Revi ® System Demonstrates Significant and Sustained Quality of Life Benefits Across All Domains for the Majority of Patients with Urgency Urinary Incontinence at 24 Months
PARK CITY, Utah--(BUSINESS WIRE)-- BlueWind Medical, Ltd., a leader in implantable Tibial NeuroModulation (iTNM) and developer of the Revi ® System, a patient-centric tibial neuromodulation solution for urgency urinary incontinence (UUI), announced today 24-month Quality of Life (QoL) results from the OASIS pivotal study showing sustained and clinically meaningful improvements. The research was presented at the annual meeting of the American Urological Association (AUA) in Las Vegas.
UUI is commonly associated with decreased quality of life, an important metric that supports comprehensive quality of clinical care for patients. 1 The OASIS trial showed that Revi demonstrated consistent QoL benefits throughout 24 months, with clinically significant (≥10-point change) and sustainable improvements in symptom severity in all domains of the Overactive Bladder Questionnaire (OAB-q), including coping, concern, sleep and social, and a total transformed Health-Related QoL (HRQL) score of (87.2%). Symptom severity (transformed score), saw highly impactful improvement with a nearly 40-point reduction, from 70.3 to 32.4, 30.6, and 31.5 at six months, 12 months, and 24 months, respectively,
Additional study highlights:
As previously reported, primary efficacy and safety endpoints were met with a UUI response rate of 79.4% (≥50% decrease in UUI) and no device- or procedure-related serious adverse events.
At 24 months, 96.8% reported treatment benefit, 96.7% reported satisfaction, and 100% reported a willingness to continue therapy.
Importantly, even in participants who did not meet the efficacy endpoint at 24 months (21%), appreciable therapeutic benefit was still noted; in patients with large leaks within this subgroup, 58.8% reported no large leaks in their 24-month voiding diaries. Additionally, 83.3% reported treatment benefit, 66.7% reported satisfaction, and 100.0% reported a willingness to continue Revi therapy.
The OASIS study demonstrates that iTNM with Revi represents a highly effective treatment modality for UUI that results in clinically meaningful and sustainable improvements in both bladder-related and overall health-related QoL. These important QoL improvements were seen within six months of implant activation and were sustained through 24 months.
'OASIS findings presented today continue to underscore the strength of Revi's efficacy alongside improvements in quality of life for people living with disruptive UUI,' said Roger Dmochowski, M.D., Chief Medical Advisor, BlueWind Medical, who presented the research findings. 'UUI can derail active and full lives and is often associated with significant distress. The data presented today builds on an extensive body of evidence supporting Revi as an intervention that restores quality of life for many patients.'
About Urge Urinary Incontinence (UUI) and Quality of Life
UUI, also known as Urgency Urinary Incontinence, is a chronic condition, which means it won't go away by itself. It can be a disabling condition with physical, psychological, and social consequences that may significantly impact quality of life. 1 UUI is associated with a high negative impact on patient's quality of life, including causing people with symptoms to stay at home, decreasing physical activities and attributing weight gain to an inability to exercise. Women are significantly more likely to report disturbed sleep, decreased self-esteem, decreased sexuality, and feelings of overall declining health related to UUI. 2
About the OASIS Study
The OASIS (Overactive Bladder Stimulation System Study) trial is a prospective, multicenter, single-arm, open-label clinical study of 151 adult women (mean age 58.8 years) with UUI (urgency urinary incontinence; overactive bladder-wet syndrome [OAB-wet]). The trial evaluated the efficacy and safety of Revi in treating UUI symptoms in patients with OAB-wet. Primary efficacy and safety endpoints were assessed at six and 12 months, with 97 participants completing the 24-month assessment.
Revi is the first iTNM device for the treatment of UUI labeled for use without prior failure of more conservative therapies, including medication. With concerns 3 about the potential link between anticholinergic agents and dementia risk, there is an increased need for flexible, non-pharmacologic treatment options.
For more information on BlueWind Medical and the Revi System, please visit bluewindmedical.com.
About BlueWind Medical Ltd.
BlueWind Medical is transforming the field of neuromodulation therapy through the development of innovative, patient-centric medical technology for the treatment of disease. BlueWind is committed to enhancing the quality of life and overall well-being of patients with an initial focus on those living with urge urinary incontinence (UUI). BlueWind's Revi® System is the first and only implantable tibial neuromodulation device activated by a battery-operated external wearable to receive FDA clearance for patients with UUI. Revi is the only neuromodulation therapy on the market that allows physicians to use their discretion to determine whether the patient should fail or not tolerate more conservative treatments before using the Revi System rather than mandating 'step-therapy.' For additional information about BlueWind Medical, please visit bluewindmedical.com.
