Our Prolieve Thermodilatation System was originally developed and commercialized by the current Medifocus management, product development, clinical and regulatory teams. In June 2012, Medifocus reached an agreement with Boston Scientific for the purchase of all of the assets of its Prolieve business,including all Prolieve inventory, the Rocky Mountain Mobile Services mobile distribution assets, as well as the intellectual property associated with the Prolieve technology.
The Prolieve system provides a 45-minute in-office treatment that combines our microwave thermotherapy capability with a proprietary balloon compression technology to both heat the prostate and dilate the prostatic urethra. The purpose of the Prolieve system is to provide a relatively painless and effective alternative to drug therapy and certain types of surgical procedures to treat the symptoms of BPH.
The Prolieve system consists of a microwave generator and conductors and a computer and software programs that control the focusing and application of heat, plus a specially designed balloon catheter, and consists of two fundamental elements:
The combined effect of this “heat plus compression” therapy is twofold: first, the heat denatures the proteins in the wall of the urethra, causing a stiffening of the opening created by the inflated balloon, forming a biological stent. Second, the heat serves effectively to kill off prostate cells outside the wall of the urethra, thereby creating sufficient space for the enlarged natural opening. In addition, the Prolieve system’s temperature (46º C to 54º C) is sufficient to kill prostatic cells surrounding the urethra wall, thereby creating space for the enlargement of the urethra opening. However, the relatively low temperature is not sufficient to cause swelling in the urethra.
The Prolieve is designed with patients’ needs and comfort in mind. In general, it does not require sedation or post-operative catheterization and provides rapid symptomatic relief from BPH. BPH patients can be treated using Prolieve in urologic offices throughout the United States. In addition, the Prolieve treatment is also made available to physicians utilizing our nationwide mobile service provider, Rocky Mountain Mobile Services.
Medifocus’ strategy to capitalize on the proprietary Prolieve Thermodilatation platform is to generate revenues through our mobile service and the sale of our disposal catheter kits. Our Management believes, over time, Prolieve Thermodilatation will be the leading in-office therapy for treatment of BPH symptoms.
Figure 1: This is a schematic illustration of a cross section of a prostate BEFORE treatment with the Prolieve System.
Figure 2: This is a schematic illustration of a cross-section of a prostate immediately AFTER treatment with the Prolieve System.
Figure 3: This is a schematic illustration of the Prolieve BPH treatment device.