FemPulse has recently achieved a significant milestone by obtaining an investigational device exemption (IDE) from the US Food and Drug Administration (FDA). This approval allows the company to conduct a pivotal clinical trial for its neuromodulation system designed to treat overactive bladder (OAB). The IDE will enable FemPulse to advance its prospective, multicenter, randomized controlled trial named EVANESCE-II.
The FemPulse Ring: A Breakthrough in OAB Treatment
Innovative Design and Functionality
The FemPulse Ring is an internal wearable device that represents a significant advancement in OAB treatment. According to FemPulse’s CEO, Alexandra Haessler, the device follows a “set it and forget it” approach, offering a discreet and patient-managed solution. The ring is vaginally inserted and removable, providing continuous neuromodulation therapy targeting the nerves that regulate bladder function. Users can control the pre-programmed software via a personal handheld device, and the ring requires replacement after six months without needing invasive surgery. This innovative approach aims to reduce the patient burden associated with regular medication intake and more invasive procedural interventions.
The discreet nature of the FemPulse Ring addresses the significant discomfort and social challenges that many OAB patients face. Women using the FemPulse Ring can continue with their daily activities without the constant worry of OAB symptoms disrupting their lives. The ease of use through a personal handheld device further adds to its appeal, making it a user-friendly option for aged patients who might be less inclined to engage with complex medical devices.
Addressing Medication Limitations
Haessler highlights that medications for OAB often result in limited efficacy and intolerable side effects, leading up to 80% of patients to discontinue their use. This underscores the urgent need for alternative therapies like FemPulse’s system. The FemPulse Ring aims to provide a more effective and tolerable treatment option for patients suffering from OAB. Traditional OAB medications often have adverse effects such as dry mouth, constipation, and blurred vision, reducing patient compliance and overall treatment success.
In contrast, the FemPulse Ring’s mechanism of action promises to sidestep these common side effects by directly targeting the nerves responsible for bladder control. Its non-invasive design means fewer medical complications and a better quality of life for users. The potential for continuous neuromodulation offered by the FemPulse Ring is a focal point of the upcoming EVANESCE-II trial and represents a hopeful development for the numerous individuals whose lives are disrupted by OAB.
Clinical Trial Overview: EVANESCE-II
Trial Objectives and Design
The EVANESCE-II trial aims to confirm the safety and efficacy of the FemPulse System in women with OAB and establish the device’s non-inferiority to tolterodine, a muscle relaxant commonly sold under Pfizer’s brand name Detrol. Tolterodine is FDA-approved for treating OAB with symptoms of urge urinary incontinence, urgency, and frequency. It operates by relaxing the bladder wall muscles, thus increasing the bladder’s urine storage capacity. Participants in the trial will be closely monitored to compare the results between the FemPulse Ring and tolterodine, focusing on determining the therapeutic equivalence or superiority of the device.
The trial’s design is rigorous, with a double-blind, placebo-controlled, and randomized structure to eliminate bias and ensure robust data collection. FemPulse has taken extensive steps to ensure the trial’s protocols meet the highest clinical research standards. Data from this trial will not only demonstrate the FemPulse Ring’s efficacy but also reinforce its safety profile. The trial results are expected to be a pivotal moment for the company as they aim to provide a viable alternative to existing OAB medications.
Patient Enrollment and Primary Endpoint
The pivotal trial will cover approximately 150 patients across up to 15 sites in the US. The primary endpoint will assess the difference in mean change from baseline to Week 26 between device and medication groups in the number of voids per day (VPD) based on a 7-day bladder diary. This trial builds on previously completed clinical studies conducted both in the clinic and at home, both of which yielded positive safety and efficacy results. These multicenter trials are critical for capturing diverse data reflective of the broader population and ensuring the FemPulse Ring’s applicability to various demographics.
