Hmm, that's not really an answer.
A better answer would be: existing FDA clearances might have some value.
It wouldn't be terribly difficult to achieve substantial equivalence to BIEL's products, but it would require a little time and money. I suppose that if there was any evidence of market viability, someone like Enovis might consider buying the product rather than making their own. That part about market viability is really the sticking point though, don't you think?
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