Medifocus Inc. announced that on November 21, 2018, the FDA had approved a PMA (Post Market Approval) Supplement for new labeling based on the results of company's 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 the only patented and FDA approved Thermodilatation device on the market. It is a combination therapy simultaneously using Focused Microwave Heating together with Pressurized Balloon Dilatation therapy. 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. Additionally, the majority of patients experience significant and immediate relief of their BPH symptoms. With the approval of this PMA Supplement for new labeling, Medifocus Inc. can officially claim durable and lasting clinical benefits for at least 5 years of follow-up.