REG - Futura Medical PLC - Positive Eroxon® & Eroxon® “Intense” HUT results

Futura MedicalAnnouncement

23/03/2026 07:00

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RNS Number : 5820X  Futura Medical PLC  23 March 2026

23 March 2026

Futura Medical plc

("Futura" or the "Company")

Positive results from Eroxon® & new Eroxon® "Intense" Home User Test

Futura Medical plc (AIM: FUM), the consumer healthcare company behind Eroxon®
and that specialises in the development and global commercialisation of
innovative and clinically proven sexual health products, is pleased to report
the results of the Home User Test ("HUT") conducted on the current Eroxon®
product and prototype product Eroxon® 'Intense' ("Intense").

The results of the HUT are positive (with an overall improvement on the
original Phase 3 study for Eroxon®) and give the Company confidence that the
Intense formula gives a statistically significant greater sensorial effect
over the current Eroxon® formulation especially in the first two minutes
after application.

Home User Test results summary

The study compared the new Intense formula with current Eroxon® over 4 weeks
in 223 subjects (112 tested Eroxon® and 111 tested Intense). Subjects were
based in the United Kingdom and were recruited on-line. Each subject was
individually interviewed to assess their suitability for inclusion into the
study. Subjects were male, 18-59 years of age and 94% assessed as suffering
from mild to moderate erectile dysfunction ("ED").

In this selected demographic, both Eroxon® and Intense were judged to have
high efficacy rates. Subjects stated that they were satisfied with the
hardness of their erection in 70% and 71% of their sexual encounters using
Eroxon® or Intense, respectively. Subjects also recorded that their erections
lasted long enough to have sexual intercourse in 84% and 85% of encounters,
respectively.

Using the clinically validated and most widely used measure of erection
functionality (the IIEF-EF scale*), subjects in both groups showed a highly
significant and clinically important improvement in their erectile function.
The improvement versus baseline (pre-treatment) was at least as good as
reported in the Phase 3 clinical study FM71, which was used to obtain
regulatory approval in the US.

The study also showed that when either Eroxon® or Intense was applied onto
the study participant by their partner it increased effectiveness and showed
significantly higher erection maintenance.

The study confirmed the sensorial enhancement of Intense over Eroxon® with
statistically significant greater intensity during the first two minutes after
application.

Additionally, both products were well tolerated in men and their female
partners.

Both formulations received favourable 4- or 5-star ratings in 49% and 53% of
subjects for Eroxon® and the Intense formula respectively. Over 50% of study
participants said they would be somewhat or very likely to purchase either
product.

In summary, the HUT study confirmed that a more targeted approach of marketing
to consumers under 60 years of age with mild to moderate ED will likely lead
to higher efficacy and satisfaction rates and thus higher in-market repeat
purchase rates. Encouraging users to use the product with their partners as
part of foreplay will likely also improve the overall product experience. The
Intense formula will appeal to those consumers seeking a more rapid or
stronger sensorial effect, especially in younger age groups. Detailed work is
now underway to assess and update optimal brand positioning. Meanwhile, data
necessary to support regulatory filings for Eroxon® Intense in Europe and USA
has been generated and a "Special" 510K submission has been filed with the US
FDA. Regulatory authorisation in the US and Europe is expected in H1 2026.

* Rosen, Riley, Wagner, Osterloh, Kirkpatrick and Mishra. Urology. Volume 49,
Issue 6, June 1997, pages 822-830

Ken James, Executive Director and Head of R&D commented: "We are very
pleased to report this positive data for Eroxon® and Eroxon® Intense, and
ease of use in a real‑world setting. These findings provide further
validation of our formulation science and give us confidence as we progress
Eroxon® Intense through regulatory authorisation and build an optimal brand
position."

‎

 

Contacts:

 Futura Medical plc                 Alexander 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  Guy McDougall, Andrew Thacker                           +44 (0) 20 3657 0050

 Broker

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

                                                                                            futura@almastrategic.com (mailto: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. Multiple distribution partnership agreements are in place
for Eroxon, across major consumer markets.

 

WSD4000 is a prototype product platform 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 products have 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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