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

Radio wave therapy approved for use in Europe

December 08, 2023
dr faysal yafi in a brightly lit hospital hallway wearing glasses and a white coat

UCI Health urologist Dr. Faysal Yafi says the Vertica radiofrequency
device being tested in a clinical trial has the potential to help many
men with erectile dysfunction.

Orange, Calif. — UCI Health has opened the first U.S. clinical trial of a novel radiofrequency device designed to treat erectile dysfunction.

UCI Health urologist Dr. Faysal A. Yafi, is leading the study of the handheld Vertica® device, designed and manufactured by Ohh-Med Ltd. Yafi, medical director of Men’s Health Services at the Center for Urological Care, specializes in andrology, which includes male infertility, sexual dysfunction and low testosterone. The first clinical trial participant was enrolled this week.

The randomized, double-blind clinical study, approved by the U.S. Food and Drug Administration (FDA), will test the safety and effectiveness of the company’s home-use device as a treatment for erectile dysfunction (ED). Study participants will receive either an active or simulated device, without the knowledge of either the patient or the administering physician.

Improving blood flow

The Vertica device is designed to treat the root cause of ED by correcting venous leakage in the penis, ensuring that blood flow is regulated during erection. The device delivers low-level radio waves that gently heat the genital tissue, increasing blood flow and oxygenation to the tunica albuginea, fibrous tissue surrounding the testes and penis that plays a crucial role in erectile functioning.

The device is applied twice a week for 15 to 30 minutes, with weekly follow-up treatments as needed.

“This therapy has the potential to help many men who suffer from ED and who have no alternative solutions,” said Yafi, the study’s principal investigator and associate professor of urology at the UCI School of Medicine. “A previous pilot trial with 28 patients had surprisingly good results and showed that the Ohh-Med device is safe. We are pleased to be part of this study and expand the research into potential new treatments for ED.”

Favorable pilot study findings

Results of the proof-of-concept pilot study conducted in Israel were published in August 2023 in the International Journal of Impotence Research. The company has received approval to market the device in the European Union.

“Our cooperation with UCI Health, one of the most respected research centers for men’s health, represents a significant milestone for us,” said Daniel Lischinsky, chief executive officer of Ohh-Med Ltd., a medical technology company. “The launch of this clinical trial to determine the efficacy of our Vertica device is a major step to receiving FDA clearance.”

To learn more about the clinical trial, email eaboucha@hs.uci.edu or call 714-456-7005.

About UCI Health

UCI Health is the clinical enterprise of the University of California, Irvine, and the only academic health system in Orange County. Patients can access UCI Health at primary and specialty care offices across Orange County and at its main campus, UCI Medical Center in Orange, Calif. The 459-bed, acute care hospital, listed among America’s Best Hospitals by U.S. News & World Report for 23 consecutive years, provides tertiary and quaternary care, ambulatory and specialty medical clinics, behavioral health and rehabilitation services. UCI Medical Center is home to Orange County’s only National Cancer Institute-designated comprehensive cancer centerhigh-risk perinatal/neonatal program and American College of Surgeons-verified Level I adult and Level II pediatric trauma center and regional burn center. UCI Health serves a region of nearly 4 million people in Orange County, western Riverside County and southeast Los Angeles County. Follow us on FacebookInstagramLinkedIn and Twitter.