Clinical Trial of a New BPH Treatment FDA Approved

Optilume Balloon Catheter System Product Photo, Courtesy of Urotronic, Inc.

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Benign Prostatic Hyperplasia (BPH) or enlarged prostates is a medical condition that affects millions of men, with over 750,000 cases diagnosed every year. Patients experience symptoms such as a weak urinating stream, nocturia, and much more. The challenge for men experiencing enlarged prostate or BPH is that traditionally, the treatment for this condition involves undergoing an invasive surgical procedure.  Plymouth-based Urotronic, Inc. looks to solve this with their Optilume BPH Catheter System solution.

In a recent success, Urotronic has received approval from the FDA to begin their clinical trial, designated as PINNACLE. As a new alternative to treating BPH, the Optilume BPH Catheter System is a minimally invasive procedure that provides patients the opportunity to receive office-based or outpatient treatment.

In a recent study from iData Research, BPH treatment devices are the fastest-growing segment in the urology market. The growth of this segment is primarily driven by minimally invasive treatments because it is a more attractive treatment option for BPH. As this new segment of treatments in Urology is explored, products from organizations such as Urotronic, Inc. can expect to positively contribute to the market.

Dr. Steven Kaplan, Professor, Icahn School of Medicine at Mount Sinai and Director of the Men’s Wellness Program, Mount Sinai Health System in New York and the principal investigator of PINNACLE  believes that “the Optilume BPH balloon pairs innovative design with powerful drug therapy to provide a simple, anatomy sparing in-office procedure that doesn’t surgically cut, burn, lase, steam or leave anything behind in the prostate like the other BPH technologies.” Dr. Kaplan further stated that “this technology holds tremendous promise.”

During a press release, investor and company board member Doug Kohrs said that “this technology is very disruptive, and the end beneficiary is going to be the patients.” He is confident that “Urotronic has embarked on an anatomy sparing approach to treating BPH that no one else has ever taken.”


For Further Information

To get in an in-depth market overview, as well as insight through primary research and procedural volumes from 18 countries, please read iData Research’s 2106 page Global Urology Market Analysis, Size, and Trends Report.

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