REG - Futura Medical PLC - Positive results from WSD4000 Home User study

Futura MedicalAnnouncement

15/01/2025 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250115:nRSO3353Ta&default-theme=true

RNS Number : 3353T  Futura Medical PLC  15 January 2025

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 dysfunction(2). 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 months(3). 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"

 

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

(2)Source: 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:

 

 Futura Medical plc              James Barder                                            investor.relations@futuramedical.com

                                                       (mailto:Investor.relations@futuramedical.com)
                                 Chief Executive Officer

                                                       +44 (0)1483 685 670
                                 Angela Hildreth

                                                       www.futuramedical.com (http://www.futuramedical.com/)
                                 Finance Director and COO

 Panmure Liberum                 Emma Earl, Will Goode, Mark Rogers (Corporate Finance)  +44 (0)20 3100 2000

 Nominated Adviser               Rupert Dearden (Corporate Broking)

 and Broker

 Stifel Nicolaus Europe Limited  Alan Selby                                              +44 (0)207 710 7600

 Joint Broker                    Ben Maddison

 Alma Strategic Communications   Rebecca Sanders-Hewett                                  +44 (0)20 3405 0205

                                 Sam Modlin                                              futura@almastrategic.com

                                 Will Ellis Hancock

 

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.

 

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCSFUESLEISEIF