Rivermark Medical Announces Fully Enrolled Multi-center OUS Clinical Trial for Innovative Benign Prostatic Hyperplasia Device
Clinical programs supported by close of oversubscribed Series B Financing
MILWAUKEE – December 7, 2023 – Rivermark Medical, a company dedicated to developing a novel therapeutic device for benign prostatic hyperplasia (BPH), announced today the full enrollment of its RAPID-II clinical trial, a multi-center OUS clinical trial with sites in Australia, New Zealand, and Mexico. The trial is funded by the company’s oversubscribed Series B financing which closed earlier this year and was led by Anduril Investors LLC, a physician-founded investor group, with participation from existing investors View Ventures and Cadence Healthcare Ventures.
“We are excited by the efficient enrollment of our RAPID-II clinical trial. This trial enables us to capture robust real-world evidence, which will demonstrate the efficacy of our technology for patients afflicted with BPH,” stated Adam Kadlec, M.D., President and CEO of Rivermark Medical. “All procedures were performed in the outpatient setting, utilizing a variety of flexible cystoscopes, and all patients were discharged without a post-operative catheter. We are thrilled with these early observations as they solidify FloStent’s unique position amongst therapeutic devices for BPH.”
BPH is a non-cancerous condition caused by an enlarged prostate, impacting the quality of life in approximately 1 in 3 men over the age of 50. It can lead to uncomfortable symptoms such as frequent urination, difficulty urinating, and urinary tract infections (UTIs). Existing therapies may result in persistent symptoms, diminished sexual function, increased risk of infection, and a challenging recovery process for patients. Rivermark’s FloStent System is a uniquely engineered nitinol stent that gently holds the prostatic urethra open to restore normal urinary flow while preserving sexual function. The device is designed for rapid patient relief with minimal discomfort, can be deployed using any flexible cystoscope during an outpatient visit, and offers fewer complications and minimal recovery time.
“Rivermark is revolutionizing the BPH treatment paradigm with a device that offers therapeutic intervention at the time of diagnosis,” stated Dr. Matt Ercolani, co-founder and managing partner of Anduril Investors LLC, and key opinion leader for several BPH treatment options currently on the market. “As an investor and clinician, I believe the technology’s ability to provide immediate relief for patients while seamlessly integrating into routine urological visits will be game-changing for the treatment of BPH.”