Teleflex’s NeoTract wins expanded FDA indication for UroLift prostate device

Teleflex (NYSE:TFX) subsidiary NeoTract said yesterday that it won expanded indications from the FDA for its UroLift prostate treatment.

Previously approved for treating benign prostate hyperplasia in men 50 and over without an obstructive median lobe, the new indications open the treatment to patients 45 or older with an obstructive median lobe. UroLift 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.

“We are excited that more men with enlarged prostate are now eligible for treatment with the UroLift System,” interventional urology president Dave Amerson said in prepared remarks. “The clinical data we have amassed on the UroLift system, including the five-year data from the L.I.F.T. [investigational device exemption] study, has solidified the product’s position as an important standard-of-care treatment for men with BPH and is further bolstered by these expanded indications. We are diligently training current UroLift users on how to treat obstructive median lobes with the UroLift System so they continue to see optimal patient outcomes.”

Last October Teleflex closed the $1.1 billion acquisition of NeoTract with an up-front cash payment of $725 million, plus another $375 million in milestones pegged to sales numbers through 2020.

NeoTract put up sales of roughly $51 million in 2016, up 178% over 2015, and was expected to post sales of $115 million to $120 million last year.

The post Teleflex’s NeoTract wins expanded FDA indication for UroLift prostate device appeared first on MassDevice.

from MassDevice http://ift.tt/2olLBQU