Dec 7, 2023, 08:00 ET
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.”
Jan 10, 2023, 08:00 ET
Rivermark Medical announces successful first-in-human use of its Flostent System For Symptomatic BPH
Company to expand clinical program as all treated patients experienced rapid symptom improvement
MILWAUKEE, Jan. 10, 2023 /PRNewswire/--Rivermark MedicalTM, 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."
About Rivermark Medical
Rivermark Medical was founded by a practicing urologist to develop the preferred first-line device therapy for BPH, allowing physicians to treat patients safely and efficiently, with minimal discomfort and reduced complications. The FloStent System is the first product Rivermark Medical plans to bring to market.