The importance of a rigorous trial design cannot be overemphasized. By assessing the FemPulse Ring against tolterodine, the company’s aim is not only to validate their device but also to provide compelling evidence to the medical community. Furthermore, successful trial results would likely encourage healthcare providers to embrace this innovative approach, potentially reducing reliance on systemic medications with their associated side effects and compliance challenges.
Broader Context: OAB and Neuromodulation Treatment
Prevalence and Impact of OAB
Overactive bladder is a prevalent condition affecting around 16% of men and 16.9% of women in the US. This condition significantly impacts healthcare costs, estimated to be approximately 2.5 times higher for OAB patients compared to non-OAB controls. The need for effective treatments is evident given the widespread nature of the condition and its associated costs. OAB not only impacts physical health but also significantly affects mental well-being due to the constant concern and embarrassment associated with the sudden need to urinate.
The financial burden on the healthcare system also underscores the economic importance of finding more efficient treatments. With current treatments often falling short in efficacy or tolerability, innovations like the FemPulse Ring could mark a significant shift, offering not only better patient outcomes but also potentially reducing healthcare costs. The development of alternative treatments is critical, as a significant proportion of the population continues to suffer from this condition without adequate relief, leading to substantial personal and societal costs.
Established and Emerging Neuromodulation Technologies
Neuromodulation has been a longstanding approach to treating OAB, with sacral nerve stimulation being a well-validated and accepted technology for over two decades. Sacral nerve stimulation involves implanting a device in the lower back to stimulate the nerves controlling the bladder and has shown high efficacy, though it is not free from adverse events. The scope of neuromodulation and its advancements is broad, with multiple medical technology companies targeting various aspects of OAB.
As the field of neuromodulation continues to evolve, it introduces non-invasive and less complex interventions, such as the FemPulse Ring, which can make significant strides in patient care. These advancements reflect a broader trend towards personalized and patient-centric treatment modalities, promising better adherence and outcomes. The ongoing development in this field signifies hope for those afflicted by OAB, offering newer, more effective, and tolerable options as compared to traditional treatments.
Competitive Landscape and Market Growth
Innovations from Other Companies
Notably, about a third of people with OAB also experience urinary incontinence, spurring multiple medical technology companies to develop innovative solutions. Examples include UroMems and Amber. UroMems’ MyoElectroMechanical System adjusts the sphincter opening around the urethral duct based on patient activity and is currently undergoing clinical trials. Meanwhile, Amber secured one of the largest Series A funding rounds for a medtech company in Europe earlier this year, raising $100 million to advance its implantable device for women with mixed urinary incontinence. These advancements highlight the industry’s commitment to addressing the unmet needs of OAB and related conditions.
Amber’s significant financial backing illustrates the confidence investors place in the future of neuromodulation technologies. These emerging solutions are promising due to their innovative approaches to managing urinary incontinence and OAB, showcasing the broader trend towards therapeutic innovation in this space. These developments and financial investments are encouraging signs that the medical community is recognizing the urgency and importance of addressing OAB to improve patient quality of life.
Market Projections and Future Directions
FemPulse has recently reached a significant milestone by securing an investigational device exemption (IDE) from the US Food and Drug Administration (FDA). This crucial approval paves the way for the company to initiate a pivotal clinical trial for its innovative neuromodulation system aimed at treating overactive bladder (OAB). Achieving the IDE status is a major step forward, as it permits FemPulse to conduct a prospective, multicenter, randomized controlled trial, which they’ve named EVANESCE-II.
Overactive bladder is a condition that affects millions of people, leading to an urgent need for more effective treatments. FemPulse’s neuromodulation system represents a promising solution that could potentially transform the management of OAB. The EVANESCE-II trial will assess the safety and efficacy of this novel treatment approach, involving diverse participants across multiple centers. By conducting this rigorous trial, FemPulse seeks to gather comprehensive data that could lead to improved therapeutic options for individuals suffering from OAB, ultimately enhancing their quality of life.
