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It has layers of protection beyond the patients. Firstly you need an infrastructure and specific proprietary software to process the results, secondly you will need a similar level of academic and clinical validation, which takes years and finally and most importantly working your way in to the KOLs and reimbursement system in the US is seriously seriously time consuming and expensive (as we have and continue to prove) and it is very very hard to dislodge an incumbent, especially with a similar type of test. We have the advantage of competing against cystoscopy, which is uncomfortable, more expensive and time consuming for the clinic ..... a similar product to our would/could only have price as a differentiator. My guess with a standing start and no patent issues, it would take a similar product a minimum of 4 to 5 years to even be in a position to face off against us commercially. Anyone who is interested would be much better off just buying us, it would be cheaper and save oodles of time.
