REG - Futura Medical PLC - Results of WSD4000 Early Feasibility Study

Futura MedicalAnnouncement

12/01/2026 07:00

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RNS Number : 4887O  Futura Medical PLC  12 January 2026

12 January 2026

Futura Medical plc

("Futura", "the Group" or the "Company")

Positive results from WSD4000 Early Feasibility Study

 

Highly statistically significant improvement achieved in female sexual
function

 

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).

 

 ·             Using the internationally recognised Total Female Sexual Function Index
               ('FSFI') scale, a highly statistically significant improvement over baseline
               was achieved in overall sexual function
 ·             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
 ·             Statistically significant improvements were achieved in five of the six FSFI
               domains: sexual arousal, lubrication, pain improvement, ability to orgasm and
               sexual satisfaction
 ·             Judged to be effective in both pre- and post-menopausal women
 ·             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
 ·             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
 ·             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 a recent pre-submission meeting and was conducted to
Good Clinical Practice ('GCP') standards and ethical principles for medical
research. An EFS study was defined by FDA as a pre-requisite for the first in
class (De Novo) medical device with OTC classification.

 

12 subjects were recruited into the study with 11 completing all elements:
five pre-menopausal and six post-menopausal. After initial screening for
suitability, subjects were formally diagnosed by using the FSFI instrument
which is a fully validated self-completed questionnaire that has become the
gold standard and most widely used measuring instrument in this scientific
field(1).

 

When entering the study, the subjects were measured pre-treatment at a
baseline after four sexual encounters using the FSFI and measured
post-treatment after four weeks and a minimum of four sexual encounters. In
addition, subjects recorded their experience after each post-treatment sexual
encounter using the FSEP instrument, another validated and widely used
questionnaire.

 

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 impaired 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. 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(3).

Ken James, Executive Director and Head of R&D, commented: "We are
delighted with the results from the Early Feasibility Study which show clear
and positive trends, demonstrating that the product can deliver a significant
improvement in impaired sexual function in women. With our specialism in
developing and bringing to market topically delivered gel formulations for
improved sexual health, we believe we can successfully build on these results
and provide a treatment for a condition that affects a significant number of
women worldwide.

We look forward to updating the market over the coming months on the next
steps for WSD4000, including results of the placebo and home user studies as a
precursor to designing a Phase 3 clinical study, as well as preparation of
product positioning, packaging and the launch strategy."

 

(1)Meston et al, Scoring and Interpretation of the FSFI. What can be learnt
from 20 years of use? J Sex Med 2020 Jan 17(1):17-25

(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                          Alex Duggan                                             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

 and Broker

 Turner Pope Investments (TPI) Ltd - Broker  Guy McDougall, Andrew Thacker                           +44 (0) 20 3657 0050

 Alma Strategic Communications               Rebecca Sanders-Hewett, Sam Modlin, Sarah Peters        +44 (0)20 3405 0205

                                                                                                     futura@almastrategic.com

 

Notes to Editors:

 

Futura Medical plc (AIM: FUM) is the developer of innovative sexual health
products, including lead product Eroxon(®) and development 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. Erectile Dysfunction
("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 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.

 

The WSD4000 is a prototype designed for the symptoms of impaired sexual
response and function in women. There is currently no regulatory approved OTC
treatment available for impaired sexual response and function in women.
WSD4000 has the potential to be an effective, breakthrough treatment for the
common symptoms associated with impaired sexual response and function, such as
lack of desire, arousal and lubrication.

 

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