Rigicon has officially launched patient enrollment in the AUSOME Study (Artificial Urinary Sphincter Outcomes Multicenter Evaluation) in the UK, marking a significant milestone in its efforts to gain FDA Premarket Approval (PMA). The study evaluates the safety, effectiveness, and patient-reported outcomes of Rigicon's next-generation artificial urinary sphincter. The first two patients were enrolled under the leadership of Dr. Rowland Rees, a respected expert in male incontinence. Rigicon will expand enrollment across global urology centers to meet the FDA's clinical requirements.
RONKONKOMA, N.Y., July 26, 2025 /PRNewswire-PRWeb/ -- Rigicon, a global leader in prosthetic urology innovation, proudly announces the commencement of patient enrollment in its pivotal AUSOME (Artificial Urinary Sphincter Outcomes Multicenter Evaluation) Study. This landmark prospective clinical investigation aims to support FDA Premarket Approval (PMA) and has successfully enrolled its first two patients in the UK under the esteemed guidance of Dr. Rowland Rees, a renowned urologist and leading authority in male incontinence treatment.
The AUSOME Study is designed to rigorously evaluate the safety, effectiveness, and patient-reported outcomes of Rigicon's groundbreaking artificial urinary sphincter technology. Recognised for advancing the state of prosthetic urology, the AUSOME Study's outcomes could significantly reshape treatment protocols and elevate patient quality of life globally.
Dr. Rowland Rees, consultant urologist and lead investigator, commented, "Being part of such an important study is truly exciting. Rigicon's innovative approach not only offers hope to countless patients experiencing urinary incontinence but also sets a new standard in prosthetic urology. Early enrollment is an encouraging sign for this transformative therapy."
Dr. Steven K. Wilson, Rigicon's Global Medical Director, added, "The AUSOME Study exemplifies Rigicon's commitment to pioneering rigorous clinical research, driving meaningful innovation in prosthetic urology."
Rigicon's device stands apart with advancements in patient comfort, usability, and durability, positioning itself as a potentially superior alternative to existing artificial urinary sphincter solutions currently available on the market.
"The initiation of patient enrollment in the AUSOME study marks a landmark moment and a new era for Rigicon," said Ahmet Melih Luleci, COO of Rigicon. "We are now proactively initiating prospective clinical studies for our current products as well as our upcoming new product lines, including electronic artificial urinary sphincter (E-AUS) and penile prostheses (E-IPP). With Dr. Rees' leadership, we're optimistic about bringing life-changing results to patients and clinicians worldwide."
This announcement underscores Rigicon's leadership in prosthetic urology, highlighting our dedication to continuous innovation, rigorous clinical validation, and an unwavering commitment to improving patient outcomes.
Rigicon plans to expand enrollment rapidly, leveraging prominent urology centres globally to complete the needed enrollment number for FDA PMA submission.
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SOURCE Rigicon
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