Prodeon Medical Completes Enrollment for Expander-2 Pivotal Trial
SUNNYVALE, Calif., Jan. 13, 2025 – Prodeon Medical, Inc., a medical device company focused on developing minimally invasive treatments for lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH), has announced the completion of patient enrollment in its Expander-2 Pivotal Trial. This trial is a multi-center, randomized, blinded, controlled study aimed at assessing the safety and efficacy of the Urocross® Expander System and the Urocross® Retrieval Sheath. These devices offer a minimally invasive, non-permanent implant-based treatment for patients suffering from LUTS secondary to BPH.
BPH affects a significant portion of the male population, with 50% of men over 50 and up to 80% of all men eventually developing the condition. This represents about 40 million men in the United States alone. Paul Edwards, President and CEO of Prodeon Medical, expressed enthusiasm about reaching this milestone, highlighting the importance of advancing innovative treatments for BPH to improve patient outcomes and quality of life.
Dr. Kevin McVary, Co-Principal Investigator of the Expander-2 Trial and a renowned Urologist at Loyola University, praised the Urocross system for its intuitive design and potential to revolutionize BPH treatment. Similarly, Dr. Dan Rukstalis, another Co-Principal Investigator and a distinguished Urologist at Virginia Tech, emphasized the revolutionary aspect of the Urocross Expander's removable design, which avoids tissue resection and sexual dysfunction, offering patients effective relief with minimal intervention.
The Expander-2 Pivotal Trial is being conducted at leading medical institutions across the USA and Canada. The data collected will support regulatory submissions and enhance the clinical understanding of this novel approach to BPH treatment. Prodeon Medical, Inc., founded in 2016, is dedicated to reimagining the treatment of BPH, one of the most common conditions affecting men worldwide, through its development of the Urocross Expander System and Retrieval Sheath. These investigational devices are not currently available for sale in the US or internationally.