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Subscriptions on an irreducible basis Subscription of the new shares is reserved by preference for existing shareholders, or assignees of their preferential subscription rights, who may subscribe on an irreducible basis, at the rate of 1 new share for 13 preferential subscription rights, without taking fractions into account. Shareholders or assignees of their preferential subscription rights who do not hold a sufficient number of existing shares or preferential subscription rights to obtain a whole number of new shares may buy or sell the number of preferential subscription rights needed to reach the multiple leading to a whole number of new shares. Subscriptions on a reducible basis Shareholders will have the right to subscribe for shares on a reducible basis, in proportion to their rights and up to the number of shares they request. 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Free subscription requests In addition to the possibility of subscribing on an irreducible and reducible basis in accordance with the terms and conditions set out above, any individual or legal entity, whether or not holding preferential subscription rights, may subscribe to this capital increase on an unrestricted basis. Persons wishing to subscribe on a voluntary basis must send their request to Crédit Industriel et Commercial (CIC Market Solutions - Émetteur Adhérent Euroclear n°025) 6 avenue de Provence 75452 Paris Cedex 9, OR to their authorized financial intermediary at any time during the subscription period and pay the corresponding subscription price. 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Press release announcing the transaction June 6, 2025 Publication of the information notice in the BALO June 10th 2025 Detachment of preferential subscription rights and start of trading of preferential subscription rights on Euronext Growth Paris June 12th, 2025 Opening of the subscription period June 18, 2025 End of DPS trading period June 20, 2025 End of subscription period june 24, 2025 Decision to exercise the extension clause Press release announcing the results of the Offer june 25, 2025 Publication by Euronext Paris of the notice of admission of the final amount of the capital increase and the allocation scale for subscriptions subject to reduction (reducible basis) june 27, 2025 Issue and settlement of new shares Admission and start of trading of the new shares on Euronext Growth Paris The above timetable will be followed by the regulatory publications of the new total number of shares and the usual legal formalities. 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Impact of the capital increase on shareholders' equity per share The table below summarizes the dilutive impact of the capital increase in euros on shareholders' equity per share under different dilution scenarios linked to the issue: Impact on shareholders' equity in euros per share Non-diluted basis Primary diluted basis(a) Total diluted basis with conversion/amortisation of OCAs(b) Case 1 Case 2 Before issue of new shares -0,05 € 0,16 € 0,27 € 0,25 € After issue of 3,556,199 new shares (100% of the Offer) 0,06 € 0,24 € 0,34 € 0,32 € After issue of 2,667,150 new shares (i.e. 75% of the Offer in the event of limitation) 0,03 € 0,22 € 0,32 € 0,30 € After issue of 4,089,628 new shares (i.e. 115% of the Offer in the event of exercise of the extension clause) 0,07 € 0,25 € 0,35 € 0,33 € (a) Reflects the dilution of : 950,700 shares allocated free of charge by the Company during the vesting period 3,635,556 BSAs issued in December 2024 may give the right to subscribe for a total of 4,544,445, shares at a price of €2.25 per share (four BSAs giving the right to subscribe for five ordinary shares). 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Shareholding of a shareholder holding 1% of the capital prior to the offer Non-diluted basis Primary diluted basis(a) Total diluted basis with conversion/amortisation of OCAs(b) Case 1 Case 2 Before issue of new shares 1,00 % 0,89% 0,82% 0,78% After issue of 3,556,199 new shares (100% of the Offer) 0.93% 0.84% 0,77% 0,73% After issue of 2,667,150 new shares (i.e. 75% of the Offer in the event of limitation) 0,95% 0,85% 0,78% 0,74% After issue of 4,089,628 new shares (i.e. 115% of the Offer in the event of exercise of the extension clause) 0,92% 0,83 0,77% 0,73% (a) Reflects the dilution of : 950,700 shares allocated free of charge by the Company during the vesting period 3,635,556 BSAs issued in December 2024 may give the right to subscribe for a total of 4,544,445 shares at a price of 2.25 euros per share (four BSAs giving the right to subscribe for five ordinary shares). (b) Reflects the cases of exercise of the Bonds Convertible into New and Redeemable Shares (OCAs) issued on February 28, 2024 and February 7, 2025, in accordance with the terms specified above. CROSSJECT is being advised in this transaction by D'Hoir Beaufre Associé Market Solutions is acting as Lead Manager and Bookrunner. Risk factors relating to the Offer Shareholders who do not exercise their preferential subscription rights will see their stake in the Company's capital diluted; The market for preferential subscription rights may offer only limited liquidity and be subject to high volatility; The market price of the Company's shares could fluctuate and fall below the subscription price of the new shares from the announcement of the offer, during the subscription period or at any time after the close of the offer; The volatility and liquidity of the Company's shares could fluctuate significantly; In the event of a fall in the market price of the Company's shares, preferential subscription rights could lose their value. Shareholders could see their interest in the Company's share capital diluted in the event of a new public offering. Issuer risk factors The Company draws the public's attention to the risk factors relating to its activities presented in section 8. Analysis of business trends in relation to the volume and complexity of business in its 2024 annual report, online on the Company's website ( and in notes 3. a) "Going concern" and 27 "Events after the period-end" to the 2024 annual financial statements. Warning Insofar as the amount of the Offer is less than €8 million (calculated over a 12-month period), the planned issue will not give rise to a prospectus approved by the AMF. About CROSSJECT CROSSJECT SA (Euronext: ALCJ; is an emerging specialty pharmaceuticals company developing medicines for emergency situations harnessing its award-winning needle-free auto-injector ZENEO® platform. CROSSJECT is in advanced regulatory development for ZEPIZURE®, an epileptic rescue therapy, for which it has a $60 million contract* with BARDA. The Company's versatile ZENEO® platform is designed to enable patients or untrained caregivers to easily and instantly deliver a broad range of emergency drugs via intramuscular injection on bare skin or even through clothing. The Company's other products in development mainly include solutions for allergic shocks and adrenal insufficiencies, as well as therapies and other emergency indications. * This project has been supported in whole or in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50122C00031. *** For further information, please contact: Investor Relationsinvestors@ 1 Gemmes Venture will sell 3,741,536 preferential subscription rights to Heights for a price of 1 euro, to enable it to subscribe to the planned capital increase on an irreducible basis, by offsetting its entire claim (taking into account the preferential subscription rights already held by Heights).Gemmes Venture will also sell 7,301,880 preferential subscription rights at a price of 1 euro to Vatel Capital to enable it to subscribe 561,683 new shares to the planned capital increase. Vatel Capital also reserves the right to acquire other preferential subscription rights on the market and will subscribe to the balance of its subscription commitment on a reducible basis. Attachment Launch of a capital increaseSign in to access your portfolio
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