic malignancy in the United States, with rising incidence and mortality rates. Endometrial carcinoma accounts for the majority of uterine cancer cases. An estimated 68,270 new cases will be diagnosed this year, according to the American Cancer Society. Clinical outcomes are highly dependent on timing: survival rates reach up to 95% when the disease is identified at an early stage, but fall below 20% in advanced disease. 

To improve survival outcomes, clinicians need diagnostic tools that reliably obtain adequate, high-quality specimens at the earliest point of concern. The Utepreva Endometrial Sampler was engineered to modernize office-based endometrial tissue and fluid sampling, addressing longstanding limitations of conventional single-mechanism devices that can compromise tissue yield and delay definitive diagnosis.

"Our mission is to save lives by expanding access to minimally invasive uterine evaluation and aiding clinicians in the detection of pre-cancer, when treatment is less invasive, and survival outcomes are significantly improved," said Dr. Jeanetta Stega, CEO of Utepreva LLC.

Superior Sampling Performance
Traditional endometrial sampler devices rely on tissue disruption or suction alone, which can limit tissue yield and may not consistently sample the full uterine cavity—potentially requiring repeat procedures to obtain an adequate specimen.

The Utepreva Endometrial Sampler uniquely integrates three complementary mechanisms of action: gentle tissue disruption, controlled suction, and optimized absorption via a sponge tip. Preclinical and design verification testing conducted by Medical Murray, a medical device manufacturer, assessed Utepreva and a commercially available endometrial sampling device using a standardized model of simulated endometrial tissue. Under controlled test conditions, Utepreva captured a greater volume of simulated tissue and demonstrated more uniform tissue disruption across the sampling surface, resulting in a statistically significant performance compared to the other device tested.

The device's sponge tip enables additional tissue sampling by absorbing fluid and cells from the uterus, while suction generated by a plunger inside the sheath aspirates cells and prevents sample loss from the brush. The collected material supports cytologic, histopathologic, and molecular analyses, enabling both cellular evaluation and advanced biomarker assessment from a single sample.

Designed for Patient Comfort and Procedural Safety
Utepreva was engineered with patient comfort and safety as central design priorities. Its slim-profile wand minimizes discomfort during insertion and removal, while an integrated cervical guard helps prevent over-insertion. The soft sponge tip reduces the risk of fundal trauma while also enhancing tissue and fluid absorption. The result is a rapid, in-office procedure completed in approximately 20 seconds without dilation, sedation, or operating room resources. 

The Future of Uterine Cancer Detection
The device is currently recommended for use in symptomatic patients—such as those presenting with abnormal or postmenopausal bleeding—as well as women at elevated risk due to age, obesity, hormone exposure, or a family history of endometrial, colon, or ovarian cancer. For these patients, timely and accurate tissue sampling is critical to early diagnosis and appropriate intervention. 

There is also potential for the device to be integrated into routine gynecologic care as a practical, standard method for early detection of uterine cancer at the population level, similar to the routine Pap smear.

"As physicians, we've seen firsthand how improved screening tools revolutionize patient outcomes," said Dr. Jeanetta Stega. "By dramatically improving tissue capture in a simple office procedure, Utepreva aims to make a similar impact on pre-cancer detection to that of Pap smears and mammography. As clinical evidence continues to build, enhanced sampling technology could ultimately lay the groundwork for broader, earlier evaluation strategies in the future." 

Available to Healthcare Providers October 2026
Caution: Federal law restricts this device to sale by or on the order of a physician (or a properly licensed practitioner).

Physicians can request samples by emailing [email protected]. 

Utepreva at ACOG
Utepreva will bring its endometrial sampling technology to the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting, taking place from May 1-3, 2026, in Washington, D.C. Visit Booth #1342 to see the Utepreva Endometrial Sampler, meet the innovators behind the device, and learn how the company is redefining diagnostic sampling for endometrial cancer detection. Dr. Jeanetta Stega and Dr. Damian Stega will present on May 2, 2026, at 1:30 p.m. ET in Theater Two.  

For more information about Utepreva, visit www.utepreva.com. 

About Utepreva
Endometrial cancer is one of the few cancers in the U.S. where both incidence and mortality are rising — yet clinicians still lack a reliable, routine path to detect it early. Utepreva is a patented, single-use endometrial sampler designed to collect more tissue while improving patient comfort compared with existing tools, helping providers obtain high-quality samples, reach answers faster, and support early cancer diagnosis.

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SOURCE Utepreva