NxThera Completes Enrollment in Rezūm II IDE Clinical Trial

Maple Grove, Minn.-based NxThera Inc., a medical device company developing technology to treat urologic diseases, today announced completion of enrollment in its Rezūm II IDE (investigational device exemption) clinical trial for the treatment of benign prostatic hyperplasia (BPH).

The trial evaluated use of the Rezūm system to treat obstructive prostate tissue by convectively delivering sterile water vapor, or steam, directly into the prostate in a minimally invasive procedure that can reportedly be performed in minutes. This multi-center clinical study enrolled 195 men in the United States aged 50 or older, who were randomized 2:1 to treatment with the Rezūm system versus a control procedure.

“The Rezūm II clinical trial is designed to collect comprehensive information for review and evaluation by FDA and physicians. We look forward to completing the required follow-up assessments and evaluating patients’ outcomes in conjunction with the promising data previously reported from NxThera’s single-arm Rezūm trials,” said co-principal investigators Kevin McVary, M.D., professor and chairman of urology at Southern Illinois University, and Claus Roehrborn, M.D., professor and chairman of urology at the University of Texas Southwestern.

“It was very rewarding and exciting to see independent clinical study teams at 14 U.S. sites complete recruitment and enrollment of the Rezūm II trial in just 44 weeks, which speaks to the number of men who are seeking alternatives to currently available BPH treatments and procedures,” said Bob Paulson, president & CEO of NxThera. “We look forward to filing our submission with the U.S. Food and Drug Administration in 2015 to seek U.S. market clearance of the Rezūm system, and the opportunity to offer a new treatment option to urologists and the millions of their patients who suffer from BPH.”

In aging men, the normal flow of urine from the bladder can be restricted, often as the result of enlarged prostate tissue that obstructs the urethra. Symptoms of BPH include increased urination frequency, sudden urges to urinate, and weak urine flow. More than 32 million men in the United States, including more than 70 percent of men over age 60, experience symptoms of BPH which, if left untreated, can result in more serious conditions such as incontinence, bladder or kidney damage, or bladder stones. More than 500 million men worldwide suffer from BPH, and while medication often is the first-line therapy for men with moderate to severe symptoms, relief often is temporary and inadequate. The Rezūm System is designed to provide sustained symptom relief without the side-effects associated with other treatments or procedures.