Rivermark Medical Enrolls First Patient in RAPID III FLOSTENT™ Study

Rivermark Medical, a company specializing in urology-focused medical devices, recently announced the initiation of the RAPID III clinical trial, designed to evaluate the FloStent™ System's safety and effectiveness. This trial aims to offer a minimally invasive treatment for benign prostatic hyperplasia (BPH) and involves the enrollment of its first participant. The trial is structured as a prospective, multicenter, randomized pivotal study and carries the identifier NCT06849258.

Sheldon Freedman, M.D., a notable urologist in Las Vegas, Nevada, executed the first procedure using the FloStent™ System at Freedman Urology. Dr. Freedman emphasized the importance of this device as a non-surgical and reversible treatment option for men suffering from BPH, expressing enthusiasm about being the inaugural site for the RAPID III study. He highlighted the device's potential to effectively address urinary symptoms while maintaining patient confidence.

The FloStent™ system serves as a first-line treatment for BPH and is intended for outpatient settings. It is deployed through a routine cystoscopy, compatible with any flexible cystoscope, and designed to enhance urinary flow, reduce patient recovery time, and maintain future treatment options. This device diverges from traditional therapies as it does not involve capital investment, and it can be easily retrieved or adjusted post-implantation using standard urological equipment.

Rivermark Medical, under the leadership of CEO and practicing urologist Adam Kadlec, MD, aims to provide solutions grounded in real-world clinical needs. Dr. Kadlec explained that the FloStent™ offers rapid symptom relief without tissue damage, minimizing risks associated with surgical and other irreversible treatments. This characteristic positions the FloStent™ as a logical initial choice for millions of men seeking BPH treatment. The commencement of the RAPID III study represents a significant milestone for Rivermark Medical, underlining the increasing demand for effective and accessible BPH therapies.

BPH, a condition affecting nearly 40 million men in the United States and over 500 million globally, significantly impacts the quality of life despite not being life-threatening. Current treatment options often present a compromise between efficacy, invasiveness, and side effects. With the introduction of a zero-capital BPH treatment in outpatient settings, Rivermark Medical empowers a wide range of healthcare providers to achieve high-quality patient outcomes.

Rivermark Medical is committed to transforming BPH treatment with innovative and straightforward therapies that emphasize positive patient outcomes and ease of use for healthcare providers. The FloStent™ is currently under investigational use, as regulated by federal law, and is not yet broadly available for clinical application.

For details on the RAPID III trial, interested parties can access information on clinicaltrials.gov. Rivermark Medical continues its mission to redefine BPH treatment, offering promising new options for those affected by this prevalent condition.