Pivotal trial launches of FloStent System for BPH

The pivotal RAPID III trial (NCT06849258), evaluating the safety and effectiveness of the FloStent System in patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), has enrolled its first participant, Rivermark Medical announced.¹

In total, the trial is aiming to enroll 215 adult patients.

The device is an investigational, minimally invasive nitinol implant designed to relieve BPH-related LUTS. According to the company, “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 first patient enrolled in the study was treated by Sheldon Freedman, MD, FACS, of Freedman Urology in Las Vegas, Nevada.

“The FloStent represents a meaningful step forward in providing men with a non-surgical, reversible treatment option for BPH," said Freedman in the news release.¹ "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."

In total, the prospective, multicenter, double-blind trial is aiming to enroll 215 adult patients across 19 clinical trial sites in the US and Australia.

Patients are eligible for enrollment in the study if they have symptomatic BPH, an International Prostate Symptom Score (IPSS) greater than 13, a peak urinary flow rate between 5 mL/sec and 13 mL/sec, a minimum voided volume greater than 125 mL, a post-void residual less than 250 mL, a prostate volume of 25 mL to 80 mL, and a prostatic urethral length of 20 mm to 50 mm.

For the study, patients with be randomly assigned 2:1 to undergo flexible cystoscopy with or without the FloStent implant deployed. The primary end point is change in IPSS score at 12 months.

"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 Adam Kadlec, MD, practicing urologist and CEO and co-founder of Rivermark Medical, in the news release.¹ "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."

The RAPID-III trial will be highlighted during a trials in progress session at the upcoming American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada.

The RAPID-III trial is preceded by the first-in-human RAPID-I trial, which completed initial clinical use in January 2023,³ and the RAPID-II trial. Twelve-month data from the RAPID-II study will also be presented at AUA.

Further, the FloStent System was assessed in an extended indication study for patients with urinary retention. In total, the pilot study enrolled 11 patients through the Pacifica Salud Costa del Este Hospital in Panama City, Panama. Successful completion of the RAPID-UR study was announced in January 8, 2024.⁴

REFERENCES

1. Rivermark Medical announces first patient enrolled in RAPID III clinical study evaluating the FloStent System. News release. Rivermark. April 23, 2025. Accessed April 25, 2025. https://www.prnewswire.com/news-releases/rivermark-medical-announces-first-patient-enrolled-in-rapid-iii-clinical-study-evaluating-the-flostent-system-302436035.html

2. A clinical study to evaluate the safety and efficacy of the FloStent in men with benign prostatic hyperplasia symptoms (RAPID-III). ClinicalTrials.gov. Last updated February 27, 2025. Accessed April 25, 2025. https://clinicaltrials.gov/study/NCT06849258

3. Rivermark Medical announces successful first-in-human use of its FloStent System for symptomatic BPH. News release. Rivermark Medical. January 10, 2023. Accessed April 24, 2025. https://www.prnewswire.com/news-releases/rivermark-medical-announces-successful-first-in-human-use-of-its-flostent-system-for-symptomatic-bph-301717132.html

4. Rivermark Medical announces completion of expanded indication study for the FloStent System. News release. Rivermark Medical. January 8, 2024. Accessed April 24, 2025. https://www.prnewswire.com/news-releases/rivermark-medical-announces-completion-of-expanded-indication-study-for-the-flostent-system-302027612.html