Rigicon has officially launched patient enrollment in the AUSOME Study (Artificial Urinary Sphincter Outcomes Multicenter Evaluation), marking a significant milestone in the company's pursuit of FDA Premarket Approval (PMA) for its artificial urinary sphincter technology. The first two patients were successfully enrolled in the UK under the guidance of Dr. Rowland Rees, a renowned urologist and leading authority in male incontinence treatment.
Clinical Study Design and Objectives
The AUSOME Study is designed as a prospective clinical investigation to rigorously evaluate the safety, effectiveness, and patient-reported outcomes of Rigicon's artificial urinary sphincter technology. The landmark study aims to provide the clinical evidence necessary for FDA PMA submission, potentially reshaping treatment protocols and elevating patient quality of life globally.
Dr. Rowland Rees, consultant urologist and lead investigator, expressed enthusiasm about the study's potential impact: "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."
Device Innovation and Market Positioning
Rigicon's artificial urinary sphincter device distinguishes itself through 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 company's approach represents a significant advancement in prosthetic urology technology.
Dr. Steven K. Wilson, Rigicon's Global Medical Director, emphasized the company's research commitment: "The AUSOME Study exemplifies Rigicon's commitment to pioneering rigorous clinical research, driving meaningful innovation in prosthetic urology."
Expansion Plans and Future Development
Rigicon plans to expand enrollment rapidly, leveraging prominent urology centers globally to complete the needed enrollment number for FDA PMA submission. The company is simultaneously developing additional product lines as part of its broader innovation strategy.
Ahmet Melih Luleci, COO of Rigicon, outlined the company's comprehensive development approach: "The initiation of patient enrollment in the AUSOME study marks a landmark moment and a new era for 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."
The announcement underscores Rigicon's leadership position in prosthetic urology, highlighting the company's dedication to continuous innovation, rigorous clinical validation, and commitment to improving patient outcomes in the treatment of urinary incontinence.
