Prodeon Medical announced the completion of patient enrollment for the Expander-2 Pivotal Trial, a study evaluating the Urocross Expander System for minimally invasive treatment of Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).
SUNNYVALE, Calif. , Jan. 6, 2025 /PRNewswire-PRWeb/ -- Prodeon Medical, Inc., a medical device company developing a minimally invasive treatment for lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH), today announced the successful completion of patient enrollment in its Expander-2 Pivotal Trial. This multi-center, randomized, blinded, controlled study is designed to evaluate the safety and efficacy of the company's novel Urocross® Expander System and the Urocross® Retrieval Sheath, a minimally invasive, non-permanent implant-based treatment for patients with Lower Urinary Tract Symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
50% of men over the age of 50 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 BPH (1,2,3). "We are excited to reach this important milestone in the Expander-2 Pivotal Trial," said Paul Edwards, President and CEO of Prodeon Medical. "Completing enrollment is a key step in our mission to advance innovative treatments for BPH that improve patient outcomes and quality of life. We are thankful to our patients, investigators, and research teams for their participation and dedication to our study."
Dr. Kevin McVary, Co-Principal Investigator of the Expander-2 Trial and a world-renowned Urologist at Loyola University, shared his insights on the Urocross system: "The Urocross Expander System is impressively intuitive. Its unique design facilitates a straightforward procedure with a sensible and fluent learning curve, and I can envision how this minimally invasive device could revolutionize how we recast BPH in the future. It offers a promising solution for patients looking for relief from their symptoms without undergoing more invasive procedures."
Dr. Dan Rukstalis, another world-renowned Urologist at Virginia Tech and Co-Principal Investigator of the Expander-2 Trial, added "The removable design of the Urocross Expander as a non-permanent prostatic implant creates a new paradigm for the treatment of men with BPH who want to avoid tissue resection and sexual dysfunction. The fact that this system works without cutting, burning, ablating, or leaving a permanent foreign body inside the prostate is truly revolutionary. It opens up a whole new world of possibilities for how we approach treatment, offering patients effective relief with minimal intervention."
The Expander-2 Pivotal Trial is being conducted at leading medical institutions across the USA and Canada. Data from this trial will be used to support regulatory submissions and further the clinical understanding of this novel approach to BPH treatment.
About Prodeon Medical
The Prodeon Medical, Inc. initiative was started in 2016 with the mission of reimagining how men can be more easily treated for one of the most common disease states in the world affecting men, an enlarged prostate leading to Benign Prostatic Hyperplasia (BPH). Prodeon Medical, Inc. has developed and is investigating an ultra-minimally invasive and patient-friendly approach to treating LUTS secondary to BPH using the Urocross Expander System and Retrieval Sheath. The Urocross Expander System and Urocross Retrieval Sheath are investigational devices and are not for sale in the US or outside the US.
For more information, please visit www.prodeonmedical.com.
1. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (BPH): AUA Guideline Amendment 2023.
2. Vuichoud C, Loughlin KR. Benign prostatic hyperplasia: epidemiology, economics and evaluation. Can J Urol. 2015 Oct;22 Suppl 1:1-6. PMID: 26497338.
3. Welén K, Damber JE. Androgens, aging, and prostate health. Rev Endocr Metab Disord. 2022 Dec;23(6):1221-1231. doi: 10.1007/s11154-022-09730-z. Epub 2022 Jun 24. PMID: 35748976; PMCID: PMC9789017.
Media Contact
Paul Edwards, Prodeon Medical, 1 6694671100, [email protected], https://prodeonmedical.com/
SOURCE Prodeon Medical
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