Teleflex (NYSE:TFX) subsidiary NeoTract said today it won Shonin approval from Japan’s Ministry of Health, Labor and Welfare for its Urolift system intended for treating benign prostatic hyperplasia.
The UroLift system uses tiny devices inserted into the urethra in a minimally invasive procedure to reopen the lower urinary tract by pushing aside tissue from the enlarged prostate, the Pleasanton, Calif.-based company said.
NeoTract said that it estimates there are approximately 2.3 million men age 50 and older in Japan who have been diagnosed with BPH.
The company said that now that it has received approval in the region, it will focus on pursuit of reimbursement over the next 12 to 18 months, followed by a select launch with academic medical centers and a full launch afterwards.
“This regulatory approval is another major milestone for NeoTract, which will allow us to bring the breakthrough UroLift System as a new option to physicians treating the millions of men in Japan experiencing the symptoms of BPH. We are pleased that the UroLift System has been adopted as a standard-of-care therapy in the United States and Europe. As in these other markets, our initial efforts in Japan will focus on establishing reimbursement to support widespread adoption,” Teleflex interventional urology biz prez Dave Amerson said in a press release.
Last month, NeoTract released data from a study of its UroLift device, touting that treatments with the device showed a 62% improvement in lower urinary tract symptoms.
