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Results of WSD4000 Early Feasibility Study
Futura Medical plc has announced positive results from its WSD4000 Early Feasibility Study involving 12 women with sexual dysfunction, showing a statistically significant improvement in overall sexual function by 6.35 units on the FSFI scale, exceeding the minimal clinically important difference of 4 units. The study also demonstrated significant improvements in arousal, lubrication, pain, orgasm, and satisfaction, with 64.2% of uses reporting moderate or high desire and 91.1% reporting conditions appropriate for a satisfactory sexual encounter. The product was well-tolerated, with a mild, transient burning sensation reported by 58% of subjects, which was often perceived as a sign of efficacy, and no subjects discontinued use. These encouraging results provide confidence to proceed with Phase 3 clinical studies, with further data expected mid-2026 from sensory and home user studies. Disclaimer*
About this update from Futura Medical Plc
[{"type":"text","content":"\n\n12 January 2026\nFutura Medical plc\n(\"Futura\", \"the Group\" or the \"Company\")\nPositive results from WSD4000 Early Feasibility Study\n \nHighly statistically significant improvement achieved in female sexual function\n \nFutura 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. \n \nThe 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.\n \nEFS results\n \nWhilst 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).\n \n\n\n\n\n· \n\n\nUsing the internationally recognised Total Female Sexual Function Index ('FSFI') scale, a highly statistically significant improvement over baseline was achieved in overall sexual function\n\n\n\n\n· \n\n\nOn 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\n\n\n\n\n· \n\n\nStatistically significant improvements were achieved in five of the six FSFI domains: sexual arousal, lubrication, pain improvement, ability to orgasm and sexual satisfaction\n\n\n\n\n· \n\n\nJudged to be effective in both pre- and post-menopausal women\n\n\n\n\n· \n\n\nUsing the Female Sexual Encounter Profile ('FSEP') metrics, meaningful improvements were achieved in all measure...