Utepreva 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. The company said it was engineered to modernize office-based endometrial tissue and fluid sampling.
The Utepreva Endometrial Sampler 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.
