EU Market Launch Clearance
Summary by AI BETAClose X
31 July 2026
Futura Medical plc
("Futura", "the Group" or the "Company")
EU Market Launch Clearance
Futura Medical (AIM: FUM), the consumer healthcare Group behind Eroxon®, that specialises in the development and global commercialisation of innovative, clinically proven sexual health products, is pleased to announce that its new Eroxon® formulation, which delivers a demonstrably stronger sensation (Eroxon® Intense) has now been cleared for launch across the European Economic Area ("EEA") and the UK.
This follows the successful completion of all design, validation and pre-market regulatory activities required to support commercial launch under the Company's existing CE certification in accordance with the EU Medical Device Regulation (MDR 2017/745), together with UKCA (UK Conformity Assessed) certification.
As previously announced, the Company is focused on strengthening the Eroxon® brand proposition, including updated consumer messaging designed to create a more targeted positioning for consumers. Cooper Consumer Health, the Company's commercial partner for Eroxon® in the EEA and UK, will now be offered the opportunity to launch Eroxon® Intense within its licensed territories.
The Company continues to expect US FDA clearance during the second half of 2026. Following clearance, it will work alongside its new US commercial partner, MPG, to prepare for the planned US launch in 2027.
Eroxon® Intense overview:
Eroxon® Intense is a new formulation of Eroxon® which is designed to have a faster and stronger sensorial action. Marketing feedback with Eroxon® has shown that whilst many men are satisfied with the current sensorial effect of the product, a faster, stronger sensation with a more rapid onset of action would be beneficial.
In March 2026, the Company announced positive results following the Home User Test conducted on the current Eroxon® product and new product Eroxon® Intense. The Test on 223 men delivered positive results, demonstrating strong efficacy, high user satisfaction and improved outcomes compared with Futura's original Phase 3 study. Participants reported satisfactory erection hardness in around 70% of sexual encounters and successful intercourse in approximately 85% of encounters, with outcomes enhanced when the product was applied by a partner. The study also confirmed Eroxon® Intense's enhanced sensorial experience versus Eroxon®, while both products received favourable user ratings and more than half of participants indicated they would be likely to purchase the products.
Alex Duggan, CEO of Futura, commented:
"Receiving EEA and UK market clearance for Eroxon® Intense is a significant milestone for Futura and an important step in broadening the Eroxon® franchise. This approval follows a series of positive studies demonstrating strong consumer acceptance, ease of use and real-world performance, providing further validation of our proprietary formulation science and reinforcing our confidence in the product's commercial potential.
Eroxon® Intense has the potential to address the needs of a broad range of consumers seeking a more intensive erectile dysfunction treatment option, while further strengthening the Eroxon® brand. By expanding the Eroxon® portfolio with a differentiated product offering, we believe we can provide our commercial partners with additional opportunities to grow the brand, broaden consumer appeal and further increase market penetration. We look forward to working closely with our partners to bring Eroxon® Intense to consumers across Europe and, subject to FDA clearance, in the United States."
Contacts:
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Futura Medical plc
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Alex Duggan Chief Executive Officer Angela Hildreth Finance Director and COO
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investor.relations@futuramedical.com +44 (0)1483 685 670
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Panmure Liberum Nominated Adviser and Broker |
Emma Earl, Will Goode, Mark Rogers (Corporate Finance)
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+44 (0)20 3100 2000
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Turner Pope Investments (TPI) Ltd - Broker |
Guy McDougall, Andrew Thacker |
+44 (0) 20 3657 0050 |
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Alma Strategic Communications |
Rebecca Sanders-Hewett, Sam Modlin, Sarah Peters |
+44 (0)20 3405 0205 futura@almastrategic.com |
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Notes to Editors:
Futura Medical plc (AIM: FUM) is the developer of innovative, consumer-focused, sexual health products, including lead product Eroxon® and development projects WSD4000 and Eroxon® Intense. Our core strength lies in our research, development, regulatory and business development expertise in developing innovative, clinically proven, insight-led and effective products to support our customers in the growing sexual health market.
Sexual health issues are prevalent globally 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. 60% of women experience at least one symptom of impaired sexual response or function in a twelve-month period, with only one in four women seeking professional help and remaining 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 fast, addresses significant unmet needs in the ED market. Multiple license or distribution partnerships are in place for Eroxon®, across major consumer markets.
WSD4000 is a project name for our development female sexual health portfolio, starting with the creation of a range of topical gels under our unique platform technology, specifically designed to treat symptoms of sexual dysfunction in women. There is currently no known 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, lubrication and ability to orgasm.
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