support group helping men deal with Erectile Dysfunction.
https://www.franktalk.org/phpBB3/
MED3000 is Futura’s breakthrough, topical gel formulation for treatment of ED. It has the potential to become the first globally available, clinically proven, OTC treatment for ED and has already been approved as Medical Device Class IIb according to MDR regulation. Additionally, specific regulatory approval for the Great Britain market post-Brexit was granted in April 2022.
Cooper, as part of its due diligence process, conducted a consumer marketing Home Use Test (“HUT”) in the United Kingdom, France and the Netherlands whereby individuals self-diagnosed with ED were provided with a four-pack sample of MED3000. The in-use results were in line with findings published in 2019 in Futura’s clinical study FM57 which showed that over two thirds of patients experienced a clinically meaningful benefit from using MED3000 in a controlled clinical setting. MED3000 performed well in the real world, consumer HUT setting, with the majority of men with ED, other than men suffering from severe ED with significant co-morbidities, seeing an improvement in erectile performance and underlining the product’s potential as a highly effective, safe, clinically proven, topical treatment for ED.
Flavio wrote:The case of MED3000 shows how corrupt this industry really is in Europe and the United States: these guys take YEARS to approve a PLACEBO.
seekonk wrote: [...]
Approving a placebo is what would be corrupt, don’t you think?
Not that that stops them (cough, antidepressants).
MED3000 works through an evaporative and unique mode of action. MED3000’s combination of volatile solvent components creates an evaporative and novel action that stimulates nerve sensors in the highly innervated glans penis rapidly, leading to smooth muscle relaxation, tumescence and erection.
We continue to target initial launches later in 2022, although exact markets have not yet been agreed with distribution partners. Further launches are expected in in 2023.