MAPLE GROVE, Minn.--(BUSINESS WIRE)--NxThera, Inc. announced today that data from the Company’s pivotal IDE trial to assess the safety and effectiveness of the Rezūm System to treat BPH will be presented at the 2015 annual meeting of the American Urological Association (AUA) in New Orleans. Dr. Kevin T. McVary, co-principal investigator, will present the early outcomes data at the late breaking abstracts Plenary II Session on Sunday, May 17th at 10:45 AM in Hall B1.
Approximately 75% of men over the age of 65 exhibit signs and symptoms of BPH. Current therapy options range from medical management to surgical intervention, both of which offer varying degrees of effectiveness and side effects. There are currently a limited number of minimally invasive treatment options available.
The Rezūm II IDE clinical trial was designed to study the safety and effectiveness of the Rezūm System, a minimally invasive treatment option which applies radiofrequency power to create water vapor thermal energy to treat obstructive prostate tissue associated with BPH. This multicenter, randomized, controlled trial is being conducted at 14 sites across the United States. Enrollment in the study was completed in August 2014 in just 46 weeks.
“As urologists, we continue to look for alternative treatment options for our BPH patients who are resistant to or dissatisfied with medical management, or who are unwilling or unable to undergo a surgical procedure,” shared Dr. Kevin McVary, Professor and Chair, Department of Urology at Southern Illinois University School of Medicine. “The Rezūm System has the potential to provide an effective alternative option for these patients. I am looking forward to sharing the early clinical experiences from the Rezūm II clinical trial with my colleagues in the global urology community.”
About NxThera:
NxThera is developing its Convective water
vapor energy (WAVE™) technology platform to treat a variety of
endourology conditions beginning with BPH, and including prostate cancer
and kidney cancer. NxThera’s Rezūm System to treat BPH uses
radiofrequency energy to create sterile water vapor, or steam, to
convectively deliver targeted, precise thermal energy treatments in a
simple, office-based or hospital procedure with minimal discomfort, and
provide improvements in urine flow and quality of life. Founded in 2008,
NxThera is located in Maple Grove, Minnesota.
Investigational Device - Pending 510(k) Clearance - Not Available For Sale in the U.S.
For more information, visit www.nxthera.com.
