Prodeon Medical, Inc., a medical device company developing an investigational outpatient treatment for lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) today announced the randomization of the first patient in the EXPANDER-2 pivotal clinical trial (NCT: 05400980, A Multi-Center, Randomized, Blinded, Controlled Study to Evaluate the Safety and Efficacy of the Urocross™ Expander System and Retrieval Sheath).
The first randomization was performed by Mark Sutton, M.D., F.A.C.S. at Houston Metro Urology in Houston, TX. Dr. Sutton specializes in comprehensive urologic services for men and women including BPH.
BPH is a condition where the prostatic tissue grows over time and obstructs the urethral lumen, leading to LUTS. Sixty percent (60%) of men over the age of 60 and up to 80% of all men overall, will eventually develop BPH with LUTS, representing about 40 million men in the United States who suffer from BPH¹,². Common symptoms associated with BPH include a wide variety of uncomfortable urinary difficulties (e.g., urgency, blockage of urine flow, as well as urinary tract, kidney and bladder problems), depression, and sleepless nights which lead to loss of productivity, which lead to a significant deterioration in the patient’s quality of life. Prescription medications prescribed for BPH are commonly associated with side effects that include, but are not limited to, headaches, dizziness, low blood pressure, and possibly cognitive decline. Traditional surgical treatment options (e.g., TURP) are commonly associated with complications such as bleeding, need for urinary catheterization, incontinence, sexual dysfunction, overnight hospital stay and a longer recovery period¹.
The EXPANDER-2 Trial is a Multi-Center, Randomized, Blinded, Controlled Study to evaluate the safety and efficacy of the Urocross Expander System and Retrieval Sheath for the treatment of LUTS, secondary to BPH. The initiation of the EXPANDER-2 Trial builds on the foundation of the EXPANDER-1 Trial, a first-in-human/feasibility clinical trial (NCT:03758222) that provided promising early safety and effectiveness data during the indwell period and after the retrieval of the Urocross Expander. The interim results of the EXPANDER-1 trial were recently published in the Journal of Prostate Cancer and Prostate Diseases [The EXPANDER-1 trial: introduction of the novel Urocross™ Expander System for treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH)].
The investigational Urocross Implant (deployed using the Urocross Delivery System), is designed to be placed in a patient’s obstructed prostatic urethra using a standard flexible cystoscope and, after a period of six months, the Urocross Implant is removed. Within the Expander-2 Trial, the Urocross Expander System and Retrieval Sheath will be used in a newly developed procedure called PURE™ (Prostatic Urethral REshaping) to relieve symptoms associated with BPH. The PURE procedure is a patient-friendly approach that allows for the use of flexible cystoscopy and minimal anesthesia requirement in a variety of settings.
“The PURE procedure using the investigational Urocross Expander System and Retrieval Sheath is an elegant, tissue sparing approach for treating BPH that does not surgically cut, resect, burn, ablate, lase, or leave anything behind in the prostate as seen with other BPH technologies currently offered or in development,” said Dr. Kevin McVary, Professor, Stritch School of Medicine, Loyola University and a Co-Principal Investigator of the EXPANDER-2 pivotal trial “. I am excited to help bring this technology to my patients in the future.”
“The Urocross Expander System and PURE procedure represent a, minimally invasive method of treating BPH symptoms that should help open the door for more men to seek treatment,” said Co-Principal Investigator, Dr. Dan Rukstalis, Vice Chair of Research for the Department of Surgery, Founding Member of the Section of Urology at the Virginia Tech Carilion School of Medicine. “I am encouraged by the promising results collected from the Expander-1 feasibility study, and the EXPANDER-2 Trial is an opportunity to seek further evidence that the Urocross system is a safe and effective treatment option for patients suffering from BPH.”
“We are excited to begin the EXPANDER-2 Clinical study which was designed in close collaboration with our Scientific Advisory Board (including our Co-Principal Investigators) and with critical inputs from the US FDA” said Paul Edwards, President and CEO of Prodeon Medical, Inc. “The Prodeon Medical Team is committed to conducting this study with the highest level of quality and compliance to gather the required clinical evidence to support this minimally invasive therapy to treat men experiencing symptoms due to an enlarged prostate.”