prostaCare introduces prostaFix – an innovative treatment gently fixing prostate enlargement
prostaFix is an innovative, easy-to-use device that treats the problems arising from an enlarged prostate that afflict 50 per cent of men over 50. It does so gently and effectively in just around 30 minutes in the doctor’s office and most importantly, it does so without any of the side effects of known treatments. No loss of sexual function, no suffering from incontinence and no long term pain after a surgical intervention or being forced to urinate in a carry around attached bag.
The treatment gap: many suffer and stand to benefit
BPH can greatly affect the quality of life of the men afflicted, and, because men are living longer, it is now one of the world’s fastest growing diseases: over the past 20 years, the BHP problem has been growing from rank 35 to rank 20 in the UN Health global burden of disease report.
The global market is huge with around 210 million men are affected by BPH and 25 per cent needing treatment.
Phase One development of the prostaFix device is now complete. An effective, safe, easy-to-use prototype has been successfully developed. Fourteen patents, in the US and Europe, have been applied for and eight have been granted. Animal and human feasibility trials have been successfully completed. The human feasibility with 16 patients showed very good results with a follow up after 1 week and after 1, 3, 6 and 12 months. It showed that prostaFix is a safe, fast, effective and well tolerated treatment.
• Quick and lasting symptomatic relief: significantly improved BPH symptom score
• Minimal side effects: preserves sexual function & continence, no device-related serious AE, much less pain.
• Excellent tolerability: well-tolerated & painless (31% patients had no increase in VAS score & avg 1.2)
• Improved QOL: 67% improvement in QOL score at 6-month
• Fast treatment time: 24-minute procedure at optimal dose
• Average necrotic region: 2.0cm x 1.2cm x 2cm at 1week
prostaCare is now ready for Phase Two – to develop a commercial production scale device and catheter and launch it into first key markets. This second phase will take around 15 to 18 months. It involves securing European CE Mark approval which includes a further human clinical trial. prostaCare will then be ready for manufacture and launch into its initial target markets in Europe and Asia: countries where the CE sign enables us to launch it already.
Following successful completion of this phase, Phase Three will see sales expansion into other European countries. The company will then prepare prostaFix for launch into the US, Australia and other global markets. This will require local regulatory approvals (eg FDA in the US, TGA in ANZ or in China the SFDA) as well as marketing trials.
prostaCare has already put strong intellectual property (IP) protection in place. It has 14 patents which cover a broad range of technological applications. Eight patents have already been granted in the US. The patents cover the treatment of both benign and cancerous tissue using DC ablation and combination therapies. The latter include DC ablation with radiation and DC ablation with chemotherapy.
In addition, the design of the control unit is covered by patent, plus other percutaneous (needle puncture) applications. There are a further four US patent applications pending. They cover transurethral DC ablation of the prostate and the prostaFix procedure. Control unit design and other percutaneous (needle puncture) applications are also covered. Two European regional patents are also pending