Study to assess safety and effectiveness of a minimally invasive, zero-capital,outpatient device therapy for BPH
Rivermark Medical, a urology-focused medical device company committed to redefining benign prostatic hyperplasia (BPH) treatment through simple, innovative solutions, today announced the enrollment of the first patient in its RAPID III clinical study. RAPID III is a prospective, multicenter, randomized pivotal clinical trial (NCT06849258) designed to evaluate the safety and effectiveness of the FloStent™ System in men experiencing lower urinary tract symptoms caused by BPH.
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The first procedure was successfully completed at Freedman Urology in Las Vegas, Nevada, by Sheldon Freedman, M.D., a board-certified urologist and early adopter of innovativeBPH therapies. “The FloStent represents a meaningful step forward in providing men with a non-surgical, reversible treatment option for BPH,” said Dr. Freedman. “We're excited to be the first site to enroll in the RAPID III study and look forward to offering our patients an option that preserves confidence while effectively addressing urinary symptoms.”
FloStent is a first-line device treatment for BPH, delivered in an outpatient setting during a routine cystoscopy using any type of flexible cystoscope. The FloStent is designed to restore normal urinary flow, minimize patient recovery time, and preserve future treatment options-enabling a continuum of care for both patients and providers. Unlike other therapies, the device has no capital component, and can be easily retrieved or adjusted after implantation using standard urological tools.
Led and co-founded by practicing urologist and CEO AdamKadlec, MD, Rivermark Medical's solutions are grounded in real-world clinical needs. “FloStent is designed to offer rapid symptom relief without damaging tissue, thus reducing the risks associated with surgery and other irreversible treatment options, which makes it a logical first-step option for the millions of men seeking treatment for BPH.” said Dr. Kadlec. “Enrolling the first patient in the RAPID III study marks a major milestone for Rivermark and reflects the growing demand for simple, effective, and accessible BPH therapies.”
BPH affects nearly 40 million men in the U.S. and over 500 million men globally. While not life-threatening, it significantly impacts quality of life. Current treatment options often require trade-offs between efficacy, invasiveness, and side effects. By enabling providers to deliver a zero-capital BPH treatment in the outpatient setting, Rivermark empowers a broad range of clinicians to deliver high-quality outcomes.
For more information about the RAPID III trial, visitclinicaltrials.gov.
About Rivermark MedicalRivermark Medical is redefining BPH treatment with simple, innovative therapies that prioritize patient outcomes and provider ease.
For more information, visitrivermarkmedical.com.
CAUTION: Investigational Device.The FloStent™ is limited by Federal (or United States) law to investigational use.
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SOURCE Rivermark Medical
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