Highly positive data from WSD4000 studies

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 the results from two studies on WSD4000: the Home User Test ('HUT') and the Placebo (Sham) Controlled Study.

The positive results from both studies enhance the Company's belief in the commercial potential for WSD4000 and demonstrate that WSD4000 is superior to placebo (sham) thereby enabling it to proceed with the clinical study with high confidence of success. The Company expects to commence the clinical study by the end of 2026, subject to additional funding.

Home User Test results summary

WSD4000 was evaluated in 228 pre-, peri or post-menopausal women over a 4-week period. The results demonstrated that WSD4000 markedly improved sexual function from using the product.

78% of women reported a general improvement in all or most aspects of sex. 78% reported a more satisfying experience and 75% noticed having some increase in interest in having sex; 81% noticed an improvement to their overall sexual function.

Overall, 68% of women rated the product 4 or 5 stars. 77% of participants had improved sexual experience after one use which increased to 84% after four uses. More specifically, after four uses:

• 83% of women experienced improved lubrication (wetness)
• 82% experienced improved genital sensation
• 75% experienced improved arousal
• 71% experienced faster arousal
• 66% experienced greater ability to achieve orgasm
• 61% experienced greater intensity of orgasm
• 58% experienced less pain and discomfort during sex

The study also showed that, in general, the product was well tolerated, with only 18% of women experiencing a transient unpleasant sensory effect but many of those still wished to continue to use the product. The sensory effect described as unpleasant in some subjects can be mitigated when commercialised by clear consumer explanation highlighting that this is part of the mode of action of the product The vast majority (84%) of women in the study claimed to like the sensory feel and lack of aroma of the product.

Placebo (sham) controlled study summary

A placebo ('sham' in US regulatory terminology) controlled study was conducted in order to design the most cost-effective clinical study to deliver a statistically significant and clinically meaningful result.

WSD4000 was evaluated versus a placebo control in an "in-clinic" cross-over study in 33 pre- and post-menopausal women. WSD4000 was statistically superior to placebo in each of the key measures (arousal, genital sensation and lubrication) at 1 min, 2 min, 3, min, 5 min, 10 min and 15 min intervals.

The results give the Company a high degree of confidence that WSD4000 will have superior efficacy to placebo(sham) in the pivotal clinical study and that subject numbers in the study will be at a cost-effective level.

Ken James, Executive Director and Head of R&D commented: "We are delighted to report this positive data from the two studies for WSD4000. The results give us confidence that WSD4000 can become the first clinically proven, regulatory approved multi-symptom treatment for sexual problems in women. We anticipate WSD4000 market launch being from early 2028, subject to completion of the pivotal clinical trial and regulatory approval. We look ahead with confidence as we take the next steps towards bringing this unique product to an under-served market."

Studies re-affirm market potential for WSD4000

Independent research data1 conducted in the US with 1,000 subjects shows that 60% of women have suffered from at least one symptom of impaired sexual response and function in the prior twelve months. Only 1 in 4 of those impacted women seek professional help. Few women (13%) experience an improvement in symptoms overtime and for 37% symptoms get worse over time​.

Currently, there is no known regulatory approved topical treatment globally for impaired sexual response and function in women that is available over the counter.

1Market research conducted by Ipsos showed 60% of women have experienced symptoms of sexual dysfunction over the last twelve months and 49% of women want to treat their symptoms. Current US female population between the ages of 22 and 75 is 113 million, of which 68 million experience symptoms.