Futura Medical Regulatory News (FUM)

15 January 2025

Futura Medical plc

("Futura" or the "Company")

Positive results from WSD4000 Home User study

Futura Medical plc (AIM: FUM), the consumer healthcare company behind Eroxon®, that specialises in the development and global commercialisation of innovative and clinically proven sexual health products, is pleased to announce the successful completion and positive results of the WSD4000 Home User study for the treatment of sexual dysfunction in women.

WSD4000 Home User study results

The 'sensory'1 study, which comprised 67 women suffering from some degree of sexual dysfunction, delivered an overall positive change in sexual function after four weeks. The majority of respondents reported increased vaginal lubrication, increased genital sensation, improved genital pleasure and an improvement in their satisfaction with the sexual experience. 57% of women used the product on more occasions than the stated minimum which is a strong indication of the respondents' positive response to the product.

In those that experienced some degree of sexual dysfunction, there was a notable uplift from the baseline with positive responses in arousal, lubrication, orgasm, satisfaction and discomfort (pain).

Following the success of the study, alongside market research on the size of the opportunity following commercialisation, the Board is recommending to proceed with an Early Feasibility Study during H1 2025. This will enable the Company to consider refinements to the methodology in a population more representative of the target user and therefore hope to increase efficacy still further, as well as further inform on perceptions of the product.

About WSD4000

WSD4000 is a topical treatment designed for sexual dysfunction in women. Currently, no regulatory approved topical treatment for sexual dysfunction in women is available over the counter. WSD4000 has the potential to be an effective, breakthrough treatment for the common symptoms associated with sexual dysfunction, such as lack of arousal, lubrication and desire.

The market for WSD4000

According to published data, between 40% and 50% of women experience at least one symptom of sexual dysfunction2. Recently, the Company commissioned IPSOS to undertake market research in the US, in 1,000 women, and this showed that around 60% have suffered from at least one symptom of sexual dysfunction in the last twelve months3. In addition, only one in four women seek professional help and despite their efforts, many women continue to struggle with symptoms of sexual dysfunction with few women (13%) experiencing an improvement in symptoms over time and 37% getting worse over time.

Ken James, Executive Director and Head of R&D, commented:

"In line with our strategic objective to broaden our product range, we have been exploring other opportunities within sexual health. We believe that female sexual health is an underserved market and under discussed problem where women are needlessly suffering in silence with unsatisfactory options available to them. We are therefore incredibly proud to be able to deliver such success from our home study results for our female sexual health product. Taking into account that essentially a healthy population took part, we are very excited by the overall positive trends coming out of the study.

A statistically significant shift was achieved in all subjects, including in the subset analysis of women with symptoms of sexual dysfunction. The data indicated that in general the product was well liked and well tolerated with high product usage.

This successful study, alongside the IPSOS data, which illustrates just how prevalent this issue is, means that we have a significant opportunity to address a large and underserved market. To that end, we intend to proceed with the necessary product development and regulatory steps required to obtain the necessary approvals to bring this product concept to commercialisation"

1A scientific study, generally in healthy volunteers, that assesses how people perceive product characteristics through their senses

2Source: McCabe MP, Sharlip ID, Lewis R, Atalla E, Balon R etal. Incidence and Prevalence of Sexual Dysfunction in Women and Men: A Consensus Statement from the Fourth International Consultation on Sexual Medicine 2015. J Sex Med. 2016 Feb;13(2):144-52

3 Ipsos research carried out on behalf of Futura Medical in the USA amongst 1,003 women, 2024

The information communicated in this announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014 as amended by the Market Abuse (Amendment) (EU Exit) Regulations 2019.

Contacts:

Notes to Editors:

Futura Medical plc (AIM: FUM) is the developer of innovative sexual health products, including lead product Eroxon® and products WSD4000 and Eroxon® Intense. Our core strength lies in our research, development and commercialisation of topically delivered gel formulations in sexual health products.

Sexual health issues are prevalent in both men and women. ED impacts 1 in 5 men globally across all adult age brackets, with approximately half of all men over 40 experiencing ED and 25% of all new diagnoses being in men under 40. Around 60% of women experience at least one symptom of sexual dysfunction, and only one in four women seek professional help, and remain chronically underserved.

Eroxon®, Futura's clinically proven lead product, has been developed for the treatment of Erectile Dysfunction ("ED"). The highly differentiated product, which is the only topical gel treatment for ED available over the counter and helps men get an erection in ten minutes, addresses significant unmet needs in the ED market. Eroxon® has been nominated for a number of healthcare industry awards and has won two to-date.

Futura has distribution partners in place in a number of major consumer markets including Haleon in the US, the largest market for ED in the world, and Cooper Consumer Health in Europe.