FemDx Medsystems Announces Successful First-in-Human Study

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SANTA CLARA, Calif.--(BUSINESS WIRE)--Apr 28, 2025--

FemDx Medsystems, a pioneering medical device company focused on advancing gynecological diagnostics, is proud to announce the successful completion of its first-in-human clinical study. The procedure was performed in February 2025 and yielded highly encouraging results, marking a significant milestone toward improving early detection and access to fallopian tubes under direct visualization.

The device is a miniaturized endoscopic system designed to visualize the fallopian tube lumen via the uterine route. In this initial study, patient cases were performed with direct visual access to the tubal ostium and lumen. Physicians reported satisfaction with overall performance.

Dr. Jose Garza, who led the study in Monterrey, Mexico. “This technology has the potential to revolutionize how we assess and access fallopian tubes for fertility evaluations and early detection of gynecologic pathology.”

“The successful first-in-human study of the device marks a significant advancement in women's health.” Ashlee Francis, CEO and Co-founder of FemDx Medsystems, commented on the milestone, “Our team is dedicated to developing innovative solutions and this achievement brings us closer to providing clinicians with effective tools.”

FemDx Medsystems plans to continue clinical validation and expand its study cohort in preparation for regulatory submissions to support commercial launch.

About FemDx Medsystems

FemDx Medsystems is a medical device company dedicated to developing innovative technologies aimed at enhancing women's health. Its flagship product, FalloView™, is the first falloposcope incorporating a CMOS chip endoscope, designed to provide direct visualization and access to the fallopian tubes. The device has received FDA 510(k) clearance, marking a significant advancement in women's health.

FemDx Medsystems, Inc. is funded by ShangBay Capital, SV Tech Ventures, Portfolia Fund, WSGR, and well-known venture investors from Silicon Valley. ShangBay Capital is a leading medical technology-focused venture firm based in Palo Alto, California. Portfolia Fund is the largest and most influential community of women investors in the world.

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CONTACT: For media inquiries, clinical trial information, or partnership opportunities, please contact:Media Contact:

Xi Ashlee Francis

CEO

FemDx Medsystems, Inc.

Email:[email protected]

Website:www.femdxmed.com

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: HEALTH TECHNOLOGY HEALTH CLINICAL TRIALS MEDICAL DEVICES

SOURCE: FemDx Medsystems, Inc.

Copyright Business Wire 2025.

PUB: 04/28/2025 02:04 PM/DISC: 04/28/2025 02:03 PM

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