RE: Can't see Rns on here12 Jan 2026 09:56
Futura Medical (AIM: FUM), the consumer healthcare Group behind Eroxon® that specialises in the development and global commercialisation of innovative and clinically proven sexual health products, is pleased to report positive results of the WSD4000 Early Feasibility Study ('EFS') which comprised of 12 women suffering from some degree of sexual dysfunction.
The positive trends and high response metrics demonstrate that the product has the potential to deliver a significant improvement in impaired sexual function in women. Given the lack of known regulatory-approved OTC treatment available for this condition in women, this represents a significant opportunity for WSD4000 globally.
EFS results
Whilst the size of the EFS study was relatively modest, the results are highly encouraging and give the Company confidence to proceed to the next steps of designing a Phase 3 clinical study which will be further informed by a small in-clinic sham / placebo controlled sensory study (results expected in mid 2026), and a 200 subject home user study (results expected in mid 2026).
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Using the internationally recognised Total Female Sexual Function Index ('FSFI') scale, a highly statistically significant improvement over baseline was achieved in overall sexual function
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On average, an improvement in overall sexual function of 6.35 units over baseline (pre-treatment) in the FSFI scale was achieved which exceeded the minimal clinically important difference of 4 units defined by expert scientific consensus
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Statistically significant improvements were achieved in five of the six FSFI domains: sexual arousal, lubrication, pain improvement, ability to orgasm and sexual satisfaction
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Judged to be effective in both pre- and post-menopausal women
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Using the Female Sexual Encounter Profile ('FSEP') metrics, meaningful improvements were achieved in all measures across the 56 sexual encounters recorded:
o 64.2% of uses were described as experiencing moderate or high desire
o 83.9% of uses reported satisfaction with arousal
o 71.4% of uses reported enough lubrication for comfortable intercourse
o 69.6% of uses resulted in orgasm
o 78.6% of uses reported moderate or high arousal
o 91.1% reported conditions appropriate for a satisfactory sexual encounter
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Every use of the gel (56 in total) resulted in a genital sensation which occurred on average in less than five minutes in 9 out of 10 uses
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The product was well tolerated. 58% subjects experienced a mild to moderate but transient "burning" sensation which in general led to higher efficacy levels indicating that subjects regarded this as a sensory signal that "the product was working". No subjects discontinued use of the product.
About the EFS
The EFS of the WSD4000 prototype followed the Food and Drug Administration's ('FDA') guidance from
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