Rivermark Medical, a company dedicated to developing first-line device therapy for benign prostatic hyperplasia (BPH), announced today the successful first-in-human (FIH) use of its FloStentTM System as part of the Company’s RAPID-1 FIH clinical study.
The procedures were performed on 15 patients by Principal Investigator (PI) Dr. Ingrid Perscky Arravanti and proctored by Primary Clinical Advisor Dr. Dean Elterman at the Pacifica Salud Hospital and the Panama Clinic in Panama City, Panama. The study evaluates the delivery, safety, and clinical effectiveness of the FloStent System.
“I am pleased to be a part of the initial cases and remain very impressed by the performance of the FloStent System. I was able to easily position and deploy the implant with standard equipment, using familiar endoscopic techniques,” stated Dr. Ingrid Perscky Arravanti, Urologist and Clinical Professor Ad Honorem at Universidad de Panama and President and Founder of the Global Men’s Health Foundation. “This therapy is extremely attractive as it offers patients instant improvement in BPH symptoms without the inconvenience and discomfort of traditional treatments.”
The Flostent System is intended to be the preferred first-line device treatment for BPH. The outpatient procedure involves 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.
“Watching the FloStent procedures firsthand, I’m enthusiastic about the ease of use and immediacy of BPH symptom relief,” said Dr. Dean Elterman, a leading Urologist and faculty member in the University of Toronto’s Division of Urology. “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.”
BPH is a non-cancerous condition caused by an enlarged prostate. It affects over 200 million men globally and can lead to uncomfortable symptoms such as frequent urination, difficulty urinating, and urinary tract infections (UTIs). It is the most common reason men seek urologic treatment and impacts the quality of life in approximately 1 in 3 men over the age of 50. Drawbacks of current treatments include lack of symptom relief, loss of sexual function, risk of infection, and uncomfortable recovery.
“Today marks an important milestone as Rivermark transitions into a clinical-stage company,” commented Adam Kadlec, M.D., CEO of Rivermark Medical and practicing Urologist at Advocate Health in Milwaukee, Wisconsin. “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.”