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UCI Health enrolls patient in first U.S. study of medical device for erectile dysfunction

 Faysal A. Yafi, MD

Dr. Faysal A. Yafi leads the study of novel radiofrequency device

The first U.S. clinical trial for a groundbreaking radiofrequency device targeting #erectiledysfunction (ED) is now underway at UCI Health. Dr. Faysal A. Yafi, a leading UCI Health urologist, is spearheading the study of the Vertica® device, developed by Ohh-Med Medical Ltd., marking a significant step in men's health research.

This randomized, double-blind clinical trial, approved by the U.S. Food and Drug Administration (FDA), aims to assess the safety and effectiveness of the Vertica device as an ED treatment. The first participant was enrolled this week, reflecting the commitment to advancing innovative solutions.

The Vertica device targets the root cause of ED by addressing venous leakage in the penis, ensuring regulated blood flow during erection. Through the application of low-level radio waves, the device gently heats genital tissue, enhancing blood flow and oxygenation to the tunica albuginea, a critical fibrous tissue surrounding the testes and penis.

Patients in the study will receive either an active or simulated device, with both the patient and the administering physician unaware of the type administered. The device is applied twice a week for 15 to 30 minutes, with additional weekly follow-up treatments as needed.

Yafi, the principal investigator and associate professor of urology, is optimistic about the potential impact of this therapy. "This treatment has the potential to assist many men who suffer from ED and lack alternative solutions. A prior pilot trial with 28 patients showed promising results, confirming the safety of the Ohh-Med device. We are pleased to contribute to this study and expand the research into potential new ED treatments."

Daniel Lischinsky, CEO of Ohh-Med Ltd., acknowledges the collaboration with UCI Health as a significant milestone. "Our partnership with UCI Health, a renowned research center for men’s health, is a crucial step in our journey. Launching this clinical trial to evaluate the efficacy of our Vertica device is pivotal towards obtaining FDA clearance."