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Rigicon Announces Expansion of UNITED Clinical Study Investigator Team; Dr. Rafael Carrion Appointed Principal Investigator for USF/TGH Site
Rigicon, Inc. is pleased to announce a significant expansion of the UNITED Clinical Study with the formal onboarding of the University of South Florida Urology Team / Tampa General Hospital research team. Dr. Rafael Carrion has been appointed Principal Investigator for the USF/TGH site, with Dr. Justin Parker and Dr. Raul Fernández-Crespo joining as Sub-Investigators.
This addition strengthens the national reach and scientific rigor of the UNITED Study evaluating the Rigicon Infla10® Dynamic Inflatable Penile Prosthesis (DIPP). The USF/TGH team joins an already distinguished group of high-volume implanters leading the study, including Dr. Paul Perito, Dr. Jonathan Clavell, and Dr. Tariq Hakky.
About the UNITED Clinical Study
The UNITED Clinical Study is a prospective, multicenter, single-arm performance-goal study evaluating the safety and effectiveness of the Rigicon Infla10® Dynamic Inflatable Penile Prosthesis (DIPP). The UNITED Study is conducted under an FDA-approved IDE and classified as a CMS Category B IDE study, meaning Medicare and Medicare Advantage plans cover most costs for eligible patients.
About Dr. Rafael Carrion
Dr. Carrion is a globally recognized expert in Sexual Medicine, Peyronie’s Disease, Men’s Health, and General Urology. He is an active member of more than eight professional organizations—including the American Urological Association, the Sexual Medicine Society of North America, and the Florida Urological Society—and has held multiple leadership roles across these groups. His academic contributions include over 100 peer-reviewed publications, more than 100 scientific abstracts, and 25+ live surgical workshops hosted at USF. He is also a recipient of the AUA Young Leadership Award, underscoring his influence within the field of urology.
About Dr. Paul Perito
Dr. Perito is internationally recognized as one of the highest-volume penile implant surgeons in the world, having performed thousands of procedures and trained hundreds of surgeons annually in minimally invasive penile prosthesis techniques. As founder of Perito Urology, he established one of the leading global centers for prosthetic urology and continues to shape best practices adopted worldwide.
About Dr. Jonathan Clavell
Dr. Jonathan Clavell, M.D., F.A.C.S., is a board-certified urologist and fellowship-trained specialist in Sexual Medicine and Prosthetic Urology. A high-volume penile implant surgeon and Adjunct Assistant Professor at the University of Texas in Houston, he is known for his expertise in erectile dysfunction, Peyronie’s disease, and penile prosthetics, delivering patient-centered care to men across the United States.
About Dr. Tariq S. Hakky
Dr. Tariq S. Hakky is a board-certified urologist and world-renowned microsurgeon based in Atlanta, Georgia. Fellowship-trained in male infertility and andrology at Baylor College of Medicine, he is the founder of Atlanta Cosmetic Urology, where he provides advanced surgical and sexual-health care for patients seeking treatment for urologic conditions, sexual dysfunction, pelvic pain, hormonal imbalance, and related concerns.
Quotes
“Our team at USF and Tampa General Hospital is honored to join the UNITED Clinical Study. I have long championed our inclusion in this milestone study because I believe deeply in the importance of expanding high-quality clinical evidence in prosthetic urology. The Infla10® Dynamic Inflatable Penile Prosthesis represents meaningful innovation, and we are committed to contributing rigorous, thoughtful research that advances care for patients worldwide.” — Dr. Rafael Carrion, Principal Investigator, USF/TGH
“The UNITED Study was built on the belief that meaningful innovation requires meaningful evidence. Bringing Dr. Carrion and the USF/TGH team into this study reflects that commitment. Their clinical expertise and academic leadership strengthen the UNITED Study in exactly the way we envisioned. We are proud to have Dr. Carrion advocating for his team’s involvement, and we look forward to the important contributions he, Dr. Parker, and Dr. Fernández-Crespo will bring to this milestone effort.” — Dr. Huseyin Luleci, Urologist & Founder, Rigicon, Inc.
About Rigicon
Rigicon is dedicated to advancing solutions in prosthetic urology through innovation, clinical evidence, and surgeon collaboration. The company’s portfolio includes inflatable and malleable penile prostheses, testicular implants, and artificial urinary sphincters designed to improve quality of life for patients worldwide.
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