SUNNYVALE, Calif., Sept. 16, 2021 /PRNewswire/ — Prodeon Medical, Inc., a medical device company developing a novel, minimally invasive treatment for lower urinary tract symptoms (LUTS) caused by enlarged and obstructive benign prostatic hyperplasia (BPH), today announced the availability of interim results of its EXPANDER-1 clinical study using the Urocross Expander System (previously branded as the XFLO). The data was presented as part of the American Urology Association (AUA) annual conference on September 11, 2021 by Professor Henry H. Woo, MD of the Australian National University. In addition to Prof. Woo, the data includes procedural contribution from Drs. Chi-Ping Huang, Chief of Department of Urology at China Medical University Hospital (Taiwan); William Huang, Chief of Department of Urology at Taipei Veteran’s General Hospital; and Dean Elterman of the University of Toronto.
The EXPANDER-1 Study is a multicenter open-label trial conducted outside the United States and is evaluating the safety and efficacy of the Urocross Expander System and Urocross Retrieval Sheath (formerly branded as XPRO) for the treatment of Lower Urinary Tract Symptoms (LUTS) in patients with BPH. Prof Woo stated, "Based on these early results, we are thrilled that the primary clinical objective of the feasibility and safety study have been positive." He continued, "This unique technology was designed to reduce urinary symptoms by reshaping the prostatic urethra. The clinical data is likewise pleasing and justifies moving this technology into randomized controlled trials."
Preliminary results from 39 patients treated in this study demonstrate that the procedure using the Urocross Expander System is feasible and safe with no reported procedural complications. There were two related serious adverse events reported during the follow-up that were resolved without sequalae. Specific to the data from patients with planned retrieval at 6-months, immediate symptom improvement as measured by the International Prostate Symptom Score (IPSS) was observed at 3- and 6-months post-implant (-48% and -49% respectively) and was sustained and measured at 3- and 6-months post-retrieval (-52% and -46% respectively).
Dr. Elterman stated, "The data suggests that patient symptom relief is sustained post-retrieval which is an exciting advancement in the management of this chronic condition because it preserves affected anatomy for future interventions if required." According to Dr. C.P. Huang, "BPH has become an important global health concern in all countries and many men are looking for minimally invasive alternatives to medications and major surgeries".
About Urocross Expander System
The Urocross Expander System (formerly branded as XFLO) and Urocross Retrieval Sheath (formerly branded as XPRO) are for Investigational Use Only and are not for sale in the U.S. or outside the U.S. The Urocross Expander System consists of two primary components: the Urocross Delivery System and the preloaded Urocross Expander Implant. The implant is made of Nitinol and delivered to the prostatic urethra through the working channel of a flexible cystoscope. When deployed, the implant’s struts expand to place gentle and constant pressure on the obstructive lobes of the prostate. During the implant dwell time, it is intended to reshape the prostatic urethra in a procedure described as PURE (Prostatic Urethral REshaping).
About Prodeon Medical
The Prodeon Medical initiative was started in 2016 with the mission of rethinking the treatment of the lower urinary tract symptoms due to Benign Prostatic Hyperplasia (BPH). The company’s first technology under development is a promising new minimally invasive procedure that allows patient-oriented therapy via flexible cystoscopy and does not preclude future treatment options. Learn more at www.prodeonmedical.com
SOURCE Prodeon Medical, Inc