A Toronto-based biotechnology company announced exciting news Monday from the U.S. Food and Drug Administration (FDA)
Medifocus, Inc. (TSX-Venture:MFS), which also has headquarters in Maryland, said that on November 21, the FDA approved a PMA (Post Market Approval) Supplement for new labeling based on the results of our Post Approval Study (PAS).
The study involved 225 men with Benign Prostatic Hyperplasia (BPH) treated using the Prolieve® system. The Prolieve® Transurethral ThermoDilatation™ Therapy (TUTD™) offers a unique “Thermodilatation” treatment for BPH.
Prolieve is a combination therapy simultaneously using Focused Microwave Heating together with Pressurized Balloon Dilatation therapy, and is the only patented and FDA approved Thermodilatation device on the market.
BPH is a medical condition resulting in enlargement of the prostate gland and affects over about 50% of all men over the age of 50. The unique combination treatment is a 45-minute, in-office, outpatient procedure which is performed and well-tolerated under local anesthesia.
Patients do not require a post treatment foley catheter about 90% of the time in contrast to the other invasive or even minimally invasive treatment options.
Stock prices perked on Monday’s news, as MFS grew half a cent, or 20%, to three cents, on volume of 196,000
This article provided by NewsEdge.