Prodeon Medical, Inc., Announces Randomization in the Pivotal Expander-2 Clinical Trial Evaluating the Company’s Investigational Treatment for Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia
SUNNYVALE, Calif., September 26, 2022 /PRNewswire/ — 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 of 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 carried out by Marc SuttonMD, FACS at Houston Metro Urology at Houston, TX. Dr. Sutton specializes in comprehensive urology services for men and women, including BPH.
BPH is a condition in which prostate tissue grows over time and obstructs the urethral lumen, resulting in LUTS. Sixty percent (60%) of men over the age of 60 and up to 80% of all men in general will eventually develop BPH with LUTS, which is approximately 40 million men worldwide. United States who suffer from BPH¹,². Common symptoms associated with BPH include a wide variety of uncomfortable urinary difficulties (eg, urgency, blockage of urine flow, as well as urinary tract, kidney, and bladder problems), depression and sleepless nights that lead to loss of productivity, which leads to a significant deterioration in the patient’s quality of life. Prescription medications prescribed for BPH are commonly associated with side effects which include, but are not limited to, headaches, dizziness, low blood pressure, and possibly cognitive decline. Traditional surgical treatment options (eg, TURP) are often associated with complications such as bleeding, need for urinary catheterization, incontinence, sexual dysfunction, overnight hospitalization, and period longer recovery¹.
The EXPANDER-2 trial is a multicenter, randomized, blinded, controlled study to evaluate the safety and efficacy of the Urocross Expander System and Recovery Sheath for the treatment of LUTS, secondary to BPH . Launch of EXPANDER-2 trial builds on foundation of EXPANDER-1 trial, a first-in-man/feasibility clinical trial (NCT: 03758222) that provided promising early safety data and efficacy during the stay period and after recovery from the Urocross stent. Interim results from 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 into a patient’s obstructed prostatic urethra using a standard flexible cystoscope and, after a period of six months, the Urocross implant is removed. As part of the Expander-2 trial, the Urocross Expander System and Recovery Sheath will be used in a new procedure called PURE™ (Prostatic youreturn REshaping) to relieve symptoms associated with BPH. The PURE is a patient-friendly approach that allows 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 to the treatment of BPH that does not surgically cut, resect, burn, ablate, leaves nothing 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 Co-Principal Investigator of the pivotal EXPANDER-2 trial “I am excited to help bring this technology to my patients in the future.”
“The Urocross Expander System and the PURE procedure represent a minimally invasive method of treating BPH symptoms that should enable more men to seek treatment,” said co-lead investigator Dr. Dan Rukstalis, vice chair of research in the department of surgery, founding member of the section of urology at Virginia Tech Carilion School of Medicine. “I am encouraged by the promising results garnered from the Expander-1 feasibility study, and the EXPANDER-2 trial is an opportunity to seek additional evidence that the Urocross System is a safe and effective treatment option. for patients with 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 input from the US FDA,” said Paul EdwardsPresident and Chief Executive Officer of Prodeon Medical, Inc. “Prodeon’s medical team is committed to conducting this study with the highest level of quality and compliance to gather the clinical evidence required to support this minimally invasive therapy to treat men with symptoms due to an enlarged prostate.”
About Prodeon Medical, Inc.
The Prodeon Medical, Inc. initiative was launched in 2016 with a mission to reimagine how men can be more easily treated for one of the world’s most common medical conditions affecting men, an enlarged prostate leading to hyperplasia. benign prostate (BPH). Prodeon Medical, Inc. has developed and is studying a minimally invasive, user-friendly approach for the treatment of LUTS secondary to BPH known as PURE (Prostatic youreturn REshaping) using the Urocross expansion system and recovery sheath. The Urocross Expansion System and Urocross Recovery Sheath are experimental devices and are not for sale in the United States or outside of the United States.
Learn more on www.prodeonmedical.com
- Management of Benign Prostatic Hyperplasia / Lower Urinary Tract Symptoms: AAU Guideline 2021.
- Campbell Walsh Wein Urology, 12e Editing; Prodeon data on file.
SOURCE Prodeon Medical