Rivermark Medical’s FloStent System for Symptomatic BPH Evaluated in RAPID-1 FIH Study

January 10, 2023—Rivermark Medical, a developer of a first-line device therapy for benign prostatic hyperplasia (BPH), announced the successful first-in-human (FIH) use of the company’s FloStent system as part of the RAPID-1 FIH clinical study. The study is evaluating the delivery, safety, and clinical effectiveness of the FloStent system, which is the company’s first product.

According to Rivermark Medical, the procedures were performed on 15 patients by the study’s Principal Investigator Ingrid Perscky Arravanti, MD, and proctored by Primary Clinical Advisor Dean Elterman, MD, at the Pacifica Salud Hospital and the Panama Clinic in Panama City, Panama.

“I am pleased to be a part of the initial cases and remain very impressed by the performance of the FloStent system,” commented Dr. Perscky Arravanti in the company’s press release. “I was able to easily position and deploy the implant with standard equipment, using familiar endoscopic techniques. This therapy is extremely attractive as it offers patients instant improvement in BPH symptoms without the inconvenience and discomfort of traditional treatments.” Dr. Perscky Arravanti is a urologist and Clinical Professor Ad Honorem at Universidad de Panama. Additionally, she is President and Founder of the Global Men’s Health Foundation.

Dr. Elterman, who is a faculty member in the University of Toronto’s Division of Urology in Toronto, Canada, added, “Watching the FloStent procedures firsthand, I’m enthusiastic about the ease of use and immediacy of BPH symptom relief. Being able to perform this procedure quickly using common flexible cystoscopes will allow urologists worldwide to offer the FloStent system in a variety of outpatient settings, making it easier for patients to seek and receive device treatment.”

Rivermark Medical’s Flostent treatment for BPH is an outpatient procedure involving the placement of a nitinol stent during a routine flexible cystoscopy with minimal patient recovery time and no need for a urethral catheter. The stent gently holds the prostatic urethra open to restore normal urinary function, preserve sexual function, and improve a patient's overall quality of life. If desired, the device can be easily retrieved or repositioned after implantation, noted the company.

Adam Kadlec, MD, who is CEO of Rivermark Medical, is a practicing urologist at Advocate Health in Milwaukee, Wisconsin.

Dr. Kadlec stated in the press release, “Today marks an important milestone as Rivermark transitions into a clinical-stage company. We are excited at the prospect of being able to offer the most accessible BPH device therapy in the world—a first-line, minimally-invasive outpatient therapy that can be performed with existing equipment, offering BPH patients immediate and reliable relief. In the coming months, we look forward to building upon the momentum of our FIH experience by gathering additional clinical evidence demonstrating the value of the FloStent system.”